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2011 NEWSLETTER TRANSPLANT COUNCIL OF EUROPE CONSEIL DE L’EUROPE Vol. 16 • Nº 1 • SEPTEMBER • 2011 INTERNATIONAL FIGURES ON DONATION AND TRANSPLANTATION - 2010
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Page 1: Newsletter Europe 2011

2011

NEWSLETTERTRANSPLANT

COUNCILOF EUROPE

CONSEILDE L’EUROPE

Vol

. 16

• N

º 1

• SE

PT

EM

BE

R •

201

1

INTERNATIONAL FIGURES ONDONATION AND TRANSPLANTATION - 2010

Page 2: Newsletter Europe 2011

INTERNATIONAL FIGURES ON ORGAN, TISSUE & HEMATOPOIETICSTEM CELL DONATION & TRANSPLANTATION ACTIVITIES. DOCUMENTS PRODUCED BY THE COMMITTEE OF EXPERTS ON THE ORGANISATIONAL ASPECTS OF CO-OPERATION IN ORGAN TRANSPLANTATION (2010)

Editor: Rafael Matesanz

Foot Note- For the purposes of this Newsletter the following definitions were used:An actual donor (HBD and NHBD) is a deceased person from whom at least one organ has been recovered for the purpose of solid or-gan transplantation, in contrast to a utilised donor, who is an actual donor from whom at least one solid organ has been transplanted.The number of utilised donors is therefore lower than the number of actual donors.Multiorgan donor: An actual donor from whom at least two different types of organs have been recovered for the purpose of transplantation.One double-kidney transplant (TX) and one double-lung TX are counted as 1 TX.One heart/ lung TX is counted as 1 lung TX, 1 heart TX and 1 heart/ lung TX.Absolute number: Include all figures corresponding to all donors/patients adults and children. Paediatric: Includes only paediatric activity (patients aged < 15 years).Nº TX Centres: One centre can include adult and pediatric program for each organ - type transplant.

AULA MÉDICA EDICIONES. Isabel Colbrand, 10-12 - 2ª planta. 28050 Madrid (España)Tel. 91 358 64 78. Fax 91 358 99 79. Depósito legal: M-9.990-1996. ISSN: 2171-4118.

NATIONAL DATA PROVIDED BY:

Organización Nacional de Trasplantes (ONT) – SpainRafael MatesanzBeatriz MahilloMarina Alvarez

AUSTRIAJacqueline Smits (ET)BELGIUMJacqueline Smits (ET)BULGARIATeodora DzhalevaCYPRUSStalo GroutaGeorge KyriakidesCZECH REPUBLICPavel Brezovský DENMARKFrank Pedersen (SKT)ESTONIAPeeter DmitrievFINLANDFrank Pedersen (SKT)FRANCECristelle CantrelleGERMANYBrigitte OssadnikJosephine WadewitzJacqueline Smits (ET)GREECEEfi NikolaouHUNGARYMihály Sándor IRELANDMaeve RaesideITALYAndrea RicciPaola Di CiaccioLATVIASergey TrushkovLITHUANIAVita AnulytèLUXEMBURGGérard ScharllJacqueline Smits (ET)MALTACarmel AbelaNETHERLANDSJacqueline Smits (ET)POLANDPiotr MalanowskiPORTUGALMaria Joao AguiarCatarina BolotinhaROMANIADan LuscalovSLOVAKIALudovit LacaSLOVENIAJacqueline Smits (ET)SPAINCarmen MartínManuel SerranoDavid UruñuelaSilvia MartínSWEDENFrank Pedersen (SKT)

UNITED KINGDOM Mark JonesCalire Counter

(ET) EUROTRANSPLANT Austria,Belgium, Croatia, Germany,Luxemburg, Netherlands, Slovenia

(SKT) SCANDIATRANSPLANTDenmark, Finland, Norway, Sweden,Iceland

ALGERIAMaurizio Di Fresco (MTN) Farid HaddoumAUSTRALIALee ExcellCANADABob WilliamsLiz Anne Gillham-EisenCROATIAMirela Buši Jacqueline Smits (ET)GEORGIAGia TomadzeICELANDFrank Pedersen (SKT)ISRAELTamar AshkenaziLEBANONMaurizio Di Fresco (MTN) Marwan MasriAntoine EstephanMACEDONIAGoce SpasovskiMOLDOVAIgor CodreanuNEW ZEALANDLee ExcellNORWAYFrank Pedersen (SKT)PALESTINEMaurizio Di Fresco (MTN) Mohammed AyyoubSWITZERLANDDagmar VernetSYRIAMaurizio Di Fresco (MTN) Bassam SaeedTUNISIAMaurizio Di Fresco (MTN) Mohamed Salah Ben AmmarTaieb Ben AbdallahTURKEYTürKay SeyhanUSAwww.unos.org

(MTN) MEDITERRANEANTRANSPLANT NETWORKAlgeria, Cyprus, Egypt, France,Greece, Israel, Italy, Lebanon, Lybia,Morocco, Spain, Tunisia

ARGENTINACarlos SorattiMartín Alejandro TorresRicardo Rubén Ibarwww.grupopuntacana.orgBOLIVIAOlker Calla Rivadeneirawww.grupopuntacana.orgBRASILHeder Murari Borbawww.grupopuntacana.orgCHILEwww.grupopuntacana.orgCOLOMBIAJuan Gonzalo López Casaswww.grupopuntacana.orgCOSTA RICAClive Montalbert-Smithwww.grupopuntacana.orgCUBAwww.grupopuntacana.orgDOMINICANAFernando Morales Billiniwww.grupopuntacana.orgECUADORwww.grupopuntacana.orgEL SALVADORMauricio VenturaGUATEMALAHONDURASMEXICOEnrique Martínez GutiérrezOmar Sánchez Ramírezwww.grupopuntacana.orgNICARAGUATulio René Mendieta AlonsoPANAMACesar Cuero Zambranowww.grupopuntacana.orgPARAGUAYwww.grupopuntacana.orgPERUwww.grupopuntacana.orgURUGUAYInés AlvarezRaul José Mizrajiwww.grupopuntacana.orgVENEZUELACarmen Luisa Lattuf de MilanésZoraida Pacheco Graterolwww.grupopuntacana.org

GRUPO PUNTA CANAArgentina, Bolivia, Brasil, Chile,Colombia, Costa Rica, Cuba,Dominicana, Ecuador, El Salvador,España, Guatemala, Honduras,México, Nicaragua, Panamá,Paraguay, Perú, Portugal, PuertoRico, Uruguay y Venezuelawww.grupopuntacana.org

Page 3: Newsletter Europe 2011

NEWSLETTERTRANSPLANT 2011

CONTENTS• International Figures on Organ Donation and Transplantation Activity.

Year 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

• International Data on Organ Donation and Transplantation Activity, Waiting List and Family Refusals. Year 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . 31

• International Data on Tissues and Hematopoietic Stem Cell Donation and Transplantation Activity. Year 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

• The Madrid Resolution on Organ Donation and Transplantation. National Responsibility in Meeting the Needs of Patients, Guided by the WHO Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

• Cooperation Between Countries of the Black Sea Area (BSA): Development of the Activities Related to Donation and Transplantation of Organs, Tissues and Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

1-NEWSLETTER 2011:aula medica 04/08/11 12:37 Página 1

Page 4: Newsletter Europe 2011

1-NEWSLETTER 2011:aula medica 04/08/11 12:37 Página 2

Page 5: Newsletter Europe 2011

3

International Figures on Organ Donation

and Transplantation Activity. Year 2010

COUNCIL OF EUROPE

CONSEIL DE L’EUROPE

1-NEWSLETTER 2011:aula medica 04/08/11 12:37 Página 3

Page 6: Newsletter Europe 2011

10.0

20.8

12.6

17.0 17

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13.3

15.8

13.0

16.8

15.9

19.6

23.3

20.5

30.7

3.3 2.

7

3.9

3.6

21.6

32.0

23.8

12.6

12.6

16.4

13.7

20.5

6.0

30.2

10.9

4.4

0.5

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1-NEWSLETTER 2011:aula medica 04/08/11 12:37 Página 4

Page 7: Newsletter Europe 2011

16.7

53.7

39.4

32.4 30

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26.2

35.9

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34.7

48.5

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1-NEWSLETTER 2011:aula medica 04/08/11 12:37 Página 5

Page 8: Newsletter Europe 2011

36.7

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30.4 26

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24.9

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33.0

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1-NEWSLETTER 2011:aula medica 04/08/11 12:37 Página 6

Page 9: Newsletter Europe 2011

16.7

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 7

Page 10: Newsletter Europe 2011

18.2

14.6

9.3 2.

3

6.2

15.7

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 8

Page 11: Newsletter Europe 2011

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 9

Page 12: Newsletter Europe 2011

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 10

Page 13: Newsletter Europe 2011

3.1

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 11

Page 14: Newsletter Europe 2011

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 12

Page 15: Newsletter Europe 2011

EU

RO

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 13

Page 16: Newsletter Europe 2011

CA

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 14

Page 17: Newsletter Europe 2011

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 15

Page 18: Newsletter Europe 2011

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1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 16

Page 19: Newsletter Europe 2011

DE

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16.1

17

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 17

Page 20: Newsletter Europe 2011

LIV

ER

TR

AN

SPLA

NT

-in

clu

ded

all

th

e co

mb

inat

ion

s-A

nn

ual

Rat

e p.

m.p

. 201

0

0.7

0.3

4.8

8.0

7.2

0.3

1.7

2.0

3.9

3.5

0.7

18

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 18

Page 21: Newsletter Europe 2011

HE

AR

T T

RA

NSP

LAN

T-i

ncl

ud

ed H

eart

/ L

un

g T

X-

An

nu

al R

ate

p.m

.p. 2

010

0.1

1.3

1.8

0.9

0.1

0.3

0.2

1.2

2.1

0.0

0.0

19

0.0

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 19

Page 22: Newsletter Europe 2011

LUN

G T

RA

NSP

LAN

T(S

ingl

e +

Dou

ble

)-i

ncl

ud

ed H

eart

/ L

un

g T

X-

An

nu

al R

ate

p.m

.p. 2

010

0.1

1.0

0.3

0.50.

0

0.6

20

0.0

0.0

0.0

0.0

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 20

Page 23: Newsletter Europe 2011

PAN

CR

EA

S T

RA

NSP

LAN

T-i

ncl

ud

ed a

ll t

he

com

bin

atio

ns-

An

nu

al R

ate

p.m

.p. 2

010

0.0

0.2

1.5

0.7 1.

