Transplantation and transfusion : projects and actions for saving and improving the quality of life of citizens by facilitating transplantation and blood transfusion in the European Union.
Date: 2013-11-15
Institutions: Directorate-General for Health and Consumers, Executive Agency for Health and Consumers
Subjects: EU Member State, EU programme, cooperation policy, health policy, impact study, medical research, organ transplantation, public awareness campaign

  Transplantation 
       Transfusion

and

Projects and Actions for saving and  
improving the quality of life of citizens 
by facilitating transplantation and blood 
transfusion in the European Union

Executive Agency 
for Health and 
Consumers

Acknowledgements

This publication is the result of the joint work of Martina Melis (Cagliari, Italy), Jesús López Alcalde 
(Madrid, Spain) and Csilla Kaposvári (Strasbourg, France). 

Comments, interviews and further material were provided by the project coordinators and project 
members of the respective projects and activities. 

Comments were provided by the ‘Substances of human origin’ team of the Directorate-General for 
Health and Consumers of the European Commission.

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‘Monolith’ by Cornelia Brandstetter
A pair in tight embracement. They are almost a monolith, mutually understanding and accepting each 
other’s plight; donating an organ, giving life.
Giving in this manner transforms the world to hopeful green, the atmosphere to life-giving air.
The sensitive use of colour gives this picture strong emotional power. 

The views expressed in the report do not necessarily reﬂect the opinion of the European Commission 
and are not binding.

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Luxembourg: Publications Oﬃce of the European Union, 2013

ISBN 978-92-9200-020-2  
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Transplantation 
and
 Transfusion

Projects and Actions for saving 
and improving the quality of 
life of citizens by facilitating 
transplantation and blood 
transfusion in the European Union

 
At the Organ Donation Day in Zagreb (Croatia) 2010, medical students formed a street performance and used 

bodies to shape a formation and simulation of a beating heart in the main city square of Bana Jelačiča.

(EDD project, see later in this publication)

Further information on the projects can be found:

— on the Health Programme Projects database at:
http://ec.europa.eu/eahc/projects/database.html

— on the DG Health and Consumers Health Portal at:
http://ec.europa.eu/health-eu/index_en.htm

— on the DG Health and Consumers website at:
http://ec.europa.eu/health/

The Executive Agency for Health and Consumers (EAHC) implements the EU Health Programme, 
the EU Consumer Programme and the EU Better Training for Safer Food Initiative. See more at:
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Foreword

In medicine, blood, tissue and cell — as well as organ — transplants are used to provide treat-
ments to our citizens. Blood and blood components are essential in major surgery and to deal 
with traumas and bleeding. Transplants of organs are life-saving for many patients with serious 
chronic conditions, allowing them to return to normal daily activities. Tissue and cell transplants 
help restore body functions like eye-sight, skin barriers or immunity.

The European Commission’s role here is to develop high standards of quality and safety of sub-
stances of human origin used in medicine, as foreseen in the Treaty on the Functioning of the 
European Union. 

Our aim is to ensure safety throughout the European Union, so that when a citizen needs blood, 
some tissue or even an organ, he or she can rely on the safety of these substances. Donations need 
to be checked for safety, both for the donor and for the future recipient. The consequent steps 
leading to transfusion and transplantation need to respect minimal safety and quality require-
ments. All these professional activities are therefore subject to appropriate oversight activities, 
including authorisations, inspections, vigilance and traceability.

These medical practices are progressing continuously and therefore require the know-how and 
expertise of all actors in the ﬁeld. The European Commission’s services work closely together with 
professional actors as well as with the national authorities who oversee activities within their 
respective countries. 

One way to bring together such EU-wide expertise for the beneﬁt of patients is through projects 
and actions supported under the EU Health Programme. This publication presents an overview of 
the many projects that pursue the objective of oﬀering access to safe and high-quality therapies. 
Many such projects foster the sharing of knowledge amongst experts and authorities, and thus 
bring European added value to national eﬀorts in providing safe and secure transplantation and 
transfusion therapies throughout the European Union.

I am conﬁdent that these projects will encourage all European organisations involved to continue 
to work together towards the common goal of improving the quality of life of European citizens.

Tonio BORG
European Commissioner for Health

Introduction

Since 2003, about 50 projects and other activities have been funded by the European Union in 
the area of transplantation and transfusion, in the framework of the EU health and research 
framework programmes and other European funding schemes. 

These projects and activities include exchanges of best practice, standards for inspections, manu-
als and registers as well as training workshops. Most of them directly contributed to the imple-
mentation and transposition of the three major directives in the ﬁeld of substances of human 
origin (SoHO), namely: (1) Directive 2002/98/EC on ‘setting standards of quality and safety for the 
collection, testing, processing, storage and distribution of human blood and blood components’; 
(2) Directive 2004/23/EC on ‘setting standards of quality and safety for the donation, procure-
ment, testing, processing, preservation, storage and distribution of human tissues and cells’; 
and (3) Directive 2010/45/EU on ‘standards of quality and safety of human organs intended for 
transplantation’.

This brochure introduces each project with a short summary and provides descriptions of their 
major outputs. It aims to give as comprehensive an overview as possible and to provide references 
for later in-depth reading. It furthermore aims to illustrate how the outcomes of the projects 
presented shape the safety of patients, medical professionals and donors in Europe. 

Projects were selected according to their contribution to the implementation of the abovemen-
tioned directives and were not restricted to a particular funding scheme. 

The publication has three sections, according to the projects’ contribution to the implementation 
of the directives: projects in the area of blood and blood components (red background); projects 
in the area of human tissues and cells for transplantation (blue background); and projects in the 
area of organ donation and transplantation (orange background).

Projects have been summarised by means of desk research. In addition, interviews were conducted 
with project coordinators and participants. The main outputs are represented in graphical form 
and an information box has been provided for each project, giving references for further reading. 
This approach is intended to bring an ‘outside’ perspective on the projects and activities and to 
let the brochure serve as an overview for reference purposes. 

This brochure was produced by the Executive Agency for Health and Consumers (EAHC) in close collaboration with the Directorate-

General for Health and Consumers of the European Commission. The agency, set up by the European Commission in 2005, has 

the mission, among others, of supporting the implementation of the EU health programmes, of disseminating knowledge and best 

practice generated by the actions funded and of fostering exchange and cooperation between European public health professionals. 

Contents

Foreword ............................................................................................................... 3

Introduction ......................................................................................................... 4

List of acronyms ............................................................................................... 8

Blood and Blood Components ............................................................... 11

Overview of projects in this section .............................................................................................................................. 15

Development of a pan-European standard operating procedure (SOP) methodology 
reﬂecting European best practice within the area addressing the quality and safety 
of blood (EU-Q-Blood-SOP project) ................................................................................................................ 16

Development of pan-European standards and criteria for the inspection of blood 
establishments (EuBIS) ......................................................................................................................................... 20

Creating a safe and suﬃcient donor population in Europe: comparing and 
recommending good donor management practice (DOMAINE) .....................................................24

EU Optimal Blood Use Project (EUOBU) ....................................................................................................... 28

Quality Systems in the Blood Transfusion Field including inventory Visits,  
Audits and Proﬁciency Testing Scheme (PTS) studies (CoE EDQM)............................................. 32

Ad hoc cooperation between EC and the CoE/EDQM on speciﬁc matters related  
to human substances (blood) in order to further develop and strengthen EU policy 
actions in this ﬁeld (TS066 CoE2011) .......................................................................................................... 36

Training sessions for inspectors in the ﬁeld of blood and blood components (CATIE) .....41

EU-wide overview of the market of blood, blood components and  
plasma derivatives with a particular focus on their availability for patients  
(EAHC/2011/Health/15) ......................................................................................................................................... 44

Improving the safety of blood and organ supply by creating the research  
infrastructure to monitor emerging pathogens and develop new screening  
tests (BOTIA) ................................................................................................................................................................ 47

Genomics and Blood Substitutes for 21st Century Europe  
(EURO BLOOD SUBSTITUTES) ............................................................................................................................ 50

Rapid SPR for parallel detection of pathogens in blood (RaSP) .................................................... 54

Development of a Blood Screening Assay for Diagnosis of Prion Diseases  
in Humans (PRIONSCREEN) ................................................................................................................................. 58

Human tissues and cells for transplantation ............................... 63

Overview table of projects in this section ................................................................................................................. 67

European registry for organs, tissues and cells (EUROCET project) ........................................... 68

Joint Accreditation Committee ISCT Europe & EBMT (JACIE) ......................................................... 72

European Union standards and training for the inspection of tissues  
establishments (EUSTITE) .................................................................................................................................... 76

Promoting optimisation, safety, experience sharing and quality implementation 
for donation organisation and networking in unrelated haematopoietic stem cell 
transplantation in Europe (POSEIDON) .........................................................................................................81

European Good Tissue Practices (Euro-GTPs) .......................................................................................... 84

Vigilance and Surveillance of Substances of Human Origin (SoHO V&S) ............................... 89

European Quality System for Tissue Banking Project (EQSTB) ...................................................... 94

Building reference compendia for the application of a single European coding  
system for tissues and cells (Eurocet128, EAHC/ 2011/HEALTH/03) ........................................ 98

Evaluation of legislation and related guidelines on the procurement, storage and  
transfer of human tissues and cells in the European Union — an evidence-based  
impact analysis (Tiss.EU) ................................................................................................................................... 102

Reprogramming the immune system for the establishment of tolerance (RISET) ......... 107

Strengthen and develop scientiﬁc and technological excellence in research and  
therapy of leukaemia (CML, AML, ALL, CLL, MDS, CMPD) by integration of the  
leading national leukaemia networks and their interdisciplinary partner groups  
in Europe (European LeukemiaNet) ..............................................................................................................112

Transplantation Research Integration across Europe (TRIE) .........................................................117

Comparative analysis of medically assisted reproduction in the EU: regulation  
and technologies (SANCO/2008/C6/051) .................................................................................................121

Analysis and comparison of testing methods and testing laboratories in the EU  
and third countries for the biological markers speciﬁed in the blood and tissues  
and cells Directives (SANCO/2008/C6/012) ........................................................................................... 125

Organ donation and transplantation .............................................. 131

Overview of projects in this section ........................................................................................................................... 135

Improving the knowledge and practice of Organ Donation (DOPKI) ....................................... 136

European Group for Coordination of National Research Programmes on  
Organ Donation and Transplantation (ALLIANCE-O) .........................................................................141

European Training Programme on Organ Donation (ETPOD) ....................................................... 146

European Living Donation and Public Health (EULID) .......................................................................151

European Framework for the Evaluation of Organ Transplants (EFRETOS) ........................ 156

European Living Donor Psychological Follow-up (ELIPSY) ............................................................ 162

Developing Guidelines for the Organisation of a Public Organ Donation Day (EDD) ..... 166

European Quality System Indicators and methodology on Organ Donation (ODEQUS) .....173

Coordinating a European Initiative among National Organisations for Organ 
Transplantation (COORENOR) ......................................................................................................................... 177

2ND Conference on Organ Transplantation: Ethical, Legal and Psychosocial  
Aspects — Expanding the European Platform (ELPAT) .................................................................. 184

Joint Action on Mutual Organ Donation and Transplantation Exchanges:  
Improving and developing deceased organ donation and transplantation  
programmes (MODE) ........................................................................................................................................... 188

Achieving Comprehensive Coordination in Organ Donation throughout the  
European Union (Joint Action ACCORD) .................................................................................................... 193

European Training Course for Trainers in Transplant Donor Coordination in  
the European Union .............................................................................................................................................. 199

Study on the set-up of organ donation and transplantation in the EU Member  
States, uptake and impact of the EU Action Plan on Organ Donation  
and Transplantation (2009–2015) .............................................................................................................. 204

Living Organ Donation in Europe (EULOD) .............................................................................................. 208

List of acronyms

Accord

joint action on achieving comprehensive coordination in organ donation 
throughout the European Union 

AFSSAPS

Agence française de sécurité sanitaire des produits de santé  (French Agency 
for the Safety of Health Products)

ALLIANCE-O

‘European group for coordination of research programmes on organ donation 
and transplantation’ project

BIG V & S

Bologna initiative for global vigilance and surveillance

BOTIA

B-PTS

CATIE

CJD

CoE

‘Blood and organ transmissible infections agents’ project

blood-proﬁciency testing scheme

competent authority training on inspections in Europe

Creutzfeldt Jakob disease

Council of Europe

Coorenor

‘Coordinating a European initiative among national organisations for organ 
transplantation’ project

DG SANCO

Directorate-General for Health and Consumers

Domaine

‘Donor management’ project

DOPKI

‘Improving the knowledge and practice of organ donation’ project

EAHC

EATB

EBA

EBMT

EC

EDD

EDQM

Efretos

Elipsy

ELM

ELPAT

EMEA

EQSTB

ESHRE

ESOT

ETPOD

Executive Agency for Health and Consumers

European Association of Tissue Banks

European Blood Alliance

European Group for Blood and Marrow Transplantation

European Commission

‘European donation day’ project

European Directorate for the Quality of Medicines and Healthcare

‘European framework for the evaluation of organ transplants’ project

‘European living donor psychological follow-up’ project

European LeukemiaNet

‘Ethical, legal and psychosocial aspects of organ transplantation’ platform

European Medicines Agency

‘European quality system for tissue banking’ project 

European Society of Human Reproduction and Embryology

European Society for Organ Transplantation

‘European training programme on organ donation’ project

EU

European Union

EuBIS

EULID

EULOD

EUMDS 

‘EU blood inspection’ project

‘European living donation and public health’ project

‘Living organ donation in Europe’ project

European Myelodysplastic Syndrome Registry

EUOBU

Eurocet

Eurodonor

EURO-GTP

Eustite

‘European Union optimal blood use’ project

‘European Registry for Organs, Tissues and Cells’ project

‘European Donors And Organs Registry’ project

‘European good tissue practices’ project 

‘European Union standards and training for the inspection of tissues 
establishments’ project 

HSCT

haematopoietic stem cells transplantation

ICCBBA

International Council for Commonality in Blood Banking Automation

IFBDO

IMI JU

ISCT

JACIE

MODE

NAT

NIVEL

International Federation of Blood Donor Organisations

innovative medicines initiative joint undertaking

International Society of Cellular Therapy

Joint Accreditation Committee ISCT Europe and EBMT

joint action for mutual organ donation and transplantation exchange

nucleic acid ampliﬁcation technique

Netherlands Institute for Health Services Research 

Odecus

‘Organ donation European quality system’ project

OMCL

ONT

PBSC

PICS

oﬃcial medicines control laboratories

Organización Nacional de Trasplantes (Spanish National Transplant 
Organisation)

peripheral blood stem cells

pharmaceutical inspection cooperation scheme

Poseidon

‘Promoting optimisation, safety, experience sharing and quality 
implementation for donation in unrelated HSCT’ project

Prionscreen

‘Development of a blood screening assay for diagnosis of prion diseases in 
humans’ project

PTS

QA

QALY

QMS

RaSP

RISET

‘Visit, audits and proﬁciency testing scheme’ programme

quality assurance 

quality-adjusted life years

quality management system

‘Rapid surface plasmon resonance (SPR) detection of pathogens in blood’ 
project

‘Reprogramming the immune system for the establishment of tolerance’ 
project

SoHO

substances of human origin

SoHO V&S

vigilance and surveillance of substances of human origin

SOP

SPR

TCO 

TE

standard operating procedure

surface plasmon resonance

transplant coordination oﬃce

tissue establishment

Tiss.EU

‘Evaluation of legislation and related guidelines on the procurement, storage 
and transfer of human tissues and cells in the European Union’ project

TRIE

TPM

WHO

‘Transplantation research integration across Europe’ project

Centre for Transfer of Knowledge, Technology and Innovation of Barcelona

World Health Organisation

Blood and Blood 
Components

B L O O D   A N D   B L O O D   C O M P O N E N T S

13

Blood and blood components are essential for 
healthcare in Europe. There is no major surgery 
without blood supply. Treatments of traumas, 
acute bleeding and several chronic diseases all 
rely on the availability of blood.

Blood cannot be manufactured; neither can it 
be stored over a long period. That is why hos-
pitals need to rely on a continuous and safe 
supply of blood from donations — gi#s from 
blood donors.

In Europe, healthcare for 500 million citizens 
depends on more than 20 million donations of 
blood given by almost 15 million donors. Thirty-
seven per cent of the EU citizens have donated 
blood at least once in their lives. But when we 
look at the repeat donors the ﬁgures are much 
lower. Willingness to donate blood is also seen 
to be higher in the group of 40–54 year olds 
(46 %).

As laid down in Article 168 of the Treaty of 
the Functioning of the European Union, a com-
mon framework has been set up to ensure the 
safety and quality of blood, both for donors 
and for recipients. It is the role of the Euro-
pean Commission to ensure implementation of 
these requirements by the diﬀerent actors in 
the ﬁeld: from blood establishments collect-
ing the donated blood to hospital blood banks 
bringing the blood (components) to the bedside 
of the patient in need of a transfusion.

Legally,  the  framework  is  laid  down  in  Dir-
ective 2002/98/EC of the European Parliament 
and the Council of 27 January 2003 on setting 
standards of quality and safety for the collec-
tion, testing, processing, storage and distribu-
tion of human blood and blood components. 
Consequently, implementing legislation focuses 
on technical requirements for blood (compo-
nents)  (Commission  Directive  2004/33/EC), 
on traceability requirements and notiﬁcation 
of serious adverse reactions and events (alert 
situations) (Commission Directive 2005/61/EC) 
and on quality systems for blood establish-
ments (Commission Directive 2005/62/EC).

The key requirements of the diﬀerent actors in 
the ﬁeld are to apply: (1) clear criteria to select 
donors, (2) laboratory testing of every blood 
donation, and (3) quality standards for process-
ing donated blood. Additional requirements for 
eﬀective oversight are laid down for the com-
petent  authority  in  each  of  the  EU  Member 
States. These include the need for authorisa-
tions and inspections as well as the setting up 

of tracing systems allowing every blood bag 
to be followed and vigilance systems allowing 
prompt action in case of alerts.

There are however some concerns and issues 
that cannot just be dealt with through legisla-
tion. This is why the legal approach, focusing 
on safety and quality, is to be supported by 
well-targeted projects. During the last years, 
DG SANCO has been able to secure funding 
under the EU Health Programmes to work on 
several elements.

1.  Quality and safety measures for blood 
and blood components are evolving 
continuously with technological 
developments. Legislation is therefore 
not always the adequate tool to reﬂect 
these continuous changes in detail. Some 
of these measures need rather to be laid 
down in practical hands-on guidance 
for the blood establishments acting in 
the ﬁeld. The development of a pan-
European standard operating procedure 
(SOP) methodology reﬂecting European 
best practice within the area has led 
to such practical guidance within the 
EU-Blood-SOP project. Consequently, this 
guidance needs to be brought at best to 
the diﬀerent blood establishments in the 
ﬁeld. At this point, the good collaboration 
between the European Commission and 
the Council of Europe’s (CoE) European 
Directorate for the Quality of Medicines 
and Healthcare (EDQM) needs to be 
mentioned. The EDQM has a strong 
experience in oﬀering such guidance 
to European countries (both within and 
outside the EU), amongst others through 
their ‘Guide for the Preparation, Use and 
Quality Assurance of Blood Components’, 
currently at its 16th version. The 
Commission supports this work, amongst 
others by funding an ad hoc cooperation 
with CoE/EDQM to ensure alignment and 
complementarity between their work and 
the EU legislation.

2.  Testing of all blood donations is 

mandatory by EU legislation and is a key 
pillar of blood safety. It is, however, not 
suﬃcient to lay down in the legislation 
what tests are required; one should also 
be able to rely on the accuracy of these 
test results. The Commission has therefore 
supported several projects on the testing 
of blood, from the development of reliable 
routine tests (Rapid SPR for parallel 

14

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

detection of pathogens) in blood to the 
execution of proﬁciency tests by the 
Council of Europe in order to ensure that 
test results are comparable and reliable in 
laboratories all over Europe.

3.  Inspections are an important and 

basic tool in the hands of the national 
competent authorities in order to 
ensure safety and quality within the 
activities of the blood establishments 
in the EU. The Commission is supporting 
the development and dissemination 
of common pan-European inspection 
standards, in order to align these national 
inspections practices, and eventually 
to build mutual conﬁdence between 
authorities in diﬀerent EU Member 
States. The EUBIS project has assessed 
diﬀerences in national inspection practices 
and developed common standards. More 
recently, the CATIE project is organising 
training workshops to bring these common 
standards to diﬀerent countries.

4.  Blood is a scarce resource, it cannot be 
produced but is a gi# from donors. It 
is therefore important that the limited 
supply of blood is managed eﬃciently. 
The Commission supported and intends 
to support several projects working on 
the supply and demand side of blood. The 
EU Optimal Blood Use project (EUOBU) 

focused on health professional in order 
to improve the quality and rationalisation 
of clinical transfusion processes. The 
DOMAINE project focused on the 
assessment and management of donors 
in order to ensure a suﬃcient and reliable 
donor base.

5.  The landscape of blood supply and 

demand is complex and involves many 
actors from donation to transfusion. Some 
of these actors are public, others are 
private. Member States have policies to 
ensure self-suﬃciency of blood and blood 
components. In parallel the demand for 
donations is driven by the growing need 
and market of plasma derivatives. To 
map out all these diﬀerent and complex 
factors, the Commission has ordered an 
EU-wide overview of the market of 
blood, blood components and plasma 
derivatives.

EU Health Programme funded projects aim to 
bring together expertise from a diverse set of 
professionals  in  the  ﬁeld  and  from  authori-
ties in the diﬀerent Member States. They aim 
to develop and share knowledge to improve 
practices in the ﬁeld of transfusion, and there-
with to ensure a suﬃcient supply of safe and 
qualitative blood, blood components and blood 
products to patients in need all over Europe.

B L O O D   A N D   B L O O D   C O M P O N E N T S

15

Overview of projects in this section
Acronym

Title

EU-Q-Blood-SOP

Development of a pan-European standard operating procedure 
(SOP) methodology reﬂecting European best practice within the 
area addressing the quality and safety of blood

EuBIS

DOMAINE

Development of pan-European standards and criteria for the 
inspection of blood establishments

Creating a safe and suﬃcient donor population in Europe: 
comparing and recommending good donor management 
practice

EUOBU 

EU Optimal Blood Use Project

QS-TS programme

Quality systems in the blood transfusion ﬁeld including 
inventory visits, audits and proﬁciency testing scheme 
(PTS) studies

CATIE

BOTIA

Euro Blood 
Substitutes

RaSP

PRIONSCREEN

Ad hoc cooperation between EC and the CoE/EDQM on speciﬁc 
matters related to human substances (blood)

Training sessions for inspectors in the ﬁeld of blood and blood 
components

EU-wide overview of the market for blood, blood components 
and plasma derivatives with a particular focus on their 
availability for patients

Improving the safety of blood and organ supply by creating the 
research infrastructure to monitor emerging pathogens and 
develop new screening tests

Genomics and Blood Substitutes for 21st Century Europe

Rapid SPR for parallel detection of pathogens in blood

Development of a Blood Screening Assay for Diagnosis of Prion 
Diseases in Humans

Page

16

20

24

28

32

36

41

44

47

50

54

58

16

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Development of a pan-European standard operating 
procedure (SOP) methodology reﬂecting European best 
practice within the area addressing the quality and safety 
of blood (EU-Q-Blood-SOP project)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2004217).

In the last decade, the introduction of advanced 
technologies for the collection, processing and 
testing of blood has required an equal advance 
in high quality and safety standards of blood 
and blood components.

Increasing importance has been laid on estab-
lishing eﬀective quality management systems 
for blood establishments. Those systems are 
needed to optimise the control and monitoring 
of the complex and sophisticated processes fol-
lowed by modern blood establishments. A key 
element of quality systems is to deﬁne a com-
mon quality policy using standard processes or 
operating procedures. Standard operating pro-
cedures (SOP) are detailed, written instructions 
that serve to achieve uniformity of the perfor-
mance of a speciﬁc function and are an essen-
tial element of quality management systems.

With  the  adoption  of  Directive  2002/98/EC 
in 2002, the European Union established the 
legislative foundation for setting high levels of 
quality and safety for human blood and blood 
components throughout the blood transfusion 
chain in the European Union.

47 % of blood establishments  
needed to improve SOPs due to the 
EU legislation

To address the requirements of the Directive, 
and  in  particular  the  need  to  develop  tools 
providing practical guidance on how to install 
and maintain quality systems in blood estab-
lishments in the EU Member States, the EU-Q-
Blood-SOP project was launched in 2005, with 
a duration of 3 years.

Under the coordination of the Red Cross Blood 
Donor Service of Baden-Württemberg in Ger-
many, the project involved 16 blood establish-
ments from 16 European countries to coop-
eratively design and develop a methodology 
for the preparation of SOPs in blood establish-
ments in Europe.

The project started by taking stock of exist-
ing SOP manuals and guidelines used in the 16 
blood services involved in the project in order to 

EuBIS SOP template

identify international and national SOP manu-
als and inspection practices already in place. 
This was done through a survey questionnaire 
designed to ﬁnd out the current status of SOPs, 
their structure and regulations and/or related 
manuals.  The  survey  was  divided  into  four 
sections, each addressing questions related to 
basic validation, principal management require-
ments, areas of work (eg. donor recruitment, 
testing, management, logistics) and the way in 
which risks were identiﬁed and managed.

A survey report summarising the ﬁndings from 
the questionnaire identiﬁed a series of gaps 
and  needs.  For  example,  almost  half  of  the 
participating blood establishments were of the 
view that their present SOP system required 
changes in light of the European blood leg-
islation. Almost a third indicated demand for 
improved inspection systems by governmental 
authorities; a few indicated that their blood 
establishments  were  not  inspected  by  gov-
ernment authorities. Overall, this preliminary 
and necessary work provided solid foundations 
upon which to move forward.

Providing the tools

The aim of the EU-Q-Blood-SOP project was 
not to provide an operating procedure to be 
used in an institution; rather, it was to provide 
the tools through which each institution can 
build its standard operating procedures and 
translate it into a formal document. An SOP 
document  is  important  in  that  it  describes 
a regularly recurring operation that aﬀects the 
quality of the process. Its purpose is to ensure 
that the operations are carried out correctly 
and in a consistent way.

The EU-Q-Blood-SOP project’s ﬁnal product is 
thus an SOP manual, jointly developed by the 
project’s partners, that provides the method-
ology for creating an SOP comprising the basic 
quality elements. As the development of an 
SOP is a multi-step process that involves prep-
aration, writing, conclusion and training, the 
manual is articulated into diﬀerent chapters 
that address each step in both a descriptive 
and practical manner.

Numerous examples are provided with regard 
to master SOPs, special SOP formats for test-
ing and equipments, and SOP examples cover-
ing critical quality activities. They could also be 
used to adapt existing procedures to comply 
with current EU requirements.

B L O O D   A N D   B L O O D   C O M P O N E N T S

17

 The 2002/98/EU Directive is an important 

response to the need to protect public health and 
contributes to the high quality and safety of blood 
products and the preparedness to move blood in 
cases of pandemic crisis within the EU.   

http://www.eu-q-blood-sop.de/index.php

European standard operating procedure (SOP) methodology reﬂecting European 
best practice within the area addressing the quality and safety of blood

 ‘Common standards for SOPs will assist the 

safety of blood and blood components.’ 

18

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

This SOP methodology comprises precise qual-
ity requirements, requisites and quality terms 
linked to the EU Directives and is based on GLP/
GMP standards that have to be speciﬁed (ﬁlled-
in) in order to complete the documents. These 
quality requirements are presented in a modular 
fashion, in order to tailor the SOPs to meet local 
circumstances with respect to the diﬀerences in 
blood establishments and Member States.

In this context, the manual has been used by 
partners to consolidate or modify their exist-
ing  SOPs  system.  During  a  twinning  project 
between  Germany  and  Malta,  the  Maltese 
blood transfusion service has used the manual 
in transforming its current document system 
into a system following best practice. In this 
respect, the manual or parts of it have been 
translated by its partners and collaborating 

institutions into Czech, German, French, Roma-
nian, Macedonian and Spanish in order to assist 
the dissemination on national and international 
levels.

Overall, the SOP manual delivers practical guid-
ance on the basic structure for preparing SOPs. 
Its aim is to assist blood services to implement 
or improve their standard operating procedures 
to reﬂect European best practice. 

The  manual  has  been  downloaded  by  more 
than 414 institutions, blood establishments, 
competent  authorities  and  pharmaceutical 
industries  from  more  than  62  countries  in 
Europe and worldwide.

B L O O D   A N D   B L O O D   C O M P O N E N T S

19

Further information: 

EAHC Project Database:
http://ec.europa.eu/eahc/projects/database.html?prjno=2004217

Project website
http://www.eu-q-blood-sop.de/ 

SOP Manual
http://www.eubis-europe.eu/blood_manual_details.php?ausgabe=sop#/10/ 

Project team: 

Project leader: 

Red Cross Blood Donation Service Baden-Württemberg-Hessen, Institut für 
Transfusionsmedisin und Immunhämatologie  
Sandhofstrasse 1  
PO-BOX  
60528 Frankfurt Am Main 
GERMANY 
Tel. +49 6967820  
Fax +49 696782110  
E-mail: EU-Q-Blood-SOP@blutspende.de 

Associated partners: 

(cid:97)(cid:149) The National Blood Authority (England and North Wales), United Kingdom
(cid:97)(cid:149) Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation), Netherlands
(cid:97)(cid:149) L‘Etablissement français du sang, France
(cid:97)(cid:149) Het Belgische Rode Kruis, Belgium
(cid:97)(cid:149) The Blood Transfusion Service Board, Ireland
(cid:97)(cid:149)
(cid:97)(cid:149) National Centre of Haematology and Transfusiology, Bulgaria
(cid:97)(cid:149) Veobecná fakultní nemocnice v Praze (General Faculty Hospital Prague), Czech Republic
(cid:97)(cid:149) Országos Vérellátó Szolgálat (Hungarian National Blood Transfusion Service), Hungary
(cid:97)(cid:149)

Instytut Hematologii I Transfuzjologii (Institute of Haematology and Blood Transfusion), 
Poland

Istituto Superiore di Sanita, Italy

(cid:97)(cid:149) University of Medicine and Pharmacy ‘Victor Babes’, Romania
(cid:97)(cid:149) Põhja-Eesti Verekeskus (North-Estonian Blood Centre), Estonia
(cid:97)(cid:149) Ministry of Health of the Republic of Cyprus — Medical and Public Health Services, 

Cyprus

(cid:97)(cid:149) Landspítalinn Háskólasjúkrahús (Icelandic University Hospital), Iceland
(cid:97)(cid:149) Ċentru Nazzjonali tat-Trasfużjoni tad-Demm (National Blood Transfusion Service), Malta

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2004217).

20

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Development of pan-European standards and criteria for the 
inspection of blood establishments (EuBIS)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2006202).

