Newsletter Europe 2005

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COUNCILOF EUROPE

CONSEILDE L’EUROPE

INTERNATIONAL FIGURES ON

ORGAN DONATION AND TRANSPLANTATION - 2004

2005

FUNDACION RENALI Ñ I G O A L V A R E Z D E T O L E D O

NEWSLETTER

TRANSPLANTSEPTEMBER 2005

Vol. 10. Nº 1

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– AUSTRALIALee Excell

– AUSTRIAGuido Persijn (ET)

– BELGIUMGuido Persijn (ET)

– BULGARIAYanko Nachkov

– CANADAKim Badovinac

– CROATIAMirela Busic

– CYPRUSGeorge Kyriakides

– CZECH REPUBLICEva Pokorna

– DENMARKFrank Pedersen (SKT)

– ESTONIAPeeter Dmitriev

– EUROTRANSPLANT (ET)Germany, The Netherlands,Austria, Belgium, Slovenia,LuxemburgGuido Persijn (ET)Marjan Slot

– FINLANDFrank Pedersen (SKT)

– FRANCEYlana ChalemPhilippe Tuppin

– GEORGIAGia Tomadze

– GERMANYGuido Persijn (ET)

– GREECEGeorgia MenoudakouMarianthi Katsani

– HUNGARYPeter Borka

– ICELANDFrank Pedersen (SKT)

– IRELANDPhil Pocock

– ISRAELSharona Bem Ami

– ITALYPaola di Ciaccio

– LATVIASergej Trushkov

– LITHUANIAJulija Shirokova

– LUXEMBURGGuido Persijn (ET)

– MALTATony Bugeja

– NEW ZEALANDLee Excell

– NORWAYFrank Pedersen (SKT)

– POLANDJaroslaw Czerwinski

– PORTUGALLuisa Taveira

– ROMANIAVictor Gheorgue Zota

– SCANDIATRANSPLANT (SKT)Denmark, Sweden, Norway, Finland, Iceland Frank Pedersen

– SLOVAK REPUBLICLudovit Laca

– SLOVENIALea LamjnetGuido Persijn (ET)

– SPAINCarmen MartinMª Jose LopezCarmen Cobo

– SWEDENFrank Pedersen (SKT)

– SWITZERLANDDiane Moretti

– THE NETHERLANDSArnoud SloofGuido Persijn (ET)

– TURKEYAltay Köken

– UNITED KINGDOM Phil Pocock

– UNOS: USAwww.unos.org

– ARGENTINACarlos Alberto Soratti

– BOLIVIAwww.gpuntacana.org

– BRASILRoberto Soares

– CHILENelly de Lourdes AlvaradoJose Luis Rojas

– COLOMBIARafael Romero

– CUBAAlexander Marmol

– DOMINICANAwww.gpuntacana.org

– ECUADORIgnacio Ramirez

– EL SALVADORwww.gpuntacana.org

– GRUPO PUNTA CANAArgentina, Brasil, Bolivia, Chile, Colombia, Costa Rica,Cuba, Ecuador, El Salvador,Guatemala, Honduras, México, Panamá, Paraguay,Perú, Puerto Rico, Dominicana R., Uruguay,Venezuelawww.gpuntacana.org

– GUATEMALARudolf A. García-Gallont

– MEXICOJosé Salvador Aburto

– PANAMAwww.gpuntacana.org

– PARAGUAYEduardo Wilson Martínez

– PERUCarmen Fajardo

– PUERTO RICOE. Santiago-Delpín

– URUGUAYRaul José Mizraji

– VENEZUELACarmen Luisa Lattuf de Milanés

INTERNATIONAL FIGURES ON ORGAN, TISSUE & HEMATOPOIETIC STEM CELL DONATION &

TRANSPLANTATION ACTIVITIES. DOCUMENTS PRODUCED BY THE COMMITTEE OF EXPERTS ON THE

ORGANISATIONAL ASPECTS OF CO-OPERATION IN ORGAN TRANSPLANTATION (2004)

Editors: Rafael Matesanz & Blanca Miranda

NATIONAL DATA PROVIDED BY:

Data recorded & prepared by Organización Nacional de Trasplantes (ONT) – SpainDr. Rafael MatesanzDra. Blanca MirandaAna GarcíaMarina Alvarez

Foot Note: For the purposes of this Newsletter the following definitions were used:Organ donor: Every potential donor transferred to the operating theatre from whom, at least, one solid organ has been retrievedMultiorgan donor: Every donor from whom, at least, two different solid organs have been retrievedAbsolute number: Include all figures corresponding to all donors/patients adults and children Paediatric: Includes only paediatric activity (patients under 15 years old)

AULA MÉDICA EDICIONES. Paseo Pintor Rosales, 26. 28008 Madrid (España)Tel. 91 542 09 55. Fax 91 559 51 72. Depósito legal: M-9.990-1996

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The outstanding work of the Transplant Committee of the Council of Europe in the field of organ, tissue andcells donation and transplantation for many years is now serving as a model for other International bodies inother parts of the world for setting standards, obtaining accurate data of activity, and implementing new formsof organization.

UE has widely used the documents elaborated by this Committee for the tissue and cell directive. WHO is nowin the phase of development of the 57th World Health Assembly Resolution about Human Organ and TissueTransplantation and certainly our experience will serve as a basis for the future work in Latin America or Asia.

TRANSPLANT NEWSLETTER is now the only official publication which provides data of organ donation andtransplantation of everyday more and more countries all over the world. A wonderful example has been Lati-no America. Thanks to the cooperation of professionals and authorities of these countries and the coordina-tors of the GRUPO PUNTACANA, we started to publish their data and now we are the more accurate sourceof data for this continent. The recent approval of the project of IBEROAMERICAN COUNCIL OF ORGAN DO-NATION AND TRANSPLANTATION which will serve to harmonize these activities in Spanish and Portuguesespeaking countries can be considered as a reflex of this Committee at the other side of Atlantic ocean.

Information is an absolute need for taking decisions. It is a simple question of justice thank to all the peoplewho provides these data every year from more and more countries. We all are contributing to provide thesetherapies everyday to more and more people all over the world.

Rafael Matesanz

NEWSLETTER TRANSPLANT 2005

INTRODUCTION

FROM EUROPE TO OTHER PARTS OF THE WORLD

• INTRODUCTION: FROM EUROPE TO OTHER PARTS OF THE WORLD .......................................................... 3

• INTERNATIONAL FIGURES ON ORGAN DONATION AND TRANSPLANTATION. YEAR 2004 ............................... 5

• INTERNATIONAL DATA ON ORGAN DONATION, TRANSPLANTATION, WAITING LIST AND FAMILY REFUSALS. YEAR 2004 ....................................................................................................................................... 23

• INTERNATIONAL DATA ON TISSUE AND HEMATOPOIETIC STEM CELL TRANSPLANT ACTIVITY. YEAR 2004 ...... 39

• DOCUMENTS AND RECOMMENDATION PRODUCED BY THE TRANSPLANT COMMITTEE OF THE COUNCIL

OF EUROPE. YEAR 2004 .................................................................................................................... 43

– LINK TO: GUIDE TO SAFETY AND QUALITY ASSURANCE FOR ORGANS, TISSUES AND CELLS ................................. 44

– RECOMMENDATION REC (2004) 19 OF THE COMMITTEE OF MINISTERS TO MEMBER STATES ON CRITERIA FOR

THE AUTHORISATION OF ORGAN TRANSPLANTATION FACILITIES ..................................................................... 45