2

21

0.0

0.0

0.0

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 21

Page 24: Newsletter Europe 2011

SMA

LL B

OW

EL

TR

AN

SPLA

NT

-in

clu

ded

all

th

e co

mb

inat

ion

s-A

nn

ual

Rat

e p.

m.p

. 201

0

0.1

0.2

22

0.0

0.0

0.0

0.0

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 22

Page 25: Newsletter Europe 2011

LA

TIN

AM

ER

ICA

N C

OU

NTR

IES

Kid

ney

Tra

nsp

lan

tsLiv

er

Tra

nsp

lan

tsH

eart

Tra

nsp

lan

tsLu

ng

Tra

nsp

lan

tsP

an

cre

as

Tra

nsp

lan

tsS

mall

Bo

wel

Tra

nsp

lan

tsp

pp

pTra

nsp

lan

tsTra

nsp

lan

ts

10

10

8(4

2.4

% L

D)

21

68

(7.7

% L

D)

35

01

20

21

01

3

39

50

DEC

EA

SED

OR

GA

ND

ON

OR

S(I

nclu

ded

NH

BD

)3

95

0 D

EC

EA

SED

OR

GA

N D

ON

OR

S (

Inclu

ded

NH

BD

)

*2

01

0 d

ata

N=

17

CO

UN

TR

IES

(5

45

mil

lio

n in

hab

itan

ts)

12

23

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 23

Page 26: Newsletter Europe 2011

GLO

BA

L D

ATA

WH

O

Reg

ion

Kid

ney

N(p

mp

)2

Liv

er

N(p

mp

)2

Heart

N(p

mp

)2

Lu

ng

N(p

mp

)2

Pan

cre

as

N(p

mp

)2

To

tal

N(p

mp

)2R

eg

ion

(N)1

N (

pm

p)2

N (

pm

p)2

N (

pm

p)2

N(p

mp

)2N

(pm

p)2

N(p

mp

)2

AFR

LD:

323 (

0.8

)LD

: 5 (

0.0

1)

(9)

DD

: 140 (

0.3

)D

D:

37 (

0.0

9)

26 (

0.0

6)

8 (

0.0

2)

11 (

0.0

3)

550 (

1.3

)

AM

RLD

: 11036 (

12.1

)LD

: 336 (

0.4

)2784

(3.1

)1913

(2.1

)1393

(1.5

)42743

(47.0

)*(2

1)

DD

: 16692(1

8.4

)D

D:

8405 (

9.2

)2784 (

3.1

)1913 (

2.1

)1393 (

1.5

)42743 (

47.0

)

EM

R

(14

)

LD:

5032 (

10.1

)

DD

: 550 (

1.1

)

LD:

192 (

0.4

)

DD

: 223 (

0.4

)61 (

0.1

)10 (

0.0

2)

20 (

0.0

4)

6088 (

12.3

)(

)(

)(

)

EU

R

(38

)

LD:

5597 (

7.2

)

DD

: 16116 (

20.7

)

LD:

583 (

0.7

5)

DD

: 6994 (

9.0

)2239 (

2.9

)1535 (

2.0

)824 (

1.0

5)

33942 (

43.6

)**

*2

00

9 d

ata

24

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 24

Page 27: Newsletter Europe 2011

GLO

BA

L D

ATA

WH

O

Reg

ion

Kid

ney

N(p

mp

)2

Liv

er

N(p

mp

)2

Heart

N(p

mp

)2

Lu

ng

N(p

mp

)2

Pan

cre

as

N(p

mp

)2

To

tal

N(p

mp

)2R

eg

ion

(N)1

N (

pm

p)2

N (

pm

p)2

N (

pm

p)2

N(p

mp

)2N

(pm

p)2

N(p

mp

)2

SEA

RLD

: 5496 (

3.1

)LD

: 403 (

0.2

3)

(9)

DD

: 305 (

0.1

7)

DD

: 105 (

0.0

6)

13 (

0.0

07)

--

6322 (

3.6

)

WP

RLD

: 5313 (

3.0

)LD

: 1760 (

1.0

)280

(0.1

6)

183

(0.1

0)

68

(0.0

4)

14420

(8.2

)***

(11

)D

D:

4818 (

2.7

)D

D:

1984 (

1.1

)280 (

0.1

6)

183 (

0.1

0)

68 (

0.0

4)

14420 (

8.2

)

TO

TA

L7

14

18

(1

1.6

)2

10

27

(3

.4)

(10

2)

()

LD

: 3

27

97

(5

.3)

DD

: 3

86

21

(6

.3)

()

LD

: 3

27

9 (

0.5

)

DD

: 1

77

48

(2

.9)

54

03

(0.9

)

36

49

(0.6

)

23

16

(0.4

)

10

40

65

(17

.0)*

**

*

1N

um

ber

ofco

untr

ies

incl

uded

inth

eanaly

sis

2Abso

lute

num

ber

(rate

pm

pbase

don

the

popula

tion

from

the

countr

ies

1 N

um

ber

of co

untr

ies

incl

uded in t

he a

naly

sis.

2Abso

lute

num

ber

(rate

pm

p-

base

d o

n t

he p

opula

tion f

rom

the c

ountr

ies

with t

ransp

lanta

tion a

ctiv

ity d

ata

).

*184 s

mall

bow

el tx

incl

uded

**54 s

mall

bow

el tx

incl

uded

***14 s

mall

bow

el tx

incl

uded

****252 s

mall

bow

el tx

in

cluded

*2

00

9 d

ata

25

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 25

Page 28: Newsletter Europe 2011

26

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 26

Page 29: Newsletter Europe 2011

27

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 27

Page 30: Newsletter Europe 2011

28

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 28

Page 31: Newsletter Europe 2011

100

%V

iti

DD

Li

%V

iti

LDLi

%V

iti

Tt

lLi

80

100

%V

ariation D

D L

iver

%V

ariatio

n L

D L

iver

%V

ariation T

otal L

iver

60 40 020 -200

AF

RA

MR

EM

RE

UR

SE

AR

WP

R

29

100

%V

iti

DD

Li%

Vi

tiLD

Li%

Vi

tiT

tlL

i

80100

%V

aria

tion

DD

Live

r%

Var

iatio

n LD

Live

r%

Var

iatio

n To

tal L

iver

60 40 020 -200

AFR

AM

RE

MR

EU

RS

EA

RW

PR

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 29

Page 32: Newsletter Europe 2011

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 30

Page 33: Newsletter Europe 2011

International Data on Organ Donation and Transplantation Activity,

Waiting List and Family Refusals. Year 2010

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 31

Page 34: Newsletter Europe 2011

DO

NAT

ION

AN

D T

RA

NSP

LAN

TATI

ON

AC

TIVI

TY

EUR

OP

EAN

UN

ION

CO

UN

TRIE

SC

OU

NTR

IES

AU

STR

IAB

ELG

IUM

BU

LGA

RIA

CY

PR

US

CZE

CH

. R.

DEN

MA

RK

ESTO

NIA

FIN

LAN

DFR

AN

CE

Pop

ulat

ion

(mill

ion

inha

bita

nts)

UN

FPA

: htt

p://

ww

w.u

nfpa

.org

/pub

lic/

8.4

10.8

7.5

0.9

10.5

5.6

1.3

5.4

64.7

DO

NAT

ION

Act

ual D

ecea

sed

Don

ors

-incl

uded

NH

BD

- (p

mp)

196

(23.

3)22

1 (2

0.5)

20 (2

.7)

4 (4

.4)

206

(19.

6)73

(13.

0)23

(17.

7)92

(17.

0)15

38 (2

3.8)

NH

B A

ctua

l Don

ors

(pm

p)-

50 (4

.6)

00

2 (0

.2)

00

062

(1.0

)%

Mul

tiorg

an d

onor

s81

.677

.980

100

58.3

706

6386

.4

TRA

NSP

LAN

TATI

ON

KID

NE

YTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)40

7 (4

8.5)

453

(41.

9)48

(6.4

)32

(35.

6)36

4 (3

4.7)

232

(41.

4)39

(30.

0)17

5 (3

2.4)

2892

(44.

7)%

(Liv

ing

TX. /

Tot

al T

X.)

14.5

10.8

2575

4.7

4410

.36.

39.

8P

aedi

atric

<15

yea

rs10

9-

22

8-

363

Dec

ease

d D

onor

TX.

(pm

p)34

8 (4

1.4)

404

(37.

7)36

(4.8

)8

(8.9

)34

7 (3

3.0)

130

(23.

2)35

(26.

9)16

4 (3

0.4)

2609

(40.

3)-S

ingl

e TX

. (pm

p)34

6 (4

1.2)

400

(37.

0)36

(4.8

)8

(8.9

)34

1 (3

2.5)

130

(23.

2)35

(26.

9)16

4 (2

.0)

2553

(39.

5)-D

oubl

e TX

. (pm

p)2

(0.2

)4

(0.4

)0

-6

(0.6

)0

00

56 (0

.9)

Livi

ng T

X. (p

mp)

59 (7

.0)

49 (4

.5)

12 (1

.6)

24 (2

6.7)

17 (1

.6)

102

(18.

2)4

(3.1

)11

(2.0

)28

3 (4

.4)

NH

B K

idne

y TX

. (pm

p)5

(0.6

)61

(5.6

)-

-4

(0.4

)-

--

79 (1

.2)

LIVE

RTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)14

1 (1

6.8)

243

(22.

5)15

(2.0

)-

102

(9.7

)47

(8.4

)3

(2.3

)50

(9.3

)10

92 (1

6.9)

Pae

diat

ric <

15 y

ears

635

3-

-10

(1.8

)-

5 (0

.9)

69S

plit

Live

r TX

. (pm

p)3

(0.4

)3

(0.3

)13

(1.7

)-

0-

80 (1

.2)

Dom

ino

Live

r TX

. (pm

p)0

00

-1

(0.1

)0

-0

8 (0

.1)

Livi

ng L

iver

TX.

(pm

p)2

(0.2

)33

(3.0

)2

(0.3

)-

00

-0

17 (0

.3)

NH

B L

iver

TX.

(pm

p)1

(0.1

)25

(2.3

)0

-0

--

-3

(0.0

)

HE

AR

TTX

. -in

clud

ed H

eart

/ Lu

ng T

X.-

(pm

p)69

(8.2

)68

(6.3

)5

(0.7

)-

70 (6

.7)

22 (3

.9)

022

(4.1

)37

5 (5

.8)

Pae

diat

ric <

15 y

ears

52

--

-3

-0

12

HE

AR

T-LU

NG

Tran

spla

nts

(pm

p)-

-0

-0

0-

019

(0.3

)P

aedi

atric

<15

yea

rs-

--

--

--

-0

LUN

GTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)11

4 (1

3.6)

114

(10.

6)0

-17

(1.6

)31

(5.5

)1

(0.8

)15

(2.8

)26

3 (4

.1)

Pae

diat

ric <

15 y

ears

2-

0-

-0

-0

6S

ingl

e (p

mp)

5 (0

.6)

21 (1

.9)

0-

6 (0

.6)

7 (1

.3)

1 (0

.8)

060

(0.9

)D

oubl

e -in

clud

ed H

eart

/ Lu

ng T

X.-

(pm

p)10

9 (1

3.0)

93 (8

.6)

0-

11 (1

.0)

24 (4

.3)

-15

(2.8

)20

3 (3

.1)

NH

B –

doub

le +

sin

gle-

Lun

g TX

. (pm

p)-

13 (1

.2)

0-

00

-0

0

PAN

CR

EA

STX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)31

(3.7

)22

(2.0

)0

-20

(1.9

)-

-2

(0.4

)96

(1.5

)P

aedi

atric

<15

yea

rs0

00

--

--

-1

Kid

ney

- P

ancr

eas

TX. (

pmp)

27 (3

.2)

22 (2

.0)

0-

16 (1

.5)

--

2 (0

.4)

83 (1

.3)

Pan

crea

s TX

. Alo

ne (p

mp)

4 (0

.5)

-0

-4

(0.4

)-

--

12 (0

.2)

SMA

LL B

OW

EL

TX. –

incl

uded

all

the

com

bina

tions

- (p

mp)

--

0-

0-

-1

(0.2

)9

(0.1

)P

aedi

atric

<15

yea

rs-

-0

-0

--

-7

Live

r +

Sm

all B

owel

(pm

p)-

-0

-0

--

-4

(0.1

)S

mal

l Bow

el T

X. A

lone

(pm

p)-

-0

-0

--

1 (0

.2)

4 (0

.1)

MU

LTIV

ISC

ER

AL

(pm

p)-

-0

-0

--

-1

(0.0

)

32

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 32

Page 35: Newsletter Europe 2011

DO

NAT

ION

AN

D T

RA

NSP

LAN

TATI

ON

AC

TIVI

TY

EUR

OP

EAN

UN

ION

CO

UN

TRIE

SC

OU

NTR

IES

GER

MA

NY

GR

EEC

EH

UN

GA

RY

IREL

AN

DIT

ALY

LATV

IALI

THU

AN

IALU

XEM

BO

UR

GM

ALT

AP

opul

atio

n (m

illio

n in

habi

tant

s)U

NFP

A: h

ttp:

//w

ww

.unf

pa.o

rg/p

ublic

/81

.811

.210

.04.

660

.12.

33.

30.

50.