Ensuring that patients who receive blood trans-
fusions in the European Union are given safe 
blood is a major objective of public health at 
national and European level. Signiﬁcant pro-
gress has been made in recent years with the 
entry  into  force  of  EU  legislation  on  blood, 
based on Directive 2002/98/EC and its techni-
cal annexes (1) (2) (3). The Directives’ main objec-
tives are to ensure the provision of consistently 
safe  blood  components  across  Europe.  The 
annexes  set  out  the  technical  implementing 
measures for issues related to blood and blood 
components; traceability and the notiﬁcation 

European
Commission
Blood Legislation

2002/98/EC

2005/62/EC
Quality
Management

2004/33/EC
Technical
Requirements

2005/61/EC
Haemovigilance

EuBIS
Inspection
Manual

Common
Standards and
Criteria

EuBIS
Audit /
Inspection
Training
Guide

Guidance for
Training
including
EU/Cross-Ref

C
o
E

C
D
-
P
-
T
S

G
u
i
d
e

E

U

-

G

M

P

P
I
C
S
-
I
N
S
P
E
C
T
I
O
N

B
E

The EuBIS Project expert circle developed a manual for common European 
standards and criteria for the inspection of blood establishments for good practice 
(GP) following the EC blood legislation. (EuBIS — Common European Standards and 
Criteria for the Inspection of Blood Establishments)

(1)  Commission Directive 2004/33/EC of 22 March 2004 imple-
menting Directive 2002/98/EC of the European Parliament 
and of the Council as regards certain technical requirements 
for blood and blood components (OJ L 91, 30.3.2004, p. 25).

(2)  Commission Directive 2005/61/EC of 30 September 2005 
implementing Directive 2002/98/EC of the European Parlia-
ment and of the Council as regards traceability requirements 
and notiﬁcation of serious adverse reactions and events (OJ 
L 256, 1.10.2005, p. 32).

(3)  Commission Directive 2005/62/EC of 30 September 2005 
implementing Directive 2002/98/EC of the European Parlia-
ment and of the Council as regards Community standards and 
speciﬁcations relating to a quality system for blood establish-
ments (OJ L 256, 1.10.2005, p. 41).

of serious adverse reactions and events; and 
standards and speciﬁcations related to a qual-
ity system for blood establishments in the EU.

In  many  EU  Member  States,  there  are  very 
 rigorous regulations regarding blood donations 
and blood transfusions aimed at minimising 
the risk of a person being given blood that has 
been contaminated with a virus, such as Hepa-
titis C, or receiving blood from a blood group 
that is unsuitable for them. Inspection of blood 
establishments — namely of those structures 
or bodies involved in any aspect of the col-
lection and testing of human blood or blood 
components and their processing, storage and 
distribution when intended for transfusion — is 
one key element of risk minimisation.

However, inspections of blood establishments 
are o#en conducted according to national crite-
ria and standards which diﬀer between Member 
States. Noting that divergent national regula-
tions on the collection and treatment of blood 
were contributing to the reluctance, and at times 
refusal, to accept blood and plasma coming from 
diﬀerent Member States and even diﬀerent cen-
tres, the 2006 Work Plan of the Public Health 
Programme gave impetus to the need for equiv-
alent recognition of inspections of blood estab-
lishments among Member States. This was to be 
achieved, amongst others, through the develop-
ment and implementation of commonly accepted 
criteria and standards. Without them, the levels 
of risk from having a blood transfusion in the 
Member States could continue to diﬀer.

Reducing the risks of blood transfusion 
in Europe

The objective of the EU-Blood-Inspection Pro-
ject (EuBIS), was thus to set out a methodol-
ogy for inspecting blood establishments. EuBIS 
has been coordinated by the German Red Cross 
Blood Donation Service with the participation 
of 27 collaborating partners from 21 Member 
States, cooperative working partnerships with 
ﬁve organisations and three projects, aﬃlia-
tions with 12 partners involved in conducting its 

B L O O D   A N D   B L O O D   C O M P O N E N T S

21

inspection survey, and is supported by the Euro-
pean Blood Alliance. As such, it is the ﬁrst pro-
ject to bring together regulators and manufac-
turers to jointly develop criteria and standards.

EuBIS  activities  got  underway  in  September 
2007. The ﬁrst phase focused on the develop-
ment and distribution of a questionnaire to the 
project’s participants to collect information on 
current practices related to the inspection of 
blood establishments in the European Union. The 
results of a comparative analysis of the survey, 
in combination with Directive 2002/98/EC and 
its technical requirements, were used to estab-
lish the basic structure for the quality systems 
and pan-European blood inspection standards.

 With the EU expansion, 
the implementation of common 
pan-European standards becomes 
even more important. 
http://www.eubis-europe.eu/

Recognising that several inspection criteria and 
programmes in the healthcare area had already 
been established, from the outset the EuBIS pro-
ject consulted these sources and conferred with 
the responsible authors. These included: the Joint 
Accreditation  Committee  of  the  International 
Society of Cellular Therapy (ISCT) and the Euro-
pean Group for Blood and Marrow Transplanta-
tion (EBMT) (jointly referred to as JACIE); the 
Pharmaceutical Inspection Convention and the 
Pharmaceutical Inspection Cooperation scheme 
(jointly referred to as PIC/S); and the European 
Medicines Agency (EMEA). Moreover, EuBIS has 
collaborated and exchanged ideas with the EUS-
TITE (European Union Standards and Training for 
the Inspection of Tissues Establishments) pro-
ject, co-ﬁnanced under the 2005 Work Plan of 
the EU’s Public Health Programme. EuBIS has 
indeed drawn extensively from EUSTITE’s ‘Guide-
lines for the Inspection of Tissue and Cell Pro-
curement and Tissue Establishments’.

Comprehensive and collaborative 
eﬀorts lead to the development 
of a good practice manual for the 
inspection of blood establishments 
in Europe

In  order  to  develop  the  basic  structure  of 
the  manual,  the  project’s  participants  were 
divided  into  four  working  groups,  each  with 

Common European Standards and Criteria for the Inspection of Blood 

Establishments (http://www.eubis-europe.eu/eubis_manual_details.php)

responsibility for a speciﬁc subject area. These 
were:  quality  management  system  evalua-
tion; donor recruitment and blood collection; 
processing and testing; and blood component 
issuing, storage and logistics.

The result of extensive collaborative eﬀorts 
by the working groups has been a Manual that 
sets out common criteria and standards for the 
inspection of blood establishments; require-
ments for the implementation or expansion of 
quality management systems to be inspected; 
inspection checklists which closely follow Dir-
ective 2002/98/EC and its technical require-
ments, and evaluation criteria for inspections 
and a benchmark system for deviations and 
improvements.

Using commonalities between Member States 
and the requirements and deﬁnitions given by 
the EU blood legislation, the manual summa-
rises good practice standards. The implementa-
tion of these standards can lead to improving 

22

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Common European Standards and Criteria for the Inspection of Blood 

Establishments — Audit / Inspection — Training Guide  

(http://www.eubis-europe.eu/eubis_manual_details.php)

the safety of blood. This in turn can reduce 
the incidence of harm to patients that would 
 otherwise arise from citizens travelling around 
the enlarged EU, and from the movement of 
blood components within the EU, either through 
the open-border policy or through crisis man-
agement measures.

An ongoing work: The EUBIS Academy 
Training Programme

A major aim of the European Commission is to 
give practical assistance to competent authori-
ties and blood establishments in implementing 
the Directive′s requirements. Since the end of 
the project, the participants have founded the 
EuBIS  Academy,  which  organises  an  annual 
training  programme  for  inspectors  of  blood 
establishments based on the EuBIS manual 
and  guide.  This  follow-up  work  is  aimed  at 
ensuring that the standards and criteria are 
commonly accepted. It oﬀers the possibility to 
exchange knowledge and experience in setting 
up requirements in quality systems and inspec-
tion standards among participants from diﬀer-
ent EU Member States and internationally.

In addition, the EuBIS manual and guide have 
been integrated as a reference standard by 
the European Blood Alliance and are used by 
the quality management working party of the 
International Society of Blood Transfusion for 
its annual Academy Programme. 

The EuBIS training programme included more 
than 70 trainees for the face-to-face train-
ing sessions and more than 800 participants 
in seminars. The manual and guide have been 
downloaded by 530 institutions (blood estab-
lishments, competent authorities and pharma-
ceutical industry) from 78 countries in Europe 
and worldwide.

B L O O D   A N D   B L O O D   C O M P O N E N T S

23

Further information: 

EAHC Project Database:
http://ec.europa.eu/eahc/projects/database.html?prjno=2006202 

Project website
http://www.eubis-europe.eu 

SOP Manual
http://www.eubis-europe.eu/blood_manual_details.php?ausgabe=sop#/10/ 

Project team: 

Project leader: 

Red Cross Blood Donation Service Baden-Württemberg-Hessen, Institut für 
Transfusionsmedizin und Immunhämatologie  
Sandhofstrasse 1  
PO-BOX  
60528 Frankfurt Am Main 
GERMANY 
Tel. +49 6967820  
Fax +49 696782110 
E-mail: EuBIS@blutspende.de

Associated partners: 

Landspitalinn Haskolasjukrahus, Icelandic University Hospital, Iceland

(cid:97)(cid:149)
(cid:97)(cid:149) Ministry of Health, Elderly and Community Care, Malta
(cid:97)(cid:149) University of Medicine and Pharmacy ‘Victor Babes’, Romania
(cid:97)(cid:149) National Centre of Haematology and Transfursiology, Bulgaria
(cid:97)(cid:149) Medical and Public Health Services — Ministry of Health, Cyprus
(cid:97)(cid:149) Department of Blood Banking, Faculty Hospital Ostrava, Czech Republic
(cid:97)(cid:149) Etablissement Francais Du Sang, France
(cid:97)(cid:149) Regierungspräsidium Darmstadt, Germany
(cid:97)(cid:149) Hungarian National Blood Transfusion Service (HNBTS)/Országos Vérellátó Szolgálat 

(OVSZ), Hungary
Irish Blood Transfusion Service, Ireland
Irish Medicines Board, Germany
Istituto Superiore di Sanità, Italy

(cid:97)(cid:149)
(cid:97)(cid:149)
(cid:97)(cid:149)
(cid:97)(cid:149) NHS Blood and Transplant, United Kingdom
(cid:97)(cid:149) POHJA-EESTI VEREKESKUS, Estonia
(cid:97)(cid:149)
(cid:97)(cid:149) Belgische Rode Kruis, Belgium
(cid:97)(cid:149) Stichting Sanquin Bloedvoorziening, Netherlands

Institute of Haematology and Blood Transfusion, Poland

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2006202).

24

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Creating a safe and suﬃcient donor population in Europe: 
comparing and recommending good donor management 
practice (DOMAINE)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2007202).

Blood donor management is the very ﬁrst of 
many  steps  in  the  blood  transfusion  chain. 
Various groups of patients beneﬁt from blood 
transfusions. Their needs arise from trauma, 
surgery and blood diseases such as leukaemia, 
sickle cell anaemia or thalassaemia (a genetic 
defect, mainly prevalent in south-east Europe, 
which results in reduced rate of synthesis or 
no synthesis of one of the globin chains that 
make up hemoglobin (4). Other patient groups, 
such as patients with haemophilia or immuno-
globin deﬁciencies, beneﬁt from blood-derived 
therapeutic products.

Blood establishments throughout Europe now 
collect over 20 000 000 units of whole blood 
from 13 000 000 donors per year. European 
medical practices rely on a safe and suﬃcient 
blood supply which falls under the responsi-
bility of blood establishments. To be able to 
fulﬁl this duty, blood establishments need to 
maintain a suﬃcient number of eligible donors.

Many blood banking standards have already 
been  established  to  comply  with  European 

All ﬁve steps in donor management in relation to the subpopulations onto which 

they exert their eﬀect (Donor Management Manual, p. 38).

(4)  http://en.wikipedia.org/wiki/Thalassaemia

rules. However, European directives deal pre-
dominantly with technical and medical matters, 
providing little guidance for the ‘so#’ side of 
managing the relationship with donors.

Donors are of paramount importance to the 
blood supply. In the absence of artiﬁcial blood 
products, there is no alternative to donor blood 
(products). In addition, the fact that the major-
ity of blood donations in Europe are made on 
a voluntary and unpaid basis makes the man-
agement of donors even more crucial.

Appropriate donor management — deﬁned as 
that set of actions that allows to attract and 
maintain a suﬃcient and reliable donor base 
selected from the general population — has 
thus become a demanding and crucial factor 
in the blood transfusion supply chain.

Prior to the DOMAINE project, the role of blood 
donor management across Europe had never 
been  critically  investigated  and  evaluated, 
and only a few eﬀective practices had been 
identiﬁed.

Over the last few years there has been a grow-
ing need for European cooperation in the ﬁeld 
of donor management. Blood donors with dif-
ferent blood types are required as patients, 
and  their  diseases,  increasingly  migrate  all 
over Europe. To respond to these needs and ﬁll 
these gaps, the DOMAINE project was launched 
in 2008.

DOMAINE is a European project that 
focuses on good donor management.

‘DOMAINE was the ﬁrst project that attempted to, 
and succeeded in, describing in detail the whole 
process  of  blood  donor  management.  Prior  to 
this project, there was a clear gap in this area 
at European level,’ recalls Dr Wagenmans, the 
DOMAINE  project  coordinator.  By  comparing 
and  recommending  good  donor  management 
practice, DOMAINE aimed at contributing to the 

establishment  of  a  safe  and  suﬃcient  blood 
supply.

From  2008  to  2011,  the  DOMAINE  project, 
which  brought  together  18  blood  establish-
ments  from  18  European  countries,  one 
patient-driven  organisation  (Thalassaemia 
International Federation) and one representa-
tive from the south-eastern Europe Health Net-
work, worked on improving donor management 
practices throughout Europe. ‘It was a great 
experience. All partners were very enthusias-
tic and cooperative and willing to share their 
knowledge  and  experience  with  each  other,’ 
says Dr Wagenmans.

Through a three-phase approach, the project 
concentrated on various aspects of donor man-
agement, including donor recruitment strate-
gies, donor retention strategies, deferral proce-
dures and blood bank policy regarding patients 
requiring long-term transfusion.

In the ﬁrst phase, a survey was conducted to 
analyse donor management practice in Europe. 
This  survey  was  sent  out  to  participants  and 
blood establishments in Member States, which 
were not involved as partner in the project. The 
International Federation of Blood Donor Organi-
sations (IFBDO) and the Thalassaemia Interna-
tional Federation were also asked to comment on 
aspects of the blood donation process, and the 
relation between blood establishments and the 
blood recipients. By analysing the existing blood 
donor management practice across the EU, the 
DOMAINE project identiﬁed good practices, guide-
lines and performance indicators for donor man-
agement that were in place. The second phase 
focused on bringing this knowledge together into 
a manual on good donor management. The ﬁnal 
phase aimed to train blood establishment profes-
sionals on the content of this manual.

The Manual facilitates the 
implementation of good practice 
across Europe

The Donor Management Manual focuses on prac-
tical issues in donor management. It is aimed at 
donor managers and policymakers in the realm of 
blood donor management. The manual provides 
information on practical issues in donor manage-
ment including: architecture and infrastructure; 
donor base; donor recruitment; donor retention; 
collection; multiple-transfused patients; special 
situations; human resources management; infor-
mation technology; and ethical considerations. 

B L O O D   A N D   B L O O D   C O M P O N E N T S

25

Donor management for collecting blood products is a chain process, 
where each step depends on the success of the previous. The chain 
process consists of consecutive actions and steps, leading from 
donor recruitment to the required blood products. 

Blood donors are recruited from the general population. People who 
are interested are called prospective donors. They form the pool of 
potential donors. Recruitment activities need to be targeted towards 
this group of prospective donors to raise blood donor awareness 
and to urge them to become blood donors. A certain number of 
prospective donors will actually decide to present themselves 
at a blood establishment to become blood donors. They will be 
registered in the donor data base as newly registered donors.

Registered donors who are eligible to donate will receive an 
invitation to make a donation. Donors can also be invited in a more 
general way through blood donation appeals through the media. 
In addition, there are people who visit the blood establishment 
spontaneously and will be registered on the spot.

Both personally and generally invited donors who do present 
themselves to donate are called attending donors. These donor 
candidates show up at the blood establishment to undergo medical 
screening (donor selection) determining donor eligibility. In some 
countries, the newly registered donor will only undergo a more or 
less speciﬁc selection procedure and laboratory tests. A donation 
procedure is not performed at this very ﬁrst visit. When a donor 
is not eligible to donate, he or she receives either temporarily or 
permanently deferred status. Temporarily deferred donors will 
receive a new invitation to donate, while permanently deferred 
donors will be signed out of the donor data base. All donors 
who pass the donor selection successfully can make a donation. 
Most donation procedures are successful and will result in blood 
products. A small number of donations fail due to adverse events 
or unsuccessful procedures. Some of these complications can lead 
to a donor stopping his or her donor career. However, in general, 
successful donors will be invited again a$er a certain time interval.

A ﬁnal step within the donor management process focuses on 
donor retention. Successful donor retention aims at minimising the 
population of permanently stopped donors. The pool of stopped 
donors is formed by no-show donors, permanently deferred.

The above is extracted from the Donor Management Manual. The manual further 

deals with collection; donor safety issues; multiple transfused patients; and special 

situations. (http://www.domaine-europe.eu/Portals/0/Manual/Donor%20Mangement%20

Manual%20ﬁnal%20version%20part%201.pdf)

 Doing things correctly facilitates all 

subsequent parts of the transfusion chain and make 
blood transfusion therapy safer and cheaper. Doing 
things incorrectly at this very first step affects the 
entire chain, often in an irreparable way. 

http://www.domaine-europe.eu

26

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

 Almost 50 blood establishments from 34 

European countries have contributed to the 
manual by sharing their information in the 
‘voluntary, non-remunerated’ way, characteristic 
of the world of blood donation. The manual, 
therefore, brings together knowledge and 
experience in blood donor management  
from all over Europe. 
http://www.domaine-europe.eu

The Manual serves as a toolkit to facilitate the 
implementation of good practice across Europe. 
It includes tools and examples of incentives to 
motivate future and current donors to become 
regular donors.

The Donor Management Manual is now avail-
able in ﬁve languages: English, Spanish, Portu-
guese, Dutch and French. The original, English 
version is both available as a book and in PDF 
form (5). The Spanish, Portuguese and French 
versions are only available in PDF form.

The Donor Management Training 
Programme continues beyond the 
project

A Training Programme for using the Donor Man-
agement Manual was also developed and estab-
lished to provide practical tools on how each 
blood establishment can best use the Manual to 
achieve optimal practice within its local context. 
The training programme is aimed at managers 
and policymakers involved in any of the donor-
related ﬁelds of activity, such as donor services, 
personnel management, marketing or facility 
management. It is based on the Donor Manage-
ment Manual and addresses several topics that 
are organised in ﬁve modules: the donor man-
agement process, donor database management, 
donor marketing and communication, collection 
operations management and donor safety.

A ‘train the trainer’ approach was developed in 
the course of the project. Trainers equipped to 
distribute the Manual within their own country 
were trained. Each project partner delegated 
blood establishment professionals to participate 
in the Training Programme. These professionals 
were then able to implement the Manual in their 
own country and, as such, achieve sustainability 
of optimal donor management practice.

Since 2011, the training has been made avail-
able  in  conjunction  with  the  training  pro-
grammes of the EuBIS project and the Optimal 
Blood Use project under the coordination of the 
European Blood Association.

Overall, the project and its outputs have trig-
gered a lot of interest at European and wider 
level. The manual itself is now also used out-
side Europe, in countries of south-east Asia, 
Africa and east Asia.

The DOMAINE Donor Management Manual focuses on practical issues in donor 

management. It is aimed at donor managers and policymakers in the realm of 

blood donor management.

(5)  http://www.domaine-europe.eu/Manual/tabid/56/Default.aspx

B L O O D   A N D   B L O O D   C O M P O N E N T S

27

Further information: 

EAHC Project Database:
http://ec.europa.eu/eahc/projects/database.html?prjno=2007202 

Project website
http://www.domaine-europe.eu/ 

Donor Management Manual
http://www.domaine-europe.eu/Manual/tabid/56/Default.aspx

Project team: 

Project leader: 

Stichting Sanquin Boedvoorziening (SSB) 
Plesmanlaan 125 
1066 CX Amsterdam 
NETHERLANDS 
Tel. +31 243279034 
Fax +31 243279471 
E-mail: w.dekort@sanquin.nl 

Associated partners: 

(cid:97)(cid:149) Thalassaemia International Federation — TIF, Cyprus
(cid:97)(cid:149) Ministry of Health, Elderly and Community care — MHEC, Malta
(cid:97)(cid:149) Etablissement Francais du Sang — EFS, France
(cid:97)(cid:149)
Irish Blood Transfusion Service — IBTS, Ireland
(cid:97)(cid:149) NHS Blood and Transplant — NHSBT, United Kingdom
(cid:97)(cid:149) Blood Transfusion centre of Slovenia — BTCS, Slovenia
(cid:97)(cid:149) DRK Blutspendedienst Baden-Württemberg Hessen GmbH — BSD-BH, Germany
(cid:97)(cid:149) Medical & Public Health Services — CBE, Cyprus
(cid:97)(cid:149) Het Belgische Rode Kruis — BRK, Belgium
(cid:97)(cid:149) Országos Vérellátó Szolgàlat / Hungarian National Blood Transfusion Service — OVSZ/

HNBTS, Hungary

Instituto Portugues do Sangue, IP — IPF / IP, Portugal

(cid:97)(cid:149) Austrian Red Cross — ARC, Austria
(cid:97)(cid:149)
(cid:97)(cid:149) Scottish National Transfusion Service — SNBTS, United Kingdom
(cid:97)(cid:149) North Estonian Regional Hospital — Estonian Bloodbankers, Estonia

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2007202).

28

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

EU Optimal Blood Use Project (EUOBU)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2006209).

A quality transfusion process is the ‘trans-
fusion of the right unit of blood to the right 
patient  at  the  right  time,  and  in  the  right 
condition  and  according  to  appropriate 
guidelines’ (6).

The EU Optimal Blood Use project, launched 
in 2008 and co-funded by the European Com-
mission  Public  Health  Programme  and  the 
Scottish National Blood Transfusion Service 
for a duration of 3 years, aimed at promoting 
improvement in the quality of clinical trans-
fusion processes. Through the collaborative 

 The manual is a resource for improving 
safety and effectiveness of the clinical transfusion 
process and promoting the optimal use of blood 
components across the EU. 

Patients’ questions:

One way of introducing the concept of quality management in 
clinical transfusion is to consider some questions that any patient 
might ask if they believe that a transfusion may be given.

Here are some examples:

(cid:97)(cid:149) Do I really need to have a blood transfusion?
(cid:97)(cid:149) Will it help me?
(cid:97)(cid:149) Could a transfusion do me harm?
(cid:97)(cid:149) Will they give me the right blood?
(cid:97)(cid:149) Will I feel unwell during the transfusion?
(cid:97)(cid:149)

If I start to feel bad during the transfusion will someone 
come to help me?
(cid:97)(cid:149)
If I need blood in an emergency will they get it to me in time?
(cid:97)(cid:149) Will someone knowledgeable take the time to explain all this 

(cid:97)(cid:149)

to me?
Is the hospital staﬀ properly trained to give me the 
transfusion?

(cid:97)(cid:149) How do I know that the hospital does these things well?

The above is extracted from the Manual of Optimal Blood Use —  

Support for safe, clinically eﬀective and eﬃcient use of blood in Europe  

(http://www.optimalblooduse.eu/_assets/pdf/blood_use_manual.pdf, p. 12). 

(6)  http://www.optimalblooduse.eu/_assets/pdf/blood_use_manu-

al.pdf

eﬀorts of partners from 18 EU countries, the 
project has developed a resource, the Optimal 
Blood Use Manual, aimed at assisting profes-
sionals to improve the safety and eﬀective-
ness of the clinical transfusion process and to 
promote the optimal use of blood components 
across the EU.

What is optimal blood use?

Optimal  use  of  blood  is  the  safe,  clinically 
eﬀective and eﬃcient use of donated human 
blood.  It  is  safe  when  there  are  no  adverse 
reactions or infections. It is clinically eﬀective 
when it beneﬁts the patient. It is eﬃcient when 
no unnecessary transfusions are performed 
and, when they are, these are done at the time 
the patient needs it.

Why is optimal blood use important?

Blood is a human substance and is a precious 
and scarce resource, and many countries may 
at times encounter diﬃculties matching supply 
with demand. The supply of blood components 
in the EU depends substantially on the support 
of voluntary donors. Transfusion services pro-
mote blood donation as an essential contribu-
tion to the care of patients. Hospitals and blood 
collection services have thus an obligation to 
demonstrate to blood donors that each gi# of 
human tissue is carefully, wisely and eﬀectively 
used and that it can be fully accounted for. 
Patients themselves need assurance that blood 
is safe, available and used only when required.

The safety of hospital treatment and the eﬀec-
tiveness of care are major concerns in health-
care systems. Some studies have shown that 
patients  can  suﬀer  avoidable  harm  due  to 
errors and accidents caused by quality failures 
in hospitals. These can occur in many aspects 
of the process of care, including in each of the 
main steps of the clinical transfusion process.

For example, errors in clinical decisions may 
lead to the wrong component or dose given; 
errors  in  ordering  blood  components  may 
result  in  a  patient  receiving  blood  intended 
for another person; errors in pre-transfusion 

testing may include the selection of an inap-
propriate procedure or the non-checking of a 
patient  sample  and  request  for  consistency 
and completeness; errors in delivering blood to 
the clinical area may produce delays in sup-
plying  blood;  errors  in  administering  (trans-
fusing) blood may lead to the transfusion of 
an outdated pack or to a patient receiving an 
incorrect blood component; errors in monitoring 
the transfused patient may include the non-
detection of adverse reactions or the incorrect 
management of such adverse reactions. The 
consequences of such errors range from the 
wasting of blood units to harm to the patient, 
risk of exsanguinations, serious complications 
and ultimately death.

For these reasons all hospitals should be in 
a position to ensure that their practice of blood 
transfusion is safe, clinically eﬀective and eﬃ-
cient. Overall, a quality management system 
for transfusion is a key component of a hospi-
tal’s wider quality system.

Developed through the sharing of information 
and  best  practices  across  the  project’s  part-
ners, the Optimal Blood Use Manual speciﬁcally 
addresses these issues. It is intended for hospital 
transfusion committees and for medical, nursing 
and laboratory staﬀ who have responsibility for 
patient safety and the quality of care in relation 
to blood transfusion. It further serves other per-
sonnel who are concerned with quality improve-
ment, risk management, accreditation, training 
and assessment. Patients concerned about the 
safety of transfusions can also ﬁnd it useful.

 The Optimal Blood Use 

Manual provides guidance and 
resources to develop a quality 
system for the clinical transfusion 
process. 

A  quality  system  for  the  clinical  transfusion 
process should provide assurance to patients, 
the community and clinicians that treatment is 
safe, eﬀective and eﬃcient and that the people 
who carry out each step of the process know 
what they are doing, how to do it and why they 
are  doing  it.  It  should  provide  evidence  that 
tasks are carried out correctly and consistently 
using the right procedures. And it should lead 
to improvement in quality by providing evidence 
about performance and by encouraging  everyone 
concerned  to  learn  from  both  mistakes  and 
successes.

B L O O D   A N D   B L O O D   C O M P O N E N T S

29

Common steps of the clinical transfusion process and its infrastructure in EU countries  
Source: http://www.optimalblooduse.eu/content/1-synopsis, p. 4

Manual of Optimal Blood Use — Support for safe, clinically eﬀective and eﬃcient 

use of blood in Europe.

30

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Evidence

For many important aspects of transfusion practice, there is not 
a ﬁrm basis of empirical evidence that identiﬁes the most eﬀective 
process or treatment. The manual provides an illustration of 
evidence-based practice recommendations with extracts from the 
2009 guidelines of the Bundesaertztekammer (German Medical 
Association). In addition, the web version of the manual provides 
links to the underpinning evidence where there is high quality 
information as judged by established grading systems. An extensive 
database of clinical trials and systematic reviews of evidence 
relating to transfusion can be found at www.transfusionguidelines.
org.uk.

The above is extracted from the Manual of Optimal Blood Use — Support for safe, 

clinically eﬀective and eﬃcient use of blood in Europe  

(http://www.optimalblooduse.eu/content/24-evidence). 

EC Directive 2005/62/EC requires that person-
nel in blood establishments shall be trained 
and assessed to be competent in their tasks. To 
facilitate the introduction of a quality system, 
the manual therefore includes a speciﬁc chap-
ter on ‘How to implement a training programme 
to support transfusion practice’. This provides 
an introduction to some of the practical issues 
that are likely to be encountered when apply-
ing the Directive’s training and assessments 
requirements to all staﬀ that have a role in the 
clinical transfusion process. The English ver-
sion of the Manual has been translated into 
seven  languages  and  is  available  online  at:  
http://www.optimalblooduse.eu/

B L O O D   A N D   B L O O D   C O M P O N E N T S

31

Further information: 

EAHC Project Database:
http://ec.europa.eu/eahc/projects/database.html?prjno=2006209 

Project website
http://www.optimalblooduse.eu/ 

Manual of Optimal Blood Use - Support for safe, clinically eﬀective and eﬃcient use of blood 
in Europe
http://www.optimalblooduse.eu/_assets/pdf/blood_use_manual.pdf 

Project team:

Project leader: 

Scottish National Blood Transfusion Service 
Ellen’s Glen Road Liberton, Scotland 
Edinburgh
EH17 7QT
UNITED KINGDOM
Tel. +44 135365978
Fax +44 135365961 
E-mail: merredith.hart@snbts.csa.scot.nhs.uk 

Associated partners: 

(cid:97)(cid:149) Austrian Red Cross, Austria
(cid:97)(cid:149) Põhja-Eesti Verekeskus, Estonia
(cid:97)(cid:149) Blood Transfusion Centre of Slovenia (Zavod RS ZA Transfuzijsko Medicino (ZTM)), 

Slovenia

(cid:97)(cid:149) University of Medicine and Pharmacy ‘Victor Babes’, Romania
(cid:97)(cid:149)
Institute Of Haematology and Transfusion Medicine, Poland
(cid:97)(cid:149) Agenzia Regionale della Sanità — Regione autonoma Friuli Venezia Giulia, Italy
(cid:97)(cid:149) DRK Blutspendedienst baden Württemberg Hessen gGmbH, Germany
(cid:97)(cid:149) NHS Blood and Transplants, United Kingdom

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2006209).

32

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Quality Systems in the Blood Transfusion Field including 
inventory Visits, Audits and Proﬁciency Testing Scheme (PTS) 
studies (CoE EDQM)

This direct agreement between the EC and the Council of Europe has received co-funding from the European Union 
in the framework of the Health Programme 2008–2013 (Grant: 20085301). This cooperation has been continued 
in 2011 (Grant: 20115101).

The  Visits,  Audits  and  Proficiency  Testing 
Scheme (PTS) Programme ensures that safe 
blood components can be obtained in neigh-
bouring European countries when needed.

The  provision  of  safe  and  compatible  whole 
blood and labile blood components — such as 
plasma and erythrocyte concentrates — for 
transfusion and their appropriate use involves 
a number of processes. Each step in the pro-
cesses brings its risks for errors — from the 
selection of blood donors and the collection, 
processing and testing of donated blood to the 
testing  of  patient  samples,  storage  and  the 
issues of compatible blood and its administra-
tion to the patient.

 The on-site visits and proficiency testing 
programmes in the field of blood transfusion 
support the EU in fulfilling its Treaty obligation to 
set standards of quality and safety of substances of 
human origin for medical use.  

Direct Agreement QS-TS-CoE 20085301, Annex I

The blood transfusion laboratories play a key 
role in the blood ‘transfusion chain’. The aim 
of  a  blood  transfusion  laboratory  in  testing 
blood samples from patients and donors is to 
provide safe blood for transfusion. Transfusion 
laboratory practice relates to all processes and 
procedures put in place to achieve this aim. 
Quality failures in testing or other laboratory 
procedures can have serious implications for 
the recipients of blood and blood products.