– RECOMMENDATION REC (2005) 11 OF THE COMMITTEE OF MINISTERS TO MEMBER STATES ON THE ROLE AND

TRAINING OF PROFESSIONALS RESPONSIBLE FOR ORGAN DONATION (TRANSPLANT «DONOR CO-ORDINATORS») ....... 47

CONTENTS

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International figures onorgan donation and

transplantation activityYear 2004

COUNCILOF EUROPE

CONSEILDE L’EUROPE

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CA

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Ann

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16,7

19,6

13,7

20,9 13

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1311,9

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16

20,5

22,6

18 13,4

0,5 0,

9

6

10

2

11,4

8,8

21,1

34,6

2112

,6

22,1

13,8

15,5

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2

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17,8

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18,4

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39,3

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0,9 1,

8

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30,6

47,8

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20

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CANADÁ

USA

AUSTRALIA

NEW ZEALAND

POPULATION: 31,9 millions (pmp)Cadaveric donors 414 (13),0Cadaveric Kidney Transplant 603 (18,9)Living Kidney Transplant 413 (12,9)Liver Transplant 420 (13,2)Heart Transplant 146 0(4,6)Heart - Lung Transplant 3 0(0,1)S. Lung + D. Lung Transp. 135 0(4,2)Pancreas Transplant 61 0(1,9)

POPULATION: 297 millions (pmp)Cadaveric donors 7.150 (24,1)Cadaveric Kidney Transplant 9.354 (31,5)Living Kidney Transplant 6.647 (22,4)Liver Transplant 6.168 (20,8)Heart Transplant 2.055 0(6,9)Heart - Lung Transplant 39 0(0,1)S. Lung + D. Lung Transp. 1.173 0(3,9)Pancreas Transplant 1.484 0(5),0

POPULATION: 20,1/4,1 millions Australia N. ZealandCadaveric donors (pmp) 218 (10,8) 40 0(9,8)Cadaveric Kidney Transplant 405 (20,1) 58 (14,2)Living Kidney Transplant 246 (12,2) 48 (11,8)Liver Transplant 177 0(8,8) 36 0(8,8)Heart Transplant 78 0(3,8) 6 0(1,4)Heart - Lung Transplant 6 0(0,2) –0000–0S. Lung + D. Lung Transp. 98 0(4,8) 12 0(2,9)Pancreas Transplant 31 0(1,5) 2 0(0,4)

CANADÁ

USA

AUSTRALIA

NEW ZEALAND

Kidney Liver Heart Lung PancreasPatients awaitingfor a transplant by2004, 31st Dec. 2.975 667 129 181 154Patients deadwhile on the WLduring 2004 0.058 096 026 043 003

Kidney Liver Heart Lung PancreasPatients awaitingfor a transplant by2004, 31st Dec. 1.399 104 45 87 30Patients deadwhile on the WLduring 2004 – – – – –

Kidney Liver Heart Lung PancreasPatients awaitingfor a transplant by2004, 31st Dec. 301 12 10 7 4

Kidney Liver Heart Lung PancreasPatients admittedto the waiting listduring 2004 27.298 10.180 2.908 1.964 2.788Patients awaitingfor a transplant by2004, 31st Dec. 61.924 17.336 3.309 3.659 4.159Patients deadwhile on the WLduring 2004 21.548 09.537 3.150 1.882 2.604

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CADAVERIC DONORSAnnual Rate p.m.p. 2004

14,1

21,8

3,1

0,3

6,81,9

7,7

6

1

0,3

0,2

10,8 19,2

8,9

3,2

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CADAVERIC KIDNEYTRANSPLANT & / LIVING

KIDNEY TRANSPLANTAnnual Rate p.m.p. 2004

1,51,4

16,50

02,8

166,1

0,55,5

102,1

3,64,21

10,27,3

8,91,9

1,60,9

01,2

15,35

15,62,2 26,3

0

3,22,6

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% LIVING KIDNEY TRANSPLANTS /TOTAL KIDNEY TRANSPLANTS

8,6

10027,9

0

92

17,953,4

41,7

17,5

36,1

100

2,7 0

12,3

44,4

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LIVER TRANSPLANTAnnual Rate p.m.p. 2004

2,3

17,9

1

2

5,3

3

0,2

0,4

6,6

4,7

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HEART TRANSPLANTHeart - Lung Transp. Included

Annual Rate p.m.p. 2004

0,3

4,6

0,2

1,1

0,2

1,9 3,1

1,4

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LUNG TRANSPLANTSingle + Double Lung