4

DO

NAT

ION

Act

ual D

ecea

sed

Don

ors

-incl

uded

NH

BD

- (p

mp)

1296

(15.

8)44

(3.9

)15

9 (1

5.9)

58 (1

2.6)

1298

(21.

6)34

(14.

8)36

(10.

9)3

(6.0

)9

(22.

5)N

HB

Act

ual D

onor

s (p

mp)

00

00

3 (0

.1)

11 (4

.8)

00

0%

Mul

tiorg

an d

onor

s87

3943

.4-

75.4

2.5

58.3

100

100

TRA

NSP

LAN

TATI

ON

KID

NE

YTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)29

37 (3

5.9)

135

(12.

1)30

7 (3

0.7)

174

(37.

8)16

94 (2

8.2)

66 (2

8.7)

71 (2

1.5)

6 (1

2.0)

14 (3

5.0)

% (L

ivin

g TX

. / T

otal

TX.

)22

.620

13.7

13.2

10.7

3.0

11.3

021

.4P

aedi

atric

<15

yea

rs-

27

243

01

00

Dec

ease

d D

onor

TX.

(pm

p)22

72 (2

7.8)

108

(9.6

)26

5 (2

6.5)

151

(32.

8)15

12 (2

5.2)

64 (2

7.8)

63 (1

9.1)

6 (1

2.0)

11 (2

7.5)

-Sin

gle

TX. (

pmp)

2250

(27.

5)-

265

(26.

5)14

7 (3

2.0)

1386

(23.

1)64

(27.

8)63

(19.

1)6

(12.

0)11

(27.

5)-D

oubl

e TX

. (pm

p)22

(0.3

)-

04

(0.9

)12

6 (2

.1)

00

00

Livi

ng T

X. (p

mp)

665

(8.1

)27

(2.4

)42

(4.2

)23

(5.0

)18

2 (3

.0)

2 (0

.9)

8 (2

.4)

03

(7.5

)N

HB

Kid

ney

TX. (

pmp)

00

0-

017

(7.4

)0

00

LIVE

RTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)12

82 (1

5.7)

25 (2

.2)

43 (4

.3)

38 (8

.3)

1014

(16.

9)0

13 (3

.9)

3(6

.0)

0P

aedi

atric

<15

yea

rs-

13

067

00

00

Spl

it Li

ver

TX. (

pmp)

107

(1.3

)0

00

84 (1

.4)

00

00

Dom

ino

Live

r TX

. (pm

p)5

(0.1

)0

00

00

00

0Li

ving

Liv

er T

X. (p

mp)

90 (1

.1)

00

012

(0.2

)0

00

0N

HB

Liv

er T

X. (p

mp)

00

00

00

00

0

HE

AR

TTX

. -in

clud

ed H

eart

/ Lu

ng T

X.-

(pm

p)39

3 (4

.8)

5 (0

.4)

20 (2

.0)

3 (0

.7)

273

(4.5

)0

10 (3

.0)

3 (6

.0)

1 (2

.5)

Pae

diat

ric <

15 y

ears

-1

40

190

00

0

HE

AR

T-LU

NG

Tran

spla

nts

(pm

p)16

(0.2

)0

00

4 (0

.1)

00

00

Pae

diat

ric <

15 y

ears

-0

00

00

00

0

LUN

GTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)29

8 (3

.6)

2 (0

.2)

-4

(0.9

)10

7 (1

.8)

00

2 (4

.0)

0P

aedi

atric

<15

yea

rs-

1-

03

00

00

Sin

gle

(pm

p)44

(0.5

)-

-0

37 (0

.6)

00

2 (4

.0)

0D

oubl

e -in

clud

ed H

eart

/ Lu

ng T

X.-

(pm

p)25

4 (3

.1)

--

4 (0

.9)

70 (1

.2)

00

00

NH

B –

doub

le +

sin

gle-

Lun

g TX

. (pm

p)0

--

00

00

00

PAN

CR

EA

STX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)16

3 (2

.0)

-9

(0.9

)8

(1.7

)47

(0.8

)0

00

0P

aedi

atric

<15

yea

rs-

-0

01

00

00

Kid

ney

- P

ancr

eas

TX. (

pmp)

144

(1.8

)-

9 (0

.9)

8 (1

.7)

27 (0

.4)

00

00

Pan

crea

s TX

. Alo

ne (p

mp)

13 (0

.2)

-0

016

(0.3

)0

00

0

SMA

LL B

OW

EL

TX. –

incl

uded

all

the

com

bina

tions

- (p

mp)

10 (0

.1)

--

06

(0.1

)0

01

(2.0

)0

Pae

diat

ric <

15 y

ears

--

-0

30

00

0Li

ver

+ S

mal

l Bow

el (p

mp)

5 (0

.1)

--

01

(0.0

)0

00

0S

mal

l Bow

el T

X. A

lone

(pm

p)4

(0.0

)-

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4 (0

.1)

00

1 (2

.0)

0

MU

LTIV

ISC

ER

AL

(pm

p)5

(0.1

)-

-0

1 (0

.0)

00

00

33

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 33

Page 36: Newsletter Europe 2011

DO

NAT

ION

AN

D T

RA

NSP

LAN

TATI

ON

AC

TIVI

TY

EUR

OP

EAN

UN

ION

CO

UN

TRIE

SC

OU

NTR

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NET

HER

LAN

DS

PO

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EDEN

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.638

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047

.09.

461

.9

DO

NAT

ION

Act

ual D

ecea

sed

Don

ors

-incl

uded

NH

BD

- (p

mp)

227

(13.

7)50

9 (1

3.3)

323

(30.

2)70

(3.3

)91

(16.

8)41

(20.

5)15

02 (3

2.0)

118

(12.

6)10

15 (1

6.4)

NH

B A

ctua

l Don

ors

(pm

p)84

(5.1

)0

00

00

130

(2.7

)0

373

(6.0

)%

Mul

tiorg

an d

onor

s76

.247

.069

.075

.054

87.8

81.0

89.0

72.3

TRA

NSP

LAN

TATI

ON

KID

NE

YTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)86

7 (5

2.2)

999

(26.

2)57

3 (5

3.6)

212

(10.

0)16

9 (3

1.3)

61 (3

0.5)

2225

(47.

3)37

0 (3

9.4)

2724

(44.

0)%

(Liv

ing

TX. /

Tot

al T

X.)

54.6

58.

941

.54.

10

10.8

45.4

37.7

Pae

diat

ric <

15 y

ears

2839

162

30

5810

101

Dec

ease

d D

onor

TX.

(pm

p)39

4 (2

3.7)

949

(24.

9)52

2 (4

8.8)

124

(5.8

)16

2 (3

0.0)

61 (3

0.5)

1985

(42.

2)20

2 (2

1.5)

1698

(27.

4)-S

ingl

e TX

. (pm

p)39

1 (2

3.5)

947

(24.

8)52

0 (4

8.6)

123

(5.8

)15

7 (2

9.1)

61 (3

0.5)

1960

(41.

7)19

9 (2

1.2)

1676

(27.

1)-D

oubl

e TX

. (pm

p)3

(0.2

)2

(0.1

)2

(0.2

)1

(0.0

)5

(0.9

)0

25 (0

.5)

3 (0

.3)

22 (0

.3)

Livi

ng T

X. (p

mp)

473

(28.

5)50

(1.3

)51

(4.8

)88

(4.1

)7

(1.3

)0

240

(5.1

)16

8 (1

7.9)

1026

(16.

6)N

HB

Kid

ney

TX. (

pmp)

129

(7.8

)0

04

(0.2

)0

015

8 (3

.4)

-58

0 (9

.4)

LIVE

RTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)13

5 (8

.1)

237

(6.2

)24

5 (2

2.9)

51 (2

.4)

33 (6

.1)

23 (1

1.5)

971

(20.

7)13

7 (1

4.6)

712

(11.

5)P

aedi

atric

<15

yea

rs23

3415

00

046

991

Spl

it Li

ver

TX. (

pmp)

8 (0

.5)

00

00

020

(0.4

)-

113

(1.8

)D

omin

o Li

ver

TX. (

pmp)

1 (0

.1)

037

(3.5

)0

00

8 (0

.2)

7 (0

.7)

4 (0

.1)

Livi

ng L

iver

TX.

(pm

p)4

(0.2

)20

(0.5

)0

9 (0

.4)

00

20 (0

.4)

8 (0

.9)

24 (0

.4)

NH

B L

iver

TX.

(pm

p)16

(1.0

)0

00

00

18 (0

.4)

-10

4 (1

.7)

HE

AR

TTX

. -in

clud

ed H

eart

/ Lu

ng T

X.-

(pm

p)46

(2.8

)79

(2.1

)50

(4.7

)7

(0.3

)21

(3.9

)19

(9.5

)24

3 (5

.2)

56 (6

.0)

124

(2.0

)P

aedi

atric

<15

yea

rs2

62

01

-0

630

HE

AR

T-LU

NG

Tran

spla

nts

(pm

p)1

(0.1

)0

00

0-

4 (0

.1)

05

(0.1

)P

aedi

atric

<15

yea

rs-

00

00

-0

00

LUN

GTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)67

(4.0

)12

(0.3

)10

(0.9

)0

0-

235

(5.0

)51

(5.4

)16

2 (2

.6)

Pae

diat

ric <

15 y

ears

30

00

0-

40

5S

ingl

e (p

mp)

5 (0

.3)

7 (0

.2)

5 (0

.5)

00

-10

5 (2

.2)

15 (1

.6)

26 (0

.4)

Dou

ble

-incl

uded

Hea

rt/

Lung

TX.

- (p

mp)

62 (3

.7)

5 (0

.1)

5 (0

.5)

00

-13

0 (2

.8)

36 (3

.8)

136

(2.2

)N

HB

–do

uble

+ s

ingl

e- L

ung

TX. (

pmp)

-0

00

0-

8 (0

.2)

022

(0.4

)

PAN

CR

EA

STX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)20

(1.2

)20

(0.5

)15

(1.4

)0

01

(0.5

)94

(2.0

)26

(2.8

)19

5 (3

.2)

Pae

diat

ric <

15 y

ears

00

00

00

05

Kid

ney

- P

ancr

eas

TX. (

pmp)

14 (0

.8)

19 (0

.5)

14 (1

.3)

00

1 (0

.5)

71 (1

.5)

26 (2

.8)

151

(2.4

)P

ancr

eas

TX. A

lone

(pm

p)5

(0.3

)1

(0.0

)1

(0.1

)0

00

17 (0

.4)

039

(0.6

)

SMA

LL B

OW

EL

TX. –

incl

uded

all

the

com

bina

tions

- (p

mp)

-0

00

0-

5 (0

.1)

-18

(0.3

)P

aedi

atric

<15

yea

rs-

00

00

-3

-11

Live

r +

Sm

all B

owel

(pm

p)-

00

00

--

-2

(0.0

)S

mal

l Bow

el T

X. A

lone

(pm

p)-

00

00

-1

(0.0

)-

10 (0

.2)

MU

LTIV

ISC

ER

AL

(pm

p)-

00

00

-4

(0.1

)1

6 (0

.1)

34

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 34

Page 37: Newsletter Europe 2011

DO

NAT

ION

AN

D T

RA

NSP

LAN

TATI

ON

AC

TIVI

TY

OTH

ER C

OU

NTR

IES

CO

UN

TRIE

SA

LGER

IAA

UST

RA

LIA

CA

NA

DA

CR

OA

CIA

GEO

RG

IAIC

ELA

ND

ISR

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ON

MA

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.422

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44.

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37.

54.

32.

0

DO

NAT

ION

Act

ual D

ecea

sed

Don

ors

-incl

uded

NH

BD

- (p

mp)

1 (0

.0)

302

(13.

5)49

5 (1

4.5)

135

(30.