Quality testing is essential to reduce 
blood transfusion’s risks

established, performed in a quality-focused 
way and continuously monitored to improve 
outcomes.  The  implementation  of  a  quality 
system in the laboratory serves to reduce risk 
associated to blood transfusion, i.e. to ensure 
that appropriate tests are performed on the 
correct  samples,  that  accurate  results  are 
obtained and that correct blood product is pro-
vided to the right patient at the correct time. 
To monitor the proper implementation of QS, 
visits, audits and proﬁciency testing scheme 
(PTS) studies should be regularly carried out.

Proﬁciency testing scheme studies are used by 
accrediting bodies and regulatory agencies to 
assess laboratory competence. It is a form of 
external quality testing using inter-laboratory 
comparisons  to  determine  the  performance 
of individual laboratories for speciﬁc tests or 
measurements  and  to  monitor  laboratories’ 
continuing performance.

The laboratory aspect of the transfusion pro-
cess is carried out in diﬀerent ways across the 
European Union. In some settings, a local hos-
pital blood bank manages the blood component 
inventory  and  the  clinical  blood  transfusion 
laboratory services. In others, the blood estab-
lishment provides compatible blood directly to 
hospitals.

To  ensure  that  the  results  obtained  by  the 
testing laboratories of blood establishments in 
Europe would be comparable and that perfor-
mance quality systems (QS) including quality 
assurance (QA) (7) are maintained, appropri-
ate  systems  need  to  be  in  place  across  the 
EU. At the launching of the QS-TS Programme 
in 2008, there was neither a European pro-
gramme  for  quality  assurance  (QA)/quality 
system (QS) evaluation nor a proﬁciency test-
ing scheme programme for testing laboratories 
in the blood transfusion ﬁeld. Existing national 

An  eﬀective  quality  system  (QS)  provides 
a  framework  within  which  activities  are 

(7)  Quality assurance includes the entire process of providing 

patient care, from the time the physician orders the test until 
treatment of the patient based on the results of the test.

B L O O D   A N D   B L O O D   C O M P O N E N T S

33

or local initiatives generally focused on a lim-
ited subset of testing methods and allowed for 
evaluation of laboratories at a national or local 
level only. Several countries did not have any 
comparable programme at all.

The QS-TS Programme was launched in 2008 
to contribute to the establishment of an eﬀec-
tive  common  system  for  quality  assurance 
and  performance  measurement  for  whole 
blood and labile blood components screening 
and quality control in Europe. The programme 
was a joint initiative by the EC/EAHC and the 
Council of Europe. Managed by the European 
Directorate for the Quality of Medicines and 
HealthCare (EDQM) of the Council of Europe, its 
speciﬁc focus was on the proﬁciency of testing 
laboratories and in particular on undertaking 
proﬁciency testing scheme studies and an on-
site visits programme.

The studies focused on the proﬁciency of test-
ing laboratories responsible for the biological 
qualiﬁcation of blood donations (screening for 
markers  of  transfusion-transmissible  infec-

 The Blood-Proficiency 

Testing Scheme (B-PTS) 
Programme is ensuring safety 
by testing the reliability of 
laboratory results all over 
Europe.  

tions, e.g. HIV, HCV; characterisation of blood 
donations for immunohaematological mark-
ers, e.g. ABO erythrocyte antigen, rhesus, Kell 
antigen and other biochemical or hemostasis 
markers). The studies were accompanied by 
two on-site visits undertaken in the course of 
the project to assist testing laboratories in their 
preparation for audits and to help them imple-
ment state-of-the-art methods within appro-
priate QA environments.

During the course of the programme, priority 
was given to the tests which are required by 
Directive 2002/98/EC. Four PTS studies were 
carried out with 138 participating laborato-
ries — between 24 and 43 for each study. The 
PTS studies were conducted on the detection 
of  the  Hepatitis  C  Virus  by  the  nucleic  acid 
ampliﬁcation technique (NAT); the detection of 
the Hepatitis B surface antigen by serological 
assays; the detection of the Human Immuno-
deﬁciency virus by Nucleic Acid Ampliﬁcation 

Report on the Collection, Testing and Use of Blood and Blood Components in Europe.

Technique  (NAT);  and  the  detection  of  the 
Human Immunodeﬁciency Virus Antibody (HIV-
Ab) by serological assays. The programme was 
open to all countries which are members of the 
EU and the Council of Europe, and 26 (8) coun-
tries joined in.

The programme is extended following 
demand in EU Member States

The programme was able to reveal failures in 
the completion of the abovementioned assays. 
Eleven laboratories were in fact classiﬁed by 

(8)  These were: Austria, Belgium, Bulgaria, Croatia, the Czech 
Republic, Denmark, Finland, France, Germany, Greece, 
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, 
Montenegro, Poland, Portugal, Serbia, Slovenia, Spain, Sweden, 
the Netherlands and the United Kingdom.

34

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

 To maintain a high level of performance 
in the laboratory, it is essential to monitor the 
functioning of reagents, equipment, techniques 
and procedures. Good record keeping and 
documentation, use of standard operating 
procedures and laboratory worksheets, and 
implementation of safety guidelines further 
improve the quality of performance. 

this programme as unsatisfactory, and have 
since been able to put in place corrective meas-
ures and preventive actions.

Marie-Laure  Hecquet,  the  EDQM  scientiﬁc 
oﬃcer in charge of this programme, notes ‘The 
blood establishments welcomed this initiative 
as the programme was tailor-made to blood 
establishments and was the ﬁrst of this kind. 
Each study design is based on the methods 
and screening strategies used in blood estab-
lishments. Laboratories would like to see future 
developments in the programme, in particular 
to increase the number of PTS per year and 
enlarge the programme to other assays.’

Council of Europe is therefore really appreciated 
as it is expected to have a greater demand in 
the future.’

The  on-site  visit  programme  was  ﬁnalised 
at  the  end  of  2012  and  results  have  been 
reported. A survey to understand the European 
situation with regards to the implementation of 
the quality management system in European 
blood establishments was elaborated and sent 
in  June  2012  to  European  blood  establish-
ments. More than 200 answers were received. 
The results show that there is a big demand for 
help in the implementation or further develop-
ment of quality management systems (QMS) by 
establishments. The survey also shows that the 
norms and standards used for implementing 
a QMS are heterogeneous and varies between 
countries. ‘This would be the most challenging 
issue of the programme’ — notes Hecquet — 
‘as  support  documents  used  to  perform  the 
visits,  would  have  to  take  into  account  this 
speciﬁcity.’

This  programme  helps  laboratories  them-
selves to improve their performance but also 
contributes to building mutual trust between 
European laboratories. Results of PTS studies 
are a tool to demonstrate that safe blood 
components can be 
obtained  in  neigh-
bouring  countries. 
This is of great impor-
tance  in  the  con-
text of issues raised 
on  self-sufficiency 
and  will  establish 
a basis for reﬂection 
with  regards  to  the 
exchange  of  blood 
and blood components within Europe. Addition-
ally, it will also provide feedback on the valida-
tion of the methods used in Europe in the ﬁeld 
of blood transfusion.

 The Council of Europe 

is, to be sure, the laboratory in 
which experiments in European 
cooperation are conducted.
Robert Schuman, one of the founding  

fathers of the Council of Europe, 1951 

The programme was 
initially  limited  to 
a  certain  number  of 
laboratories  during 
the pilot phase. How-
ever,  Marie-Laure 
Hecquet  highlights 
that the contract has 
been  renewed  for 
2  more  years:  ‘The 
programme  is  continuing  as  there  is  a  great 
demand in all European countries and the pro-
gramme is open to a greater number of labo-
ratories. The co-funding from the EU and the 

B L O O D   A N D   B L O O D   C O M P O N E N T S

35

Further information: 

EDQM website
http://www.edqm.eu/ 

Blood transfusion guidance at EDQM
http://www.edqm.eu/en/blood-transfusion-mission-65.html 

The Collection, Testing and Use of Blood and Blood Components in Europe
http://www.edqm.eu/medias/ﬁchiers/The_Collection_Testing_and_Use_of_Blood_and_Blood_3.pdf

Project team: 

Project leader: 

Department of Biological Standardisation, OMCL Network & HealthCare (DBO) 
European Directorate for the Quality of Medicines & HealthCare (EDQM),  
Council of Europe 
7, allée Kastner 
Cs 30026 
67081 Strasbourg  
FRANCE   
Tel. +33 388412152 
Fax +33 388412770

EU contribution

This direct agreement between the EC and the Council of Europe has received co-funding 
from the European Union in the framework of the Health Programme 2008–2013 
(Grant: 20085301). This cooperation has been continued in 2011 (Grant: 20115101).

36

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Ad hoc cooperation between EC and the CoE/EDQM on 
speciﬁc matters related to human substances (blood) in order 
to further develop and strengthen EU policy actions in this 
ﬁeld (TS066 CoE2011)

This project has received co-funding from the European Union in the framework of the Health Programme 2008–
2013 (Grant: 20105305).

To  provide  all  those  working  in  the  ﬁeld  of 
transfusion medicine — from blood services 
to hospital departments to regulators — with 
a compendium of measures designed to ensure 
the safety, quality and eﬃcacy of blood com-
ponents, the Council of Europe (CoE) developed 
a Guide as a technical annex to its Recommen-
dation No R (95) 15 (9) on the preparation, use 
and quality assurance of blood components in 
transfusion medicine.

The Guide (10) is now at its 16th edition and has 
grown to become the basis for a large number 
of national regulations, as well as for the blood 
directives of the European Commission. The lat-
est edition of the Guide contains recommen-
dations on blood collection, blood components, 
technical  procedures,  transfusion  practices 
and quality systems for blood establishments. 

 The application of the common European 
standards for quality management systems (QMS) 
will ultimately improve the quality and safety of 
blood and blood components in the Member States 
and will lead to the implementation of comparable 
systems. Furthermore, it will avoid duplication of 
efforts between EU and CoE Member States and 
strengthen cooperation between different European 
stakeholders. Ultimately, it will reduce the risk of 
blood transfusions for patients and thus contribute 
to the improvement of public health in the Member 
States. 

Ad hoc cooperation with the CoE/EDQM, TS066 CoE2011, Technical Speciﬁcation

It further contains recommendations for the 
establishment of a quality management sys-
tem (QMS).

Directive  2002/98/EC  and  its  implementing 
directives also set out European quality and 
safety requirements for blood and blood com-
ponents.  Implementing  Directive  2005/62/
EC speciﬁcally sets out standards and speci-
ﬁcations relating to quality systems for blood 
establishments and requires that the Commis-
sion develop good practice guidelines for qual-
ity system standards and speciﬁcations.

This project was launched through the ad hoc 
cooperation between the EC/EAHC and the CoE/
European Directorate for the Quality of Medi-
cines and HealthCare (EDQM) on speciﬁc mat-
ters related to human substances (blood). Its 
aim is to develop such good practice guidelines.

The EC (DG SANCO) and the CoE 
work together to further develop 
and strengthen EU policy actions on 
quality management systems (QMS) 
in European blood establishments

The  objective  of  the  project  is  to  elaborate 
common European standards for quality man-
agement systems (QMS) to be implemented in 
blood establishments and hospital blood banks 
involved in the collection, testing, processing, 
storage and distribution of human blood and 
blood  components.  These  standards  aim  to 
become the references on which blood estab-
lishments will develop, implement and maintain 
their QMS, and can even be used as a basis by 
authorities when inspecting blood establish-
ments in the EU and wider Europe.

(9)  http://www.msc.es/profesionales/saludPublica/medicinaTrans-

fusional/recomendaciones/docs/Rec95_15.pdf

(10)  http://www.centronazionalesangue.it/sites/default/ﬁles/guida_

edqm_16_edizione.pdf

The  CoE  and  DG  Health  and  Consumers 
(SANCO)  have  respective  regulations  and 
guidelines applying in this domain. This work 
will allow the completition of these standards 

B L O O D   A N D   B L O O D   C O M P O N E N T S

37

Guide for the Preparation, Use and Quality Assurance of Blood Components, 

16th Edition.

in order to establish a sound and updated com-
mon set of standards in QMS that are revised 
and approved by a group of recognised experts. 
At the same time, these standards can be fully 
aligned  with  the  EU  legislation  in  this  ﬁeld. 
While involving a larger number of states and 
countries, dissemination of those standards 
throughout  and  beyond  Europe  will  support 
the harmonisation and diﬀusion of good prac-
tices. This may further help to prepare the way 
towards accreditation and will ensure that com-
mon standards will not only be applied by the 
EU Member States but also by the 47 Council of 
Europe Member States that are not part of the 
European Union. Such further step of harmoni-
sation and standardisation of practices will be 
of beneﬁt primarily to the safety of patients 
at a time when exchanges of substances of 
human origin and mobility of pathogens are 
continuously increasing.

This joint EU/Council of Europe project builds 
on the ongoing activities of the EDQM in the 
ﬁeld of blood transfusion and other relevant 
documents used by the blood establishments, 
including Directive 2005/62/EC, the detailed 
principles  and  guidelines  of  good  manufac-
turing practice (GMP), as referred to in Article 
47 of Directive 2001/83/EC, and the outcome 
of related projects under the EU Health Pro-
gramme (e.g. EU-BIS European Blood Inspection 
System (11)).

This collaborative eﬀort led to the adoption of 
a commonly agreed document that was sub-
mitted for public consultation in the summer of 
2012. Council of Europe Member State national 
health authorities and other interested parties 
in the blood ﬁeld were invited to submit com-
ments on the elaborated document. The ﬁnal-
ised standards will be published in the 17th edi-
tion of the ‘Guide to the preparation, use and 
quality assurance of blood components’ in the 
course of 2013. This Guide is regularly updated 
to keep it in line with scientiﬁc progress. There-
fore,  these  QMS  standards  will  continue  to 
evolve and improve with the rest of the Guide 
in the future.

(11)  http://www.eubis-europe.eu/

38

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Guide for the Preparation, Use and Quality Assurance of Blood 
Components

Why a European guide?

In the ﬁeld of blood transfusion, cooperation among Member States started back in the 1950s. 
From the outset, the activities were inspired by the following guiding principles: promotion 
of voluntary, non-remunerated blood donation, mutual assistance, optimal use of blood and 
blood products and protection of the donor and the recipient.

The Council of Europe has elaborated a guide on the preparation, use and quality assurance of 
blood components as a technical appendix to its Recommendation No. R (95) 15. 

Work on Recommendation No. R (95) 15 started in 1986, when the Select Committee of 
Experts on Quality Assurance in Blood Transfusion Services published proposals on quality 
assurance in blood transfusion services. Based on these proposals, the Select Committee 
produced a more comprehensive guide on blood components in 1995. The immediate success 
and acceptance of this document was such that the Committee of Ministers adopted it as 
a technical appendix to the Recommendation No. R (95) 15.

This guide is a compendium of requirements designed to ensure the safety, quality and 
eﬃcacy of blood components.

The Recommendation requires that the guide is updated to keep it in line with scientiﬁc 
progress. The European Committee on Blood Transfusion (CD-P-TS), the Steering Committee in 
charge of blood transfusion activities for the European Directorate for the Quality of Medicines 
& HealthCare (EDQM) of the Council of Europe, assisted by leading European experts, is 
responsible for producing regular updates.

This review includes a public consultation and comments are invited from national health 
authorities as well as all interested parties before a new edition is published.

Who is the guide designed for?

The guide is a tool speciﬁcally designed for blood transfusion professionals working in 
transfusion services and establishments, hospitals and regulatory authorities.

What information does the guide contain?

The guide contains standards and recommendations on blood collection, preparation and use 
of blood and its components, as well as technical procedures, transfusion practices and quality 
systems for blood establishments. It represents the basis for the establishment of national 
regulations and certain European directives.

Publication and purchase of the guide

The guide is available in the two oﬃcial languages of the Council of Europe (English and 
French). Other translations done either by the EDQM or under the responsibility of external 
parties and with the agreement of the EDQM are available (for example: Greek, Polish, 
Romanian, Russian and Turkish).

The above is extracted from the General Information on the Blood Transfusion Guide (http://www.edqm.eu/en/blood-organ-

guides-1131.html).

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39

The EDQM

The European Directorate for the Quality of 
Medicines and HealthCare (EDQM) (12) of the 
Council of Europe is a European organisation 
involved in harmonisation and coordination of 
standardisation, regulation and quality control 
of medicines, blood transfusion, organ trans-
plantation, pharmaceuticals and pharmaceuti-
cal care.

In 1997, the EDQM established a quality assur-
ance (QA) programme open to all oﬃcial medi-
cines control laboratories (OMCLs), with the aim 
of ensuring a harmonised approach concerning 

the implementation of quality management 
systems (QMS), based on the ISO/IEC 17025 
standard ‘General requirements for the com-
petence of testing and calibration laboratories’ 
and complemented by speciﬁc OMCL Guide-
lines.  The  QA  programme,  co-sponsored  by 
the European Commission (DG Enterprise and 
Industry), includes inventory visits and audits. 
Since the beginning of the programme in 1997, 
49 visits and 71 audits have been carried out 
at OMCL sites, by which the EDQM has gained 
considerable experience in the ﬁeld of auditing 
and has oﬀered a valuable tool to OMCLs to 
improve and harmonise their QMS.

(12)  http://www.edqm.eu/en/Homepage-628.html

HOW DO WE BUILD EUROPEAN STANDARDS FOR BLOOD TRANSFUSION? 6 Marie-Laure Hecquet©2013 EDQM, Council of Europe. All rights reserved. Non-commercialisation of substances of human origin  (cid:41)Voluntary and non-remunerated donation Self-sufficiency Protection for both the donors and the recipients Working Groups —  Technical exper(cid:415)se GTS B-PTS AG B-QM CD-P-TS  European Commi(cid:425)ee on Blood Transfusion(Steering Commi(cid:425)ee)  OUTCOMES: RESOLUTIONS, ANNUAL REPORTS, GUIDES, QUALITY MANAGEMENT PROGRAMME  TS066 40

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Further Information: 

EDQM website
http://www.edqm.eu/ 

Blood transfusion guidance at EDQM
http://www.edqm.eu/en/blood-transfusion-mission-65.html 

The Collection, Testing and Use of Blood and Blood Components in Europe
http://www.edqm.eu/medias/ﬁchiers/The_Collection_Testing_and_Use_of_Blood_and_
Blood_3.pdf

Project team: 

Project leader: 

Department of Biological Standardisation, OMCL Network & HealthCare (DBO) 
European Directorate for the Quality of Medicines & HealthCare (EDQM),  
Council of Europe 
7, allée Kastner 
Cs 30026 
67081 Strasbourg 
FRANCE  
Tel. +33 388412152 
Fax +33 388412770

EU contribution

This project has received co-funding from the European Union in the framework of the Health 
Programme 2008–2013 (Grant: 20105305).

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41

Training sessions for inspectors in the ﬁeld of blood and 
blood components (CATIE)

This service contract has been ﬁnanced from the European Union in the framework of the Health Programme 
2008–2013 (Call for Tender: EAHC/2011/HEALTH/13, Contract 20116101).

The inspection of blood establishments is a key 
element in ensuring the quality and safety of 
blood and blood components in the EU. Yet, as 
highlighted by the earlier EuBIS project, diﬀer-
ing national practices on inspections of blood 
establishments can contribute to reluctance, 
and  at  times  refusal,  to  accept  blood  and 
plasma coming from diﬀerent Member States 
and even diﬀerent centres.

which will enhance trust and reciprocal under-
standing among competent inspections author-
ities across the whole EU. At national level, the 
enhancement of the inspectors’ knowledge will 
contribute to reinforcing their two-fold respon-
sibility — namely to ensure the quality and 
safety of blood and blood components and to 
ensure compliance with EU and national regula-
tory requirements.

To align inspection practices and build mutual 
conﬁdence between inspection systems, the 
European Commission’s Directorate-General for 
Health and Consumer Aﬀairs and the Execu-
tive Agency for Health and Consumers (EAHC) 
launched a call for tenders aimed at establish-
ing a uniform set of knowledge and way of 
undertaking inspections across the EU and to 
further disseminate best practice and expertise.

The award was won by the CATIE consortium 
(Competent Authority Training on Inspections 
in  Europe),  composed  of  several  competent 
authorities (13) in the ﬁeld of safety and quality 
of blood products. Since January 2012, the con-
sortium has worked o develop an inspectors’ 
training programme on common standards and 
criteria for the inspection of blood establish-
ments across the EU.

Towards an EU common approach and 
methodology to prepare and conduct 
inspections in blood establishments

There  is  clear  strategic  value  in  the  CATIE 
undertaking. Through the programme, in fact, 
inspectors will acquire an EU common approach 
and  methodology  to  prepare  and  conduct 
inspections in blood establishments and will be 
updated on new methodologies and processes, 
including evaluation and managements of risks, 
quality assurance systems and vigilance and 
surveillance. At the EU level, this will contrib-
ute to establishing a common knowledge base 

(13)  http://www.catie-europe.eu/consortium-members-and-

subcontrators.php

The CATIE facilitator manual containing the educational material, edition 1.0, 2013

42

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Article 8 of the 2002/98/EC on ‘Inspection and control measures’ states that ‘Member 
States shall ensure that the competent authority organise inspections and appropriate 
control measures in blood establishments to ensure that the requirements of this Directive 
are complied with. Inspection and control measures shall be organised by the competent 
authority on a regular basis … Such inspection and control measures shall be carried out by 
oﬃcials representing the competent authority who must be empowered to: (a) inspect blood 
establishments as well as facilities of any third parties on its own territory entrusted by the 
holder of the designation, authorisation, accreditation or licence … ; (b) take samples for 
examination and analysis; (c) examine any documents relating to the object of the inspection, 
subject to the provisions in force in the Member States at the time of the entry into force of 
this Directive and which place restrictions on these powers with regard to the descriptions of 
the method of preparation.’

CATIE is thus working to develop training tools 
and materials that will be used by the compe-
tent authorities in the EU Member States for 
the purpose of regulatory inspections.

The training package takes also into account 
other educational material developed by other 
projects funded by the EC, such as DOMAINE, 
EUOBU and EUSTITE.

The training approach includes distance learn-
ing and training sessions. The distance learning 
modules aim to prepare trainees for the face-
to-face training sessions (workshops). Trainees 
are oﬀered preparatory material via the CATIE 
website to allow them to prepare for the work-
shops that follow this preliminary phase.

Each workshop is designed to last 4 days and 
consists of ﬁve modules: Module One comprises 
theoretical sessions on European regulations, 
processes,  management  of  serious  adverse 
events and reactions; Module Two is based on 
exercise sessions on risk identiﬁcation, analy-
sis, evaluation, reduction and review of events, 
classiﬁcation of non-compliance and role-plays; 
Module Three focuses on on-site inspections; 
Module Four essentially consist of a ﬁnal exam-
ination leading to a certiﬁcation by DG SANCO/
EAHC; and the last module includes an evalu-
ation session.

The training material draws upon ﬁrst-hand 
experience of inspectors involved in the con-
sortium as well as on the manual and guide 
developed by the EuBIS project. For example, 
as part of the on-site inspection module, par-
ticipants will be asked to use the inspection 
criteria and standards developed by the EuBIS 
project (manual and guide) including the corre-
sponding documents to prepare the inspection. 

Moreover, the composition of the consortium — 
which  brings  together  competent  authorities 
from  diﬀerent  administrative  structures  and 
geographical background and thus represent dif-
ferent national regulatory inspection systems — 
helps to ensure that the educational material can 
be easily understood and adapted to the various 
national backgrounds of the trainees. The CATIE 
consortium  is  also  aﬃliated  to  the  European 
Blood  Alliance  (EBA)  and  the  Pharmaceutical 
Inspection Convention/Scheme (PIC/S) Expert Cir-
cle on Blood and Tissue. While the EBA supports 
the  CATIE  consortium  through  its  network  of 
blood establishments, the PIC/S aﬃliation func-
tions as a link to the regular workshops organ-
ised by PIC/S for inspectors. Further links are also 
established with the EDQM and the WHO.

The CATIE training was oﬀered to competent 
authorities  and  governmental  institutions 
of all EU Member States allowing for two to 
ﬁve inspectors per each of the 27 EU Mem-
ber States to be trained.  Four CATIE training 
courses were conducted — in Budapest (Hun-
gary), Bilbao (Spain), Sliema (Malta) and Rome 
(Italy) — including a test following the distance 
learning and a ﬁnal exam. Eighty participants 
from  31  countries  (25  Member  States)  suc-
cessfully completed the course. Their positive 
evaluations reﬂected their satisfaction with the 
course and the quality of the training.

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43

Further information: 

Project website
http://www.catie-europe.eu/ 

Project team: 

Project leader: 

Red Cross Blood Donation Service Baden-Württemberg-Hessen  
Institut für Transfusionsmedizin und Immunhämatologie  
Sandhofstrasse 1  
PO-BOX  
60528 Frankfurt Am Main 
GERMANY 
Tel. +49 6967820  
Fax +49 696782110  
E-mail:  info@catie-europe.eu 

Associated partners: 

(cid:97)(cid:149) Paul-Ehrlich-Institut (PEI), Germany 
(cid:97)(cid:149) Centro Nazionale Sangue (CNS), Italy 
(cid:97)(cid:149) Autoridade para os Serviços de Sangue e da Transplantcao (ASST), Portugal 
(cid:97)(cid:149) Ministerio de Sanidad, Politica Social e Igualdad (MSPSI), Spain 
(cid:97)(cid:149) Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), France 
(cid:97)(cid:149)

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP), 
Slovenia 
in coordination with the German Red Cross, Blood Donor Service (GRCBDS), Germany. 

(cid:97)(cid:149)

EU contribution

This service contract has been ﬁnanced from the European Union in the framework of 
the Health Programme 2008–2013 (Call for Tender: EAHC/2011/HEALTH/13, Contract 
20116101).

44

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

EU-wide overview of the market of blood, blood components 
and plasma derivatives with a particular focus on their 
availability for patients (EAHC/2011/Health/15)

This service contract has been ﬁnanced from the European Union in the framework of the Health Programme 
2008–2013 (Call for Tender: EAHC/2011/HEALTH/15, Contract 20116181).

One of the main concerns of national health 
competent  authorities  for  blood  and  blood 
components, as well as for the European Com-
mission and international institutions like the 
World Health Organisation, are to maintain an 
adequate blood supply for patients requiring 
transfusion and to warranty the safety of the 
products for transfusion together with the pre-
vention of the transmission of infectious dis-
eases. At national level, few EU Member states 
report regular shortages of whole blood; how-
ever, occasionally, shortages of blood, blood 
components or plasma derivatives can occur.

 Self-sufficiency in safe blood and blood 
products based on voluntary non-remunerated blood 
donation means that the national needs of patients 
for safe blood and blood products, as assessed within 
the framework of the national health system, are met 
in a timely manner, that patients have equitable 
access to transfusion services and blood components, 
and that these products are obtained from voluntary 
non-remunerated blood donations of national, 
and where needed, of regional origin, such as from 
neighbouring countries. 

WHO Expert Consensus Statement on achieving self-suﬃciency in safe blood and blood 
products, based on voluntary non-remunerated blood donation (VNRBD), WHO 2011 (14)

Most countries have national policies for self-
suﬃciency of blood and blood components, yet 
less than half seem in fact to have deﬁned the 
very concept of self-suﬃciency.

Article 20(1) of the 2002 EC Directive (15) states 
that Member States should take the neces-
sary measures to encourage voluntary unpaid 

blood donation. The aim of promoting voluntary 
unpaid donation for blood products is to assist 
Member States in obtaining the maximum level 
of self-suﬃciency for these products.

In March 2011 a report (16) on voluntary and 
unpaid donations in the EU was published by 
the European Commission. This report shows 
that Member States overall comply with Art-
icle 20(1) of the Directive requiring all states to 
take the necessary measures to ensure volun-
tary and unpaid blood donations are the main 
sources for whole blood and blood components 
provision. Results of the report show that leg-
islative provisions and guidelines on voluntary 
and unpaid blood donation are also well estab-
lished across the EU. Additionally, according to 
the report, 27 out of the 29 reporting countries 
promote policies to raise awareness for volun-
tary unpaid donations.

There are public and private actors 
involved within the blood market

There are public and private actors involved 
within the blood and plasma market. There is 
a need to map the facilities and settings in the 
EU countries that collect, process (like frac-
tionation (17) plants), store and distribute the 
ﬁnal products, and all information regarding 
logistics.

A related aspect that needs further insight is 
the  role  and  impact  of  the  growing  market 
of  plasma  derivatives  on  supply  and  qual-
ity aspects. Following the progress made by 
immunology science indicating the potential 
therapeutic applications of plasma fractions, 
over the last years the plasma industry has 
developed a wide range of products for the 
treatment of speciﬁc groups of patients. As 

(14)  http://www.who.int/bloodsafety/Expert_Consensus_Statement_

(16)  http://ec.europa.eu/health/blood_tissues_organs/docs/blood_

Self-Suﬃciency.pdf

reportdonation_en.pdf

(15)  http://ec.europa.eu/health/ﬁles/eudralex/vol-1/dir_2002_98/

(17)  Fractionation refers to the general processes of separating 

dir_2002_98_en.pdf

the various components of blood plasma.

B L O O D   A N D   B L O O D   C O M P O N E N T S

45

a consequence, the manufacturing of these 
medicinal products from plasma derivatives 
has  signiﬁcantly  raised  the  demand  for  the 
plasma  used  by  the  pharmaceutical  indus-
try. This is why it is important to understand 
the impact of this increased need and how it 
aﬀects the supply and donation of blood and 
plasma, particularly with regard to the fact that 
the demand for all these products is limited by 
the limited availability of donors.

Additionally,  data  on  the  economic  aspects 
of this market including cost-eﬀectiveness of 
the current practices for the collection, test-
ing, storage and distribution will be of help for 
the preparation of guidance documents to help 
Member States to achieve self-suﬃciency and 
also to verify the appropriateness of the cur-
rent EU legislation.

In order to further develop the EU policy and leg-
islation with regard to self-suﬃciency and qual-
ity and safety of these products for transfusion, 
the European Commission is therefore funding 
a  study  aimed  at  gathering  and  analysing 
information on the global and EU market of 
blood and blood components, including plasma 
and plasma derivatives in the European Union.

The study is structured around some key areas. 
One focuses on the characteristics of the blood 
and  blood  component  markets  —  such  as 
market size, prices, actors, concerns and con-
ﬂicts, supply and demand volumes and other 
elements in order to better understand these 
markets. A second area of focus is the map-
ping of the main actors involved in the blood 
and plasma derivates markets, for each of the 
then 27 EU Member States and overall on the 
EU level, in order to better understand the roles 
and position of the public and private actors in 
this sector. A third area explores the impact of 
the growing market of plasma derivatives on 
supply and quality aspects of blood and blood 
products including plasma. This exploration is 
aimed at collecting information about the avail-
ability and supply shortages of those products 
in Europe in order to identify eﬃcient utilisa-
tion practices in Europe and the movements 
of those products inside Europe — including 
bilateral agreements and the trade of these 
products between European countries and non-
EU countries.

The  study,  launched  in  January  2012  for 
a  duration  of  14  months,  is  coordinated  by 
Creativ-Ceutical.