Heart - Lung Transp. IncludedAnnual Rate p.m.p. 2004

1,8

0,3

0,2

0,1

0,8 0,3

0,4

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PANCREAS TRANSPLANT–included all the combinations–

Annual Rate p.m.p. 2004

2,8

0,4

0,2 1,6

0,1

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International data on organdonation and transplantation activity,

waiting list and family refusalsYear 2004

COUNCILOF EUROPE

CONSEILDE L’EUROPE

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uded

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58 (7

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120

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le -

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incl

uded

all

the

com

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tions

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mp)

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p)30

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Alo

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ll th

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LTIV

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ERA

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49 (0

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Page 25

25

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29

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1310

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ic T

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284

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(pm

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(4’3

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(11’

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199

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Pae

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66

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Live

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Page 26

26

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Page 27

27

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ears

LUN

GTX

– in

clud

ed a

ll th

e co

mbi

natio

ns -

(pm

p)31

(0.8

3)43

(0.2

4)6

(0.4

)4

(0.0

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aedi

atric

<15

yea

rs2

(<18

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e (p

mp)

26 (0

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ble

- in

clud

ed H

eart

/ Lu

ng T

X -

(pm

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– d

oubl

e +

sing

le -

Lun

g TX

(pm

p)

PAN

CR

EAS

TX –

incl

uded

all

the

com

bina

tions

- (p

mp)

9 (0

.2)

100

(0.3

7)1

(0.0

66)

Pae

diat

ric <

15 y

ears

-Kid

ney

- P

ancr

eas

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mp)

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.2)

1 (0

.066

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ancr

eas

TX A

lone

(pm

p)

SMA

LL B

OW

ELTX

– in

clud

ed a

ll th

e co

mbi

natio

ns -

(pm

p)1

(0.0

05)

1 (0

.066

)2

(0.0

4)P

aedi

atric

<15

yea

rs-L

iver

+ S

mal

l Bow

el (p

mp)

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. TX

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ne (p

mp)

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.066

)

MU

LTIV

ISC

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mp)

5

Page 28

28

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uded

all

the

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bina

tions

- (p

mp)

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24 (1

6.6)

39 (1

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72 (2

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ric <

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ears

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mp)

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94 (3

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4 (0

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Livi

ng T

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69 (5

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1253

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05)

7 (2

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26 (0

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24 (6

.1)

108

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ney

TX (p

mp)

LIVE

RTX

– in

clud

ed a

ll th

e co

mbi

natio

ns -

(pm

p)10

0 (1

)2

(0.4

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(0.2

)70

(17.

9)2

Pae

diat

ric <

15 y

ears

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it Li

ver

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mp)

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Live

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Liv

er T

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mp)

3 (0

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HEA

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clud

ed H

eart

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tra

nspl

ant-

(pm

p)20

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(0.2

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(4.6

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2)P

aedi

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<15

yea

rs

HEA

RT-

LUN

GTr

ansp

lant

s (p

mp)

Pae

diat

ric <

15 y

ears

LUN

GTX

– in

clud

ed a

ll th

e co

mbi

natio

ns -

(pm

p)3

(0.3

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(1.8

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(0.3

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ble

- in

clud

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ng T

X -

(pm

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(0.3

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oubl

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sing

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Lun

g TX

(pm

p)

PAN

CR

EAS

TX –

incl

uded

all

the

com

bina

tions

- (p

mp)

11 (2

.8)

5 (1

.6)

Pae

diat

ric <

15 y

ears

5 (1

.6)

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ney

- P

ancr

eas

TX (p

mp)

-Pan

crea

s TX

Alo

ne (p

mp)