7)-

3 (1

0.0)

60 (8

.0)

2 (0

.5)

0N

HB

Act

ual D

onor

s (p

mp)

1 (0

.0)

67 (3

.0)

72 (2

.1)

0-

02

(0.3

)-

0%

Mul

tiorg

an d

onor

s0

80-

85.8

-10

062

100

0

TRA

NSP

LAN

TATI

ON

KID

NE

YTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)98

(2.8

)84

1 (3

7.7)

1234

(36.

2)24

4 (5

5.5)

8 (1

.8)

5 (1

6.7)

143

(19.

1)74

(17.

2)12

(6.0

)%

(Liv

ing

TX. /

Tot

al T

X.)

97.9

34.8

39.3

8.2

100

100

54.5

94.6

100

Pae

diat

ric <

15 y

ears

2214

--

1-

110

2D

ecea

sed

Don

or T

X. (p

mp)

2 (0

.1)

548

(24.

6)74

9 (2

2.0)

224

(50.

9)-

-65

(8.7

)74

(17.

2)0

-Sin

gle

TX. (

pmp)

2 (0

.1)

542

(24.

3)73

7 (2

1.6)

214

(48.

6)-

-63

(8.4

)4

(0.9

)0

-Dou

ble

TX. (

pmp)

06

(0.3

)12

(0.4

)3

(0.7

)-

-2

(0.3

)-

0Li

ving

TX.

(pm

p)96

(2.7

)29

3 (1

3.1)

485

(14.

2)20

(4.5

)8

(1.8

)5

(16.

7)78

(10.

4)70

(16.

3)12

(6.0

)N

HB

Kid

ney

TX. (

pmp)

011

7 (5

.2)

80 (2

.3)

--

-3

(0.4

)-

LIVE

RTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)6

(0.2

)20

8 (9

.3)

451

(13.

2)10

5 (2

3.9)

--

46 (6

.1)

1 (0

.2)

0P

aedi

atric

<15

yea

rs0

5-

--

-5

-0

Spl

it Li

ver

TX. (

pmp)

031

(1.4

)17

(0.5

)2

(0.4

)-

-1

(0.1

)-

0D

omin

o Li

ver

TX. (

pmp)

0-

0 (0

.0)

--

--

-0

Livi

ng L

iver

TX.

(pm

p)6

(0.2

)4

(0.2

)64

(1.9

)2

(0.4

)-

-7

(0.9

)-

0N

HB

Liv

er T

X. (p

mp)

012

(0.5

)16

(0.5

)-

--

--

0

HE

AR

TTX

. -in

clud

ed H

eart

/ Lu

ng T

X.-

(pm

p)0

68 (3

.0)

170

(5.0

)36

(8.2

)-

-11

(1.5

)-

0P

aedi

atric

<15

yea

rs0

2-

--

-2

-0

HE

AR

T-LU

NG

Tran

spla

nts

(pm

p)0

3 (0

.1)

2 (0

.1)

--

--

-0

Pae

diat

ric <

15 y

ears

0-

--

--

--

0

LUN

GTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)0

123

(5.5

)18

0 (5

.3)

--

-32

(4.3

)-

0P

aedi

atric

<15

yea

rs0

3-

--

-2

-0

Sin

gle

(pm

p)0

10 (0

.4)

25 (0

.7)

--

-22

(2.9

)-

0D

oubl

e -in

clud

ed H

eart

/ Lu

ng T

X.-

(pm

p)0

113

(5.1

)15

5 (4

.5)

--

-10

(1.4

)-

0N

HB

–do

uble

+ s

ingl

e- L

ung

TX. (

pmp)

027

(1.2

)9

(0.3

)-

--

--

0

PAN

CR

EA

STX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)0

34 (1

.5)

73 (2

.1)

6 (1

.4)

--

3 (0

.4)

-0

Pae

diat

ric <

15 y

ears

0-

--

--

0-

0K

idne

y -

Pan

crea

s TX

. (pm

p)0

33 (1

.5)

50 (1

.5)

5 (1

.1)

--

3 (0

.4)

-0

Pan

crea

s TX

. Alo

ne (p

mp)

0-

23 (0

.7)

1 (0

.2)

--

0-

0

SMA

LL B

OW

EL

TX. –

incl

uded

all

the

com

bina

tions

- (p

mp)

01

(0.0

)1

(0.0

)-

--

--

0P

aedi

atric

<15

yea

rs0

--

--

--

-0

Live

r +

Sm

all B

owel

(pm

p)0

-0

(0.0

)-

--

--

0S

mal

l Bow

el T

X. A

lone

(pm

p)0

-1

(0.0

)-

--

--

0

MU

LTIV

ISC

ER

AL

(pm

p)0

1 (0

.0)

3 (0

.1)

--

--

-0

35

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 35

Page 38: Newsletter Europe 2011

DO

NAT

ION

AN

D T

RA

NSP

LAN

TATI

ON

AC

TIVI

TY

OTH

ER C

OU

NTR

IES

CO

UN

TRIE

SM

OLD

OVA

NEW

ZEA

LAN

DN

OR

WAY

PALE

STIN

ESW

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84.

34.

94.

57.

822

.511

.075

.731

7.6

DO

NAT

ION

Act

ual D

ecea

sed

Don

ors

-incl

uded

NH

BD

- (p

mp)

038

(8.8

)10

2 (2

0.8)

098

(12.

6)0

16 (1

.5)

272

(3.6

)79

43 (2

5.0)

NH

B A

ctua

l Don

ors

(pm

p)0

1 (0

.2)

00

00

0-

-%

Mul

tiorg

an d

onor

s0

7692

099

00

232

-

TRA

NSP

LAN

TATI

ON

KID

NE

YTX

. –in

clud

ed a

ll th

e co

mbi

natio

ns-

(pm

p)0

112

(26.

0)26

3 (5

3.7)

7 (1

.6)

294

(37.

7)38

5 (1

7.0)

132

(12.

0)25

02 (3

3.0)

1689

8 (5

3.2)

% (L

ivin

g TX

. / T

otal

TX.

)0

53.6

31.6

100

38.8

100

87.9

84.2

37.1

Pae

diat

ric <

15 y

ears

0-

-0

824

7-

748

Dec

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83 (1

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114

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Pae

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TX.

(pm

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NH

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TX.

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HE

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X.-

(pm

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32 (6

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Pae

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20

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HE

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T-LU

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Tran

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ll th

e co

mbi

natio

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(pm

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32 (6

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Pae

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TX. (

pmp)

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CR

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STX

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ll th

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mbi

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(pm

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15 (3

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78 (3

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Pae

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Pan

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Live

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--

36

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 36

Page 39: Newsletter Europe 2011

DO

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Act

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Pae

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698

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69 (1

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93 (2

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40

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37

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 37

Page 40: Newsletter Europe 2011

DO

NAT

ION

AN

D T

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38

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 38

Page 41: Newsletter Europe 2011

WA

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39

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 39

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40

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 40

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41

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OTH

ER C

OU

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42

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ER C

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NTR

IES

CO

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43

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 43

Page 46: Newsletter Europe 2011

WA

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44

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 44

Page 47: Newsletter Europe 2011

WA

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45

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 45

Page 48: Newsletter Europe 2011

FAM

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46

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 46

Page 49: Newsletter Europe 2011

International Data on Tissue and Hematopoeitic Stem Cell

Donation and Transplantation Activity. Year 2010

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 47

Page 50: Newsletter Europe 2011

Data recorded & prepared by: EUROCET - European Network of Competent Authorities for Tissues and Cells - Team (www.eurocet.org)

TISSUE & HEMATOPOIETIC STEM CELL NATIONAL DATA PROVIDED BY:

48

AUSTRIABELGIUMBULGARIAIordan PeevCYPRUSCarolina StylianouCZECH REPUBLICPavel B ezovskýEva K emenováDENMARKESTONIAPille HarrisonEliisa LukkFINLANDFRANCEArnaud De GuerraGERMANYJohanna StrobelRalf R. TönjesGREECEHUNGARYIRELANDITALYFiorenza BarianiLetizia LombardiniLATVIAAnita DaugavvanagaLITHUANIADainora MedeisieneLUXEMBURGMALTARichard ZammitMiriam VellaNETHERLANDSPOLANDArtur KaminskiIzabela Uhrynowska-TyszkiewiczPORTUGALMargarida Amil DiazCatarina BolotinhaROMANIARosana TurcuAndrei NicaSLOVAKIAJan KollerSLOVENIADanica AvsecLea LampretSPAINBibiana RamosMarina AlvarezRosario MarazuelaSWEDENHelena StrömMona HanssonUNITED KINGDOM Christiane Niederlaender Lucy Sahota

CROATIAVanja NikolacKristina StankoviSandra TomljenoviICELANDMACEDONIANORWAYSWITZERLANDTURKEYHalil Yilmaz SurNuran Erden

ARGENTINACarlos SorattiMartín Alejandro TorresRicardo Rubén IbarBOLIVIAOlker Calla RivadeneiraBRASILHeder Murari BorbaCOLOMBIAJuan Gonzalo López CasasCOSTA RICAClive Montalbert-SmithDOMINICANAFernando Morales BilliniMEXICOEnrique Martínez GutiérrezOmar Sánchez RamírezNICARAGUATulio René Mendieta AlonsoPANAMACesar Cuero ZambranoURUGUAYInés AlvarezRaul José MizrajiVENEZUELACarmen Luisa Lattuf de MilanésZoraida Pacheco Graterol

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 48

Page 51: Newsletter Europe 2011

PR

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49

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PR

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DAT

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YEA

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50

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 50

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PR

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CO

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of

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onatio

ns

480

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13

114

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0,6

21,0

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00

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00

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51

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 51

Page 54: Newsletter Europe 2011

PR

ELIM

INA

RY

DAT

A O

N T

ISSU

ES -

YEA

R 2

010

OTH

ER C

OU

NTR

IES

Co

un

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CR

OA

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LA

ND

MA

CE

DO

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AY

SW

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OF

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52

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Page 55: Newsletter Europe 2011

PR

ELIM

INA

RY

DAT

A O

N T

ISSU

ES -

YEA

R 2

010

LATI

NA

MER

ICA

N C

OU

NTR

IES

Co

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try

ARG

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ABR

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53

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PR

ELIM

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54

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 54

Page 57: Newsletter Europe 2011

PR

ELIM

INA

RY

DAT

A O

N T

ISSU

ES -

YEA

R 2

010

EUR

OP

EAN

UN

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55

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 55

Page 58: Newsletter Europe 2011

PR

ELIM

INA

RY

DAT

A O

N T

ISSU

ES -

YEA

R 2

010

EUR

OP

EAN

UN

ION

CO

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56

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Page 59: Newsletter Europe 2011

PR

ELIM

INA

RY

DAT

A O

N T

ISSU

ES -

YEA

R 2

010

OTH

ER C

OU

NTR

IES

Cou

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57

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 57

Page 60: Newsletter Europe 2011

PR

ELIM

INA

RY

DAT

A O

N T

ISSU

ES -

YEA

R 2

010

LATI

NA

MER

ICA

N C

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58

1-NEWSLETTER 2011:aula medica 04/08/11 12:38 Página 58

Page 61: Newsletter Europe 2011

The Madrid Resolution on Organ Donation and Transplantation. National Responsibility

in Meeting the Needs of Patients, Guided by the WHO Principles

2-NEWSLETTER 2011:aula medica 04/08/11 12:40 Página 59

Page 62: Newsletter Europe 2011

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The Third Global Consultation on Organ Donation andTransplantation was organized by the WHO in collaborationwith the ONT and TTS and supported by the EuropeanCommission. The Consultation, held in Madrid on March23 to 25, 2010, brought together 140 government officials,ethicists, and representatives of international scientific andmedical bodies from 68 countries.

Participants in the Madrid Consultation urged the WHO, itsMS, and professionals in the field to regard organ donationand transplantation as a part of every nation’s responsibilityto meet the health needs of its population in a comprehensivemanner and address the conditions leading to transplantationfrom prevention to treatment. Donation from deceasedpersons, as a consequence of death determined by neurologiccriteria (brain death) or by circulatory criteria (circulatorydeath), was affirmed as the priority source of organs and ashaving a fundamental role in maximizing the therapeuticpotential of transplantation.