46

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Further information: 

Company’s website
http://www.creativ-ceutical.com 

Project team: 

Project leader: 

Creative Ceutical 
215, rue du Faubourg St-Honoré 
75008 Paris 
FRANCE 
Tel. +33 176704793 
Fax +33 153754924

And

33 Boulevard du Prince Henri 
1724 Luxembourg 
LUXEMBOURG 
Tel. +352 20880329

EU contribution

This service contract has been ﬁnanced from the European Union in the framework of 
the Health Programme 2008–2013 (Call for Tender: EAHC/2011/HEALTH/15, Contract 
20116181).

B L O O D   A N D   B L O O D   C O M P O N E N T S

47

Improving the safety of blood and organ supply by creating 
the research infrastructure to monitor emerging pathogens 
and develop new screening tests (BOTIA)

This Speciﬁc Targeted Research Project has received co-funding from the European Union in the framework of the 
6th Research Framework Programme (FP6-POLICIES Grant: 6487).

In the western world, including western Europe 
and the US, blood and organ donors are rou-
tinely  screened  for  a  range  of  blood-borne 
viruses with highly sensitive tests. This has dra-
matically improved the safety of blood supply. 
However, we are far from being able to provide 
a 100 % guarantee on the safety of donated 
blood and organs. This is due to a range of dif-
ferent reasons.

One is the risk posed by new or mutated forms 
of infectious agents. At present, it takes many 
years to assess the dangers posed by these 
emerging  pathogens  and  to  develop  meas-
ures  to  protect  against  them,  and  it  is  not 
even  feasible to screen for all the pathogens 
we already know about. The bottleneck in this 
process is the lack of infrastructure required 
to conduct systematic and statistically sound 
studies on the relevance of newly discovered 
viruses and other agents in blood.

Appropriate and cost-eﬀective screening pro-
cedures are not fully available. In this regard, 
the  cost  of  genomic  screening  in  developed 
countries is a major issue in blood transfusion 
because of its low cost-eﬀectiveness. Addition-
ally, many ‘state-of-the-art’ tests are not suit -
able  for  other  parts  of  the  world  because 
they are complex, instrument dependent and 
expensive. As a consequence, the safety of the 
blood supply is less guaranteed in a number of 
countries.

Immunodeﬁciency and latent viruses 
add further complications

There are also further issues related to im -
munodeﬁciency and to the diﬃculties in assess-
ing the risks posed by latent viruses, such as 
herpes  viruses.  Many  recipients  of  donated 
blood and organs have in fact some immune 
deﬁciency,  placing  them  at  greater  danger 
from infection by these viruses. Immunodeﬁ-
cient blood/organ recipients have decreased 
natural resistance to viral infection and can 
be infected with considerably lower — o#en 

even undetectable — amounts of virus than 
the immunocompetent counterpart. When the 
immune control breaks down, reactivation of 
both latent and persistent viruses can occur. 
This can have serious clinical complications.

The BOTIA project set up an EU-wide 
sample repository to quickly assess 
blood-borne agents

The BOTIA project (Blood and Organ Trans-
missible  Infectious  Agents),  supported  by 
a grant from the EU’s Sixth Research Frame-
work  Programme  (FP6)  and  involving  seven 
European partners from Belgium, France, Ger-
many, Italy, Poland, Spain and the United King-
dom, was developed to address these issues 
and  to  contribute  to  constitute  a  repository 
available for improving the safety of the blood 
supply and organ transplantation.

The project set up an infrastructure consist-
ing of an EU-wide sample repository of paired 
donor and recipient samples to enable the fast 
assessment of emerging blood-borne agents 
and thus allow for appropriate measures to be 
taken without delay. This was done by estab-
lishing  a  European-wide  collection  of  well- 
documented, linked samples from blood donors 
and their recipients, collected at pre- and post-
transfusion. The collection of the samples was 
done over a 3-year period in order to obtain 
a large sample size and cover a large exposure 
period.

A computerised data management system, to 
enter information, track samples, manage and 
analyse data of samples and tests results, was 
then developed. This enables the selection of 
appropriate materials for studies when new 
infectious agents are detected.

At the Institut National de la Transfusion San-
guine, from where the project is coordinated, 
the  BOTIA  team  highlights  that  ‘The  BOTIA 
project has demonstrated the eﬃciency of the 
collaboration of transfusion teams gathered 

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Project description from the SINAPSE database (https://europa.eu/sinapse/sinapse/)

 The clinical relevance of a blood-borne 

infectious agent is based on six criteria: 
transmissibility by transfusion/transplantation; 
pathogenicity; prevalence; persistence; availability of 
screening methods; and immune status of recipient. 
Currently, it takes many years before the clinical 
relevance of new/mutated pathogens has been 
assessed and appropriate measures taken. 

http://www.ints.fr/EuropeIntBotia.aspx

around  a  common  project.  Such  a  success 
allows therefore envisaging further studies at 
the European scale on the topic of transfusion 
safety with regard to infections.’

BOTIA turns into a ‘permanent project’

Such a European repository would, however, 
make no sense if its existence was limited in 
time.  For  some  participating  countries,  the 
BOTIA project has turned into a kind of ‘perma-
nent project’, allowing them to obtain biological 
materials on the infectious risk of transfusion 
at any given moment.

‘A strictly uniform European strategy for ﬁght-
ing blood-borne agents does not exist and is 
not to be wished, as each country has to take 
into account its own situation in relation to the 
prevalence, or even the existence, in its terri-
tory, of such transfusion-transmitted agents. In 
the case of the variant of the Creutzfeld Jacob 
Disease (vCJD), for example, only two countries 
among the European Community — the United 
Kingdom and France — have been confronted 
with the risk. The situation was in no way the 
same in the other European countries. Conse-
quently, a strategy based on identical safety 
rules for all European countries would make no 
sense,’ notes the BOTIA team.

Rather, the experience of a particular country 
in the ﬁeld of transfusion safety may well be 
useful for other countries, in particular through 
the carrying out of common quality controls of 
biological tools for the screening of blood-borne 
agents, or in the constitution of a repository, 
which can be used for European studies aim-
ing at the strengthening of transfusion safety. 
Indeed, this has been the purpose of this project.

B L O O D   A N D   B L O O D   C O M P O N E N T S

49

Further information: 

Project website
http://www.ints.fr/EuropeIntBotia.aspx
http://ec.europa.eu/research/fp6/ssp/botia_en.htm

Project team: 

Project leader: 

Institute National de la Transfusion Sanguine (INTS) 
Prof. Philippe Rouger 
6 rue Alexandre Cabanel
75739 Paris cedex 15 
FRANCE  
Tel. +33 143060483 
E-mail: prouger@ints.fr

Partners: 

Institute National de la Transfusion Sanguine (INTS), France

(cid:97)(cid:149)
(cid:97)(cid:149) University of Cambridge (UCAM), United Kingdom
(cid:97)(cid:149) Ospedale A. Manzoni, Dipartimento di Medicina Trasfusionale e die Ematologia, Lecco 

(DTMH), Italy

(cid:97)(cid:149) Scientiﬁc Institute of Public Health, Ministry of Public Health (IPH), Belgium
(cid:97)(cid:149) Centre de Transfusio I Banc de Teixits (CTBT), Spain
(cid:97)(cid:149) Academic Medical Centre (AMC), The Netherlands
(cid:97)(cid:149) DRK Blutspendedienst Baden-Wuerttemberg-Hessen GmbH, Institut fuer 

Transfusionsmedizin (DRK BSD), Frankfurt/Main, Germany

(cid:97)(cid:149) Reseaumatique S.A., France
(cid:97)(cid:149)

Institute of Haematology and Transfusion Medicine (IHT), Poland

EU contribution

This Speciﬁc Targeted Research Project has received co-funding from the European Union in 
the framework of the 6th Research Framework Programme (FP6-POLICIES Grant: 6487).

50

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Genomics and Blood Substitutes for 21st Century Europe 
(EURO BLOOD SUBSTITUTES)

This Speciﬁc Targeted Research Project has received co-funding from the European Union in the framework of the 
6th Research Framework Programme (FP6-2002-LIFESCIHEALTH).

Blood transfusion has its origins in the 1660s 
when  Richard  Lower,  and  later  Jean-Baptiste 
Denis, began the ﬁrst transfusions of blood, ini-
tially from animal to animal, and subsequently 
from animals to humans. In December 1818, 
James Blundell performed the ﬁrst transfusion 
from one human patient to another, thereby lay-
ing the foundations for the dramatic reﬁnements 
in transfusion practice and the establishment of 
blood banks which occurred in the 20th century.

Modern  blood  transfusion  in  industrialised 
countries is a universally practised and remark-
ably safe clinical procedure. Blood or concen-
trated (‘packed’) red cells are routinely trans-
fused  following  extensive  blood  loss  or  as 
a treatment for chronic anaemia. In these situ-
ations, the aim of the transfusion is to not only 
increase blood volume, but also to increase the 
arterial oxygen content thereby enhancing the 
delivery of oxygen to the tissues.

 What we are looking for is 
the powdered milk equivalent for 
blood. 

Professor Chris Cooper, Essex University — Euro Blood  

Substitutes project’s partner

Blood  transfusion  is 
not, however, a zero-
risk  intervention  and 
there  are  several 
physiological  and 
practical  problems 
associated  with  this 
procedure.  Blood 
is  in  fact  a  biologic 
material that has the 
potential to transmit diseases. Despite improved 
screening and processing, European citizens are 
becoming increasingly concerned about blood 
safety. Such concerns are making people more 
reluctant to donate blood or receive it through 
transfusions. In addition, blood is a scarce good 
with a limited supply, dependent on the willing-
ness of individuals to donate.

Safe, eﬀective and commercially 
viable blood substitutes can help to 
overcome blood transfusions’ risks

Blood substitutes are oxygen-carrying ﬂuids that 
aim to provide an alternative to the transfusion 
of blood. Put simply, they are ﬂuids which, when 
injected into the blood, provide volume expan-
sion and make a signiﬁcant contribution to both 
systemic oxygen transport and tissue oxygena-
tion. When coupled with the use of autologous 
blood (the patient’s own blood or blood compo-
nents), oxygen therapeutics will be a crucial part 
of future blood-conserving strategies to avoid 
patient exposure to donor blood and reduce the 
risk  of  contracting  diseases  transmissible  via 
blood.

In 2004, a 12-member academic and industrial 
European team led by the University of Not-
tingham initiated the 3-year project Genom-
ics and Blood Substitutes for 21st Century 
Europe (‘Euro Blood Substitutes’). The aim of 
the project was to develop an integrated tech-
nological platform for generating blood substi-
tutes for critical blood components, in particu-
lar oxygen carriers using microorganisms, such 
as bacteria and yeasts as living cell ‘factories’. 
‘We’re aiming to produce a replacement oxygen 
carrier, rather than a complete blood substitute 
because blood is a complex soup of materials 
that have many other roles besides carrying 
oxygen to the tissues,’ explained Dr Lowe, the 
project coordinator.

Under the project, researchers worked to mod-
ify the genes of the oxygen-carrying part of the 
blood (haemoglobin) and used cell factories to 
mass produce artiﬁcial molecules that would 
be able to oxygenate the body’s cells just as 

eﬃciently, but without the possibility of con-
tamination with disease.

In a 2005 interview preceding the presentation 
of the ﬁrst project’s results at the Society for 
Experimental Biology’s annual meeting, Dr Lowe 
explained: ‘We are using genomics to modify the 
haemoglobin as well as looking at ways to attach 
it to large molecules so that it stays in the body 
longer during transfusions. We are aiming to ﬁnd 
the optimum molecules for oxygen-binding and 
transport as well as the best culture conditions 
for mass producing it for the future.’

The potentials for blood substitutes 
are as huge as the challenges posed 
by their production

The challenges faced by this new project were 
to both genetically engineer the microorganisms 
to synthesise haemoglobin (Hb) proteins, extract 
and purify them without adversely altering their 
biochemical  characteristics,  and  to  identify 
ways to scale-up the production of Hb to a com-
mercial scale. Even a predicted annual use of 
a unit dose of ~50 g Hb in, say, 5 % of the Euro-
pean population was estimated to require the 
production of ~2 000 kg of protein — in itself 
a major commercial undertaking.

The project received major EU funding through 
the  Sixth  Research  Framework  Programme, 
since  the  potential  for  production  of  blood 
substitute components from microorganisms 
was considered huge. In principle, in fact, the 
use of blood substitutes could solve many of 
the problems associated with using blood for 
transfusion. Speciﬁc clinical targets have been 
identiﬁed  for  such  blood  substitutes,  most 
especially their use to replace acute blood loss 
during surgery or following trauma. In people 
who refuse blood transfusions or those unable 
to  a  receive  transfusion  for  clinical  reasons 
(e.g.  patients  with  autoimmune  haemolytic 

B L O O D   A N D   B L O O D   C O M P O N E N T S

51

Blood substitutes are needed and would be very helpful also on 
the battleﬁeld. Which is why the American military ﬁrst started 
researching the possibility of developing a synthetic blood substitute 
during the Vietnam War. It is very hard to have adequate amounts 
of blood in war zones, due to the rate at which blood expires. 
While the useful shelf life of donated blood when stored at 4 °C in 
a refrigerator is only ~42 days (even with the use of modern nutrient 
additives, such as mannitol, glucose and adenine), artiﬁcial blood 
has a longer shelf life (around 1 year) and can be stored at room 
temperature. It can also be universally given as it does not require 
diﬀerent types for each blood type.

In countries with a high HIV prevalence, blood substitutes would 
be also particularly useful for blood transfusions. These countries 
usually cannot aﬀord to test all blood that is donated. Therefore, 
people can become infected with HIV or other diseases through 
blood transfusions. If and when artiﬁcial blood becomes available in 
these regions, blood transfusions will become much safer and could 
even help reduce HIV transmission through blood transfusion. 

http://blogs.dickinson.edu/mindmeetsmatter/category/
artiﬁcial-blood-artiﬁcial-oxygen-carriers/

disease), an eﬀective blood substitute could 
be life saving.

Engagement with stakeholders

In addition to scientiﬁc research, the project 
also looked into the perceptions of beneﬁt and 
risk associated with the transfusion of blood, 
blood products or, most especially, potential 
blood  substitutes.  As  public  attitudes  play 
a crucial role in realising the potential of sci-
entiﬁc and technological advances, the project 
conducted  a  survey  (in  the  United  Kingdom 
and the Netherlands) on what relevant stake-
holder  groups  knew  about  transfusion;  how 
safe people perceived blood and blood prod-
ucts to be; how the latter information would 
inﬂuence their own or others’ perceptions of 
risk linked to transfusion; and to what extent  
approved blood substitutes would be preferred 

52

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

What blood substitutes are in development and how developed are they?

BLOOD PRODUCTS

TYPE

EXAMPLES

STAGE OF 
DEVELOPMENT

NOTES

Donor Blood

A, B, AB, O
(+ / -)

Blood transfusions were 
developed in the 17th 
century.
Blood banks have been 
operating since the 1930’s

Currently about 2.5 million units of blood are collected annually in the UK1. 
Approximately 5% of the population donates blood. Blood types must be matched; 
people can have one of four types of blood: A, B, AB, O each of which can be either 
positive or negative e.g. A+

Substitute made 
from Chemicals

Perﬂurocarbons
Oxygent

First-trialled in 
humans, 1978. Limited 
approval in the US

Perﬂurocarbons are a liquid that can hold a lot of oxygen - enough to breathe when 
immersedin the liquid2 but blood attracts oxygen whereas these chemicals only absorb 
it - so patients using perﬂurocarbons as an oxygen carrier must breathe pure oxygen.

Substitute made 
from Cows’ 
haemoglobin

Hemopure

In clinical trials in the UK 
and USA; limited use in 
South Africa

Substitute made 
from Human 
haemoglobin

PolyHeme

Clinical trials completed

Haemoglobin is the part of red blood cells, within blood, that attracts and holds 
oxygen. It is a protein with some iron in it. Some blood substitutes are based on this 
protein (because it is the crucial bit of blood for carrying oxygen). Bovine haemoglobin 
is relatively easily available and is quite robust, outside of red blood cells. Only the 
haemoglobin is used so other things in the cow blood are not transferred.

Human haemoglobin is no more plentyful than donor blood so to make a blood 
substitute from human haemoglobin alternate sources of human haemoglobin have 
been used. One possibility is using GM technology make human haemoglobin. However 
haemoglobin outside of red blood cells is not very robust and can degrade so it needs to 
be further modiﬁed in some way to remain eﬀective.

LAST UPDATED

APRIL 2006

http://www.psychology.nottingham.ac.uk/staﬀ/pﬀ/euroblood/

over a person’s own or donor blood. Overall, the 
results (18) showed that donor blood was con-
sidered signiﬁcantly more eﬀective and more 
ethical than all the potential blood substitutes 
evaluated.  Blood  substitutes  based  on  syn-
thetic ‘chemicals’ (i.e. abiotic materials) were 
rated by respondents as similar to ‘grown from 
bacteria’ (recombinant Hb-based) substitutes 
in terms of eﬀectiveness, but were viewed as 
more ethical. Substitutes based on ‘cow blood’ 
(bovine Hb) were perceived as the least ethi-
cal. All the blood substitutes were perceived as 
having similar eﬀectiveness, albeit to a lower 
extent than for donor blood.

Information  on  what  stakeholders  perceive 
to be the beneﬁts and risks of the receipt of 
blood and blood substitutes are important for 
future transfusion strategies and the design of 
new decision aids and physician training aids. 
This is particularly the case for blood substi-
tutes as these become approved for routine 
clinical use.

(18)  http://www.psychology.nottingham.ac.uk/staﬀ/pﬀ/euroblood/

results.htm

B L O O D   A N D   B L O O D   C O M P O N E N T S

53

Further information: 

Project website:
http://www.psychology.nottingham.ac.uk/staﬀ/pﬀ/euroblood/index.htm 

CORDIS database:
http://cordis.europa.eu/projects/rcn/75269_en.html

Further:
http://www.healthcompetence.eu/converis/publicweb/project/3337?show=Person

Project team: 

The University of Nottingham 
Dr Kenneth C. Lowe 
University Park 
Nottingham  
NG7 2RD 
UNITED KINGDOM
Tel. +44 1159513311 
Fax +44 1159513251

Other principal investigators:   

(cid:97)(cid:149) Andrea Bellelli (Universita degli Studi di Roma ‘La Sapienza’) 
(cid:97)(cid:149) Leif Bulow (Lunds Universitet) 
(cid:97)(cid:149) Michele Perrella (Universita degli Studi di Milano) 
(cid:97)(cid:149) Andrea Mozzarelli (Universita degli Studi di Parma) 
(cid:97)(cid:149) Chris Cooper (University of Essex) 
(cid:97)(cid:149) Patrick Menu (Universite Henri Poincare Nancy 1) 
(cid:97)(cid:149) Andras Eke (Semmelweis Egyetem) 
(cid:97)(cid:149)
(cid:97)(cid:149) Mats Andersson (Alligator Bioscience AB) 
(cid:97)(cid:149) Willi Glettig (LCC Engineering & Trading GmbH) 
(cid:97)(cid:149) Christopher Prowse (Common Services Agency) 
(cid:97)(cid:149) Agatha Brand (Sanquin Blood Supply Foundation) 

Jens Nielsen (Technical University of Denmark) 

EU contribution

This Speciﬁc Targeted Research Project has received co-funding from the European Union in 
the framework of the 6th Research Framework Programme (FP6-2002-LIFESCIHEALTH).

54

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Rapid SPR for parallel detection of pathogens in blood (RaSP)

This Speciﬁc Targeted Research Project has received co-funding from the European Union in the framework of the 
6th Research Framework Programme (FP6-2005-SSP-5-A, Grant: SP5A-CT-2006-044515).

While blood transfusions, tissue transplanta-
tion or organ transplantation can be life-sav-
ing, they are not without risks. Blood establish-
ments need to screen donors for risk factors 
and test donated blood to reduce the risk of 
transfusion-related infections, but they occa-
sionally still occur. It usually takes 12 hours 
of laboratory work to know whether a blood 
sample is safe. This is already quite a long 
period  of  time  in  the  case  of  blood  dona-
tions, and it can be too long a time for organ 
transplantations.

The lab technologies used for screening diseases 
such as HIV and hepatitis therefore need to be 
improved  —  both  in  their  capacity  to  detect 
pathogens and in their ability to deliver speedy 
results. In addition, there is a need to test donor 
blood in a cheap and fast way, especially in less 
developed countries where the rate of infected 
blood is high due to high prevalence of diseases.

The Rapid SPR for parallel detection of path-
ogens in blood (RaSP) project, that ran from 
2007 to 2009 with EC co-funding through the 
FP6, took up these challenges.

Combining  the  interdisciplinary  know-how 
of three research institutes, three university 
departments and three companies located in 
Europe, associated states and international 

cooperation countries, RaSP has been able to 
develop a very fast, cheap and at the same 
time very sensitive method to simultaneously 
detect the pathogens HIV, Hepatitis C, Hepa-
titis  B  and  syphilis.  The  method  developed 
by  the  project  has  the  additional  potential 
to  detect  more  than  100  blood  pathogens 
simultaneously.

RaSP develops a simple desktop 
method to detect multiple pathogens

‘Once  the  method  will  be  implemented  in 
a real product, the analysis will be done with 
a  simple  and  small  desktop  system  which 
is easy to use and which produces accurate 
results able to detect the presence of multi-
ple blood pathogens,’ explains Dr Velten, the 
project  coordinator.  Within  10–20  minutes 
the doctor will know  whether there are any 
pathogens, in the blood. Infected blood could 
then be immediately excluded from the blood 
banking procedure.

RaSP aimed to exploit a new type of surface 
plasmon resonance (SPR) transducing princi-
ple that allows a signiﬁcant increase of sen-
sitivity compared to the state-of-the-art SPR 
systems.

inlet (sample injection)

rotation
platform

outlet (waste)

thermo stabilisation

microﬂuidic measurement cell

transducer chip

imaging optics

ccd
camera

transducer 
unit

computer

y
l
p
p
u
s

r
e
w
o
p

temperature 
control

current
control

laser
diode

analytical device

Fig 3: RaSP System Concept Overview.

RaSP System Concept Overview (19)

(19)  http://www.rapid-spr.com/documents/Emerging %20

Epidemics %20Research.pdf

 
B L O O D   A N D   B L O O D   C O M P O N E N T S

55

A two-channel SPR for parallel or diﬀerential SPR measurements in liquids or in  
gases with wide angle range up to 17 degrees (22)

measurement time of about 10 minutes. SOP 
2 is based on the measurements of changes 
of the SPR signal a#er the dissociation of the 
antigen-antibody complex in acidic conditions. 
In contrast to SOP 1, this procedure requires 
a longer measurement time of about 40 min-
utes  but  it  is  less  inﬂuenced  by  non-speciﬁc 
eﬀects  and  is  not  sensitive  to  variations  of 
the refractive index of the clinical samples. Dr 
Velten  however  says  that  ‘Although  the  ﬁrst 
results were promising and conﬁrmed the fea-
sibility of the RaSP method there is still a long 
way  to  go  from  the  ﬁrst  prototype  to  a  real 
product.’

 This diagnostic method represents a revolution 

in the field of rapid diagnostics. It can be conducted 
in one step, on location where the blood is collected 
from donors, and it does not need any sophisticated 
laboratory preparation. Its applications in the 
medical sector will reduce the risk of dealing with 
contaminated biological materials and help to 
prevent persons from risks posed by contaminated 
blood. 

 (23)

The immunosensitive diagnostic assay (20) is 
based on the very speciﬁc immune reaction 
between antigens and antibodies. More con-
cretely, the project has developed a glass chip 
covered with antibodies; tiny surface oscilla-
tions are induced in the chip and if the relevant 
virus  binds  with  an  antibody,  the  oscillation 
changes. While the technique is not new, the 
chip that has been newly developed oﬀers new 
advantages, in particular the fact that the new 
chip is more resistant to ﬂuctuations in temper-
ature. Additionally, the new chip consists of four 
analysis squares, which means that the blood 
can be examined for four diﬀerent pathogens 
during each single test.

The  chip  is  encapsulated,  which  makes  the 
blood follow a deﬁned course on the chip. Blood 
samples put onto the chip will not come into 
contact with the user nor with the non-dispos-
able parts of the RaSP analytical instrument. 
Thus any contamination of the user and the 
RaSP instrument can be avoided.

The prototype compares favourably 
with conventional methods

The  capabilities  of  the  ﬁrst  RaSP  prototype 
system  were  evaluated  in  two  countries  by 
performing experiments with clinical samples 
that were compared with the results of conven-
tionally used methods like ELISA. The meas-
urements were performed by using transducer 
slides with immobilised antigens and antibod-
ies against the four pathogens Hepatitis B and 
C, HIV, and Treponema pallidum (21). ‘A remark-
able result of the performed experiments was 
the  sensitivity  to  antibodies  of  Hepatitis  B, 
because it was the ﬁrst documented applica-
tion of multiple SPR-technologies for the direct 
analysis of clinical samples. The comparison 
with ELISA showed a value of the correlation 
coeﬃcient between these techniques of about 
43 %,’ notes Dr Velten.

Two diﬀerent standard operating procedures 
(SOP) were developed for the work with real 
samples.  The  ﬁrst  method  (SOP  1)  is  based 
on the signal observed a#er the replacement 
of a reference liquid by the serum that is to 
be analysed. Its main advantage is the short 

(20)  An assay is a quantitative or qualitative test of a substance to 
determine its components; frequently used to test for the pres-
ence or concentration of infectious agents or antibodies, etc.

(22)  http://www.rapid-spr.com/

(21)  Treponema pallidum is a bacteria with subspecies that cause 

(23)  http://www.rapid-spr.com/objectives.php?RaSPSESSION=2c84d

treponemal diseases such as syphilis, bejel, pinta and yaws. 

f5355e85dﬀ08b35ec0db8f158a

56

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

The RaSP method may become 
a standard blood screening method

This diagnostic method represents a revolu-
tion in the ﬁeld of rapid diagnostics. The RaSP 
method  could  indeed  become  a  standard 
method  for  screening  donor  blood.  Further-
more, other bio-analytical applications are con-
ceivable for this system, such as the detection 
of emergency markers, food monitoring (detec-
tion of food-related pathogens) and monitor-
ing of environmental pathogens and biological 
warfare agents.

‘The project showed that the RaSP method is 
feasible. We have solved many individual prob-
lems. These solutions are needed as building 
blocks  if  a  company  will  take  up  the  RaSP 
results for building a real product. Examples 
of such results include new antibodies, new 
methods for immobilising (printing) antibodies 
in a deﬁned pattern, concepts and methods for 

SPR-chip packaging, so"ware and electronics 
for signal readout and fabrication of metallic 
nanopatterns. However, RaSP is not a company, 
it is a project. We cannot produce a diagnos-
tic product and apply for EC mark. Thus there 
is currently no RaSP product which could be 
used in routine diagnostic tests,’ concludes Dr 
Velten.

To become a routine diagnostic test, 
RaSP needs the private sector

The real exploitation of the project results will 
have to be done by companies who take up the 
RaSP results and turn them into real products. 
One company has already expressed interest 
in using some of the project results for improv-
ing their next generation of SPR products, and 
another will use RaSP results for future anti-
body production.

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57

Further information: 

Project website
http://www.rapid-spr.com/ 
http://www.healthcompetence.eu/converis/publicweb/project/1234?show=Person 

Project team: 

Scientiﬁc coordinator:  

Dr Thomas Velten 
Fraunhofer Institute for Biomedical Engineering (IBMT) 
Ensheimer Strasse 48 
66386 Sankt Ingbert,  
GERMANY

E-mail: thomas.velten@ibmt.fhg.de

Other principal investigators:  

(cid:97)(cid:149) Hunor Santha (Budapest University of Technology and Electronics)
(cid:97)(cid:149) Kyle Jiang (The University of Birmingham)
(cid:97)(cid:149) Vladimir Mirsky (Universitaet Regensburg) 
(cid:97)(cid:149) Waleed Waleed Nazmy El-Mazny (Holding Company for Biological Products and 

Vaccines (VACSERA))

(cid:97)(cid:149) Robert Deak (Mikromikomed KFT) 
(cid:97)(cid:149) Alexandre Zybine (Leibniz-Institut Fur Analytische Wissenscha$en-ISAS-EV) 
(cid:97)(cid:149) Thomas Hirsch (MIVITEC GMBH) 
(cid:97)(cid:149) Anton Samoylov (Institute of Semiconductor Physics, National Academy of Science of 

Ukraine) 

EU contribution

This Speciﬁc Targeted Research Project has received co-funding from the European Union in 
the framework of the 6th Research Framework Programme (FP6-2005-SSP-5-A, Grant: 
SP5A-CT-2006-044515).

58

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Development of a Blood Screening Assay for Diagnosis of 
Prion Diseases in Humans (PRIONSCREEN)

This Speciﬁc Targeted Research Project has received co-funding from the European Union in the framework of the 
6th Research Framework Programme (FP6-2005-SSP-5-A, Grant: SP5A-CT-2007-044438).

blood  donation (24).  The  transmission  of  the 
disease occurred in the incubation period of 
the donors, which demonstrates that this route 
can be highly eﬃcient. Precautionary measures 
to avoid transmission — such as leucodeple-
tion (25) and donor deferral — can be taken. 
However,  these  increase  the  costs  of  blood 
and blood products, reduce the donor popula-
tion and might lead to a shortage of available 
blood products.

To reduce public health risks related to 
undetected infected blood donors, the 
PRIONSCREEN project was designed

From  a  public  health  perspective,  unde-
tected  sub-clinically  infected  blood  donors 
bear a great risk for secondary vCJD trans-
mission,  persistence  and/or  even  spread  of 
vCJD epidemic within the human population. 
Post- mortem brain tissue is currently used to 
diagnose vCJD. However, a screening method 
applicable and repeatable in easily accessible 
tissues  and  ﬂuids  such  as  blood  is  urgently 
required  to  screen  blood  donors  for  abnor-
mal prions at an early stage of infection. Such 
a method needs to be able to reﬂect disease 
pathology in the early stages and therefore be 
able to indicate a prion infection.

The  project  PRIONSCREEN,  Development 
of  a  blood  screening  assay  for  diagnosis 
of  prion  diseases  in  humans,  coordinated 
by the University of Göttingen and compris-
ing ﬁve European partners, was launched in 
2007  with  a  3-year  funding  from  the  Sixth 
Research Framework Programme (FP6). The 

(24)  However, according to the WHO only four cases of vCJD 

infection have been associated with blood transfusion: three 
of these cases developed symptoms of vCJD several years 
a#er transfusion, and one died from unrelated causes before 
developing symptoms of vCJD, but was shown to be infected 
with vCJD (http://www.who.int/mediacentre/factsheets/fs180/
en/).

(25)  Leucodepletion is a process by which leucocytes are removed 
from donated blood. Leukocytes, or white blood cells, are cells 
of the immune system involved in defending the body against 
both infectious disease and foreign materials. The number of 
leukocytes in the blood is o#en an indicator of disease.

The word prion, coined in 1982 by Stanley B. Prusiner, is derived from the words 

protein and infection. A prion is an infectious agent composed of protein in 

a misfolded form.

The word prion, coined in 1982 by Stanley B. 
Prusiner, is derived from the words protein and 
infection. A prion is an infectious agent com-
posed of protein in a misfolded form.