SMA

LL B

OW

ELTX

– in

clud

ed a

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ns -

(pm

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<15

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iver

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mal

l Bow

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MU

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ERA

L(p

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Page 29

29

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2833

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g 20

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330

893

5250

1160

1427

81P

atie

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awai

ting

for

a TX

by

2004

, 31st

Dec

108

243

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247

415

2547

Pat

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s de

ad w

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on

the

WL

durin

g 20

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267

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328

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RT

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X C

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126

11

Pat

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mitt

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o th

e W

L du

ring

2004

9593

7533

2342

975

69

21P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

75

3474

184

277

613

1822

Pat

ient

s de

ad w

hile

on

the

WL

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g 20

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1216

24

8717

22

13

HEA

RT-

LUN

GN

ºTX

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TRES

:9

Pat

ient

s ad

mitt

ed t

o th

e W

L du

ring

2004

29P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

39

Pat

ient

s de

ad w

hile

on

the

WL

durin

g 20

0418

LUN

GN

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TRES

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121

Pat

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s ad

mitt

ed t

o th

e W

L du

ring

2004

100

6616

459

176

405

9P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

57

4622

414

144

457

24

Pat

ient

s de

ad w

hile

on

the

WL

durin

g 20

0413

113

81

4410

8

PAN

CR

EAS

NºT

X C

ENTR

ES:

18

2P

atie

nts

adm

itted

to

the

WL

durin

g 20

0438

375

511

121

313

Pat

ient

s aw

aitin

g fo

r a

TX b

y 20

04, 3

1stD

ec36

536

1318

115

814

Pat

ient

s de

ad w

hile

on

the

WL

durin

g 20

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58

141

SMA

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TRES

:1

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ient

s ad

mitt

ed t

o th

e W

L du

ring

2004

3P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

4

Pat

ient

s de

ad w

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on

the

WL

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Page 30

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Pat

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ring

2004

22

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613

2519

211

9043

2P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

171

497

6561

375

434

1485

169

1201

1626

Pat

ient

s de

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on

the

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g 20

04

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812

413

3873

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D o

n di

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is t

reat

men

t du

ring

2004

19

015

340

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320

16

1P

atie

nts

adm

itted

to

the

WL

durin

g 20

04

118

1359

5329

023

4P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

21

130

1457

410

529

0P

atie

nts

dead

whi

le o

n th

e W

L du

ring

2004

27

137

525

36

HEA

RT

NºT

X C

ENTR

ES:

318

61

42

Pat

ient

s ad

mitt

ed t

o th

e W

L du

ring

2004

68

498

635

213

35P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

12

164

06

417

872

Pat

ient

s de

ad w

hile

on

the

WL

durin

g 20

04

2493

11

428

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RT-

LUN

GN

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:2

Pat

ient

s ad

mitt

ed t

o th

e W

L du

ring

2004

18

Pat

ient

s aw

aitin

g fo

r a

TX b

y 20

04, 3

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14P

atie

nts

dead

whi

le o

n th

e W

L du

ring

2004

7

LUN

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:2

141

1P

atie

nts

adm

itted

to

the

WL

durin

g 20

04

4118

632

7P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

44

238

458

Pat

ient

s de

ad w

hile

on

the

WL

durin

g 20

04

1066

9

PAN

CR

EAS

NºT

X C

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ES:

13

171

41

Pat

ient

s ad

mitt

ed t

o th

e W

L du

ring

2004

12

614

30P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

720

514

25P

atie

nts

dead

whi

le o

n th

e W

L du

ring

2004

72

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2004

8

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ient

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2004

Page 31

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2520

243

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Pat

ient

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mitt

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2004

22

438

357

282

832

1403

2808

2729

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ting

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2004

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108

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488

116

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2975

301

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2004

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the

WL

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04

312

1460

130

115

154

631

875

1018

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atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

7

670

117

8615

573

725

310

466

712

1733

6P

atie

nts

dead

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le o

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e W

L du

ring

2004

1

116

36

1521

6296

9573

HEA

RT

NºT

X C

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ES:

21

173

412

74

121

131

Pat

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s ad

mitt

ed t

o th

e W

L du

ring

2004

9

939

436

4559

2420

629

08P

atie

nts

awai

ting

for

a TX

by

2004

, 31st

Dec

3

1611

316

1845

182

111

4512

910

3309

Pat

ient

s de

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on

the

WL

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g 20

04

15

362

616

1726

3150

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RT-

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:P

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WL

durin

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04

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nts

dead

whi

le o

n th

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L du

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2004

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:1

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64

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to

the

WL

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g 20

04

120

938

4188

120

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awai

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for

a TX

by

2004

, 31st

Dec

145

3117

861

272

8718

17

3659

Pat

ient

s de

ad w

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on

the

WL

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04

126

63

1446

4318

82

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CR

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X C

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32

259

27

114

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the

WL

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04

9812

395

2627

88P

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for

a TX

by

2004

, 31st

Dec

796

3435

3630

154

441

59P

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nts

dead

whi

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n th

e W

L du

ring

2004

3

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13

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33

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WL

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04

82

1424

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for

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by

2004

, 31st

Dec

6

16

119

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dead

whi

le o

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e W

L du

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2004

2

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Page 32

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412

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atie

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by

2004

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2004

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Pat

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2004

, 31st

Dec

12

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2004

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10

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Page 33

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Page 39

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International data on tissue andhematopoietic stem cell

transplant activityYear 2004

COUNCILOF EUROPE

CONSEILDE L’EUROPE

Page 40

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Page 42

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Page 43

43

�

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Documents produced by theTransplant Committee of the

Council of EuropeYear 2004

COUNCILOF EUROPE

CONSEILDE L’EUROPE

Page 44

44

�

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This Guide includes standards for procurements, preservation,processing and distribution of organs, tissues and cells. It is thefirst international text on this topic adopted by Health Authorities.

ISBN: 92-871-5518-6Format: 16 x 24 cmNo. of pages: 95

SYNOPSIS

The purpose of this guide is to provide guidance for all those involved in the transplantation tomaximise the quality, and thereby the success rate, of transplants, and to minimise the risks to allinvolved in this complex procedure. It includes safety and quality standards for procurement, pre-servation, processing, and distribution of organs, tissues and cells of human origin (allogeneic andautologous) used for transplantation purposes.

As the European Union Directive on Tissues and Cells (2004/23/EC) was recently adopted, theEuropean Commission will build on the Council of Europe’s guide when establishing technicalstandards under the directive. This co-operation will ensure that the same standards are appliedthroughout Europe.

CONTENTS

1. Introduction.2. Quality management: principles for ensuring the quality of organs, tissues and cells.3. Selection of donors.4. Organ procurement and preservation.5. Tissue and cell procurement.6. Tissue establishments.7. Transplantation practices.Appendices.

http://www.coe.int/T/E/Social_Cohesion/Health/Activities/Organ_transplantation/

GUIDE TO SAFETY AND QUALITYASSURANCE FOR ORGANS,

TISSUES AND CELLS - 2nd Edition (2004)

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RECOMMENDATION REC(2004)19OF THE COMMITTEE OF MINISTERSTO MEMBER STATES ON CRITERIA

FOR THE AUTHORISATIONOF ORGAN TRANSPLANTATION FACILITIES

Adopted by the Committee of Ministers on 15 December 2004at the 909th meeting of the Ministers’ Deputies

The Committee of Ministers, under the terms of Ar-ticle 15.b of the Statute of the Council of Europe,

Considering that the aim of the Council of Euro-pe is to achieve greater unity between its mem-bers and that this aim may be pursued inter alia by the adoption of common action in the healthfield;

Taking into account Resolution No. R (78) 29 onharmonisation of legislation of member states relatingto removal, grafting and transplantation of humansubstances, the final text of the 3rd Conference of Eu-ropean Health Ministers (Paris, 16-17 November1987); Articles 19 and 20 of the Convention of HumanRights and Biomedicine, and Articles 3 and 4 of theAdditional Protocol to the Convention on HumanRights and Biomedicine, on Transplantation of Organsand Tissues of Human Origin;

Considering that:

– organ transplantation is a well-established, life-saving, and effective treatment: a successful or-gan transplantation may be the only treatmentavailable for some forms of end stage organ fai-lure and is the most clinically and cost effectivetreatment for chronic renal failure;

– organ exchange and circulation of recipientsamong member states is becoming a more fre-quent phenomenon, and that a minimum com-mon standard should be guaranteed to the citi-zens;