Every country, in light of its own level of economic andhealth system development, should progress toward the globalgoal of meeting patients’ needs based on the resources obtainedwithin the country, for that country’s population, and throughregulated and ethical regional or international cooperation

when needed. The strategy of striving for self-sufficiencyencompasses the following features: actions should (1) beginlocally, (2) include broad public health measures both todecrease the disease burden in a population and to increasethe availability of organ transplantation, (3) enhancecooperation among the stakeholders involved, and (4) becarried out based on the WHO Guiding Principles and theDeclaration of Istanbul, in particular emphasizing voluntarydonation, non-commercialization, maximization of donationfrom the deceased, support for living kidney donation, andmeeting the needs of the local population in preference to“transplant tourists.”

This new paradigm calls for the development of acomprehensive strategic framework for policy and practice,directed at the global challenges created by an increasingincidence of chronic diseases and a shortage of organs fortransplantation. Self-sufficiency advocates nationalaccountability for the establishment of an effective planningcontext for diseases treatable through organ transplantationand characterized by adequate capacity management, regulatorycontrol, and an appropriate normative environment (Fig. 1).

1. National capacity management involves: (a) developmentof an adequate and appropriate healthcare infrastructure

The Madrid Resolution on Organ Donation and Transplantation. National Responsibility in Meeting

the Needs of Patients, Guided by the WHO Principles

Figure 1. Schematic representation of the concept of national accountability in meeting the donation and transplantation needs of the popu-lation. CKD-chronic kidney disease; CVD-cardiovascular disease; COPD-chronic obstructive pulmonary disease.

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and workforce consistent with the country’s level ofdevelopment and economic capacity; (b) adequate andappropriate financing of organ donation and transplantationprogramme; and (c) management of need by investmentin chronic disease prevention and vaccination.

2. National regulatory control consists of (a) adequatelegislation, covering declaration of death, organprocurement, fair and transparent allocation, consent,establishment of transplant organizations, and penaltiesfor organ trafficking and commercialization; (b) regulationscovering procedures for organ procurement, reimbursement,and allocation rules; and (c) systems for monitoring andevaluation, including traceability and surveillance, andfor enabling evaluation of programme performance.

3. National authorities need to lead normative change, froma perception of organ donation as a matter of the rightsof donor and recipient to one of responsibility across alllevels of society, through unambiguous legislation, committedsupport, and ongoing education and public informationcampaigns. Meeting needs of patients while avoiding theharms of transplant tourism and commercial donationfrom living persons is an ethical imperative that relies onthe assumption of a collective responsibility for donationafter death by all citizens and residents, thereby contributingto the common good of transplantation for all.

The health of all populations will benefit from a comprehensiveresponse to diseases contributing to endstage organ failure,from prevention to access to effective organ transplantationprogrammes made possible by a sufficient supply of donororgans. There is also a strong economic imperative to improverates of transplantation and therefore organ donation: kidneytransplantation is less costly to provide than dialysis, andtherefore, maximizing rates of kidney transplantation wouldsignificantly reduce overall expenditure on renal replacementtherapies. Kidney transplantation also results in better survivaland quality of life outcomes and enables greater productivityand community participation. The perception of organtransplantation as an expensive and luxury clinical practiceis invalid; rather it is cost effective, mainstream, and a cardinalfeature of comprehensive health services. Beyond theunmistakable medical benefits to patients affected by end-stage organ failure, organ transplantation is a key to thechallenge facing healthcare providers worldwide ofunsustainable expenditures on dialysis services and haspotential to generate further practical consequences for healthsystems.

From a public perspective, the pursuit of self-sufficiencyrelies on a communal appreciation of the value of organdonation after death. The concept of donating human bodyparts to save the life of another as a civic gesture is one thatshould be taught at school alongside health education todecrease the need for transplants. The pursuit of self-sufficiencyin organs for transplantation exemplifies the public healthand community values of equity, transparency, reciprocity,and solidarity, while it is the only safeguard against thetemptation of yielding to trade in human organs.

In preparation for and during the meeting in Madrid, eightWorking Groups identified specific goals and challenges andproposed solutions and recommendations from a numberof perspectives. The Working Groups identified the commonchallenges faced by both developing and developed countries,the unique issues of particular societies and regions, andprovided a rich and extensive set of recommendations directedat governments, international organizations, and healthcareprofessionals regarding how to best maximize donationsfrom deceased persons (including the development of TheCritical Pathway for organ donation; Fig. 2) and how tosuccessfully progress toward meeting the needs of patients.

IMPLEMENTING SELF-SUFFICIENCY:RECOMMENDATIONS FROM THE MADRIDCONSULTATION

The human right to health and dignity includes the recognitionof all human needs for transplantation. While self-sufficiencyis conceived as a common global goal, the capacity to meetpatients’ needs should be found primarily within each country’sown resources, involving regulated regional or internationalcooperation when appropriate. The requirements of organdonation and transplantation programmes with respect toresourcing, proper organization, regulation and the oversightof procurement, processing and transplantation of humanbody components from living and deceased persons arematters that rightly come under the responsibility ofgovernments, as outlined in Resolution WHA57.18.

Consistent with the political and ethical obligations ofgovernments toward their citizens, the pursuit of self-sufficiencypromotes the health and protects the interests of populations.Although the practical implementation of self-sufficiencywill vary for different countries, influenced by economicfactors, health sector development, and existing healthpriorities, the inherent values of the self-sufficiency paradigmand the WHO Guiding Principles on human cells, tissuesand organs should guide organ donation and transplantationpolicy and practice in all contexts. The following overarchingaspects of self-sufficiency were identified during The MadridConsultation as subject to specific recommendations:

Preventing the Need for Transplantation and IncreasingOrgan Availability are National Responsibilities

• Organ donation and transplantation have a role in thenational health policies of all countries, regardless ofcurrent transplant capability.

• Of equal importance to infrastructure and professionaldevelopment in organ donation and transplantation issustained investment in prevention to reduce future needsfor transplantation, through intervention in the majorrisk factors for end-stage organ failure and the developmentof health systems able to meet the challenges of chronicdiseases such as diabetes, cardiovascular disease (CVD),and hepatitis.

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• National transplantation legislation consistent with theWHO Guiding Principles is fundamental. It providesadequate protection from exploitation and unethical practicesand eliminates legislative impediments constraining thescience and medicine of donation from deceased persons.

• Public support for organ donation necessitates normativechange. To this end, education of the public should beginin school, emphasizing individual and community ethicalvalues such as solidarity and reciprocity. Self-sufficiencyis founded in three main ethical premises:

– The human right to health encompasses transplantationand disease prevention.

– Organs should be understood as a social resource; equitymust therefore govern both procurement and allocation.

– Organ donation should be perceived as a civic responsibility.

Donation and Transplantation Reflect ComprehensiveHealth Care

• The critical functions of oversight, maintenance ofprofessional standards and ethics, regulation, policy setting,

and monitoring and evaluation of organ donation andtransplantation programmes are most effectively managedby a National Transplant Organization (NTO).

• Data registries are necessary for operational support(waiting list management and organ allocation) and formonitoring and surveillance of practices and outcomes.

• Monitoring and surveillance should encompass thefollowing data: national prevalence and incidence ofend-stage organ failure and diseases contributing toend-stage organ failure (need); availability of relatedinfrastructure and access to organ replacement therapies;outcomes of organ replacement therapy; acceptance ontotransplant waiting lists and time to receipt of an organ;organ donation practices, standards and activities;practices, standards and activities in organ donationfrom living persons; and outcomes of transplantation(patient and graft survival). International harmonizationof such metrics would facilitate comparisons betweensystems and international benchmarking, identify regionsin need of data, guide national policy making, and enableresearch.

Figure 2. The critical pathway for organ donation. This figure was published in Transplant Int 2011; 24: 373–378. The figure has been repro-duced with permission granted by Wiley-Blackwell.

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Opportunities to Donate Should Be Provided in as ManyCircumstances of Death as Possible

• The critical pathway provides a framework for the processof donation from deceased persons, which will aid globalharmonization of practice.

• The key to self-sufficiency is maximizing donation fromdeceased persons: facilitating donation in as manycircumstances of death as possible, maximizing the outcomesfrom each donor, and optimizing the results oftransplantation. Donation after both brain death andcirculatory death should be regarded as ethically proper.Organ donation from living persons should be encouragedas complementary to donation after death, by providingappropriate regulatory frameworks and donor care.

• Physicians and nurses involved in acute care have a centralrole in identifying possible donors and facilitating donationafter death, and therefore should be supported by thenecessary educational, technical, legal and ethical tools toassume leadership in this regard within their facility.

EXECUTIVE SUMMARY

PREAMBLE

In response to the global disparities in access to transplantation,a growing demand for organs, and the self-evident harms oftransplant tourism, a meeting of 140 representatives ofinternational scientific and medical bodies, governmentofficials, and ethicists was held in Madrid, Spain, on March23 to 25, 2010. This Third Global Consultation was organizedby the WHO, TTS and ONT, and supported by the EuropeanCommission. The purpose of the meeting was to call for aglobal goal of national responsibility in satisfying organdonation and transplantation needs, with sufficiency basedon resources obtained within a country for that country andthrough regulated and ethical regional or internationalcooperation, when needed. The concept of a nationalresponsibility encompasses the following features: (1) actionshould begin locally (not precluding international cooperation);(2) strategies should be targeted to decrease the transplantationneeds of a population and increasing organ availability, andshould enhance cooperation between stakeholders involved;(3) these strategies must be based on solid ethical principles:solidarity, voluntary donation, and non-commercialization(1); and (4) strategies should be tailored to the local realities.

The Third WHO Global Consultation carries forward theprinciples laid out in the WHO Guiding Principles for HumanCell, Tissue and Organ Transplantation, and the Declarationof Istanbul on Organ Trafficking and Transplant Tourism(1, 2). The WHO Guiding Principles articulate the importanceof pursuing national or subregional self-sufficiency in organsfor transplantation, in particular through increased effortsto promote donation after death. The Declaration of Istanbulfurther states that “Jurisdictions, countries and regions shouldstrive to achieve self-sufficiency in organ donation by providing

a sufficient number of organs for residents in need from withinthe country or through regional cooperation.” The goal ofthe Madrid consultation was to confront the self-sufficiencyparadigm from a practical perspective, developing acomprehensive strategic framework for policy and practicedirected at the global challenges of a shortage of organs fortransplantation and unmet patient needs. Therefore, theMadrid Resolution expresses both a pledge to progress insatisfying organ donation and transplantation needs, and aroadmap of how this may be achieved.

It was the intent that the consultation process should becomprehensive and holistic, encompassing different perspectivesstudied and discussed during the meeting. Eight differentworking groups were convened, with group members chosento represent a variety of different clinical experiences andgeographical regions, and to provide an interdisciplinaryunderstanding of the issues. The eight groups identifiedspecific goals and challenges, and proposed solutions andrecommendations with respect to the following topics:

1. Assessing needs for transplantation.

2. System requirements.

3. Meeting needs through donation.

4. Monitoring outcomes.

5. Fostering professional ownership in the emergencydepartment (ED) and intensive care unit (ICU).

6. The role of public health and society.

7. Ethics.

8. Measuring progress.

Each group was led by three individuals, who in advance ofthe meeting, worked together to guide the preparation of adraft document for discussion and refinement during themeeting. The outcomes of the working groups were alsodiscussed in a plenary session. The final eight documentsproduced by the working groups complete the MadridResolution on Organ Donation and Transplantation and arebased on a large body of evidence collected by participantsbefore the consultation and reflecting their particularexperiences representing 68 nations. The Madrid Resolutionidentifies the common challenges faced by both developingand developed countries, and the unique issues of particularsocieties and regions, and provides a diverse body ofrecommendations to governments, international organizations,and healthcare professionals regarding how to successfullymeet the needs of patients. This document represents animmediate resource for policy makers and guide for practicalinitiatives. It is hoped that the Madrid Resolution will alsoinspire new work in this emerging and important field.