This is diﬀerent from all other known infec-
tious agents (virus/bacteria/fungus/parasite), 
which contain nucleic acid (either DNA, RNA or 
both). Prions are responsible for the transmis-
sible spongiform encephalopathies in a vari-
ety of mammals, including bovine spongiform 
encephalopathy (BSE, also known as ‘mad cow 
disease’) in cattle and Creutzfeldt-Jakob dis-
ease (CJD) in humans. CJD is at times called 
a  human  form  of  mad  cow  disease  even 
though classic CJD is not related to BSE. How-
ever, given that BSE is believed to be the cause 
of variant Creutzfeldt–Jakob (vCJD) disease in 
humans, the two are o#en conﬂated. Prions do 
not replicate, they cause other prion proteins 
to become misfolded. All known prion diseases 
aﬀect the structure of the brain or other neural 
tissue and are currently untreatable and uni-
versally fatal.

For  many  decades,  CJD  was  thought  to  be 
transmissible among humans only via contact 
with infectious nervous system tissue. However, 
recently it was shown that variant Creutzfeldt-
Jakob disease (vCJD) can be transmitted by 

B L O O D   A N D   B L O O D   C O M P O N E N T S

59

Graphical representation of a possible outcome of the PRIONSCREEN project.

aim of PRIONSCREEN was to develop easily 
applicable tests for prion diseases in humans 
and potentially in animals. Such tests would be 
more eﬀective for diagnostic purposes and as 
a screening assay in blood donors.

Since conventional tests require a brain autopsy 
or biopsy, and surrogate markers o#en only 
show positive results in the advanced stages 
of the disease, the project was set to identify 
potential biomarkers (26) of Creutzfeldt-Jakob 
disease (CJD) via a blood test using multimodal 
approaches such as the detection of disease-
speciﬁc  early  markers  or  abnormal  protein 
aggregation. This work was directed towards 
the identiﬁcation of speciﬁc interacting part-
ners on a protein, mRNA and DNA level.

‘The prion protein that is believed to cause CJD 
exhibits two isoforms, cellular Prion protein PrPC 
and  abnormal  PrPSc,  which  provoke  a  trans-
missible spongiform encephalopathy. Recent 
ﬁndings suggest that PrPC is a multifunctional 

(26)  A biomarker is a term o#en used to refer to a protein meas-

ured in blood whose concentration reﬂects the severity or 
presence of some disease state. More generally a biomarker 
is anything that can be used as an indicator of a particu-
lar disease state or some other physiological state of an 
organism. A biomarker is o#en a traceable substance that is 
introduced into an organism as a means to examine organ 
function or other aspects of health.

protein  participating  in  several  cellular  pro-
cesses. Hence, through the project we sought 
to identify the cellular proteins that speciﬁcally 
interact with PrPC and the common genetic vari-
ant of Prion protein,’ explains Prof. Dr Inga Kerr, 
one of the project coordinators.

A"er years of research and trials, the 
project identiﬁes new candidates for 
diagnostic markers

With several years of research and clinical tri-
als, the team was successful with their unique 
approaches to identify the novel candidates for 
diagnostic markers in PrPC and in diﬀerent CJD 
subtype patient´s CSF and blood. Additionally, 
the project established a well-characterised 
sample and data banks for infected blood and 
brain tissue.

The samples are available for further research 
on biological ﬂuids in patients with CJD and 
other prion diseases, especially for further test 
evaluation and harmonisation. The project team 
also developed microﬁltration assays for the 
detection of prions in the blood of experimen-
tally infected animals and from human tissue 
samples collected at an early disease stage. 
‘Importantly, the team characterised the PrP and 

60

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

various PrP isoforms in patients aﬀected by CJD 
and in controls,’ says Prof. Dr Kerr. ‘A novel and 
extremely interesting contribution is the identiﬁ-
cation of various PrP interacting proteins, which 
expand our understanding on PrP function in 
physiological conditions and in disease and will 
allow  better  diagnosis  and  potentially  better 
therapies in future.’

 In addition to the scientific outcome of this 
initiative, the project fostered intense collaborative effort 
among different European labs. Such collaboration was 
in itself a remarkable achievement. 
Prof. Dr Kerr, project coordinator

Overall this study has provided valuable new 
insights in the exploration of the PrPC biology 
and in the establishment of diagnostic assays 
for  PrPdiseases  in  humans.  By  performing 
blood and CSF (cerebrospinal ﬂuid) proteom-
ics (protein analysis) and a functional genomic 
analysis (gene analysis) of plasma samples 
from sCJD patients and humanised mice, 49 
diﬀerentially expressed proteins and a panel of 
seven dysregulated genes could be identiﬁed.

If conﬁrmed by validation studies on a wide 
number of CJD (including other CJD subtypes) 
and  neurological  controls  (e.g.  Alzheimer’s 
disease,  Parkinson  disease,  Frontotemporal 
dementia), the CJD-speciﬁc plasma proteomic 
and  cellular  genomic  pattern  hold  a  strong 
potential for the development of a novel, spe-
ciﬁc test in an ELISA format to support the in 
vivo diagnosis of CJD.

‘Our results show, for the ﬁrst time, the occur-
rence of an apparent CJD-speciﬁc alteration of 
blood physiology and this opens an entirely new 
line of research to understand the peripheral 
pathogenesis of this disorder,’ concludes Prof. 
Dr Kerr.

The research outcome acquired a very positive 
feedback from scientists all over the world. In 
addition to the scientiﬁc outcome of this initia-
tive, the project fostered intense collaborative 
eﬀort among diﬀerent European labs. Such col-
laboration was in itself a remarkable achieve-
ment. Besides the identiﬁcation and characteri-
sation of novel candidates for diagnostic mark-
ers, the project helped to establish further test 
evaluation and harmonisation of the various 
protocols amongst the project partners. Further 
follow-up projects using Prionscreen as a basis 
are being planned.

B L O O D   A N D   B L O O D   C O M P O N E N T S

61

Further information: 

Project website
http://www.prionscreen.de 
http://ec.europa.eu/research/health/infectious-diseases/emerging-epidemics/
projects/161_en.html 

Health Competence Database:
http://www.healthcompetence.eu/converis/publicweb/project/1230?show=Person 

Project team: 

Project info:

Prof. Dr Inga Zerr  
Prof. Dr Victor Armstrong 
Prof. Dr Walter Schulz-Schaeﬀer 

Georg-August University of Göttingen 
Departments of Neurology, 
Clinical Chemistry and Neuropathology 
National Reference Centre for TSE 
Robert-Koch-Str. 40, 37075 Göttingen 
GERMANY

Tel. +49 551396636 
Fax +49 551397020

E-mail:  
IngaZerr@med.uni-goettingen.de;  
varmstro@med.uni-goettingen.de;  
wjschulz@med.uni-goettingen.de 

Other principal investigators:  

(cid:97)(cid:149) Dieter Naumann (Robert Koch-Institut)
(cid:97)(cid:149) Maurizio Pocchiari (Istituto Superiore di Sanità)
(cid:97)(cid:149) Cornelia M. van Duijn (Erasmus Medical Centre Rotterdam)
(cid:97)(cid:149) Eva Judita Mitrová (Slovenska Zdravotnicka Univerzita v Bratislave)
(cid:97)(cid:149) Michael Bruce Coulthart (Public Health Agency of Canada)
(cid:97)(cid:149) Alison Green (The University of Edinburgh) 

EU contribution

This Speciﬁc Targeted Research Project has received co-funding from the European Union in 
the framework of the 6th Research Framework Programme (FP6-2005-SSP-5-A, Grant: 
SP5A-CT-2007-044438).

Human tissues 
and cells for 
transplantation 

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

65

The transplantation of human tissues and cells 
is a strongly expanding ﬁeld of medicine oﬀer-
ing excellent opportunities for the treatment of 
as yet incurable diseases. Among substances of 
human origin (SoHO), tissues and cells are the 
most heterogeneous category, involving both 
living and deceased donors, and covering vari-
ous types of tissues/cells, such as:

(cid:98)(cid:553) replacement tissues, also considered 

‘traditional’ tissues like bone, cartilage and 
tendons, heart valves and blood vessels, 
ocular tissues (cornea, sclera) and skin; in 
the last decade, additional tissues and cells 
have been added to this category, among 
them hepatocytes, pancreatic cells and 
chondrocytes can be mentioned;

(cid:98)(cid:553) haematopoietic stem cells, which include 
bone marrow, peripheral blood stem cells, 
umbilical cord blood stem cells and other 
stem cells;

(cid:98)(cid:553) reproductive tissues and cells, which include 

gametes (sperm, eggs), embryos and 
testicular/ovarian tissues.

At the EU level, there are approximately 3 700 
tissue establishments (TEs) which are involved 
in the donation, procurement, testing, process-
ing, storage and distribution of this wide vari-
ety of tissues and cells. Hundreds of thousands 
of tissues and cells are procured, and tens of 
thousands of patients receive such products 
every year, while other tens of thousands of 
tissues and cells are preserved and stored for 
future use.

Presently the EU legislation for tissues and cells 
includes three Directives: one mother directive, 
which provides the framework legislation, and 
two further implementing directives, which pro-
vide more detailed requirements for Member 
States:

(cid:98)(cid:553) Directive 2006/86/EC of the European 

Parliament and of the Council as regards 
traceability requirements, notiﬁcation of 
serious adverse reactions and events and 
certain technical requirements for the 
coding, processing, preservation, storage 
and distribution of human tissues and cells.

These Directives created an EU benchmark for 
the standards that must be met when carrying 
out any activity involving tissues and cells for 
human application.

Directive 2004/23/EC of the European Parlia-
ment  and  of  the  Council  of  31 March 2004 
applies to the donation, procurement, testing, 
preservation, storage and distribution of human 
tissues and cells intended for human use. It also 
relates to manufactured products derived from 
human tissues and cells intended for human 
use. In the case of products made industrially 
from tissues and cells, which within the Euro-
pean Union fall under Regulation 1394/2007 
on advanced therapy medicinal products, the 
Directive applies merely to donation, procure-
ment and testing.

The Directives outline, regarding tissue and cell 
donation, the following.

(cid:98)(cid:553) Member States must encourage voluntary 

and unpaid donations of tissues and 
cells. However, donors may receive 
a compensation strictly limited to making 
good the expenses and inconveniences 
related to the donation (e.g. travel 
expenses). Promotion and publicity activities 
in support of the donation of human tissues 
and cells with a view to oﬀering or seeking 
ﬁnancial gain or comparable advantage 
are not allowed. The general rule is that 
Member States must endeavour to ensure 
that the procurement of tissues and cells is 
carried out on a non-proﬁt basis.

(cid:98)(cid:553) Directive 2004/23/EC of the European 

(cid:98)(cid:553) The consent of donors, recipients or their 

Parliament and of the Council on setting 
standards of quality and safety for the 
donation, procurement, testing, processing, 
preservation, storage and distribution of 
human tissues and cells;

(cid:98)(cid:553) Directive 2006/17/EC of the European 

Parliament and of the Council on certain 
technical requirements for the donation, 
procurement and testing of human tissues 
and cells;

next of kin is obligatory. They must receive 
information on the purpose and nature of 
the procurement, the associated risks, the 
analytical examinations, the recording and 
protection of donor details and medical 
conﬁdentiality. In case of deceased donors, 
all this information must be provided 
to the next of kin and all the necessary 
authorisations must be obtained from the 
next of kin before any procurement takes 
place.

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

(cid:98)(cid:553) Member States must take all necessary 

measures to ensure that all data collected 
and to which third parties have access 
are rendered anonymous. Measures must 
be adopted to ensure data security and 
prevent unauthorised modiﬁcations to ﬁles 
and records.

Ethical  considerations  do  not  fall  under  the 
scope  of  these  Directives  and  remain  the 
responsibility of the Member States. In addi-
tion, the Directives do not cover research using 
human tissues and cells (e.g. in vitro research 

or in animal models) and do not interfere with 
decisions  by  Member  States  on  the  use  or 
non-use of any speciﬁc types of human cells, 
such as germ cells or embryonic stem cells.

The European Commission has supported the 
Member States in their eﬀorts to implement 
the European Tissue and Cells Directives by 
providing funding for several projects under 
the  EU  Health  Programmes,  but  also  under 
various other funding schemes of the European 
Commission.

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67

Overview table of projects in this section

Title

Page

Acronym

EUROCET

JACIE

EUSTITE

POSEIDON

Euro-GTPs

SoHO V&S

EQSTB

Eurocet128

Tiss.EU

RISET

European 
LeukemiaNet

European registry for organs, tissues and cells project

Joint Accreditation Committee ISCT Europe and EBMT

European Union standards and training for the inspection of 
tissues establishments

Promoting optimisation, safety, experience sharing and quality 
implementation for donation organisation and networking in 
unrelated haematopoietic stem cell transplantation in Europe

European Good Tissue Practices

Vigilance and Surveillance of Substances of Human Origin

European Quality System for Tissue Banking Project

Building reference compendia for the application of a single 
European coding system for tissues and cells

Evaluation of legislation and related guidelines on the 
procurement, storage and transfer of human tissues and cells in 
the European Union — an evidence-based impact analysis 

Reprogramming the immune system for the establishment of 
tolerance

Strengthen and develop scientiﬁc and technological excellence 
in research and therapy of leukaemia by integration of the 
leading national leukaemia networks and their interdisciplinary 
partner groups in Europe

TRIE

Transplantation research integration across Europe

Comparative analysis of medically assisted reproduction in the 
EU: regulation and technologies

Analysis and comparison of testing methods and testing 
laboratories in the EU and third countries for the biological 
markers speciﬁed in the blood and tissues and cells Directives

68

72

76

81

84

89

94

98

102

107

112

117

121

125

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

European registry for organs, tissues and cells 
(EUROCET project)

This project has received co-funding from the European Union in the framework of the e-TEN programme  
of the European Commission, DG Communications Networks, Content and Technology (DG CNECT,  
formerly DG INFSO).

Achievements in tissue and cell transplantation 
have improved the results of cures and quality 
of life for patients suﬀering from diseases that 
were incurable before the beginning of trans-
plant medicine. However, concerns about the 
quality and safety of these substances in the 
European Union have been rising. In order to 
regulate this part of medical practice, the Euro-
pean Union issued three Directives (27) (28) (29), 
between 2004 and 2006.

In addition, although donation and transplan-
tation has for long been part of daily medi-
cal practice in Europe, there was not a Euro-
pean-wide database which facilitated medical 
professionals to ﬁnd organs, tissues and cells 
for  transplant  patients.  Each  Member  State 
maintained national registries, but an overall 
integrated  information  and  communication 
system across the European Union was lack-
ing. And it was clear that the centralisation of 
this  information  could  signiﬁcantly  improve 
the quality and safety of organ donation and 
transplantation. This is the background in which 
EUROCET was born.

The  EUROCET  project  was  funded  by  the 
European Union under its e-TEN programme 
(e-TEN stands for trans-European e-services 
programme,  which  ﬁnished  at  the  end  of 
2006 and provided funds to make e-services 
available throughout the European Union (30). 
The EUROCET project was coordinated by the 
Instituto Superiore di Sanitá (Italy) and lasted 

(27)  Directive 2004/23/EC — ‘Setting standards of quality and 
safety for the donation, procurement, testing, processing, 
preservation, storage and distribution of human tissues and 
cells’.

(28)  Directive 2006/17/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
certain technical requirements for the donation, procurement 
and testing of human tissues and cells’.

(29)  Directive 2006/86/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
traceability requirements, notiﬁcation of serious adverse 
reactions and events and certain technical requirements for 
the coding, processing, preservation, storage and distribution 
of human tissues and cells’.

18 months, starting on September 2005 and 
ﬁnishing on February 2007. It involved a con-
sortium created by 20 partners coming from 
the following EU Member States: Italy, France, 
Spain, the United Kingdom, Belgium, the Neth-
erlands, Germany, Slovenia, Hungary, Poland, 
the Czech Republic, Slovakia and Estonia.

As the EUROCET team highlighted (31), the project 
was built on the successes of EURODONOR (Euro-
pean donors and organs registry), a previous pro-
ject which created a registry on organ donation 
and transplantation activity in the old EU Member 
States (Belgium, Greece, Italy, Netherlands, Spain 
and the United Kingdom). EURODONOR could be 
seen as the ‘mother project’. As EUROCET was 
launched in 2005, it was able to be extended 
to six new Member States (the Czech Republic, 
Estonia, Hungary, Poland, Slovakia and Slovenia).

EUROCET created a registry shared by 
Member States

What did the EUROCET project seek? The goal 
was to create a common registry shared by 
both old and new Member States for the data 
collection on organ, tissue and cell donation 
and transplantation activity. The EUROCET reg-
istry was designed to support the collection and 
analysis of data supplied by the participating 
countries, as well as the delivery of information 
to the professional users and citizens (31).

Coordinated by the Italian National Transplant 
Centre  (Rome),  the  registry  represented  the 
realities of diﬀerent Member States, with the 
following key objectives:

(cid:98)(cid:553) standardise methodologies for data 

collection and processing;

(cid:98)(cid:553) share knowledge in this ﬁeld;

(cid:98)(cid:553) strengthen the cooperation and delivery of 

oﬃcial and updated information.

(30)  http://ec.europa.eu/information_society/activities/eten/

index_en.htm

(31)  www.eurocet.org

Nowadays,  the  registry  remains  active  as 
an  online  system.  Data  suppliers  can  use  a 
ﬁle  transfer  at  a  dedicated  e-mail  address 
(eurocet@iss.it)  or  can  access  the  EUROCET 
system with a user identiﬁcation, which ensures 
that  only  authorised  users  transmit  oﬃcial 
information to the database. More over, infor-
mation provided has to be compliant with the 
national  regulations  regarding  privacy  and 
data protection: ‘all data collected is therefore 
aggregated data or individual anonymous data, 
which does not require speciﬁc security agree-
ments or protection’ (32).

The registry represents a central repository of 
validated and updated information on organ, 
tissue and cell donation and transplantation 
activity across Member States. 

From the EUROCET project to the 
EUROCET Network

Even  though  EUROCET  ﬁnished  in  February 
2007, this has not signiﬁed the end of EUROCET.

EUROCET has evolved from a project to a net-
work which supports the collection and analysis 
of data supplied by the participating countries, 
as well as the delivery of information to the 
professional users and citizens. Since 2008 the 
Italian National Transplant Centre (Rome) is in 
charge of coordinating the EUROCET network. 
Today EUROCET hosts the following.

1. The European Registry of the Competent 
Authorities for tissues and cells (33)

The EUROCET network maintains an accessible 
and updated register of Competent Authorities 
across Europe. In the ﬁeld of tissues and cells 
for human application (including haematopoi-
etic cells, gametes and embryos), the Com-
petent Authorities are organisations desig-
nated by each Member State as required by 
Dir ective 2004/23/EC. The EUROCET network 
goes beyond the then 27 EU Member States, 
currently including 34 countries. Because Mem-
ber States and non-EU countries can have more 
than one Competent Authority for tissues and 
cells, a total of 59 Competent Authorities are 
recorded in EUROCET (33).

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

69

 The European Union encourages the use of the 
EUROCET portal to fulfil some of the obligations of the 
tissues and cells directives. 

2. The registry of tissue establishments com-
ing from all Competent Authorities

Tissue establishments are authorised centres 
that receive, test, process, store and distrib-
ute  tissues  or  cells  (including  gametes  and 
embryos) for human application in the Euro-
pean Union. EUROCET responds to the require-
ments of the EU Directives by publishing an 
updated registry of all tissues establishments 
in the European Union (34). Presently there are 
more than 4 500 establishments recorded (35).

3. Data regarding tissues and cells’ donation 
and transplantation provided by all national 
Competent Authorities

Nowadays, data on donation and transplanta-
tion are reported by the Competent Authorities 
to EUROCET on a voluntary basis (36). These data 
are periodically published in the ‘International 
Figures on Donation and Transplantation’ (37).

4. An instrument which provides a standard 
terminology for organs, tissues and cells

A glossary was agreed among the European 
countries involved in the EUROCET project with 
the objective of harmonising the terminology 
used in the ﬁeld of organ, cell and tissue dona-
tion and transplantation. This glossary is avail-
able on the EUROCET website (31).

EUROCET — an important website for 
donation and transplantation activities

EUROCET  has  become  a  valuable  website 
(www.eurocet.org) in the European Union for 
all citizens, patients, professional operators and 
institutions interested in organs, tissues and 
cells donation and transplantation activities (31). 
Both EU and international professional opera-
tors and institutions can rely on the complete 

(34)  www.iss.it/ecet/tiss/index.php?lang=2&tipo=18&anno=2009

(35)  www.ncbi.nlm.nih.gov/pmc/articles/PMC3267997/pdf/

tmh0038-0352.pdf

(32)  http://ec.europa.eu/information_society/activities/eten/cf/opdb/

(36)  www.iss.it/ecet/dati/index.php?lang=2&tipo=12&anno=2009

cf/project/index.cfm?mode=desc&project_ref=ETEN-517417

(33)  www.iss.it/ecet/scie/index.php?lang=2&tipo=23&anno=2009

(37)  Council of Europe: International ﬁgures on donation and trans-
plantation — 2010. Newsletter Transplant 2011;16:47–58.

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

and updated databases of the EUROCET web-
site. According to the EUROCET team, this has 
turned to be a popular channel to increase pub-
lic awareness and sensibility towards the value 
of donation (35).  In this sense, the website has 
proved to be a powerful tool for communication 
and dissemination.

The  use  of  the  EUROCET  portal  has  been 
encouraged by the European Union as a way 
to fulﬁl some of the obligations of the tissues 
and cells directives (35). This reﬂects the impor-
tant work EUROCET is performing in order to 
contribute to the setting of standards of quality 
and safety in the ﬁeld of organ, tissue and cell 
donation and transplantation in Europe.

For more information about the EUROCET Net-
work, see ‘The EUROCET Network: Support for 
Coding, Vigilance and Surveillance’ (35).

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

71

Further information:

EC DG CNECT Project Factsheet:
http://ec.europa.eu/information_society/activities/eten/cf/opdb/cf/project/index.
cfm?mode=detail&project_ref=ETEN-517417

Project website
http://www.eurocet.org/

Project team:

Project leader:
Italian National Transplant Centre
Istituto Superiore di Sanità
Viale Regina Elena 299
00161 Rome RM
ITALY 
Tel. +39 0649904040-1
Fax +39 0649904101
E-mail: eurocet@iss.it

Associated partners:

Istituti Ortopedici Rizzoli, Italy

(cid:97)(cid:149) Sihtasutus Tartu Ulikooli Kliinikum, Estonia
(cid:97)(cid:149) Agence de la Biomédecine, France
(cid:97)(cid:149) Hungarotransplant Egeszsegugyi Koordinalo Kozhasznu Tarsasag, Hungary
(cid:97)(cid:149) Finsiel — Consulenza e Applicazioni Informatiche S.P.A., Italy
(cid:97)(cid:149)
(cid:97)(cid:149) Eutelis Consult Italia & Associates — S.R.L., Italy
(cid:97)(cid:149) Stichting Donor Action Foundation, Netherlands
(cid:97)(cid:149) Stichting Bio Implant Services, Netherlands
(cid:97)(cid:149) Stichting Eurotransplant International Foundation, Netherlands
(cid:97)(cid:149) Centrum Organizacyjno-Koordynacyjnego do Spraw Transplantacji Poltransplant, Poland
(cid:97)(cid:149) Wroclaw Medical University, Poland
(cid:97)(cid:149) Artman Technologies S.R.O., Slovakia
(cid:97)(cid:149) University Hospital Martin, Slovakia
(cid:97)(cid:149) Zavod Republike Slovenije Za Presaditve Organov in Tkiv Slovenija Transplant, Slovenia
(cid:97)(cid:149) Fundacio Bosch i Gimpera, Spain
(cid:97)(cid:149) Organizacion Nacional de Trasplantes, Spain
(cid:97)(cid:149) Fundacio Privada Transplant Services Foundation, Spain
(cid:97)(cid:149) United Kingdom Transplant, United Kingdom
(cid:97)(cid:149) Transplantations Coordinating Centre, Czech Republic

EU contribution

This project has received co-funding from the European Union in the framework of the e-TEN 
programme of the European Commission, DG CNECT.

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Joint Accreditation Committee ISCT Europe & EBMT (JACIE)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2003208).

JACIE (38)  stands  for  the  Joint  Accreditation 
Committee ISCT Europe & EBMT. In turn, ISCT 
stands for the International Society for Cellular 
Therapy (39), and EBMT for the European Group 
for  Blood  and  Marrow  Transplantation (40). 
JACIE is a non-proﬁt body established in 1998 
for the purposes of assessment and accredi-
tation in the ﬁeld of haematopoietic stem cell 
transplantation.

The  JACIE  accreditation  programme  was 
funded in 2004 by the European Union under 
its Public Health Programme. The project was 
coordinated by Fiona Mc Donald, who was the 
Executive Oﬃcer of EBMT at that time. Dur-
ing 14 months, from January 2004 to Febru-
ary 2005, partners from six Member States 
(Belgium, France, Netherlands, Spain, Sweden, 
and the United Kingdom) worked together with 
the same aim: to provide vital impetus to the 
JACIE programme and to ensure its integral 
role in the setting of standards, inspection and 

 The JACIE project is considered an example 

of how EU funding can facilitate the harmonisation, 
implementation and use of common standards. 

 (42)

accreditation for establishments involved in 
haematopoietic stem cell collection, process-
ing and transplantation in Europe.

The  EU-funded  project  aimed  at  promoting 
high-quality patient care and laboratory perfor-
mance in centres dedicated to haematopoietic 
stem cell collection, processing and transplan-
tation through an internationally recognised 
system of accreditation.

What is haematopoietic stem cell 
transplantation and why is the JACIE 
accreditation programme important in 
this ﬁeld?

Tissues and organs in the body are made of 
specialised  cells  that  assure  their  speciﬁc 
functions.  Maintenance  and  repair  of  these 
tissues  and  organs  depend  upon  resident 
unspecialised adult stem cells, which are still 
at an early stage of development and retain 
the potential to turn into the diﬀerent types 
of cells of a particular tissue or organ. In the 
bones, the haematopoietic stem cells give rise 
to all kinds of blood cells (41). For this reason, 
the haematopoietic stem cell transplantation, 
o#en performed for patients with certain blood 
cancers, such as leukaemia, is considered one 
of the most important medical advances in the 
second half of the 20th century.

Accreditation of a centre is the process which 
certiﬁes its competency. In this sense, a cen-
tre accredited by JACIE demonstrates that it 
is performing its functions according to qual-
ity standards. In cells transplant programmes, 
this  accreditation  certiﬁes  that  the  clinical, 
collection and laboratory units are all work-
ing together to achieve excellent practices and 
increased guarantees for patients. And this is 
important because working according to quality 
standards beneﬁts transplant patients (42).

JACIE Annual Report 2011 (http://www.jacie.org/about/annual-report)

(38)  www.jacie.org

(39)  www.celltherapysociety.org 

(41)  http://ec.europa.eu/research/fp6/index_en.cfm?p=1_stem_home

(40)  www.ebmt.org

(42)  www.jacie.org/about

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

73

The JACIE project provided concrete 
input to the EU Directive on standards 
for the quality and safety of human 
tissue and cells

The EU-funded project produced a new edi-
tion (the second edition at that time) of the 
JACIE´s Standards and of the JACIE´s Accredi-
tation Manual, both in line with the EU Direc-
tive of human tissues and cells (43). According 
to the project team, JACIE achieved a great 
distribution of this manual, as 83 % of active 
transplant centres in Europe at that moment 
received copies of it. By doing so, JACIE oﬀered 
Member States a set of standards and a pro-
gramme  of  accreditation  fulfilling  the  EU 
requirements.  Therefore,  JACIE  contributed 
to harmonise healthcare facilities involved in 
haematopoietic stem cell collection, processing 
and transplantation across Europe (44). Nowa-
days, the 5th edition of the Standards and the 
Accreditation Manual, published in March 2012, 
are available on the JACIE website (45).

Another objective of the project was to pro-
vide vital impetus to the implementation of 
the JACIE accreditation programme in a core 
number of centres in Europe. In order to facili-
tate this, the European JACIE Oﬃce was estab-
lished in Barcelona. This reinforcement of the 
central resources proved to be fundamental 
to enhance eﬀectiveness of the existing JACIE 
network.

Furthermore, an eﬀective online system, JACIE 
Online (46),  was  developed.  This  online  tool 
oﬀers all steps, from the beginning until the 
end, that a centre must follow when it applies 
for its accreditation. Therefore, the tool facili-
tates the collection, tracking and monitoring of 
information on the implementation of the JACIE 
accreditation. According to the project team, 
during the project ‘18 out of the 19 countries 
within the current JACIE network had accepted 
to administer the JACIE accreditation process 
via the online system’. This tool has increased 
the  comparability  of  data  across  Member 
States (44). 

(43)  Directive 2004/23/EC — ‘Setting standards of quality and 

safety for the donation, procurement, testing, processing, pres-
ervation, storage and distribution of human tissues and cells’.

(44)  Final Technical Implementation Report Grant agreement 

No 2003208 Action: JACIE.

(45)  www.jacie.org/standards

JACIE Accrediation Manual (47)

 The project demonstrated that the  
accreditation process is viable and has the full  
support of professionals. 

 (44)

Another achievement of the JACIE project in 
2004 was the development of programmes 
and training materials for two types of train-
ing courses:

(cid:98)(cid:553) a course in preparing a quality management 

system according to JACIE standards;

(cid:98)(cid:553) an inspector training course, which 
was designed to prepare healthcare 
professionals to carry out inspections in 
transplant centres.

(46)  www.jacie.org/news/onlinesystemforaccreditations

(47)  http://www.jacie.org/standards

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During the project period, 25 inspections were 
conducted in health institutions and facilities, 
and eight new countries joined the JACIE net-
work. Although the JACIE accreditation process 
supposed a considerable strain on resources 
for the majority of participating centres, these 
centres  felt  the  eﬀort  was  worthwhile  and 
that  their  programmes  had  beneﬁted  from 
the process. The project team considered vital 
the conﬁdence of participating centres in the 
beneﬁts  of  the  JACIE  accreditation  process, 
as this would be decisive for the promotion 
and future success of the JACIE accreditation 
programme (44).

According to several surveys completed during 
the project, there was an important need for 
training clinical staﬀ (doctors and nurses) in 
quality management as well as for improving 
the quality management culture in the clinical 
setting. Therefore, JACIE deﬁned this area as 
a relevant one for the coming years, and con-
sidered that educational material about quality 
management in the transplant centres should 
be provided (44).

The  list  with  information  on  the  accredita-
tion status of all centres currently participat-
ing in the JACIE programme can be consulted 
online (49).  This  list  is  regularly  updated  with 
centres that have received accreditation. The 
increasing number of accredited centres indi-
cates the potential impact of projects like JACIE.

JACIE webpage (48)

During 2004, four courses were held on these 
issues and were attended by a total of 105 
professionals from across Europe. According 
to the ﬁnal report of the project, ‘these profes-
sionals came from diﬀerent backgrounds (clini-
cal, collection and processing) and the courses 
proved an excellent opportunity for sharing of 
best practice between diﬀerent disciplines and 
countries.’  The  courses  were  evaluated  and 
rated as highly satisfactory (44).

As  stated  by  the  ﬁnal  report  of  the  project, 
‘common training courses and exams should 
help to ensure that the JACIE accreditation pro-
gramme is applied with equal rigour through-
out Europe and thereby contribute to the over-
all harmonisation of standards and systems of 
accreditation’ (44).