– member states should therefore provide high-quality transplant services for the benefit of theircitizens. Considering the limited organ supply, allnecessary steps should be taken to make sureall available organs are properly safeguarded andused so as to maximise the benefit to patients;

– the highest professional standards are to bemaintained in the area of organ transplantation,

Recommends that the governments of memberstates take all necessary measures to ensure the fo-llowing:

1. An appropriate mechanism for the authorisa-tion1 of health care facilities carrying out organtransplantations2 should be set up. In order toobtain authorisation these facilities should meetthe following criteria:

– feasibility of programme, based on clinical ne-ed assessment and a documented estimateof organ supply, to ensure that projected ac-tivity levels are sufficient to maintain clinicalexpertise and programme quality;

1 For the purpose of this Recommendation, the term «authori-sation» refers to any appropriate mechanism for designating, aut-horising, accrediting or licensing health care facilities carrying outorgan transplantations.

2 This Recommendation refers to the facilities where organs arebeing «implanted».

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– standards of vocational training of teammembers, and infrastructural conditions rela-ting to availability of beds, intensive care facilities, and diagnostic and therapeuticback-up services (radiology, microbiology, im-munology services, etc.), and to care provi-ded by nursing, physiotherapy, social servicesand related medical professionals.

2. Medical professionals forming part of an organtransplant team should be properly qualified andtheir previous training in the field of transplanta-tion should be documented and personalised.

3. A quality-management system should be put inplace to evaluate performance against establis-hed national and/or international standards asapplicable, and to ensure the quality of the pro-cess of organ procurement and transplantation,following the principles described in the Coun-cil of Europe’s Guide to safety and quality assu-rance for organs, tissues and cells.

4. Authorisations should be regularly reviewedagainst agreed quality criteria and standards, aswell as against audit results.

5. Outcome results for each type of transplantshould be within the margins of internatio-

nal registers, at an equivalent degree of com-plexity of patients. In order to guarantee clini-cal results and cost-effective performance, mi-nimal yearly activity standards shall beestablished in order to maintain an active pro-gramme.

6. These minimal activity standards, required to ke-ep active each kind of transplant programme,should be related to the mean number of cada-veric organs available to the transplant team inrecent years.

7. Any transplant centre which, after several war-nings, continues to fail to meet activity or out-come criteria may have its authorisation with-drawn.

8. No new transplant centre may be authorised ifthere are not enough organs available to ena-ble a new centre to reach the required stan-dards.

9. Any new transplant centre should be authorised,accredited or licensed on the basis of agreedcriteria and initially should be limited in time. If,within an agreed timescale, the new centre do-es not achieve the required standards, authori-sation shall be withdrawn.

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RECOMMENDATION REC(2005)11OF THE COMMITTEE OF MINISTERSTO MEMBER STATES ON THE ROLEAND TRAINING OF PROFESSIONALS

RESPONSIBLE FOR ORGAN DONATION(TRANSPLANT «DONOR CO-ORDINATORS»)

Adopted by the Committee of Ministers on 15 June 2005at the 930th meeting of the Ministers’ Deputies

The Committee of Ministers, under the terms of Ar-ticle 15.b of the Statute of the Council of Europe,

Considering that the aim of the Council of Euro-pe is to achieve greater unity between its mem-bers and that this aim may be pursued, inter alia, by the adoption of common action in the healthfield;

Taking into account Resolution (78) 29 on the har-monisation of legislation of member states relatingto removal, grafting and transplantation of humansubstances, the final text of the 3rd Conference ofEuropean Health Ministers (Paris, 16 and 17 No-vember 1987); Articles 19 and 20 of the Conventionon Human Rights and Biomedicine, and Articles 3and 4 of the Additional Protocol to the Conventionon Human Rights and Biomedicine concerningTransplantation of Organs and Tissues of HumanOrigin, and principles established in the 1998 Coun-cil of Europe consensus document entitled «Meetingthe organ shortage»;

Considering that organ transplantation is a well-es-tablished, life-saving, and effective treatment: a suc-cessful organ transplant may be the only treatmentavailable for some forms of end stage organ failureand is the most clinically effective and cost-effectivetreatment for chronic renal failure;