The Resolution

Meeting the needs of patients with respect to organ donationand transplantation is a national responsibility that should bemet primarily through a country’s own resources, with specific

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regulated and ethical regional or international cooperation whenappropriate. National accountabilities can be broadly definedas the creation of a national planning context for chronicdiseases treatable through organ transplantation thatencompasses capacity control, regulatory control, anddetermination of the appropriate ethical environments.

1. National capacity control involves: (a) development ofadequate and appropriate healthcare infrastructure andworkforce development, consistent with development leveland economic capacity; (b) adequate and appropriatefinancing of organ donation and transplantationprogrammes; and (c) management of need by investmentin chronic disease prevention and vaccination.

2. National regulatory control consists of: (a) adequatelegislation, covering declaration of death, organprocurement, fair and transparent allocation, consent,establishment of transplant organizations, penalty of organtrafficking, and commercialization; (b) regulation coveringprocedures for organ procurement, reimbursement, andallocation rules; (c) systems for monitoring and evaluation,including traceability and surveillance, and enablingevaluation of programme performance.

3. National authorities need to lead normative change, fromorgan donation as a right of donor and recipient to aresponsibility across all levels of society, through education,unambiguous legislation, and committed support. Meetingneeds of patients while avoiding the harms of transplanttourism and commercial donation from living personsis an ethical imperative that relies on collective responsibilityfor donation after death, thereby contributing to thecommon good of transplantation for all. The WHOGuiding Principles for Human Cell, Tissue and OrganTransplantation provide the foundation for all effortstoward progress in meeting transplantation needs.

Recommendations

Informing The Resolution are the detailed recommendationsof the eight working groups convened as a part of the ThirdWHO Global Consultation on organ donation andtransplantation. The key recommendations of these workinggroups are as follows:

Recommendations With Respect to Assessment of Transplantation Needs

1. True need for transplantation cannot be defined byavailability of treatment. Instead assessment of need mustbe multifactorial and take into account:

a) True incidence of end-stage organ failure, irrespectiveof treatment availability (in all age groups and for allorgans).

b) Complexity of conditions and the drivers of need.

c) Nonmedical factors (e.g., economic, cultural, attitudinal,competing health priorities) that modify actual transplantneeds within that setting.

2. Internationally consistent definitions, data, and tools needto be developed to accurately and comprehensively measuretransplantation needs, thereby enabling a broaderunderstanding of the issues facing different countries andfacilitating the identification of global solutions.

3. An international registry of organ donation andtransplantation should be established. The following nationallevel data should be made available for this purpose:

a) National prevalence and incidence of end-stage organfailure and of diseases contributing to end-stage organfailure.

b) Availability of treatment for end-stage organ failure(transplant and non-transplant).

c) Waiting-list statistics, including “true” wait times.

d) Progression and outcomes of organ dysfunction.

e) Referral to organ replacement therapy (assist devisesand transplantation).

f) Time to workup, time to acceptance onto the waitinglist, and time to receipt of an organ.

4. All countries should have the ability to assess their needsfor transplantation. Governments should:

a) Support the identification of organ failure or replacementneeds as a priority for public health improvement;

b) Allocate resources to registry development (operationaland surveillance/monitoring) and furthermore createa registry for conditions leading to the need for organtransplantation;

c) Invest in prevention programmes to reduce needs;

d) Ensure the equity principle is applied in needs assessment;

e) Create or support infrastructure and allotment ofresources for all aspects of needs assessment.

5. With respect to needs assessment in transplantation, WHOshould:

a) Identify as a resolution that all countries shall have theability to assess their needs for transplantation by 2020;

b) Identify and outline the need for the use of a coreminimum dataset by which international comparisonswill become meaningful.

6. Professional societies and healthcare providers should:

a) Ensure consistency of definitions and use of metricswith respect to registry data;

b) Support identification of organ failure as a strategicpriority;

c) Foster international enquiry, collaboration, anddevelopment in the area of needs assessment;

d) Promote and support education relating to needsassessment, including technical advice regardingmethodologies, data interpretation, and applications;

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e) Promote scientific enquiry in the area of needs assessment,including validation studies;

f) Ensure linkages with governmental agencies and policymakers to support translation of research.

Recommendations With Respect to Systems and Organization

1. Clear and unambiguous legislative and regulatoryframeworks are the foundation on which successful systemsfor organ donation and transplantation, based on ethicaland transparent practices with respect to organ procurement,recovery, allocation and transplantation, are built.Governments should therefore:

a) Enact transplantation legislation consistent with theWHO Guiding Principles. Legislation should address:

• Standards for determining and declaring death;

• Organ procurement from deceased and living persons;

• Fair and transparent allocation to wait-listed patients,based on medical criteria;

• Respect for the wishes of the deceased concerningconsent;

• Establishment of transplant organizations;

• Prohibition of organ trafficking and commercialization.

Governments should also:

b) Incorporate donation and transplantation into nationalhealth policies as a priority;

c) Support donation after death;

d) Invest in basic infrastructure and professional training;

e) Create a national waiting list and comprehensive registryof donors and recipients;

f) Create the necessary systems for ongoing regulationand oversight to ensure transparency and facilitatereview of progress and the implementation of newstrategic policies;

g) Lead public awareness of organ transplantation andcommit to public education.

2. NTOs responsible for coordination and oversight, ethicalpractice, regulation, policy setting, maintenance of nationaldata registries, and data protection are essential. Corefunctions are to include:

a) Surveillance of practices, standards, and outcomes inorgan donation and transplantation;

b) Assurance of ethically proper organ procurement andallocation, transparency of all organ donation andtransplantation processes, and traceability of donatedhuman materials;

c) Standardization of procedures and performancemanagement of Organ Procurement Organizations(OPOs), related non-government organizations (NGOs),

individual transplantation centers, ethics committees,and transplant teams;

d) Regulation and management of the reimbursement ofreasonable and verifiable expenses incurred by theliving donor, and reimbursement of hospitals that incurcosts in donating or procuring organs;

e) Oversight of the division of responsibilities across allorganizations involved in organ donation andtransplantation;

f) Public endorsement of organ donation andtransplantation and support of the process with massmedia education and promotion.

3. When organization is based on OPOs, these organizationsmanage procurement activities independently of hospitaltransplant units, subject to government approval andregulation. The nature of OPOs will vary according todifferent national requirements and realities, although theessential functions are the same in every setting, whichare as follows:

a) Surveillance and detection of possible/potential donorsat every acute care hospital.

b) Donor management for the recovery of viable organs.

c) Coordination of procurement, through a designatedOrgan Procurement Coordinator (OPC).

4. Performance is dependent on successful integration andcoordination across systems. All countries performingtransplantation need to organize a unified coordinationthat regulates organ donation and transplantation processes.In addition, international coordination facilitates cross-border exchange of organs, information and research, andit is critical to combat organ trafficking and transplanttourism.

Recommendations with Respect to Organ Donation

1. Countries and jurisdictions should aim to maximizedonation from deceased persons, maximize the outcomefrom each deceased donor, and optimize results oftransplantation.

a) Donation from deceased persons is a requirement;transplantation activity cannot rely on living donors.

b) Both donation after brain death (DBD) and donationafter circulatory death (DCD) are to be considered.

c) Countries should enable transplants from living donors,as complementary to donation from deceased persons,by providing appropriate ethical and legal frameworksand donor care.

2. Donation after death is a process, at any stage of whichlosses of potential donors may occur. Therefore, to maximizedonation from deceased persons, an organizational approachshould be adopted with explicitly defined actions, roles,and responsibilities across the entire process. The CriticalPathway for organ donation is to be considered a general

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framework of reference for systematizing the deceaseddonation process. The objectives of The Critical Pathwayare as follows:

a) To provide a common systematic approach to theprocess of donation from deceased persons, both forDBD and DCD.

b) To create common triggers to facilitate the prospectiveidentification and referral of the possible deceased organdonor and precipitate the deceased donation process.

c) To provide common procedures to estimate the potentialof organ donation from deceased persons and evaluateperformance in the deceased donation process.

3. With respect to organ donation from deceased persons,governments should:

a) Eliminate legislative impediments constraining themedicine and science of donation from deceased personsand organ transplantation;

b) Provide adequate support (including financial support)for organ donation from deceased persons andtransplantation programmes;

c) Ensure equitable access to transplantation therapiesand transparency of the system;

d) Through a NTO (see Recommendations with respectto Systems and Organization, number 2) provide oversightand ensure the development and implementation of thefollowing:

• The Critical Pathway;

• Protocols for all steps of the process of donation afterdeath, especially timely identification and referral;

• Appointment of trained professionals, includingdonor coordinators, who are accountable forperformance;

• A data registry for ongoing evaluation of donationprocesses, estimation of the potential of donationfrom deceased persons, evaluation of overallperformance, identification of areas for improvement,and factors critical to success;

• Professional training and promotion of a nationalculture of donation.

4. With respect to donation from deceased persons, theWHO should:

a) Promote the international implementation of TheCritical Pathway;

b) Monitor the collection of relevant data assessingperformance in organ donation for internationalbenchmarking;

c) Foster regional cooperation in organ sharing thatpreserves equity between donor and recipientpopulations, and the efficient transplantation ofotherwise discarded organs.

5. With respect to organ donation from deceased and livingpersons, healthcare professions should:

a) Make every effort to maximize the number of organsrecovered and transplanted;

b) Support and promote DCD;

c) Present the option of donation from living persons tofamilies, with all practices in the donation of organsfrom living persons consistent with the principles ofThe Declaration of Istanbul.

Recommendations with Respect to Monitoring of Outcomes in the Pursuit of Self-Sufficiency

1. The purpose of registering data on transplant activitiesand outcomes is to identify areas in need of improvement;to enable system transparency, equity, and compliance; andto monitor system improvement both longitudinally withina given system and between systems through internationalbenchmarking. Registries should be not only concernedwith donors and recipients but also with infrastructureavailability. They are a tool for quality assurance and policymaking, and registry data may furthermore be used toraise awareness of the need for organ donation amongthe lay public and policy makers.

2. In all countries/regions, data should ideally be collectedin the following areas:

a) Available infrastructure (hospital and organizational);

b) Regulatory oversight and health policy;

c) Current and likely future needs for transplantation;

d) Access to the waiting list and to transplantation;

e) Waiting-list outcomes;

f) Travel for transplantation and transplant tourism;

g) Organ donation from deceased persons;

h) Organ donation from living persons; and

i) Outcomes of transplantation (patient and graft survival).

3. Two complementary data collection systems are proposed:

a) A national/regional system, which has operationalfunctions (allocation) and monitoring and evaluation.

b) An international system with a global perspective, underan International Data Group. The International DataGroup would establish standardized definitions/metrics,provide assistance to national/regional registries, facilitatecomparisons between systems and internationalbenchmarking, identify regions in need of data, guideindividual nations and systems, and facilitate researchinto special patient groups where small patient numberswould otherwise be restrictive.

4. With respect to monitoring, governments should:

a) Support national/regional registries with infrastructureand human resources;

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b) Establish responsibility for operation and governanceof this registry;

c) Facilitate cooperation between government and NGOsin monitoring outcomes and disseminating informationto the scientific community, the public, and policymakers; and

d) Use registry data to assess the impact of policy changeand inform the need and direction of new legislationand policy.

5. Professionals and professional societies should:

a) Provide content expertise;

b) Cooperate on the consistency of data elements acrossthe continuum of organ failure (i.e., chronic kidneydisease, dialysis, and transplantation); and

c) Facilitate development of an International Data Groupfor the ongoing collection of data that will empowerindividual countries and regions in the pursuit of self-sufficiency.