JACIE was recently highlighted as an exemplary 
project in a 2011 review of EU funded projects: 
‘It is also outstanding in its continuing activities 
a"er the end of the project period and its suc-
cess with regard to international collaboration 
and contribution to public health policies and 
regulation’ (50).

The best materials obtained from the training 
courses were compiled into a consolidated doc-
ument, which turned out to be of great value 
to facilities that were considering to apply for 
or were in the process of applying for a JACIE 
accreditation and did not know where to start. 
The document illustrated how other facilities 
had approached the JACIE accreditation pro-
cess; therefore it provided a good basis to start 
working with.

(48)  http://www.jacie.org/

(49)  www.jacie.org/accredited-centres

(50)  http://ec.europa.eu/health/programme/docs/

ex_post_evaluation_en.pdf

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75

Further information:

Project website
http://www.jacie.org
http://ec.europa.eu/eahc/projects/database.html?prjno=2003208

Project team:

European Group for Blood and Marrow Transplantation
P. Debyelaan 25
PO-BOX
6229 HX Maastricht
NETHERLANDS
Tel. +34 934549543
Fax +34 934531263

Associated partners:

(cid:97)(cid:149) Belgian Haematological Society, Belgium
(cid:97)(cid:149) Société française de greﬀe de moelle et de thérapie cellulaire, France
(cid:97)(cid:149) Dutch National Registry, Netherlands
(cid:97)(cid:149) Spanish Group for Haematopoietic Transplantation, Spain
(cid:97)(cid:149) Swedish Society of Haematology, Sweden
(cid:97)(cid:149) British Society of Blood and Marrow Transplantation, United Kingdom

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2003208).

Maximum EC contribution:
EUR 167 526.13

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European Union standards and training for the inspection of 
tissues establishments (EUSTITE)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2005204).

EUSTITE  stands  for  European  Union  stand-
ards and training for the inspection of tissues 
establishments. EUSTITE was a multinational 
project funded by the European Union under 
its Public Health Programme. It lasted 3 years, 
from December 2006 to December 2009. The 
project was coordinated by the Italian National 
Transplant Centre (Rome) and brought together 
partners from 11 organisations coming from 
10 diﬀerent Member States (Austria, Bulgaria, 
Denmark, France, Ireland, Italy, Poland, Spain, 
Slovakia and the United Kingdom). The World 
Health Organisation (WHO) also participated in 
the project.

EUSTITE aimed to support the implementation 
of three European Union Directives (51) (52) (53) 
which require all Member States to take regu-
latory actions to ensure the appropriate quality 
and safety of tissues and cells for transplan-
tation and assisted reproduction. This applies 
to tissues for transplantation (such as corneas, 
heart valves, bone and skin), to haematopoi-
etic  stem  cells  and  to  cells  used  in  fertility 
treatments.

According to these Directives, each Member 
State has to designate at least one Competent 
Authority responsible, among others, for the 
following aspects:

(cid:98)(cid:553) inspecting and certifying tissue and cell 

procurement;

(cid:98)(cid:553) inspecting and certifying the centers 

(referred to as tissue establishments) where 
these tissues and cells are processed or 
stored;

(51)  Directive 2004/23/EC — ‘Setting standards of quality and 

safety for the donation, procurement, testing, processing, pres-
ervation, storage and distribution of human tissues and cells’.

(52)  Directive 2006/17/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
certain technical requirements for the donation, procurement 
and testing of human tissues and cells’.

(53)  Directive 2006/86/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
traceability requirements, notiﬁcation of serious adverse 
reactions and events and certain technical requirements for 
the coding, processing, preservation, storage and distribution 
of human tissues and cells’.

(cid:98)(cid:553) putting vigilance systems in place, in 

order to report serious adverse events and 
serious adverse reactions in the ﬁeld of 
transplantation and assisted reproduction.

When EUSTITE was conceived, most EU Member 
States had recently implemented or were plan-
ning to implement systems for the inspection 
and certiﬁcation of tissue establishments, and 
were starting to put vigilance systems in place. 
At that time, there was a wide variation regard-
ing the approaches being taken and the stage of 
development of these initiatives in Europe. For 
this reason, EUSTITE attempted to provide guid-
ance in inspection and vigilance, in order promote 
their standardisation across Member States.

EUSTITE attempted to develop 
common guidelines for inspection  
and vigilance

EUSTITE  aimed  to  promote  standardisation 
across Member States to best practice in com-
pliance with the tissues and cells Directives. The 
speciﬁc project objectives were the following.

(cid:98)(cid:553) Inspection: To promote standardisation in 
the inspection of tissue establishments, 
by providing high quality guidelines for the 
conduct of inspections and by standardising 
the training for inspectors.

(cid:98)(cid:553) Vigilance: To develop common tools and 
guidance for implementation of vigilance 
systems of adverse events and adverse 
reactions related to tissues and cells for 
human application. This system may be 
used in the future as a European or a global 
model for vigilance and surveillance. 
With this aim, the WHO was included as 
a partner in recognition of the need to 
consider vigilance in the global context.

The partners in the consortium were selected 
to represent the scope and level of develop-
ment regarding the inspection activity of tis-
sue establishments in the European Union. With 
this aim, organisations both with and without 
experience to that date were included. Other 

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77

relevant organisations collaborated with the 
consortium, although not as partners; this was 
the case of the Pharmaceutical Inspectorate 
Cooperation Scheme (PICS), the European Asso-
ciation of Tissue Banks (EATB) or JACIE (54).

What were the main outputs of the 
EUSTITE project?

1. Inspection of tissue and cell procurement 
and  tissue  establishment  (Guidelines  for 
Competent Authorities) (55)

According  to  EUSTITE,  a  ﬁrst  edition  of  the 
guidelines was developed by a dra#ing group 
following a review of existing national docu-
ments and guidance in related ﬁelds. A second 
edition  was  developed,  incorporating  inputs 
from  various  project  activities  which  had 
highlighted good practice in the ﬁeld. Finally, 
the  guidelines  were  the  subject  of  an  open 
consultation (56).

The ﬁnal version of the guidelines proposed  (56):

(cid:98)(cid:553) qualiﬁcations and training of inspectors: 
education and experience, initial training, 
specialised training, certiﬁcation 
and continuous development, and 
responsibilities, among other issues;

(cid:98)(cid:553) inspection scheduling: prioritisation for 
the scheduling of routine inspections; 
planiﬁcation of additional (non-routine) 
inspections;

(cid:98)(cid:553) diﬀerent types of inspection;

(cid:98)(cid:553) how to conduct an inspection;

(cid:98)(cid:553) formats for the collection of information 
prior to inspections and the reporting of 
inspections.

According to the evaluations performed dur-
ing the project, the guidelines were considered 
as a high-quality document, very useful and 

(54)  JACIE (www.jacie.org) is a non-proﬁt body whose primary aim 
is to promote high-quality patient care and laboratory perfor-
mance in haematopoietic stem cell collection, processing and 
transplantation centres through an internationally recognised 
system of accreditation. 

EUSTITE, Deliverable 18, Inspection Guidelines, Edition II

in line with the European legislation, so they 
would be practically applicable across the EU, 
although some adaptations should be consid-
ered in countries with an inspection system 
already in place (57).

The European Union used the EUSTITE Inspec-
tion Guidelines as the basis for developing the 
Operational Manual for Competent Authorities 
for Tissues and Cells in the EU (58) (59). There-
fore, the EUSTITE work clearly achieved the 
goal of supporting Member States that were 
establishing such regulatory systems for the 

(57)  Project EUSTITE, Deliverable 8, Final project evaluation report.

(55)  Project EUSTITE, Deliverable 18, Inspection of tissue and cell 

(58)  http://eur-lex.europa.eu/LexUriServ/LexUriServ.

procurement and tissue establishment (Guidelines for Com-
petent Authorities), Second edition, May 2008.

do?uri=CELEX:32010D0453:EN:NOT

(59)  http://ec.europa.eu/health/blood_tissues_organs/docs/

(56)  Fehily D, et al. Organs, tissues and cells 2008; (3): 167-74.

manual_en.pdf

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EUSTITE Vigilance Documents (http://www.sohovs.org/soho/mod/resource/view.php?id=43)

ﬁrst time. Furthermore, it also promoted the 
standardisation  of  regulatory  systems  that 
were already well established.

69 participants from 28 European 
countries were trained in these 
guidelines

2. The training courses for inspectors of tis-
sue establishments

EUSTITE  designed  a  training  programme  for 
inspectors in order to capacitate them according 
to the EU Directives and to the EUSTITE guide-
lines on inspection. The programme comprised 
four courses that took place between June 2008 
and July 2009. Each course was divided in two 
parts: 6 weeks of e-learning via the Internet, 
and a 3-day residential course, which was held 
in Vienna, Soﬁa, Copenhagen and Como.

According  to  the  project  team,  ‘the  courses 
included  69  participants  originating  from 
28  European  countries’.  Furthermore,  a#er 
a thorough evaluation, it was concluded that the 
training programme was well appreciated by 
the participants, the tutors and the guest obser-
vers. For example, the courses were deﬁned as 

‘excellent’ by 42 of the 69 participants. Most 
of them highlighted that the courses were very 
interesting, relevant and practically applicable. 
In short, the model seemed to be a very useful 
tool for the training of inspectors (57).

3. Vigilance and surveillance tools and guid-
ance for tissues and cells used in transplan-
tation or assisted reproduction

In the European Union context in which EUSTITE 
was planned, Member States were attempting 
to follow the requirements of the Dir ectives 
on  tissues  and  cells.  In order to do  so,  they 
were  actively  designing  and  implementing 
systems for the notiﬁcation and management 
of  adverse  events  and  reactions  associated 
with tissues and cells used in transplantation 
or assisted reproduction, that is, vigilance and 
surveillance systems.

Vigilance  and  surveillance  systems  include 
ongoing data collection, analysis to convert this 
data into statistics, interpretation of this analy-
sis to produce information and dissemination of 
this information to those who can take appropri-
ate action (60). However, guidance on what should 

(60)  http://ecdc.europa.eu/en/healthtopics/spotlight/spotlight_

surveillance/Pages/Key_message_1.aspx

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79

A ﬁnal document with tools and guidance for 
vigilance and surveillance in tissues and cells 
was generated. It provided tools for the deﬁ-
nition,  classiﬁcation  and  evaluation  as  well 
as  notiﬁcation  and  management  of  serious 
adverse reactions and serious adverse events 
within and between EU Member States. These 
criteria were incorporated into the guidance 
provided to Member States for the completion 
of their annual vigilance reports to the Euro-
pean Union (63) (64).

EUSTITE Vigilance & Surveillance ﬁnal 
recommendations

A  number  of  general  recommendations  for 
improving vigilance and surveillance for tissues 
and cells were made to the European Union. 
In addition, EUSTITE highlighted a number of 
areas for further work, particularly the need for:

(cid:98)(cid:553) investigation guidance;

(cid:98)(cid:553) training;

(cid:98)(cid:553) guidance for vigilance in assisted 

reproduction;

(cid:98)(cid:553) guidance for the investigation of illegal and 

fraudulent activity;

(cid:98)(cid:553) a greater engagement of clinicians to 

ensure eﬀective vigilance.

These issues are now being taken forward in 
a new EU-funded project, SoHO V&S, which 
stands for Vigilance and Surveillance of Sub-
stances of Human Origin, a project also coor-
dinated by the Italian National Transplant Cen-
tre. Started in March 2010, this new project will 
continue to contribute to the implementation of 
the tissues and cells Directives in the European 
Union.

be reported, how it should be classiﬁed, when 
it should be shared nationally or internationally 
and how it should be managed was not available 
at that time for vigilance and surveillance in the 
ﬁeld of tissues and cells used in transplantation 
and assisted reproduction. In this sense, it was 
possible that a Member State developed inde-
pendent systems on its own that later found 
to be incompatible with other systems in the 
European Union. This would ﬁnally cause that 
important safety and quality information was 
not shared eﬀectively among countries.

EUSTITE  constituted  a  group  of  experts  to 
review the existing systems in Member States 
and globally for vigilance and surveillance in 
the ﬁeld of tissues and cells used in transplan-
tation  and  assisted  reproduction.  The  WHO 
chaired this task in recognition of the need to 
consider vigilance in the global context (61). 

The aim was to identify systems being used at 
that time in Member States or elsewhere that 
could be useful to other states which were still 
developing their system. This working group 
also identiﬁed commonalities in approaches 
to vigilance and surveillance systems between 
Member  States  which  would  allow  a  better 
basis for a common European reporting system.

Finally, tools and guidance for evaluation and 
management of serious adverse events and 
reactions  associated  with  tissues  and  cells 
were  developed  and  tested  during  a  1-year 
pilot phase (from 1 July 2008 to 30 June 2009) 
involving 20 Member States. This pilot phase 
attempted to evaluate the applicability of the 
tools and to help their improvement before ﬁnal 
submission to the European Commission (62).

According to Stephanie Sullivan, the pilot coor-
dinator, ‘the pilot demonstrated the feasibility 
of multinational cooperation in vigilance and 
surveillance in the area of tissue and cells for 
human application. The tools developed dur-
ing the EUSTITE project were tested in multi-
ple countries on a large number of real serious 
adverse reactions and serious adverse events 
and were found to be easily applied by Com-
petent Authorities vigilance oﬃcers, although 
some reservations were expressed in relation to 
their direct applicability in the ﬁeld of assisted 
reproduction’ (62).

(61)  Project EUSTITE, Review of vigilance and surveillance systems 

for tissues and cells.

(63)  www.sohovs.org/soho

(62)  Project EUSTITE, Deliverable 11b, Vigilance and Surveillance 

EUSTITE Pilot Report.

(64)  www.organsandtissues.net/index.php?id=91&tx_ttnews[tt_new
s]=574&cHash=08c5f51e0fa89fef161d5e403844e55

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Further information:

Project website
http://ec.europa.eu/eahc/projects/database.html?prjno=2005204
http://www.sohovs.org/soho/mod/resource/view.php?id=43

Project team:

Instituto Superiore di Sanità — Centro Nazionale Trapianti
Viale regina Elena 299
PO-BOX
00161 Rome RM
ITALY
Tel: +39 0649901
Fax +39 0649387118

Project leader:
Alessandro Nanni Costa
E-mail: cnt@iss.it

Associated partners:

(cid:97)(cid:149) Bundesministerium für Gesundheit und Frauen, Austria
(cid:97)(cid:149) Organización Nacional de Transplante, Spain
(cid:97)(cid:149) Agence de la Biomédecine, France
(cid:97)(cid:149) Fakultna Nemocnica s Poliklinikou Bratislava — University Hospital Bratislava, Slovakia
(cid:97)(cid:149) Krajowe centrum Bankowania Tkanek I Komórek (National Centre of Tissue and Cell 

Banking), Poland

Irish Medecines board, Ireland

(cid:97)(cid:149) Laegemiddelstyrelsen (Danish Medicines Agency), Denmark
(cid:97)(cid:149)
(cid:97)(cid:149) Executive Agency for Transplantation, Bulgaria
(cid:97)(cid:149) Human fertilisation and Embriology Authority, United Kingdom
(cid:97)(cid:149) Agence Française de Securité sanitaire des Produits de Santé, France
(cid:97)(cid:149) World Health Organisation, Switzerland

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2005204).

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81

Promoting optimisation, safety, experience sharing 
and quality implementation for donation organisation 
and networking in unrelated haematopoietic stem cell 
transplantation in Europe (POSEIDON)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2006210).

Haematopoietic stem cells (HSC) are immature 
cells that retain the potential to turn into the 
diﬀerent types of blood cells. HSC are o#en 
transplanted to patients with malignant (leu-
kaemia,  lymphoma,  etc.)  or  non-malignant 
haematological disorders (inherited disorders, 
autoimmune diseases, etc.), in order to rebuild 
the body’s immunity or capacity to produce 
blood cells. This is a process known as haema-
topoietic stem cells transplantation (HSCT).

HSC mostly live in the ‘bone marrow’ (located 
in the centre of certain bones), dividing them-
selves to produce blood cells. Once blood cells 
are mature they leave the bone to enter the 
bloodstream. However, a small number of HSC 
also get into the bloodstream, where they are 
called ‘peripheral blood stem cells’ (PBSC) (65). 
Finally, HSC are also present in the foetal blood 
remaining in the umbilical cord a#er delivery. 
Therefore, HSC can be collected from the bone 
marrow, the bloodstream or the umbilical cord 
to be transplanted.

Only a third of patients requiring 
haematopoietic stem cells 
transplantation have a suitable family 
donor

HCST  saves  lives.  However,  only  a  third  of 
patients  requiring  HSCT  have  a  compatible 
family donor, so HSC must be obtained from 
unrelated compatible donors.

There are two main sources to obtain un related 
HSC: the registries of volunteer donors (for bone 
marrow and PBSC) and banks of cord blood, yet 
ﬁnding unrelated compatible donors continues 
to be diﬃcult. Therefore, the European Union 
aims to facilitate patients in getting a secure, 

eﬃcient and egalitarian access to HSCT from 
unrelated compatible donors.

POSEIDON  stands  for  ‘Promoting  optimisa-
tion,  safety,  experience  sharing  and  quality 
implementation for donation organisation and 
networking in unrelated haematopoietic stem 
cell transplantation in Europe’. POSEIDON was 
a project funded by the EU in the framework of 
the EU Public Health Programme (2003–2008). 
During 42 months, from June 2007 to Novem-
ber 2010, the Institut National de la Santé et de 
la Recherche Médicale (France) coordinated the 
project, which was supported by seven asso-
ciated partners from diﬀerent Member States 
(Hungary, Norway, France and Spain).

The  project  focused  on  improving  the  steps 
prior to donation for transplantation, namely 
the recruitment of donors, typing strategies 
(the assessment of HSC compatibility with the 
potential recipient), the organisation of donor 
registries  and  cord  blood  banks,  and  donor 
search.

There are three EU Directives (66) that provide 
a common legal framework for HSCT in the 
EU.  POSEIDON  also  gathered  data  on  these 
Directives  across  Member  States.  This  data 
provided key information about the status of 
the implementation of the Directives in each 
country and the diﬃculties experienced in their 
transposition.

Encouraging a more egalitarian access 
to unrelated haematopoietic stem cell 
transplantation in Europe

One of the aims of POSEIDON was to encour-
age an egalitarian access to unrelated HSCT 
throughout  the  European  Union.  For  this 

(65)  American Cancer Society: www.cancer.org/acs/groups/cid/

(66)  Directive 2004/23/EC, Directive 2006/17/EC and Directive 

documents/webcontent/003215-pdf.pdf

2006/86/EC.

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reason, the project also focused on the situ-
ation of minorities and immigrant populations 
in Europe (legal issues, health problems, etc.), 
as these groups may be more prone to hav-
ing a limited access to HSCT. The actions taken 
in the EU towards the representation of these 
minorities in HSC registries were also analysed.

According to POSEIDON, there were inequalities 
in access to HSCT among minorities. Minorities 
coming from countries with large numbers of 
donors registered had usually access to these 
sources  for  transplantation  through  interna-
tional exchanges. However, an important prob-
lem of access to HSCT was detected in other 

communities, such as those coming from Africa, 
with scarce HSC registries in their countries of 
origin.

POSEIDON identiﬁed the Internet as an under-
exploited  tool  with  broad  possibilities  to 
enhance HSC recruitment of minority donors. 
According  to  the  project,  there  should  be 
a much more intensive use of the Internet to 
capture the attention of potential donors from 
speciﬁc ethnic minority groups.

The  POSEIDON  consortium  with  the  ﬁnan-
cial support of the European Union promoted 
a better, safer and wider national and European 
landscape for HSC exchanges and HSCT.

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83

Further information:

Project website
http://ec.europa.eu/eahc/projects/database.html?prjno=2006210

Project team:

Institut National de la Santé et de la Recherche Médicale
37, allée Jules Guesde
31073 Toulouse
FRANCE
Tel. +33 561145959
Fax +33 561145623

Associated partners:

(cid:97)(cid:149) Országos Gyógyintézeti Központ, Hungary
(cid:97)(cid:149) Universitetet i Oslo , Norway
(cid:97)(cid:149) Tundástársadalom Alapítvány, Hungary
(cid:97)(cid:149) European Federation for Immunogenetics, France
(cid:97)(cid:149) Universidad del Pais Vasco / Euskal Erriko Unibertsitatea , Spain
(cid:97)(cid:149) Agence de la biomédicine , France
(cid:97)(cid:149) Centre National de la Recherche Scientiﬁque, France

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2006210).

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European Good Tissue Practices (Euro-GTPs)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2007207).

In Europe, there are regulations which provide 
the general basis for performing tissue banking 
activities in a professional and coherent man-
ner (68) (69) (70). However, it is important that the 
concrete procedures performed in tissue banking 
are harmonised among all tissue establishments 
in Europe so that high quality and the safety of 
transplanted tissues can be guaranteed.

The objectives of the  
Euro-GTP project were:

(cid:98)(cid:553) to develop detailed European good tissue 
practices for the activities carried out 
in tissue establishments (71), in order 
to contribute to the harmonisation of 
these activities among European tissue 
establishments; to achieve this objective, 
the European Good Tissue Practice 
Guidance for tissue establishments 
activities was elaborated (72);

(cid:98)(cid:553) to develop a training model for tissue 

establishment personnel based on these 
good tissue practices.

According  to  the  ﬁnal  report  of  the  project, 
‘the aim was to apply these practices Euro-
pean-wide to increase the know-how and the 
level of performance of tissue banking staﬀ, 
and to harmonise the techniques used in order 
to provide tissues for transplant of high quality 

(68)  Directive 2004/23/EC — ‘Setting standards of quality and 

safety for the donation, procurement, testing, processing, pres-
ervation, storage and distribution of human tissues and cells’.

(69)  Directive 2006/17/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
certain technical requirements for the donation, procurement 
and testing of human tissues and cells’.

(70)  Directive 2006/86/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
traceability requirements, notiﬁcation of serious adverse 
reactions and events and certain technical requirements for 
the coding, processing, preservation, storage and distribution 
of human tissues and cells’.

(71)  A tissue establishment is a tissue bank or a unit of a hospital 
or another body where activities of processing, preservation, 
storage or distribution of human tissues and cells are under-
taken. It may also be responsible for procurement or testing 
of tissues and cells. 

(72)  Euro-GTP Project. Euro GTP Guidance, http://eurogtps.com/
Portals/0/pdf/Euro %20GTP %20Final %20Delivery.pdf

The Euro GTP Guidance document (67)

Euro-GTP  stands  for  European  Good  Tissue 
Practices. It was a 3-year project funded by the 
European Union in the framework of the 2nd 
Health Programme. The project, which began in 
September 2008 and ﬁnished in October 2011, 
was  coordinated  by  the  Transplant  Services 
Foundation  (Barcelona,  Spain),  and  involved 
12 partners in total from seven diﬀerent EU 
Member States (Netherlands, Italy, Germany, 
Belgium, Poland, Finland and Spain).

(67)  http://eurogtps.com/Portals/0/pdf/Euro %20GTP %20

Final %20Delivery.pdf

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85

and safety, hence reducing the risk of disease 
transmission to recipients’ (73). Jaime Tabera, 
from the Transplant Services Foundation (Bar-
celona) and a member of the Euro-GTP team, 
stated that ‘Euro-GTP aims to provide guid-
ance in areas where it is lacking or where the 
Directives are diﬃcult to interpret, such as the 
cases that have emerged during the EUSTITE 
project’ (74).

Before starting the elaboration of the guide-
lines,  the  project  team  attempted  to  have 
a  better  understanding  of  the  situation  on 
regulations  and  tissue  banking  procedures. 
In order to do so, a number of activities were 
done:  a  questionnaire  on  the  methods  used 
for tissue banking processes was distributed 
to tissue establishments; a survey circulated 
among  current  and  future  European  Union 
inspectors of tissue establishments with ques-
tions focusing on their audit ﬁndings, the dif-
ﬁculties they experienced in implementing the 
current regulation and their opinion about the 

(73)  Euro-GTP Project, Final technical report.

(74)  Eustite project, Deliverable 13, Final conference report.

worth of a more detailed and realistic guidance 
at European level. Finally, relevant documents 
and regulations were analysed. As a result, the 
project team was able to deﬁne the contents 
of the European Good Tissue Practice Guidance.

1. The European Good Tissue Practice 
Guidance(72)

The European Good Tissue Practice Guidance 
provides a detailed information package for tis-
sue bankers and tissue establishment inspec-
tors in Europe. According to the project team, 
these guidelines describe the current minimum 
regulatory requirements of the European tissue 
and cells Directives  (68) (69) (70) and go one step 
further by providing a set of practical recom-
mendations for good practice in the European 
tissue  establishments (72).  As  stated  by  the 
authors, ‘the guidelines were developed to be 
a helpful tool for all kinds of tissue establish-
ments in diﬀerent phases of their development 
and evolution as well as for competent authori-
ties when performing tissue establishments’ 
inspections’ (72).

TRAINING AND EXPERIENCEQUALITY STANDARDSCODIFICATION SYSTEMTISSUE EVALUATION GMP AND DIRECTIVESTISSUES AND ATMPEXPOSED VS NOT EXPOSEDPARAMETRIC RELEASERECOVERY AIR QUALITYSTABILITY STUDIESSEGREGATION OF STATUSVALIDATION AND RISK ASSESSMENTTE AND TRANSPLANTATION CENTRESTISSUE-RECIPIENT MATCHINGEU-GTP AIMS TO ANSWER86

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As highlighted by the project team, this guid-
ance drew upon the work of previously Euro-
pean Union funded projects, particularly the 
EQSTB project and the EUSTITE project. EQSTB 
published a Guide of Recommendations for Tis-
sue Banking deﬁning the fundamental quality 
and safety key points, a training system for 
tissue establishment personnel, a prototype of 
a tissue registry, and a model for auditing tis-
sue establishments (Guide for Auditing). At the 
same time, EUSTITE developed guidance and 
training  for  Competent  Authority  inspectors 
along with tools and guidance for vigilance and 
surveillance. This demonstrates the strong and 
continuing commitment of the European Union 
in its concern to support harmonisation of activ-
ities among tissue establishments in Europe (72).

The European Good Tissue Practice Guidance 
encompassed procedural recommendations on: 
(i) donor screening and selection for each tissue 
type; (ii) tissue procurement, processing, pres-
ervation and storage; and (iii) how to validate 
these processes. The guidance was structured 
in two main parts: ‘generic good tissue prac-
tices’ and ‘tissue-speciﬁc good tissue practices’.

The generic section comprises practical instruc-
tions on: (i) generic processes carried out in tis-
sue establishments, (ii) risk assessment, and 
(iii)  validation  methods  for  donor  screening 
and tissue procurement, processing, preserva-
tion and storage, as well as basic requirements 
concerning infrastructure, personnel, documen-
tation management, etc.

The tissue-speciﬁc sections comprise practi-
cal instructions on donor screening and tissue 
procurement, processing, preservation, stor-
age and transportation related to skin, ocular, 
cardiovascular, musculoskeletal and amniotic 
membrane tissues.

The European Good Tissue Practice Guidance is 
available on the project website (75).

2. Good Tissue Practice ‘Hot Topics’ (76)

The key issues and the issues not covered or 
partly covered by standards or regulation were 
identiﬁed and highlighted as ‘Hot Topics’ and 

put  together  in  a  document.  This  document 
covers the following topics: donor selection; 
recovery  and  processing  environments;  tis-
sue speciﬁc quality criteria; risk management; 
traceability and vigilance; validation; facilities 
disinfection; critical third-party agreements; 
import and export; continuity plans; and a tis-
sue establishment dossier.

According to the project team, these Hot Topics 
are under regular revision. The document can 
be downloaded from the project website (77).

3. Training model for tissue 
establishments personnel

Another main objective of the project was to 
develop a training model for staﬀ of tissue 
establishments based on the deﬁned good 
practices. As stated in the ﬁnal report of the 
project,  it  was  decided  not  to  hold  a  resi-
dential training course given that the course 
was supposed to be based on the contents 
of the European Good Tissue Practice Guid-
ance, which was in dra# at that moment. For 
this reason, the residential training session 
was not organised during the period of the 
project (73) (78).

However, the Internet tool developed for the 
guidance and the Hot Topics was enhanced 
with a self-assessment instrument to allow 
professionals to verify their understanding 
and knowledge of good tissue practices. This 
training  exercise  is  available  in  electronic 
form on the project website (79). It can also 
be  downloaded  as  a  PDF  ﬁle (80).  The  pro-
ject partners considered the learning needs 
in relation to the good practices developed 
in the project, and designed quiz questions 
aimed at highlighting those issues that were 
most important or most novel in their environ-
ment. According to the team, ‘the tool allows 
many more professionals than would be able 
to attend a residential course to verify their 
understanding and knowledge of good tissue 
practices’ (73).

(75)  http://eurogtps.com/PROJECTOUTCOMES/GUIDANCE/Tableof-

(77)  http://eurogtps.com/Portals/0/pdf/GTP %20hot %20Topics.pdf

(78)  Euro-GTP Project, Deliverable 9, Evaluation report.

Contents/tabid/143/Default.aspx

(79)  http://eurogtps.com/PROJECTOUTCOMES/

(76)  Euro-GTP Project, Euro GTP Hot Topics, http://eurogtps.com/

PROJECTOUTCOMES/EuroGTPHOTTOPICS/CONTENTS/tabid/221/
Default.aspx

FinaltrainingmodelquestionnaireGtp/tabid/305/Default.aspx 

(80)  http://eurogtps.com/Portals/0/pdf/Final%20training%20

model%20questionnaire.pdf

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87

The Euro-GTP project contributed to 
a higher conﬁdence in the exchange 
of tissues for transplant among the 
Member States

The  Euro-GTP  project  provided  speciﬁc  prac-
tices to be followed in European tissue estab-
lishments in order to harmonise these decisive 
procedures in Europe. According to this project, 
apart from sharing a common regulation in the 
European Union, it is important that the concrete 
procedures performed in tissue banking are har-
monised so that high quality and the safety of 
transplanted tissues can be guaranteed.

In this sense, the Euro-GTP project contributed 
to a higher conﬁdence in the exchange of tis-
sues for transplant among the Member States 
by bringing added value into the current EU 
legislation on tissue and cells.

All the guidelines generated during the project 
are available on the project website, mainly Guid-
ance (72), Hot Topics (76) and Training Exercise (80). For 
more information, please visit the project website.

Webpage containing the guidance document (http://eurogtps.com/)

European Good Tissue Practices (Euro -GTPs)Feedfull textUpdate Hot Topics88

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Further information:

Project website
http://ec.europa.eu/eahc/projects/database.html?prjno=2007207
http://eurogtps.com/

Project team:
Transplant Services Foundation — TSF
c/ Mejia Lequerica, 1 — Ediﬁci Helios 3
PO-BOX
08028 Barcelona
SPAIN
Tel. +34 932279190
Fax +34 932278188

Associated partners:

Instituto Superiore di Sanita — ISS, Italy

(cid:97)(cid:149) Charite-Universitatsmedizin Berlin — CBC, Germany
(cid:97)(cid:149) Bio Implant Servicees Foundation — BIS Foundation, Netherlands
(cid:97)(cid:149)
(cid:97)(cid:149) Banque Universitaire de Tissus — BUTB-UCL, Belgium
(cid:97)(cid:149) Hornhautbank Muenchen Gemeinnutzige GmbH — UBM, Germany
(cid:97)(cid:149) National Centre of Tissue and Cell Banking — NCTCB, Poland
(cid:97)(cid:149) Hopital Central de la Base Reine Astrid — HCB-QA, Belgium
(cid:97)(cid:149) Tampereen Yliopisto (University of Tampere) — REGEA, Finland
(cid:97)(cid:149) Azienda Unita Locale Socio Sanitaria Nº9 — U.L.S.S Nº9, Italy
(cid:97)(cid:149) European Homogra$ Bank — EHB, Belgium
(cid:97)(cid:149) Stichting Euro Skin Bank — Huidbank — ESB, Netherlands

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2007207).