Considering the universal shortage of organs fortransplantation;

Considering that the transplant process is complex,involves various services and therefore requires effec-tive organisation and co-ordination of health care pro-fessionals;

Bearing in mind that in many member states thetraining and employment of health care professionalsresponsible for detecting potential deceased organdonors and organising the donation process has in-creased the efficiency of the procurement of organsand improved the functioning of local and nationaltransplant systems; and that such professionals canalso increase the rate of donation of tissues for trans-plantation,

Recommends that the governments of memberstates take the measures contained in the appendixto this recommendation as regards the role and trai-ning of professionals responsible for organ donation(transplant «donor co-ordinators»).

APPENDIX TO RECOMMENDATION REC(2005)11

1. A professional responsible for the identificationof potential deceased organ and/or tissue do-nors should be appointed in every hospital withan intensive care unit. This professional shouldhave appropriate training and experience, be in-dependent of any transplant teams, and have

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clearly defined responsibilities for the establish-ment, management and audit of a hospital-ba-sed system for potential deceased donor iden-tification and organ/tissue procurement. Theperson should also be responsible for monito-ring the donation and procurement process andfor identifying and implementing improvements.For the purposes of this recommendation, theprofessional will be termed a transplant «donorcoordinator».

2. Donor co-ordinators should be properly ac-countable to senior management of the relevanthealth institution and to any regional or national

transplant organisations. Donor co-ordinatorsmay be complemented by, or responsible to, ot-her transplant co-ordinators at regional or natio-nal level.

3. Donor co-ordinators, and any other transplantco-ordinators should have a high standard ofprofessional training consistent with internatio-nally recognised standards, to ensure the hig-hest possible professional and ethical standardsin organ donation and procurement. Memberstates should establish formal national or inter-national accreditation for donor co-ordinationactivities/donor co-ordinators.

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MEMBERS OF THE TRANSPLANT COMMITTEEOF THE COUNCIL OF EUROPE

AUSTRIAFerdinand MühlbacherBELGIUMLudo MuylleJean-Paul SquiffletBOSNIA AND HERZEGOVINAMarina BeraBULGARIAYanko NachkovCROATIAMirela BusicCYPRUSGeorge KyriakidesCZECH REPUBLICPremysl FrydaSylva Dusilova-SulkovaDENMARKJorn CarlsenESTONIAPeeter DmitrievEUROTRANSPLANTGermany, The Netherlands, Austria, Belgium, Slovenia, LuxemburgGuido PersijnBernard CohenFINLANDKaija SalmelaFRANCEBernard LotyGEORGIAGia TomadzeGERMANYGünter KirsteGREECEIoannis BoletisHUNGARYJozsef BorsiFerenc PernerIRELANDDavid P HicKeyISRAELTamar AshkenaziAlain BerrebiITALYAlessandro Nanni CostaGiuseppe PiccoloLATVIARafail Rozental

LITHUANIAJulija ShirokovaMALTAPeter CauchiNORWAYPer PfefferPOLANDJanusz WalaszewskiPOTUGALManuel M. AbecasisLuisa TaveiraRUSSIAN FEDERATIONNikolay V. TarabarKoROMANIAIrinel PopescuSCANDIATRANSPLANTSLOVENIADenmark, Sweden, Norway, Finland, IcelandPer PfefferArnt JakobsenSERBIA AND MONTENEGROSinisa GradinacSLOVAK REPUBLICLudovit LacaSLOVENIADanica Avsec- LetonjaSPAINRafael MatesanzSWEDENHakan GabelSWITZERLANDPhilippe MorelTURKEYBekir KeskinkilicTHE NETHERLANDSBernadette Haase-KromwijkUNITED KINGDOMChris RudgeStephen Powis

COUNCIL OF EUROPE (Secretariat)Alina TatarenkoSophie-Marie Le GuillouxJacqueline LostaoEUROPEAN COMMISSIONEduardo Fernandez-ZinckeWHOLuc Nöel

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