Recommendations with Respect to Fostering Emergencyand Intensive Care Department Professional Ownership of Organ Donation

1. Organ donation is a different process than organtransplantation and requires different skills and personnelto maximize its potential. Possible and potential deceaseddonors are found in the ICUs and increasingly in EDs.Physicians and nurses involved in acute care need to beaware of their critical role in identifying possible andpotential donors and to be engaged in the developmentof programmes for organ donation from deceased persons.Therefore, the pursuit of self-sufficiency requires ICU andED doctors and nurses to:

a) Be aware of the need for organ donation and thereforewant to facilitate it;

b) Know how to facilitate organ donation and have theeducational, technical, legal and ethical tools to do so;

c) Be supported by their colleagues, hospitals and healthauthorities in facilitating organ donation;

d) Be recognized as experts in this area and in educatingtheir colleagues;

e) Take the lead in enabling their facility to provide thisservice, including appropriate counseling for families.

2. To foster professional ownership of self-sufficiency in theED and ICU, governments should:

a) Under legal, ethical, and medical frameworks for practice,include:

• Standards for determining death, enacted by thelegislature, and accepted by the profession and public;

• Evidence-based tests and methods that physicianscan readily use to apply these standards in the EDand ICU;

• Clear statements, at institutional and governmentallevels, regarding the responsibility of various careproviders to donors and recipients.

b) Provide unambiguous guidance ensuring that individualmedical staff involved in acute care are not personallyor legally vulnerable when aiding the organ donationprocess.

3. Professional bodies should:

a) Provide training and guidance for Emergency/IntensiveCare nurses and physicians, covering:

• The need for organ donation and the importanceof the role of acute care physicians and nurses;

• Identification of possible and potential donors;

• Death determination;

• Protocols on how treatment decisions (e.g., forpatients with severe neurologic injuries) relate todonor status and to alternative (circulatory/respiratoryand neurologic) bases for determining death;

• Protocols on how to manage the dying process forpatients whose deaths will be determined oncirculatory/ respiratory or neurological grounds,and on post-death maintenance of body;

• How to make donation an understandable andacceptable choice for families of dying patients;

• Effective interaction with the OPO and transplantationteam.

b) Support the development of academic and scientificresearch activity in the emergency and intensive carecommunities to create a professional investment in thebest practice approaches that emerge.

4. Hospitals should:

a) Give local ED and ICU staff “ownership” of solvingthe problems and developing protocols for managingthe care of potential donors;

b) Identify individuals within the emergency or intensivecare team who can act as role models or “champions”to increase the profile of organ donation within thatfacility and provide education to the team on all relevantissues;

c) Appoint donor coordinators within hospitals to facilitatecommunications among emergency and intensive carestaff, bereaved families and transplantation services;

d) Include the possibility or potential for organ donationin every end-of-life care pathway in the ED/ICU;

e) Improve the interface between the ED/ICU and the localtransplant team and responsible National Authority;

f) Identify strategies to minimize the effects of lack ofresources on the conversion of potential donors toactual donors;

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g) Audit outcomes of the donation process within eachfacility to allow identification of potential areas forimprovement, set achievable targets, and formallyrecognize excellence.

Recommendations with Respect to the Role of Public Health and Society

1. Roles for public health in the pursuit of self-sufficiencyinclude:

a) Prevention of the frequent causes of end-stage organfailure (diabetes, hypertension, alcohol abuse, hepatitisB virus [HBV], hepatitis C virus [HCV], coronaryartery disease [CAD], and chronic obstructive pulmonarydisease [COPD]), including primary, secondary, andtertiary prevention;

b) Promotion of organ donation among health professionalsand the general public;

c) Development of effective healthcare systems capableof supporting efficient organ procurement, equitableallocation, safety and quality, and national diseaseprevention programmes.

2. The act of donation is itself an individual decision thatinteracts with the social setting and the institutional andregulatory framework into which an individual is embedded.Family refusal, together with failure to identify possibleand potential donors, is the most significant impedimentto increase rates of donation. Roles for society in thepursuit of self-sufficiency include:

a) Public education efforts to counter poor awareness,distrust of medicine, and misconceptions about donationand transplantation, while instilling notions ofreciprocity, solidarity, and building public willingnessto support organ donation;

b) Community funding for donation and transplantationthrough public finance and charitable sources.

3. Recommendations for public health:

a) Reduce demand for transplantation by prevention ofmajor risk factors for end-stage organ failure and bydeveloping healthcare systems able to effectively andequitably meet the challenges of chronic diseases,particularly diabetes and hypertension;

b) Develop awareness and increased willingness of medicalprofessionals to be involved in the donation andtransplantation process, encourage a stakeholder rolefor ICU/ED physicians, and develop specific educationprogrammes for primary care physicians, nurses, medicalstudents, and allied health professionals;

c) Develop culturally sensitive awareness programmes,using public health methodologies to promote trustand strengthen commitment to organ and tissuedonation in the community;

d) Increase the efficiency of healthcare systems andtransplant programmes by using private and non-

government sources of funding as appropriate, anddeveloping synergies between the government andNGOs.

4. Recommendations for society:

a) Provide regular and consistent normative changecommunication programmes and culturally sensitiveawareness programmes directed at community andfaith-based organizations;

b) Provide public recognition of donors and their familiesand actively manage adverse publicity;

c) Ensure all aspects of donation and transplantation aretransparent to the public, and develop educationalprogrammes to dispel myths and misconceptions,taking into account the range of community beliefsand values.

5. In settings where resource limitations and health sectordevelopment constrain the development of organ donationand transplantation programmes, the prevention of end-stage organ failure, within the context of wider public healthgoals, is crucial to self-sufficiency. In such settings, deliveryof transplantation therapy may be approached throughlocally relevant approaches to financing, using both privateand non-governmental sources of funding, and developingsynergies between governments, NGOs, and charities.

Recommendations with Respect to Ethics in the Pursuit of Self-Sufficiency

1. Self-sufficiency must be supported by normative change,reframing organ donation from a matter of the rights ofdonor and recipient, to a responsibility functioning at alllevels of society (individual, government, professional,etc). The self-sufficiency paradigm is based on three mainethical premises:

a) The human right to health requires that governmentsengage in prevention and providing transplantationservices. The responsible administration of scarceresources such as organs also encompasses concertedactions directed toward prevention of end-stage organfailure.

b) Organs should be understood as a social resource;therefore, equity should govern both procurement andallocation.

c) Organ donation should be perceived as a civicresponsibility toward fellow citizens; in contrast, organmarkets and transplant tourism lead to morallyunacceptable coercion and exploitation.

2. In accordance with The Declaration of Istanbul and theWHO Guiding Principles, self-sufficiency promotes thefollowing ethical principles:

a) Minimizing harm/reducing suffering—both decreasingneed for transplantation and efforts to maximize thenumber of organ available for transplantation areemphasized.

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b) Justice—an equitable distribution of benefit and burdenand the elimination of exploitation are central to theself-sufficiency paradigm.

c) Respect for persons—self-sufficiency avoids undueincentives while appealing to solidarity and civicresponsibilities toward the community.

3. With respect to ethics and self-sufficiency:

a) Governments/health authorities should be accountablefor the ethical integrity of organ donation andtransplantation systems;

b) Health professionals should receive training in theethical aspects of organ transplantation and be vigilantconcerning unethical or illegal behavior, and professionalsocieties should foster enquiry on questions of culture,values, and ethics relating to self-sufficiency;

c) Civil society should establish an ethos of socialresponsibility and solidarity in meeting the community’stransplantation needs through participation in donationafter death, necessitating the engagement of community-and faith-based organizations and NGOs.

Overall Recommendations with Respect to EffectiveProgress in the Pursuit of Self-Sufficiency

1. The capability of individual countries/regions to meettransplantation needs is determined by economic resources,systems development, and existing health priorities. The minimum level of transplantation capability is definedas the presence of a few medical professionals who havethe capability to provide appropriate presurgical andpostsurgical management of transplant recipients andliving donors in a context of no local transplantationactivity; maximum capability is defined as a comprehensivemultiorgan transplant programme that provides an adequatesupply of transplantable organs to meet the needs of thepopulation. By defining successive levels of capability, theinclusive nature of the self-sufficiency paradigm is reinforced,and it is possible to describe a framework for evolutionand achievement in organ donation and transplantationthat is adaptable to all contexts.

2. The pursuit of self-sufficiency involves the developmentand implementation of strategies aimed at increasingnational/ regional transplantation capabilities to progressfrom one level of capability to the next, in amanner thatis consistent with local realties and does not distort existinghealth priorities. Countries/regions evolve toward greaterself-sufficiency in organ donation and transplantationthrough incremental achievements in each of the followingdomains:

a) Resources and professional development for donationand coordination;

b) Legal and regulatory frameworks;

c) Resources and professional development for transplantservices;

d) Government and other resources;

e) Community involvement;

f) Assessment and minimization need for organs.

3. To enable evolution and achievement in transplantationcapability, Governments should:

a) Acknowledge their responsibilities in managing endstageorgan failure from prevention to treatment in theirpopulation and designate a focal point/coordinatingauthority;

b) Derive an integrated strategy for the care of patients withend-stage organ failure, from prevention of organ diseaseand organ failure to replacement therapies includingtransplantation, to optimize the use of resources;

c) Include the elements of organ donation andtransplantation in their national health plan and assesstheir own level of transplantation capability;

d) Allocate resources, develop infrastructure, and strengthenhealth systems to support the achievement of these goals;

e) Report national data on organ donation andtransplantation activities to the Global Observatoryon Donation and Transplantation (GODT);

f) Participate in public education and engage professionals,professional societies, NGOs, and the community;

g) Foster regional and international cooperation in thepursuit of these goals.

4. To support national/regional efforts to pursue self-sufficiency, WHO should:

a) Urge MS to adopt and implement the principles of theMadrid Resolution;

b) Urge MS to self-assess their level of transplantationcapability, to aid the identification of areas forimprovement;

c) Monitor progress in levels of achievement in the pursuitof self-sufficiency across MS:

d) Align the range of quantifiable indicators collected bythe GODT to the framework of the Madrid Resolution;

e) Develop international standards, guidelines, and tools,in collaboration with professional organizations, for theadvancement of transplantation policy and practice;

5. To support national/regional efforts to pursue self-sufficiency, professionals and professional societies should:

a) Acknowledge their responsibilities with respect to theirown professional development, adoption of ethicalpractices, maintenance of standards, and training fordonation and procurement;

b) International societies should support the establishmentand work of the relevant national societies to furthertheir missions with respect to organ donation andtransplantation;

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c) Provide professional advice to MS and assistance forthe development of standards for accreditation andquality assurance;

d) Participate in professional and public education andengage other professionals and the public in theadvancement of organ donation and transplantation;

e) Encourage research, especially clinical research directedat maximizing benefits, minimizing costs, and optimizingresource allocation in organ donation and transplantation.

CONCLUSIONS

The Madrid Resolution on Organ Donation and Transplantationrecognizes that donation and transplantation are more thana good gesture and a medical service. For patient needs tobe met, all citizens and residents must be involved. From apublic perspective, national attempts to meet patient needsrely on a communal appreciation of the value of organdonation. The concept of donating human body parts to savethe life of another as a civic gesture is one that should betaught at school as a part of health education along with

promotion of healthy life style. The organizational requirementsand allocation of resources necessary to maximize donationfrom deceased donors and ensure equitable access totransplantation services, and the implementation of preventiveinterventions to alleviate needs for transplants, mandate theactive commitment of Government. The benefits to be gainedextend way beyond the successful transplantation of patients.The pursuit of the goal of ensuring a national responsibilityin satisfying the donation and transplantation needs of a givenpopulation, outlined in the Madrid Declaration, has thecapacity to strengthen the public health and communityvalues of reciprocity and solidarity, while it is the only safeguard against the temptation of yielding to trade in humanorgans.