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89

Vigilance and Surveillance of Substances of Human Origin 
(SoHO V&S)

This project has received co-funding from the European Union in the framework of the Health Programme  
2008–2013 (Grant: 20091110).

SoHO V&S is a 3-year project funded by the EU 
Second Programme of Community Action in the 
Field of Health. SoHO V&S stands for Vigilance 
and surveillance of substances of human origin. 
The project was launched in March 2010 and 
ﬁnished in February 2013. Coordinated by the 
Italian National Transplant Centre (Rome), the 
initiative has brought together nine partners 
from seven Member States. The World Health 
Organisation (WHO) and other collaborating 
partners from outside the European Union were 
also involved, which ensured that the guidance 
produced in this project reﬂects international 
needs and realities in the context of human tis-
sues and cells for human application.

The  SoHO  V&S  project  aims  to  support  EU 
Member States in the establishment of vigi-
lance and surveillance systems for tissues and 
cells in transplantation and assisted reproduc-
tion. Vigilance and surveillance systems include 
ongoing data collection, analysis to convert this 
data into statistics, interpretation of this ana-
lysis to produce information and dissemina-
tion of this information to those who can take 
appropriate action (81).

Each Member State must put in 
place systems for vigilance of risks 
associated with tissues and cells 
in transplantation and assisted 
reproduction

More and more patients in Europe are treated 
with cells or tissues from a diﬀerent country. 
Such transplants include bone marrow, cord 
blood or corneas, amongst others. Gametes 
and embryos also circulate for use in fertility 
treatments.

For this reason, tissues and cells for human 
application  represent  a  key  area  where 
the  European  Union  has  introduced  legis-
lation  to  protect  public  health.  Several  EU 

Directives (82) (83) (84) require each Member State 
to nominate Competent Authorities responsi-
ble for implementing regulatory activities in 
the ﬁeld of human tissues and cells for trans-
plantation and assisted reproduction. Moreo-
ver, each Member State must put in place sys-
tems for vigilance and surveillance of serious 
adverse reactions and serious adverse events 
associated with such a type of activities.

SoHO V&S is not the ﬁrst EU-funded project 
addressing vigilance and surveillance in sub-
stances of human origin in the European Union, 
as it builds on the work done by the EUSTITE 
Project (2006–2009) (85). EUSTITE identiﬁed the 
need for common guidelines on the reporting 
and investigation of adverse outcomes associ-
ated with collection, processing, storage, pack-
aging and distribution of tissues and cells for 
human use. Therefore, SoHO V&S decided to 
work on this issue.

 Tissues and cells for human application 

represent one of the key areas where the EU has 
introduced legislation to protect public health. It 
requires Member States to establish systems for 
reporting of serious adverse reactions and events 
and for forwarding annual reports of this activity to 
the European Commission. 

 (86)

(82)  Directive 2004/23/EC — ‘Setting standards of quality and 

safety for the donation, procurement, testing, processing, pres-
ervation, storage and distribution of human tissues and cells’.

(83)  Directive 2006/17/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
certain technical requirements for the donation, procurement 
and testing of human tissues and cells’.

(84)  Directive 2006/86/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
traceability requirements, notiﬁcation of serious adverse 
reactions and events and certain technical requirements for 
the coding, processing, preservation, storage and distribution 
of human tissues and cells’.

(85)  EUSTITE: European Union Standards and Training for the 

Inspection of Tissue Establishments.

(81)  http://ecdc.europa.eu/en/healthtopics/spotlight/spotlight_sur-

(86)  http://ec.europa.eu/health/programme/docs/success_stories_

veillance/Pages/Key_message_1.aspx

hp_2008-2013_en.pdf

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

For its aim to establish vigilance and surveil-
lance systems for tissues and cells in trans-
plantation and assisted reproduction, the pro-
ject will introduce standard practices on how 
serious adverse events and serious adverse 
reactions associated with human tissue and 
cells are reported, evaluated and investigated. 
The  emphasis  will  be  put  on  investigation 
approaches,  on  the  role  of  the  clinical  user, 
and on areas that need speciﬁc guidance, such 
as assisted reproduction and situations where 
illegal or fraudulent activities are suspected.

Big steps have been taken so far to 
meet the project objectives

According to SoHO V&S, ‘vigilance systems for tis-
sues and cells in the European Union are generally 
at an early stage of development. There is a need 
for guidance and training of Competent Authority 
personnel, particularly in investigation’ (87).

SoHO V&S is harmonising terminology and doc-
umentation, allowing for a consensus on how to 
exchange information among Member States. 
The guidelines produced will support the imple-
mentation of the regulation on the exchange of 
human tissues and cells, as well as the better 
control against illegal and fraudulent activities 
with these products.

The Spanish National Transplant Organisation 
(ONT), one of the project partners, conducted 
a survey in 2010 about the vigilance and sur-
veillance systems for tissues and cells used in 
transplantation and in assisted reproduction in 
Europe (88). All those responding to the survey 
questions indicated that they had a vigilance 
system in place in their country. The number 
of Member States with systems in place had 
increased from 15 (56 %) in 2009 to 23 (96 %) 
in 2010. Sixty-eight per cent of the respondents 
reported that they had national systems for issu-
ing alerts when immediate action was required.

Furthermore, the survey indicated a high level of 
involvement of the Competent Authorities in the 
investigation of serious adverse events and reac-
tions. On the other hand, according to the survey, 
there was a high interest in setting up an inter-
national investigation team available to all Mem-
ber States for conducting particularly challenging 

Project brochure (89) 

investigations regarding serious adverse events 
and reactions. It is foreseen to publish the full 
survey report on the project website.

Speciﬁc guidance for vigilance in assisted 
reproduction has been developed

The Agency of Biomedicine in France (an asso-
ciated  partner  of  the  project)  leads  the  task 
of exploring the speciﬁcities of vigilance and-
surveillance in assisted reproduction. A#er an 
international workshop and a series of dra#ing 
meetings, the vigilance tools developed by the 
EUSTITE project were adapted to the assisted 
reproduction context. Moreover, speciﬁc guidance 
to vigilance in this ﬁeld has been produced and is 
available on the project website (90).

(87)  www.sohovs.org

(89)  http://www.sohovs.org/soho/

(88)  www.organsandtissues.net/index.php?id=91&tx_ttnews[tt_new
s]=574&cHash=08c5f51e0fa89fef161d5e403844e55e

(90)  www.sohovs.org/soho/ﬁle.php/1/Deliverable_5_WP5_ART_

Vigilance.pdf

Many EU Competent Authorities for tissues and 
cells lack experience and training to investigate 
cases where illegal or fraudulent activity is sus-
pected.  The  French  Agency  for  the  Safety  of 
Health Products (AFSSAPS) leads a work pack-
age of the project, which aims to understand bet-
ter the legal and regulatory framework in each 
Member State in relation to illegal and fraudulent 
activity in transplantation or assisted reproduc-
tion, and to produce speciﬁc guidance on this ﬁeld.

To this end, a survey has been performed on 
the current approaches to detect and prevent 
illegal or fraudulent activity, gathering informa-
tion from Member States on cases that have 
been  investigated  and  concluded.  Moreover, 
guidance to support Competent Authorities on 
the detection and management of illegal and 
fraudulent activity in the ﬁeld of transplanta-
tion or assisted reproduction has been com-
pleted. According to the project team, the guid-
ance developed is the ﬁrst of its kind in the ﬁeld 
of transplantation or assisted reproduction.

Prior to SoHO V&S, the EUSTITE project had identi-
ﬁed the need for common guidelines on the inves-
tigation of serious adverse reactions and serious 
adverse events in the ﬁeld of substances of human 
origin. SoHO V&S has taken over this task and is 
now working actively on it. According to Dr Ales-
sandro Nanni Costa, the SoHO V&S project coor-
dinator, the consortium has developed the dra# 
of the ‘Guidance for EU tissue and cell Competent 
Authorities on communication and investigation 
of serious adverse events and reactions associ-
ated with human tissues and cells’. This dra# was 
developed taking into account the outputs of inter-
national events in the ﬁeld, particularly the ones 
resulting from the NOTIFY meeting held jointly with 
the WHO in Bologna (Italy) in February 2011 (91). 
Moreover, the dra# has been the subject of three 
focus group consultations: one in the United King-
dom, one in Germany and another in Spain during 
February 2012. According to the project leader, this 
guidance has been submitted to wider consultation 
before the ﬁnal version is released.

The Polish partner of the project (Krajowe Cen-
trum Bankowania Tkanek i Komorek) supported 
by the major professional societies in the ﬁeld, 
is developing guidance for clinicians that use tis-
sues and cells for assisted reproduction or trans-
plantation. According to the project team, this 
guidance recognises the critical role of clinicians 
in the vigilance and surveillance of tissues and 
cells. The text will address the responsibilities of 

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

91

clinicians in relation to traceability and appro-
priate storage and use as well as their role in 
the identiﬁcation, reporting and investigation of 
adverse reactions in their patients. The guidance 
is to be published as a booklet and made avail-
able to EU Competent Authorities for translation 
and distribution nationally as they wish (92).

According to the project coordinator, training 
courses  have  been  designed  for  individuals 
who are actively involved in vigilance of tissues 
and cells. These courses constitute a unique 

 Citizens can be reassured that tissue and cell 

transplants are safer in the EU due to this widening 
knowledge, harmonisation and better connectivity 
between Member States. 
Deirdre Fehily, SoHO V&S project

Report: Promoting Vigilance and Surveillance of Organs, Tissues and Cells (93)

(92)  www.sohovs.org/soho/mod/resource/view.php?id=39

(91)  www.sohovs.org/soho/ﬁle.php/1/Final_Programme_NOTIFY.pdf

(93)  http://www.notifylibrary.org

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

opportunity for vigilance professionals to work 
together with colleagues from other Member 
States  (88). Each course consists of a four week 
e-learning module followed by a 2-day residen-
tial course. The ﬁrst course, which was held in 
Ireland and ﬁnished with the 2-day residential 
course  (18–20  June  2012),  was  very  highly 
evaluated by the participants, according to the 
project coordinator.

A new area dedicated to the SoHO V&S pro-
ject has been created in the Eurocet website 
(European  Registry  for  Organs,  Tissues  and 
Cells) (94),  in  order  to  support  the  sharing  of 
information between Competent Authorities in 

the European Union as they develop their vigi-
lance and surveillance systems.

Bologna Initiative for Global Vigilance 
and Surveillance (BIG V&S)

From September 2010 to February 2011, the 
WHO, the Italian National Transplant Centre 
and  the  SoHO  V&S  project  joined  forces  to 
launch the NOTIFY project. NOTIFY culminated 
in a large international workshop that was held 
in Bologna (Italy) in February 2011 with the 
participation of over 100 invited experts from 
36 countries.

During  the  workshop,  the  Bologna  Initiative 
for  Global  Vigilance  and  Surveillance  (BIG 
V&S) was established and a number of out-
comes were agreed, such as the creation of 
a new dedicated website for the dissemination 
of information regarding adverse events and 
reactions for organs, tissues and cells (Notify 
Library) (95).

The Human Tissue Authority (United Kingdom) 
will organise the global vigilance and surveil-
lance conference in the United Kingdom that 
will last a day and half and was held in Febru-
ary 2013.

The SoHO V&S project was selected as one of 
the 20 successful projects funded by the EU 
Health Programmes since 2003 (96). SoHO V&S 
shows how the Health Programme has helped 
to raise awareness on the role of vigilance and 
surveillance as a fundamental instrument for 
improving safety in tissue and cell transplanta-
tion and assisted reproduction.

The published guidelines on ‘V&S in Assisted Reproduction Technologies’, 

‘Communication and Investigation of Adverse Reactions and Events’, ‘The Detection 

and Investigation of Suspected Illegal or Fraudulent Activity’, ‘V&S in Living 

Donors’, ‘V&S Guidance for Clinical Users’  

(available at: http://www.sohovs.org/soho/)

(95)  www.notifylibrary.org

(96)  http://ec.europa.eu/health/programme/docs/success_stories_

(94)  http://registry.eurocet.org/soho/

hp_2008-2013_en.pdf 

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93

Further information:

Project website
http://ec.europa.eu/eahc/projects/database.html?prjno=20091110
http://www.sohovs.org/soho/

Project team:

Istituto Superiore di Sanità — ISS
Viale Regina Elena 299
PO-BOX
00161 Rome RM
ITALY
Tel. +39 0649904040
Fax +39 0649904101

Associated partners:

(cid:97)(cid:149) Agence de la Biomedecine, France
(cid:97)(cid:149) Agence Française de Sécurité Sanitaire des Produits de Santé, France
(cid:97)(cid:149) Donor Action Foundation, Belgium
(cid:97)(cid:149) Human Tissue Authority, United Kingdom
(cid:97)(cid:149)
(cid:97)(cid:149) Krajowe Centrum Bankowania Tkanek i Komorek, Poland
(cid:97)(cid:149) Organisacion Nacional de Trasplantes, Spain
(cid:97)(cid:149) The Human Fertilisation and Embryology Authority, United Kingdom

Irish Medicines Board, Ireland

EU contribution

This project has received co-funding from the European Union in the framework of the Health 
Programme 2008–2013 (Grant: 20091110).

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

European Quality System for Tissue Banking Project (EQSTB)

This project has received co-funding from the European Union in the framework of the Public Health Programme 
2003–2008 (Grant: 2003209).

Tissues and cells donated altruistically can save 
and improve the lives of recipients. For this rea-
son, the transplantation of human tissues and 
cells is a strongly expanding ﬁeld of medicine 
oﬀering great opportunities for the treatment 
of  still  incurable  diseases.  The  quality  and 
safety of these substances should be ensured, 
particularly in order to prevent the transmission 
of infectious diseases (97) (98) (99).

Tissue banking activity background is 
very diverse in Europe

A tissue establishment is a tissue bank or a unit 
of a hospital or another body where activities 
of processing, preservation, storage or distribu-
tion of human tissues and cells are undertaken. 
It may also be responsible for procurement or 
testing of tissues and cells (97).

The origin and the organisation of the tissue 
establishments in Europe are greatly unalike. 
Security and safety may vary depending on the 
tissue bank that has the control over the whole 
process, from donor selection criteria to tissue 
suitability for its transplantation. The European 
Quality System for Tissue Banking (EQSTB) pro-
ject emerged as a result of this situation.

The EQSTB project was funded by the Euro-
pean Union, speciﬁcally by DG SANCO and it 
was  coordinated  by  Hospital  Clinic  (Barce-
lona, Spain). From May 2004 until May 2007 
it involved 15 partners (representing diﬀerent 
national organisations and tissue establish-
ments) from 12 European countries.

The project’s main goal was to analyse the fac-
tors that may inﬂuence the ﬁnal tissue quality and 

(97)  Directive 2004/23/EC — ‘Setting standards of quality and 

safety for the donation, procurement, testing, processing, pres-
ervation, storage and distribution of human tissues and cells’.

(98)  Directive 2006/17/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
certain technical requirements for the donation, procurement 
and testing of human tissues and cells’.

(99)  Directive 2006/86/EC — ‘Implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards 
traceability requirements, notiﬁcation of serious adverse 
reactions and events and certain technical requirements for 
the coding, processing, preservation, storage and distribution 
of human tissues and cells’.

safety for its transplantation. Further, the project 
aimed to develop the method to ensure the stand-
ards  of  quality  and  safety  in  relation  to  tissue 
banking activities demanded by Directive 2004/23/
EC (97). To achieve these objectives, the tasks in the 
project were divided into four working groups:

1. The Standards Working Group performed an 
analysis of the diﬀerent standards that were fol-
lowed in the participating countries. This allowed 
creating The Guide of Recommendations for Tis-
sue  Banking (100),  which  included  the  following 
contents:

(cid:98)(cid:553) a description of the diﬀerent quality 

systems that apply to tissue banking and 
a provision of the general quality system 
requirements;

(cid:98)(cid:553) the legal and regulatory framework 

regarding tissue banking activities in Europe;

(cid:98)(cid:553) a description of the diﬀerent standards on 
tissue banking activities that are available 
in Europe;

(cid:98)(cid:553) a description of the quality and safety key 
points that are considered fundamental in 
tissue banking.

According to Dr Martí Manyalich (Hospital Clinic, Bar-
celona), the project coordinator: ‘The Guide of Rec-
ommendations for Tissue Banking was distributed 
across centres and since then is considered as a ref-
erence manual in Europe. These Guides are being 
used in the routine of a number of tissue establish-
ments around the world. We can mention among 
these countries Brazil, Colombia and Lebanon.’

This Working Group also surveyed tissue estab-
lishments to diagnose their capability to fulﬁl 
the European legislation on tissues and cells. 
The survey showed that most partner countries 
had more or less already implemented the EU 
Directives, or were in the process of adopting 
them (101).

(100)  Guide of recommendations for tissue banking. EQSTB (DG 
Sanco Project — European Commission). First edition: 
September 2007.

(101)  European Quality System for Tissue Banking Project, Final 
Report 2004–2007 Period, Agreement Number 2003209, 
http://ec.europa.eu/health/ph_projects/2003/action2/
docs/2003_2_06_frep.pdf

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95

The prototype of the registry proves 
that it would be possible to exchange 
tissues between establishments across 
Europe with such a database

that the training model should be structured 
into  two  complementary  courses:  an  online 
course  of  approximately  2  months  and  one 
face-to-face course of 2 days.

2. The Registry Working Group created a pro-
totype  of  an  online  European  multinational 
musculoskeletal tissue registry for the entire 
banking process, including donation, processing, 
preservation, traceability, clinical application 
and adverse reactions a#er transplantation.

 Most tissue establishments had more or less 

already implemented the European legislation 
about tissues and cells, or were in the process of 
adopting them. 

A review of the existing tissue banking training 
courses in Europe identiﬁed the ‘International 
Online Tissue Banking Course’ from the Uni-
versity of Barcelona. This course seemed to ﬁt 
extremely well with the aims of the project. As 
a result, it was adopted and its contents and 
structure  were  further  improved.  Regarding 
the face-to-face course, it was agreed that it 
should complement the online course and also 
cover practical aspects that this one could not.

A database and a web application were devel-
oped, and a search engine function was cre-
ated and put at the disposal of the participat-
ing tissue establishments. During the last year 
of the project, four partners performed a pilot 
data charge to validate the database. Each of 
them introduced 350 musculoskeletal tissue 
products into the registry, making a total of 
1 400 inserted gra#s. The validation test con-
cluded with positive feedback from the part-
ners involved in the data charge (101).

A  small  document  with  the  general  indica-
tions for the development and management of 
a computerised registry for tissue establish-
ments was provided to the European Commis-
sion, with strong emphasis on data traceability 
and data protection. According to the project 
team:  ‘The  prototype  of  the  registry  proved 
that it would be possible to exchange tissues 
between  establishments  across  Europe  with 
such a database. It was challenging to harmo-
nise the tissue product list, and, for this reason, 
it would be interesting to have in the future 
a common coding system for all tissue estab-
lishments in Europe’ (101).

As Dr Martí Manyalich said, ‘the ﬁrst version of 
the registry was developed during the project 
timeline and has been improved and adapted 
continuously  in  order  to  satisfy  each  centre 
needs.  This  served  as  a  starting  point  and 
model for the other registries that are being 
created a"erwards.’

A specialised training model for tissue 
bank personnel was designed and 
validated

3. The Training Working Group identiﬁed train-
ing needs for tissue bank personnel that could 
a#erwards  become  a  method  of  qualifying 
personnel  and  the  approved  training  model 
adopted in the European Union. It was decided 

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

A pilot training course was performed in the 
last year of the project. Twenty-eight tissue 
banking practitioners recruited on a voluntary 
basis from Belgium, Finland, France, Germany, 
Italy, Latvia, Poland, Portugal, Romania, Slo-
vak Republic, Slovenia, Spain, the Netherlands 
and the United Kingdom performed both the 
online and the face-to-face courses. The par-
ticipants, who were evaluated by answering 
questionnaires  before  and  a#er  they  took 
the courses, improved their knowledge a#er 
receiving the training and all of them received 
the  corresponding  certiﬁcation.  The  organi-
sational aspects of the course as well as the 
content were assessed, and the average scores 
obtained were high. Further, the model could be 
improved with the students’ suggestions (101).

‘The training model suggested during the pro-
ject is widely used so far, and a signiﬁcant num-
ber of countries, not only European but around 
all over the world, are applying this training 
programme,’ conﬁrmed the project coordinator.

4. The Auditing Working Group received the 
task to design a European Auditing Model of tis-
sue establishments based, among other factors, 
on the EU Directives on tissues and cells. With 
this aim, the Guide for Auditing Tissue Estab-
lishment (102)  was  developed,  which  provided 
tissue banking experts with a tool to audit tis-
sue establishments based on quality and safety 
key points and the EU Directives. There was 
a checklist provided with a set of questions that 
can be used as a self-assessment tool so that 
the tissue establishment can audit itself.

For a more detailed description of the European 
Quality System for Tissue Banking project and 
its outputs, please read the ﬁnal report of the 
project (101).

(102)  Guide for Auditing Tissue Establishment. EQSTB (DG 

SANCO Project — European Commission). First edition: 
 September 2007.

According to the project coordinator, this course 
structure permits a major ﬂexibility for par-
ticipants and reduces travel and accommoda-
tion expenses. The online education modality 
involves the development of a ﬂexible, inter-
active and bidirectional teaching and learning 
action. The face-to-face course reinforces the 
knowledge through experience and is designed 
to put into practice the knowledge acquired in 
the online modules.

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97

Further information:

Project website
http://ec.europa.eu/eahc/projects/database.html?prjno=2003209

Project team:

Hospital Clinic I Provincial De Barcelona
Villaroel, 170
PO-BOX
08036 Barcelona
SPAIN
Tel. +34 932275400
Fax +34 932275454

Associated partners:

(cid:97)(cid:149) Transplant Services Foundation, Spain
(cid:97)(cid:149) Belgian University Tissue Bank, Belgium
(cid:97)(cid:149) Agence de Biomédecine, France
(cid:97)(cid:149) Deutsches Herzzentrum Berlin, Germany
(cid:97)(cid:149)
I.R.C.C.S. Istituti Ortopedici Rizzoli, Italy
(cid:97)(cid:149) BIS Foundation, Netherlands
(cid:97)(cid:149) Netherlands Bone Bank Foundation, Netherlands
(cid:97)(cid:149) Centro Nazionale Trapianti, Italy
(cid:97)(cid:149) Organización Nacional De Transplantes, Spain
(cid:97)(cid:149) Tampere University Tissue Bank, Finland
(cid:97)(cid:149) North London Tissue Bank, United Kingdom
(cid:97)(cid:149) Ruzinov General Hospital Bratislava, Slovakia
(cid:97)(cid:149) State Forensic Medicine Centre, Latvia
(cid:97)(cid:149) National Centre of Tissue and Cell Banking, Poland
(cid:97)(cid:149) University of Medicine and Pharmacy ‘Victor Babes’, Romania

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2003209).

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Building reference compendia for the application of a single 
European coding system for tissues and cells (Eurocet128, 
EAHC/ 2011/HEALTH/03)

This service contract is ﬁnanced from the European Union in the framework of the Health Programme 2008–2013 
(Contract EAHC/2011/HEALTH/03, 20116102).

Eurocet128  is  a  service  contract  funded  by 
the European Union within the EU Health Pro-
gramme framework. The initiative, launched in 
December 2011 and with a 30-month duration 
until June 2014, was conceived by a consortium 
of two partners: the Italian National Transplant 
Centre (which leads the project) and Artman 
Technologies,  a  company  based  in  Slovakia 
with experience in designing and implementing 
information technology systems for traceability 
and management of transplantation activities.

The International Council for Commonality in 
Blood Banking Automation (ICCBBA) (103) is also 
involved as a subcontractor in the Eurocet128 
project. The ICCBBA is an international organi-
sation which manages and develops the ISBT 
128, which is the global standard for the iden-
tiﬁcation, labelling and information processing 
of human blood, cell, tissue and organ prod-
ucts across international borders and diﬀerent 
healthcare systems. According to the ICCBA, ‘by 
featuring a unique, highly ﬂexible, and compre-
hensive coding method for every collected prod-
uct, ISBT 128 provides international consistency 
to support the transfer, transfusion, or transplan-
tation of blood, cells, tissues and organs’ (104).

  Donation identification 

ISO country iden(cid:415)(cid:302)(cid:286)(cid:396)

TE code

Unique dona(cid:415)on 
number

Two characters

Six characters

13 characters

(alphabe(cid:415)c)

(alpha/numeric)

(alpha/numeric)

 Product identification 

Product code

Split number

Expiry date

Coding
system 
iden(cid:415)(cid:302)(cid:286)(cid:396)
One character 

Seven characters

Three characters 

(alphabe(cid:415)c )

(alpha/numeric)

(alpha/numeric)

Eight 
characters 
(numeric)

It is essential to maintain traceability 
of tissues and cells

Tissues and cells such as corneas, heart valves, 
cord blood or bone marrow are used in trans-
plant procedures to repair or replace damaged 
tissues or cells. Moreover, fertility treatments 
frequently involve the manipulation and trans-
fer of gametes (sperm or eggs) or embryos. 
In these activities, it is essential to maintain 
traceability, which means that the tissues or 
cells can always be linked back to the original 
centre where they were collected, as well as to 
their original human origin (105).

According to Directive 2004/23/EC (106) on tis-
sues and cells, Member States shall establish 
a system for the identiﬁcation of all human tis-
sues and cells procured, processed, stored or 
distributed on their territory, in order to ensure 
their traceability from the donor to the recipi-
ent and vice versa. This Directive also requires 
designing a single European coding system to 
provide information on the main characteristics 
and properties of tissues and cells.

Eurocet128 seeks to implement a single 
coding system in the European Union

The primary aim of the Eurocet128 project is to 
support the traceability of human tissues and 
cells that are applied to patients in the Euro-
pean Union. To achieve this goal, Eurocet128 
will develop and implement a single European 
Coding System, which will be allocated to all 
donated material at the tissue establishment. 
This system will allow human tissues and cells 
to be categorised in a reliable way for clinical 
use, for activity reporting or for vigilance and 
surveillance purposes. Furthermore, it will allow 

The European Coding System proposed by Eurocet128

(103)  www.iccbba.org

(104)  www.iccbba.org/home/isbt-128-basics/what-is-isbt-128

(106)  Directive 2004/23/EC — ‘Setting standards of quality and 

safety for the donation, procurement, testing, processing, pres-
ervation, storage and distribution of human tissues and cells’.

(105)  www.eurocet128.eu

 
 
 
          
 
 
 
 
 
 
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99

to link back to the original centre where cells 
and tissues were collected, as well as to their 
original human origin by improving traceability 
of these substances across the EU.

By using the same European coding 
system, each donated material will be 
allocated a single code at the tissue 
establishment

The work of the consortium is divided into sev-
eral activities.

1.  Provide,  test  and  ﬁnd  consent  among 
Member States for a compendium of tissue 
establishments in the EU, as well as their 
respective codes

Tissue establishments are centres that receive, 
test, process, store and distribute tissues or 
cells  (including  gametes  and  embryos)  for 
human application. Eurocet128 aims to develop 
a tissue establishment compendium in order to 
provide a publicly accessible list of authorised 
tissue establishments in the European Union 
with their relevant identifying codes and a spe-
ciﬁc minimum set of information.

Eurocet128 is not the ﬁrst EU-funded project 
addressing the traceability of human tissues 
and cells applied to patients in the European 
Union as the Tissue Establishment Compen-
dium will be constructed on the work previously 
done by EUROCET (107) (European network of the 
competent authorities for tissues and cells).This 
was also an EU-funded project, although in this 
case under the e-TEN (trans-European e-ser-
vices) programme, which contributed to make 
e-services available throughout the European 
Union (108). Today the EUROCET network collects 
from EU Competent Authorities information on 
tissue establishments, and on activities in rela-
tion to tissues, haematopoietic and reproduc-
tive cells donation and transplantation (to learn 
more about the EUROCET network, please visit 
its website: www.eurocet.org).

The Eurocet128 consortium intends to develop 
a procedure for a continuous updating of the 
tissue establishments list with details on the 
speciﬁc tissues and cells types managed, as 
well on speciﬁc activities authorised. The codes 

(107)  www.eurocet.org

(108)  http://ec.europa.eu/information_society/activities/eten/

index_en.htm

Eurocet128 will attempt to ensure that the European Coding System is compatible 

with the existing national systems and international initiatives to achieve global 

harmonisation on terminology and coding.

for the tissue establishments will be allocated 
in line with the Single European Coding System.

 By using the same European coding system, each 
donated material will be allocated a single code at the 
tissue establishment. 

2.  Provide,  test  and  ﬁnd  consent  among 
Member  States  for  a  compendium  of  tis-
sue and cells’ products and their respective 
alpha-numeric codes

The Product Compendium will be a list of types 
of tissues and cells with agreed descriptions. 
Thus, for example, the tissue ‘cornea’, indepen-
dently from the country of origin or the tissue 
establishment  where  it  was  processed,  will 
always conform to the same European Product 
Code, which will correctly identify the product 
‘cornea’. This will provide a means of harmonis-
ing product descriptions and coding throughout 
the European Union.

Eurocet128  will  attempt  to  ensure  that  the 
European Coding System is compatible with 
the existing national systems and international 
initiatives to achieve global harmonisation on 
terminology and coding.

3. Provide an online code-translator applica-
tion to code/decode alphanumeric codes and 
textual information

The Tissue Establishment Compendium and the 
Product Compendium will be implemented via 
the Code Translator, an online application. Tis-
sues and cells professionals, clinical users and 

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

a n d  
C o m p e t e n t 
Authorities. As stated 
by  Eurocet128  in  its 
project  protocol,  this 
pilot  phase  should 
involve diverse types 
of  tissue  establish-
ments  (e.g.  bones, 
cord  blood,  bone 
marrow, skin, cornea, 
assisted reproduction 
facilities, etc.).

As  soon  as  these 
tools are fully devel-
oped  and  tested, 
they will be available 
on the web together 
with  guidance  and 
manuals  for  users. 
Eurocet128  aims  to 
provide a system that 
is  user-friendly  and 
compatible  in  terms 
of  software  and 
technology  with  the 
requirements  of  the 
corresponding  host-
ing  European  Union 
agency, for example, 
with  those  of  the 
European  Medicines 
Agency.

Project leaﬂet (http://www.eurocet128.eu)

regulators will be able to enter the application 
for translating alphanumeric codes into textual 
information, as well as textual information into 
alpha-numeric codes. In particular, the appli-
cation will convert tissue establishments and 
product codes from/into detailed text informa-
tion, such as the names of the contact person, 
address,  contact  details,  tissue  type,  expiry 
date of the products, etc. Therefore, as states 
the project team, ‘the code translator will allow 
those who receive tissues or cells for human use 
to immediately establish both the origin and the 
description of the product’ (107).