REFERENCES

1. Steering committee of the Istanbul Summit. Organ trafficking andtransplant tourism and commercialism. The Declaration of Istanbul.Lancet, 2008;372:5 (Available at: http//www.declarationofistanbul.org)

2. WHO Guiding Principles; WHA 63.22/2010 (Available at: http://www.who.int/transplantation/en/)

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Cooperation between Countries of the Black SeaArea (BSA): Development of the Activities

Related to Donation and Transplantation of Organs, Tissues and Cells

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PROJECT BACKGROUND

Human to human (allogeneic) transplantation of cells, tissuesand organs has become the best and often the only treatmentfor a wide range of end stage organ failure. However, as thenumber of transplants has grown rapidly over the past twodecades, the demand for human transplantation has alsoincreased, resulting in a continuing shortage of humanmaterial, particularly organs, with the risk of encouragingunethical practices.

The development of organ transplantation in the countriesof the Black Sea Area (BSA) dates back from the late 1970s;mainly in the form of kidney transplants from Non-HeartBeating Donors (NHBD). From the early 1990s, activities inthe field of transplantation began to decline and, in somecountries, have ceased.

Over the last few years, the Council of Europe (CoE) andWorld Health Organization (WHO) began implementingsome projects that supported the development of a commonand constructive attitude towards various transplantationissues in these countries. Efforts were mainly directed towardsthe development of effective legislative frameworks and theestablishment of national transplant authorities and nationaltransplant programmes. The cooperation with Moldova is agood example of these efforts.

It is important to note that donation and transplantation ofcells, tissues and organs raise ethical and legal issues that needto be addressed according to various cultural backgrounds.Nevertheless, it is important to identify and share experiencesfrom local initiatives which could provide models forimplementation of safe donation and transplantation processes.

The work of the Council of Europe in the area of organtransplantation started in the 1950s. The relevant committeeis the European Committee on Organ Transplantation (CD-P-TO), which focuses on the elaboration of high ethical,quality and safety standards in the field of organ, tissues andcells transplantation, promoting the principle of non-commercialisation of organ donation and strengthening themeasures to avoid organ trafficking.

THE PROJECT AND KEY PLAYERS

Based on the Council of Europe recommendations and theexperience gained by the experts from the CD-P-TO in otherprogrammes in the BSA, the CD-P-TO has now started acollaborative project through which a regional strategy willbe channeled to promote transplantation activities in the area.

The Council of Europe member states from the BSA (Armenia,Azerbaijan, Bulgaria, Georgia, Moldova, Rumania, Russia,

Turkey and Ukraine) will, through this project, start a longterm regional cooperation in order to structure, develop andstrengthen activities and programmes related to the donationand transplantation of organs, tissues and cells.

A kick-off meeting, organized regionally in Chisinau(Moldova), launched the project on 1-2 July 2011. It gatheredprofessionals from the transplantation and/or the organisationalsystem nominated by their respective Ministries of Health.Specialists in the field of transplantation from countries withestablished transplant systems, such as France, Italy andSpain, participated and met together with experts from thepartner countries of the Black Sea Area.

An Advisory Board of experts from France, Italy, Spain andGermany will follow and support the progress of the BSAPROJECT.

SPECIFIC OBJECTIVES

• to review the existing laws on transplantation of organs,tissues and cells and to promote the implementation ofan effective legislative framework;

• to contribute to the establishment of national transplantauthorities and national transplant programmes wherethese do not exist, and to support efforts in strengtheningexisting transplant services;

• to educate the public, professionals and media abouttransplantation and the need for services to be developedin the countries involved in the project;

• to establish action plans for training and to identify areaswhere additional specialist expertise or training are requiredas the basis for a training and professional developmentstrategy;

• to elaborate recommendations and documents of consensusthat are agreed upon by all the participants;

• to encourage networking and enhance international co-operation;

• to establish pilot actions to be developed in specific settings.

CONTACT

Dr. Marta López-Fraga, Scientific Administrator, EDQM,Council of Europe: [email protected] Tel. +33 (0)3 90 21 45 30; Fax +33 (0)3 88 41 27 71

Dr Igor Codreanu, Project Leader Transplant Agency, Republicof Moldova: [email protected] Tel.: +373 22 28 64 66 or mobile Tel.: +373 69 20 60 69;

Web Pages: http://www.edqm.eu & http://www.transplant.md

Cooperation between countries of the Black Sea Area(BSA): Development of the activities related to donation

and transplantation of organs, tissues and cells

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BSA TRANSPLANT NETWORK DATA

Data related to national donation and transplantation activities

from all the BSA countries has been collected. This information

provides an updated overview of the legal and organisational

situation in the participating countries and sets ground forfuture regional priorities for action. Future data collectionswill improve the picture and allow following the trends andprogress. A summary of this information is shown in theTables below.

SECTION 1: LEGISLATIVE ASPECTS

Ukr

anie

Turk

ey

Ru

ssia

Rom

ania

Mol

dova

Geo

rgia

Bu

lgar

ia

Aze

rbai

jan

Arm

enia

Regulatory framework on organ transplantation and donation YES YES YES YES YES YES YES YES YES

Regulatory framework on death diagnosis YES NO YES YES YES YES YES YES YES

Law concerning prohibition of organ trafficking YES YES YES YES YES YES YES YES YES

Presumed consent (PC) or informed consent (IC)legislation PC PC PC IC PC IC PC IC PC

Donor or non-donor registry NO NO YES YES YES NO NO YES NO

SECTION 2: NATIONAL AUTHORITIES

Ukr

anie

Turk

ey

Ru

ssia

Rom

ania

Mol

dova

Geo

rgia

Bu

lgar

ia

Aze

rbai

jan

Arm

enia

Government recognized authorityresponsible for overseeing & supporting donation & transplantation (national level) YES NO YES YES* YES YES YES YES YES

Specific organization/institution responsiblefor national coordination of donation and transplantation activities YES NO YES NO YES YES NO YES YES

Periodic reports on donation and transplantation NO NO YES YES NO YES YES YES YES

Ethical Committee dealing with transplant activities nationally or regionally NO NO YES YES YES YES NO YES YES

* Non official.

SECTION 3: ORGANISATIONAL ASPECTS

Ukr

anie

Turk

ey

Ru

ssia

Rom

ania

Mol

dova

Geo

rgia

Bu

lgar

ia

Aze

rbai

jan

Arm

enia

Training programs to harmonize practices for staffinvolved in organ procurement NO NO YES NO NO YES YES YES YES

Training programs to harmonize practices for staffinvolved in organ transplantation NO NO YES NO NO YES YES YES YES

Adequate and continuous education campaigns NO YES YES NO NO NO NO NO YES

Educational campaigns in schools or universities NO NO YES NO NO NO NO YES NO

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Kidney 8 2 48 8 0 212 1.037 2.502 82

Liver 0 10 15 0 0 51 209 695 12

Pancreas 0 0 0 0 0 0 8 29 0

Heart / Lung 0 0 5/0 0 0 7/0 47 89 1

SECTION 4: TRANSPLANT ACTIVITY

UkranieTurkeyRussiaRomaniaMoldovaGeorgiaBulgariaAzerbaijanArmeniaType of transplant

activity

4.1. Number of transplant centres in participating countries

4.2. Number of transplant performed in 2010 in participating countries

Kidney 8 150 915 0 0 2.661 950 17.033 900

Liver 0 20 26 0 0 453 500 1.484 0

Pancreas 0 0 0 0 0 73 100 182 0

Heart / Lung 0 0 25/0 0 0 166/25 250 218 16

4.3. Number of patients on the waiting list at the end of 2010 in participating countries

Kidney 1 2 4 2 2 5 31 59 7

Liver 0 1 2 0 2 1 11 34 2

Pancreas 0 1 0 0 0 1 3 5 0

Heart / Lung 0 0 2/0 0 1 2/1 7 14 2

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LIST OF PARTICIPANTS CD-P-TO(2-3/10/09, Berlín)

LIST OF PARTICIPANTS CD-P-TO(12-13/05/2011, Strasbourg)

AUSTRIAMUEHLBACHER FerdinandBELGIUM

BULGARIA

CYPRUS

CZECH REPUBLIC

DENMARK

ESTONIADMITRIEV PeeterFINLAND

FRANCELAOUABDIA-SELLAMI KarimGERMANYNORBA DanielaGREECE

HUNGARYLANGER RobertIRELAND

ITALYCOZZI EmanueleNANNI COSTA AlessandroLATVIA

LITHUANIA

LUXEMBOURG

MALTA

NETHERLANDS

POLANDDANIELEWICZ RomanROWINSKI WojciechPOTUGALPENA Joao RodriguesROMANIA

SLOVAK REPUBLIC

SLOVENIAAVSEC- LETONJA DanicaSPAINMATESANZ RafaelMARAZUELA RosarioSWEDENERICZON Bo-GöranUNITED KINGDOM

(ET) EUROTRANSPLANT RAHMEL Axel(SKT) SCANDIATRANSPLANT

ARMENIA

BELARUS

BOSNIA AND HERZEGOVINA

CANADA

CROATIA

GEORGIATOMADZE GiaICELAND

ISRAEL

NORWAYPFEFFER PerOYEN OleREPUBLIC OF MOLDOVACODREANU IgorRUSSIAN FEDERATION

SERBIA

SWITZERLANDMOREL PhilippeTURKEY

ESOT

EUROPEAN COMMISSIONLE-BORGNE HélèneIBEROAMERICAN COUNCIL

UNOS

WHO

CDBIHARTEL Ingo

75

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Guide to the Safety and Quality Assurance for the Transplantation of Organs, Tissues and Cells

4th EditionWhy a European Guide?Transplant medicine and transplantation have progressed during the last decades, in a way that nobody would have imagined before. Organ transplantation is, in many cases, the only treatment for end-stage organ failure. The number of transplantations performed is only limited by organ availability, which is very much dependant on how criteria for organ donation can be extended in relation to functional parameters and the risks of disease transmission. The transplantation of organs, tissues and cells offers major therapeutic benefits and improvements in quality of life, but raises a number of questions of ethical principles.

The Council of Europe is the leading standard-setting institution in this field since the 1950s. It approaches organ transplantation from an ethical and human rights perspective, taking

compliance with the principles of non-commercialisation and voluntary donation of substances of human origin as the basis for all ethical

concerns in this respect. Its work includes assuring the safety and quality of organs, tissues and cells, tackling the organ shortage,

promoting living donations and preventing and minimising organ trafficking.

A priority of this work programme is the elaboration of the Guide to the Safety and Quality Assurance for the Transplantation of Organs, Tissues and Cells. The European Committee on Organ Transplantation (CD-P-TO), the Steering Committee in charge of transplantation activities for the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe), assisted by leading

European experts, is responsible for producing regular updates of the guide, in addition to other projects.

Who is the guide designed for?The guide collates data and gives expert opinion to provide

transplant professionals with the most up-to-date information about the advances in their field. Its aim is to provide guidance for all those

involved in order to maximise the quality of organs, tissues and cells and to minimise risks, and thereby increase the success rate of transplants. It

includes safety and quality assurance standards for procurement, preservation, processing and distribution of organs, tissues and cells of human origin used for

transplantation purposes. In order to increase safety for patients on waiting lists and recipients of organs, it is essential that physicians in charge of identifying potential

donors, transplant co-ordinators involved in managing the donation process, and transplant physicians responsible for organ allocation, have easy access to this information.

What information is contained in the guide?The guide applies to the donation and transplantation of organs, tissues and cells of human origin for therapeutic purposes.

Publication and purchase of the guideThe 4th Edition of the guide is now available in both paper and online versions in English, French and Russian. An online version in Spanish will be available by the end of 2011. Purchase of a printed guide gives access to the online version in all the available languages.

Subscribe to our free e-NewsletterSign up today to receive the EDQM’s free e-mail newsletter, “Infopub”. Information is emailed every month on the EDQM’s activities, its publications, services and upcoming events.

For more information, please visit the EDQM website: www.edqm.eu or the EDQM Store at www.edqm.eu/store.

Editionth4

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