4. Set up the code-translator application on 
the website of an EU agency, which will host, 
run, maintain and further develop the sys-
tem by the end of the project

Eurocet128  plans  to  test  in  at  least  ﬁve  EU 
Member States the use of both the compen-
dia and the online code translator application 
in a pilot phase involving tissue establishments 

Therapies  based  on 
tissue and cell trans-
plants are becoming ever more numerous and 
varied. The process — including tissue procure-
ment, product manufacture and actual gra#-
ing — involves many complex and interrelated 
steps (109). Eurocet128 will contribute to create 
a single European Coding system, which will 
ensure proper identiﬁcation of the donor and 
rapid traceability of all donated tissues and 
cells. This system will be crucial to ensure the 
quality and safety of tissues and cells and to 
comply with the standards established in the 
European Union legislation.

For  further  information,  please  download 
the leaﬂet of the project (110), which contains 
detailed  information  about  this  initiative,  or 
visit the project website.

(109)  http://ec.europa.eu/health/blood_tissues_organs/tissues/

index_en.htm

(110)  www.eurocet128.eu/eurocet128.pdf

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

101

Further information: 

Project website
http://www.eurocet128.eu

Project team:

Istituto Superiore di Sanità — ISS
National Italian Transplant Centre (CNT)
Viale Regina Elena 299
PO-BOX
00161 Rome RM
ITALY
Tel. +39 0649904040
Fax +39 0649904101

Consortium partners:

(cid:97)(cid:149) Artman Technologies, Bratislava, Slovakia (http://www.artman.sk/)
(cid:97)(cid:149) The International Council for Commonality in Blood Banking Automation (ICCBBA) 

(http://www.iccbba.org/)

EU contribution

This service contract is ﬁnanced from the European Union in the framework of the EU Health 
Programme 2008–2013 (Contract EAHC/2011/HEALTH/03, 20116102).

102

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Evaluation of legislation and related guidelines on the 
procurement, storage and transfer of human tissues and 
cells in the European Union — an evidence-based impact 
analysis (Tiss.EU)

This project has received co-funding from the European Union in the framework of the 7th Framework Programme 
(Grant: 202204).

Biobanks  are  organised  collections  where 
human tissues and cells are gathered, stored 
and  classiﬁed,  in  order  to  distribute  them 
among  researchers  for  research  projects. 
For example, samples of blood, skin, bone or 
tumours are collected. Biobanks range widely in 
scope from small disease speciﬁc collections to 
large-scale population-based repositories, and 
may be public or commercial (111).

The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe 

(http://webdoc.sub.gwdg.de/univerlag/2011/tiss_eu_book.pdf)

(111)  Cambon-Thomsen A, et al. Eur Respir J 2007; 30(2): 373–82.

Cells and tissues collected in biobanks have 
gained  great  importance  for  biomedical 
research, as they can help to understand dis-
eases and develop eﬀective therapies. For this 
reason, the European Union actively encour-
ages the networking of biobank initiatives.

Biobank research depends on the 
availability of a large number of 
samples and the consolidation of 
collections across country borders

European Union legislation has dealt with the 
handling of human tissues and cells by regulat-
ing its clinical applications, but it does not cover 
its  uses  in  the  research  ﬁeld.  Moreover,  the  
regulation  of  the  practices  in  biobanking 
research  is  heterogeneous  across  Member 
States, and a European Union regulation on 
biobanking for research is still missing. This can 
be a serious threat to transnational biomedical 
research involving human samples, by limiting 
access to samples and data. This is the context 
in which the Tiss.EU project was conceived.

Tiss.EU stands for Evaluation of legislation and 
related guidelines on the procurement, storage 
and transfer of human tissues and cells in the 
European Union — an evidence-based impact 
analysis. The project, funded by the European 
Union as a part of the Seventh Research Frame-
work  Programme,  ran  from  April  2008  until 
March 2011, and was coordinated by the Uni-
versity of Goettingen, in cooperation with the 
University of Hannover, both of them located in 
Germany. It involved 10 partners (representing 
diﬀerent universities and research institutions) 
from nine diﬀerent Member States (Germany, 
United Kingdom, Sweden, Hungary, Italy, Ireland, 
France, Netherlands and Lithuania).

The Tiss.EU project analysed the ethical and 
legal regulation of human tissue and biobank 
research across the then 27 European Member 
States plus Switzerland, attempting to identify 

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

103

regulation deﬁcits and inconsistencies. The pro-
ject focused on four aspects:

1.  procurement, storage and transfer of 

tissue and cells for research;

2.  rights and entitlements to tissue and cells;

3.  anonymisation and pseudonymisation to 

protect privacy rights;

4.  research using biobanks.

I. Procurement, storage and transfer of 
tissue and cells for research purposes

Harmonisation in these aspects appears par-
ticularly diﬃcult in the European Union, since 
regulations  are  divergent  between  Member 
States  and  may  diﬀer  even  at  the  level  of 
institutions. According to Katharina Beier and 
Silvia  Schnorrer,  researchers  of  the  project, 
‘the United Kingdom, for example, has a dis-
crete law and other reference acts on human 
tissue, whereas countries like Malta rely mainly 
on EU legislation’ (112). In certain areas, such as 
consent procedures for the protection of tissue 
donor  autonomy,  standards  varied  dramati-
cally. However, some common patterns were 
also identiﬁed. For example, in relation to the 
transfer of data and samples, the receiving 
institution or country usually adheres to the 
domestic rules of the sending country (118).

II. Rights and entitlements to tissue 
and cells — balancing the interests of 
donors, researchers and companies 

Traditionally, the European provisions assert 
that ‘the human body and its parts shall not, as 
such, give raise to ﬁnancial gain’ (113), so in most 
Member States tissue donors have no propri-
etary rights in their biological materials and 
may not receive any remuneration from them. 
On the other hand, researchers or companies 
may derive proﬁts from these tissues. In this 
context, the non-commercialisation principle 

may no longer apply if human bodily materials 
turn into products (that is the case of Germany, 
for example) (114).

The ﬁrst international workshop within Tiss.EU 
about  this  focal  theme  of  the  project,  that  is, 
‘Rights  and  entitlements  in  human  tissue  and 
cells’, was celebrated in Hannover. In summary, 
the contributions at the workshop reinforced the 
exigency to address the legal challenges of human 
tissue research thoroughly from an inter-European 
perspective. In particular, this workshop revealed 
fundamental questions of human tissue research 
that are only partly answered by national or EU 
law. However, according to the ﬁnal conclusions 
of the workshop, the existing concordances in the 
national legal approaches on biobanking in Ger-
many, Austria and Switzerland displayed a prom-
ising starting point for further legal adjustments 
within the ﬁeld (118).

III. Anonymisation and pseudonymisation 
to protect privacy rights — the transfer 
of cells and tissues also concerns the 
right to privacy

The need for protection of privacy is widely 
acknowledged in the European Union. In most 
Member States, the protection of samples and 
data is regulated by national data protection 
laws based on the European Data Protection 
Directive (115), which guarantees basic regula-
tion across Member States.

The European Data Protection Directive makes 
several exemptions for the use of health data 
‘for reasons of substantial public interest’. What 
is contested, however, is whether these exemp-
tions also apply to research; biobanks storage 
of human tissues transcends clinical purposes 
and is not aimed to treat an immediate health 
threat. According to the project team, ‘in cases 
as these, issues of consent and anonymisation 
rise to the fore’ (118).

Personal  and  genetic  data  have  a  special 
importance in ethics and law because of their 
meaningfulness to personal qualities such as, 
for example, dispositions to diseases. For this 
reason,  the  information  stored  in  biobanks 

(112)  Ethical and legal aspects of human tissue and biobank 
research in Europe: Report of the Tiss.EU project and its 
results, 2011.

(114)  C Lenk. Berliner Debatte Initial 2010:21(4); 9–18.

(113)  See, for example, the European Convention on Human Rights 
and Biomedicine (1997) or the Council of Europe’s Recom-
mendation 2006(4) on research on biological materials of 
human origin.

(115)  Directive 1995/46/EC of the European Parliament and of the 
Council of 24 October 1995 on the protection of individuals 
with regard to the processing of personal data and on the free 
movement of such data (European Data Protection Directive).

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kept  separately  by  an  authorised  person  or 
body) emerged as an important means of pri-
vacy protection in the ﬁeld of human tissue and 
biobank research (118).

Answers to these questions remain for future 
discussion and should be agreed in the follow-
ing years, in order to enable the use of donor 
data in a legal, safe and secure manner across 
Member States.

IV. Research using biobanks (112)

The signiﬁcance of biobank research is widely 
acknowledged  in  Europe:  many  countries, 
including  the  United  Kingdom,  Sweden  and 
Estonia, have established national biobanks, 
and  the  number  of  local  and  small-scale 
biobanks is also increasing.

However,  there  is  a  regulative  diversity  in 
biobanking among Member States. For example, 
some countries, such as Sweden and Spain, have 
enacted  discrete  laws  on  biobanking.  Others 
address this in a wider legal framework compris-
ing research on human tissue (the United King-
dom, for example), and other countries, in the 
absence of particular regulations, derive their 
rules from European guidelines and statutes.

Despite this regulative diversity, however, some 
common standards can be observed. For exam-
ple, participants in biobank research have the 
right to be kept informed about the use of their 
samples and data. Furthermore, the consent 
of the donor is obligatory in most countries. 
Also, donors have the right to withdraw from 
participation.

The Tiss. EU project provides free 
access to its website

The website of the Tiss.EU project (http://www.
tisseu.uni-hannover.de)  is  still  available  and 
hosts an extensive database of documents on 
human tissue and biobanking to facilitate fur-
ther research in the ﬁeld. During its term, the 
Tiss.EU project also set up a network of experts 
in the ﬁeld of human tissue research, which is 
also available on the project’s website (116).

(116)  www.tisseu.uni-hannover.de/index.php?option=com_

peoplebook&Itemid=49

The project website (http://www.tisseu.uni-hannover.de)

should not lead to identiﬁcation of the donors 
and infringe their privacy rights. This is what 
institutions that manage biobanks aim to pre-
vent by implementing the anonymisation and 
pseudonymisation of samples.

According to the project team, ‘there is con-
siderable disagreement about the provisions of 
anonymisation and pseudonymisation of sam-
ples and data across the Member States’ (118). 
Moreover, taken together, the contributions of 
the project workshops suggested that, although 
the anonymisation of samples and data might 
be  the  most  eﬀective  means  of  protecting 
donors’ privacy, ‘in the context of human tissue 
and biobank research outright anonymisation 
might neither be desirable, nor obtainable’ (118).

Why might anonymisation not be desirable in 
biobank research? Because the donors’ trace-
ability may be necessary for research in certain 
diseases. On the other hand, another important 
question which arose during the project was 
whether it was possible to obtain the complete 
anonymity of tissue samples. Some experts 
suggested that this is challenged by the pos-
sibility  of  genetic  analysis,  which  allows  for 
individual identiﬁcation (118).

Taken together, the contributions of the work-
shops suggested that the coding of samples 
(i.e.  the  code-key  is  not  accessible  for  the 
researchers who work with the samples, but 

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105

The Tiss.EU project organised nine international 
workshops and three International Status Con-
ferences during the project period. The docu-
ments generated can be found on the project’s 
website (117) and the revised reports have been 
published in a volume entitled The Ethical and 
Legal Regulation of Human Tissue and Biobank 
Research in Europe (118).

As the number of repositories that can be linked 
increases and samples and data can be more 
easily transferred across country borders, the 
value of biobank research increases. This is why 
the Tiss.EU initiative was an important step in 
promoting human tissue and biobank research.

(117)  http://www.tisseu.uni-hannover.de/index.php?option=com_cont

ent&task=view&id=68&Itemid=44

(118)  http://webdoc.sub.gwdg.de/univerlag/2011/tiss_eu_book.pdf 

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Further information:

Project website:
http://www.tisseu.uni-hannover.de

Cordis database:
http://cordis.europa.eu/search/index.cfm?fuseaction=proj.document&PJ_RCN=10230075

Project team:

Project Coordinator
University Medical Center Göttingen,
Tiss.EU Project Manager: Dr Christian Lenk
GERMANY
E-mail: clenk@gwdg.de
Tel. +49 551394186

Project partners:

(cid:97)(cid:149) University of Hannover, Medical Law and Bioethics Research Group, Centre for 

Philosophy and Ethics of Science, Germany

(cid:97)(cid:149) University of Birmingham, Centre for Global Ethics, United Kingdom
(cid:97)(cid:149) Stockholm University, Stockholm Bioethics Centre, Sweden
(cid:97)(cid:149) Central European University Budapest, Center for Ethics and Law in Biomedicine, 

Hungary

(cid:97)(cid:149) Fondazione Lanza, Padova, Center of Advanced Studies and Research in Ethics, 

Bioethics, Environmental Ethics and Social Issues, Italy

(cid:97)(cid:149) Dublin City University, Institute of Ethics, Ireland
(cid:97)(cid:149) Centre National de la Recherche Scientiﬁque, France
(cid:97)(cid:149)
(cid:97)(cid:149) Vilnius University, Dept. of Medical History and Ethics, Lithuania

Institute of Bio-Law, Legal Pathways i.O., Aerdenhout, the Netherlands

EU contribution

This project has received co-funding from the European Union in the framework of the 
7th Framework Programme (Grant: 202204).

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107

Reprogramming the immune system for the establishment  
of tolerance (RISET)

This project has received co-funding from the European Union in the framework of the 6th Framework Programme.

The RISET acronym stands for reprogramming 
the immune system for the establishment of 
tolerance. RISET was a multinational project 
funded by the European Union under the 6th 
Framework Programme (a collection of actions 
at EU level to fund and promote research) (119). 
During 66 months, from March 2005 to August 
2010, the Université Libre de Bruxelles (Bel-
gium)  and  the  University  of  Oxford  (United 
Kingdom) coordinated the RISET project, which 
brought  together  26  partners  from  all  over 
Europe  to  build  a  partnership  between  the 
academic and the private sector in the ﬁeld of 
transplantation research.

Transplantation between individuals dramati-
cally  improves  the  survival  of  patients  with 
an established organ failure. However, most 
patients who receive a transplant require taking 
powerful drugs for the rest of their lives, which 
suppresses their immune system. These drugs 
prevent the immune system from rejecting the 
transplanted organ but, on the other hand, they 
can cause serious health complications.

As time passes, immunosuppressive drugs can 
aﬀect the health of transplant recipients, for 
example by increasing the risk of infections, 
malignancies, kidney problems or diabetes. On 
the other hand, there is a need for improving 
the standard of care in transplantation medi-
cine, as some patients receive more immuno-
suppression than required, whereas others may 
not receive enough immunosuppression, which 
can cause damage in the transplant.

Transplantation tolerance would 
represent a signiﬁcant advance in 
medicine

Tailoring  immunosuppressive  drugs  to  each 
patient may be possible, according to recent 
scientiﬁc advances. Furthermore, the induction 
of transplantation tolerance may be another 
achievable goal. But what is transplantation 
tolerance? It is the focus of the RISET project, 
and could be deﬁned as the state in which the 
immune system of the recipient of a transplant 

accepts permanently the transplant in absence 
of chronic immunosuppression, so immunosup-
pressive drugs are not needed and the global 
functions of the immune system are preserved. 
To achieve transplantation tolerance would rep-
resent a signiﬁcant advance in medicine.

RISET: achieving transplantation 
tolerance by investigating innovative 
therapies

The goal of RISET was to design novel tools to 
determine and to induce transplantation toler-
ance. In this sense, the initiative aimed to trans-
late advances in transplantation research into 
clinical practice and industrial development. 
Some of the achievements of RISET were the 
following.

1. The development of tests to predict 
tolerance

RISET developed new tests to predict transplant 
tolerance, some of them ready for commercial 
development in collaboration with the indus-
try. These tests enable identifying transplant 
recipients  who  are  truly  tolerant  or  require 
minimal  immunosuppression.  This  informa-
tion is extremely useful as it indicates exactly 
how much immunosuppression each transplant 
recipient  needs  to  take,  which,  in  practical 
terms, reduces the amount of immunosuppres-
sive drugs administered and, in consequence, 
their side eﬀects.

According to one of the study groups of the 
project, ‘it is hoped that these tests will lead 
to doctors being able to deliver more person-
alised care to transplant patients in future, by 
safely  modifying  the  amount  of  medication 
patients take while preventing rejection of the 
donor organ.’ The new tests developed during 
the  project  can  be  consulted  on  the  project 
website (120).

(119)  http://ec.europa.eu/research/fp6/pdf/fp6-in-brief_en.pdf 

search-strategies-1/data-management-and-data-analysis

(120)  http://www.nds.ox.ac.uk/trig/research-overview/advanced-re-

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3. Development of a data repository

RISET created a data repository to store clini-
cal data and to follow-up patients in investi-
gation  studies  about  transplantation  toler-
ance. According to the team involved in this 
work-package, ‘integration of various sources 
of clinical data and of all the data produced 
during the experiments was the main task’. This 
allowed to optimally exploit the clinical and bio-
logical data accumulated within the project in 
order to identify and validate biomarkers of 
tolerance.

The  ﬁnal  report  of  the  project  deﬁned  this 
data repository as ‘a unique resource on the 
follow-up of patients in tolerance investigation 
studies. A longitudinal visualisation tool, the 
LifeLines programme, allows representing both 
clinical and experimental data in a uniﬁed way 
and investigating the relationship between clini-
cal events and test results in order to support 
the validation of biomarkers’.

4. Ethical guidelines for clinical studies 
on tolerance induction

The project stimulated debate around the eth-
ical aspects of tolerance induction, that allowed 
to achieve consensus on guidelines about this 
topic. The RISET ethics team produced a set of 
ethical recommendations on pilot clinical stud-
ies for tolerance induction, in particular focus-
ing on the following topics: biomarker valida-
tion, the inequality of access to transplantation 
and the novel accompanying therapies across 
Europe.

According  to  V.  Commin  and  A.  Cambon- 
Thomsen, researchers of the project, a set of 
ten speciﬁc recommendations for clinical pilot 
studies on ethical aspects of tolerance induc-
tion was validated within the RISET consortium. 
Before being published, these recommenda-
tions were submitted for comments to various 
experts,  committees,  institutions  and  other 
stakeholders .

5. Educational programmes on 
transplantation tolerance

RISET contributed to the development of edu-
cational materials on transplantation tolerance 
to distribute among patients and their families, 

http://www.ont.es/publicaciones/Documents/RISET%20NEWSLETTER%2009.pdf 

 Transplantation tolerance would represent 

a significant advance in medicine. 

2. Investigations to discover innovative 
therapies for transplantation tolerance

Some  studies  performed  during  the  project 
period  allowed  to  identify  new  genes  and 
molecules relevant for the induction of trans-
plantation tolerance. As an example, a RISET 
research group found that the tolerance of the 
recipient can be improved if a speciﬁc type of 
cell is transplanted along with the organ trans-
planted; these cells can ‘educate’ the immune 
system of the recipient in order to accept the 
new organ. Therefore, if the immune system 
of the patient receiving the transplant is edu-
cated not to reject the transplant, the need for 
immunosuppressive medicines will be reduced.

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109

Project webpage at: http://www.nds.ox.ac.uk/riset

physicians, scientists, nurses and the media. 
Moreover, educational events about the ethical 
and regulatory frameworks on transplantation 
tolerance were organised for medical law and 
transplantation professionals, as well as for 
young researchers.

The  RISET  project  captured  international 
attention.  According  to  RISET,  the  project 
appeared  in  the  international  press  many 
times. In 2007, for instance, several articles 
were  written  following  a  press  conference 
given at the RISET meeting in Madrid enti-
tled ‘Molecular signatures in transplantation 
tolerance’ .

6. Understanding the way transplanted 
patients and the general public 
perceive tolerance induction

RISET analysed the state of public debate on 
immunosuppression  and  tolerance  induction 
in  ﬁve  Member  States  (France,  Netherlands, 
Belgium, Germany and Italy) in order to under-
stand the way transplanted patients and the 
general  public  perceived  tolerance  induction. 
This  analysis  revealed  an  existing  paradox: 
although there was an array of information on 
im munosuppressive drugs, transplant patients 
felt  there  was  lack  of  information  regarding 
what they were concerned. According to Christi-
ane Kapitz and Anne Cambon-Thomsen, leaders 
of this work package, ‘transplant patients have 
a common interest in their treatment, not met by 
the information from institutions or associations’. 
As the RISET team concluded, ‘thought needs to 
be given as to the type of information that might 
reduce the anxiety of patients for whom a trans-
plant means dependence on drugs for life’. The 
complete report of this survey is available on the 
project website .

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RISET performed an intense 
dissemination of the project outputs 
by publishing over 160 publications in 
international journals

A competitive European task force to 
translate transplantation tolerance 
into clinical practice

As  part  of  its  dissemination  strategy,  RISET 
generated  over  160  publications  in  interna-
tional journals, several book chapters, and its 
ﬁndings were discussed at congresses, meet-
ings and training events . The ﬁnal ﬁndings were 
presented on 22 June 2010 at a symposium in 
the European Parliament (Brussels). The pro-
ject website , which continues to be available, 
informs  about  the  project,  its  activities  and 
main achievements.

RISET and the Immune Tolerance Network (121), 
an international clinical research consortium, 
signed a collaboration agreement to exchange 
scientiﬁc results and biological samples. The 
Immune Tolerance Network is an international 
collaboration  of  researchers,  which  shares 
a similar mission with RISET, that is, to acceler-
ate the clinical development of immune toler-
ance therapies.

New  treatments  usually  require  years  of 
research and development in the laboratory 
before they bring real beneﬁts to patients. The 
RISET consortium has sped up this process by 
building a partnership between researchers, cli-
nicians and pharmaceutical companies to work 
together to achieve the transplantation toler-
ance. This was an ambitious goal but the out-
puts of RISET are promising and suggest that 
an important step has been done to prevent 
organ rejection.

Although transplantation tolerance is far from 
being achieved, the RISET network has contrib-
uted to advance towards this ultimate goal. The 
European Union provided not only the ﬁnancial 
support but also the visibility needed to bring 
the project to success.

(121)  www.immunetolerance.org

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111

Further information:

Project website
http://www.ont.es/publicaciones/Documents/RISET%20NEWSLETTER%2006.pdf 
http://www.ont.es/publicaciones/Documents/RISET%20NEWSLETTER%2007.pdf 
http://www.ont.es/publicaciones/Documents/RISET%20NEWSLETTER%2008.pdf 
http://www.ont.es/publicaciones/Documents/RISET%20NEWSLETTER%2009.pdf 

Project team:

The Project Coordinators:
Nuﬃeld Department of Surgery
University of Oxford (UOXF)
John Radcliﬀe Hospital
Headington, Oxford 
OX3 9DU 
UNITED KINGDOM 
Tel. +44 1865221300
Fax +44 1865763545

Universite Libre de Bruxelles (ULB)
Institut d’Immunologie Medicale
Rue Adrienne Bolland, 8
6041 Gosselies
BELGIUM
Tel. +32 26509560
Fax +32 26509562

Project partners:

(cid:97)(cid:149) Charité Universitätsmedizin Berlin (CHARITE), Germany
(cid:97)(cid:149) Centre Hospitalier de Nantes (CHUN), France
(cid:97)(cid:149) Universite Rene Descartes (UDESCARTES), France
(cid:97)(cid:149) Blasticon Biotechnologische Forschung GmbH, Kiel, Germany
(cid:97)(cid:149) Centro National de Traspantes y Medicina Regeneretiva (ONT), Madrid, Spain
(cid:97)(cid:149) Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Germany
(cid:97)(cid:149) Henogen S.A., Gosselies, Belgium
(cid:97)(cid:149)
(cid:97)(cid:149)
(cid:97)(cid:149) Leiden University Medical Center (LUMC), The Netherlands
(cid:97)(cid:149) King’s College London (KCL), United Kingdom
(cid:97)(cid:149) Miltenyi Biotec MACSmolecular Business Unit, Cologne, Germany
(cid:97)(cid:149) ProImmune Ltd, Oxford, United Kingdom

Institut National de la Sante et de la Recherche Medicale, Toulouse, France
Institute for Clinical and Experimental Medicine, (IKEM), Prague, Czech Republic

EU contribution

This project has received co-funding from the European Union in the framework of the 
6th Framework Programme.

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Strengthen and develop scientiﬁc and technological excellence 
in research and therapy of leukaemia (CML, AML, ALL, CLL, 
MDS, CMPD) by integration of the leading national leukaemia 
networks and their interdisciplinary partner groups in Europe 
(European LeukemiaNet)

This project has received co-funding from the European Union in the framework of the 6th Framework Programme.

Leukaemia  is  the  cancer  of  the  blood  cells 
which are responsible for ﬁghting infections 
(known as leukocytes). It represents a chal-
lenge for society, among other reasons because 
of its frequency in all age groups. Several Euro-
pean countries have achieved a leading position 
in leukaemia research and therapy, but there is 
no true European world leadership in this sense 
yet, mainly due to fragmentation of leukaemia 
research in Europe.

Today,  the  European  LeukemiaNet  (ELN)  is 
a network of excellence integrating the leading 
European groups in management and research 
in the ﬁeld of leukaemia. It was born as a multi-
national project funded by the European Union 
under  its  6th  Framework  Programme.  The 
project lasted 86 months, starting in January 
2004  and  ﬁnishing  in  February  2011.  Coor-
dinated by Heidelberg University (Germany), 
this project set up a network for research and 
patient care in the ﬁeld of leukaemia. It brought 
together over 1 000 leukaemia specialists from 

189 institutions in 38 countries, including Swit-
zerland, Israel, the United States and Russia. 
According to Prof. Hehlmann, coordinator of the 
project, ‘honouring the success of the European 
LeukemiaNet, the contract between the Euro-
pean Union and the European LeukemiaNet was 
extended beyond the regular period of 6 years 
until February 2011’ (122).

Cooperation as the fastest path to 
making leukaemia a curable disease

‘Before  the  creation  of  the  European  Leuke-
miaNet, there were a number of pre-existing 
networks in Europe that were each individually 
developing  diagnostic  methodology,  running 
clinical trials and producing management guide-
lines,’ stated Prof. Hehlmann. ‘In this context, the 
main goal of the European LeukemiaNet was to 
create an environment in which these organisa-
tions could work more closely together, to har-
monise their eﬀorts and bring their advances 
to a wider community in a more timely fashion. 
This would allow to overcome national fragmen-
tation, and to achieve research and treatment 
goals that are not easy to accomplish by a sin-
gle country on its own’ (123) (124).

With this aim, the European LeukemiaNet inte-
grated the leading leukaemia research groups 
across  Europe,  the  industry  and  small  and 
medium-sized companies, and provided central 
management, information and communication 
structures for them.

Participating centres 

(122)  European LeukemiaNet, Seventh annual activity report.

(123)  Hehlmann R, et al, Leukemia 2004;18(4):665–9.

(124)  www.haematologica.org/content/96/1/156.long

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113

Recommendations on the topics

The project’s speciﬁc goals were:

(cid:98)(cid:553) to establish central information, 
communication, education and 
management structures;

(cid:98)(cid:553) to set up European leukaemia subnetworks 

and interdisciplinary platforms;

According  to  Prof.  Hehlmann,  the  European 
LeukemiaNet is a model of transnational coop-
eration. Working together successfully created 
a spirit of cooperation and mutual trust (124). 
The most visible results of the network were:

(cid:98)(cid:553) the cooperative research projects and trials 
performed as reﬂected in a large number of 
high impact publications;

(cid:98)(cid:553) to carry out clinical trials in order to 

discover and develop leukaemia therapies;

(cid:98)(cid:553) the guidelines and management 

(cid:98)(cid:553) to create a European registry for 

leukaemias in order to determine incidence 
and disease patterns across Europe;

(cid:98)(cid:553) to standardise diagnostic procedures and 

therapies;

(cid:98)(cid:553) to perform meta-analyses and 

evidence-based guidelines to facilitate 
decision-making.

recommendations produced for each type 
of leukaemia;

(cid:98)(cid:553) the European LeukemiaNet´s website (125), 

which has become a leukaemia information 
centre for physicians, patients, caregivers 
and the general public.

(125)  www.leukemia-net.org/

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European registries for leukaemias

The European LeukemiaNet initiated public– 
private partnerships with the industry to enable 
the creation of multinational registries. This can 
be illustrated by the European Myelodysplas-
tic Syndrome Registry (EUMDS Registry) (126), 
where  more  than  650  patients  have  been 
registered so far. Another relevant example is 
the European Treatment and Outcome Study 
(EUTOS)  for  chronic  myeloid  leukaemia (127), 
started in June 2007, which aims to improve 
understanding,  promote  best  practices  and 
enhance treatment outcomes of patients with 
chronic myeloid leukaemia.

Research projects and trials in 
leukaemia

The  European  LeukemiaNet  coordinated  and 
facilitated the performance of pan-European 
clinical trials. As a consequence, new drugs for 
the  treatment  of  leukaemia  are  under  study 
(such as nelarabine or herceptin), and a number 
of joint European trials are ongoing. As an exam-
ple, the ﬁrst joint European trial with a promising 
drug for the elderly with a speciﬁc type of acute 
lymphoblastic leukaemia was started.

Another good example of the potential of net-
working is provided by the MILE study (Micro-
array Innovations in Leukemia study), which 
involves 11 laboratories (seven from European 
LeukemiaNet, three from the United States and 
one from Singapore) and that has already inte-
grated data from more than 3 300 patients 
to reveal new patient subgroups with speciﬁc 
prognosis and survival.

Guidelines and management 
recommendations

According to the seventh annual activity report of 
the project ‘the European LeukemiaNet published 
over  35  guidelines  and  management  recom-
mendations on leukaemia diagnosis and therapy. 
These are the basis for high quality patient care 
in leukaemia across Europe’ (122). In this sense, 
recommendations for virtually every leukaemia 
and interdisciplinary speciality were produced, 
such as recommendations on the management of 

(126)  www.eumds.org

patients with neutropenia a#er intensive chemo-
therapy. These guidelines are helping healthcare 
professionals in performing their work and are 
contributing for the homogeneous management 
of patients with leukaemia across Member States.

Input for development of new 
legislation on clinical trials

The European LeukemiaNet in collaboration with 
other European societies started an initiative to 
revise the Clinical Trials 2001/20/EC Directive (128), 
which regulates clinical trials in the European 
Union. A document was produced which placed 
a focus on the speciﬁc negative eﬀects of this 
directive on independent trials, that is, trials not 
sponsored by the pharmaceutical industry. This 
topic is of very high relevance because independ-
ent trials are very common in leukaemia research. 
Furthermore, detailed suggestions were provided 
to improve the legislation on clinical trials. More 
information about this initiative is available on 
the website of the project (129).

 The European LeukemiaNet 

improved leukaemia research and 
management across Europe.

The European LeukemiaNet website 
received 48 000 visits in 2010

During the project, the European LeukemiaNet 
made the results of the network available for 
institutions, scientists, clinicians and patients’ 
organisations.  The  knowledge  generated  was 
shared  through  annual  symposiums,  scien-
tiﬁc  sessions  and  workshops  at  international 
congresses. Seven annual symposiums of the 
European  LeukemiaNet  were  held  during  the 
project (130). As an example, the 7th Annual Sym-
posium in Mannheim (Germany) was attended 
by over 450 participants from 33 countries (131).

(128)  Directive 2001/20/EC — ‘on the approximation of the laws, 

regulations and administrative provisions of the Member States 
relating to the implementation of good clinical practice in the 
conduct of clinical trials on medicinal products for human use’.

(129)  http://www.leukemia-net.org/content/international_trials/

index_eng.html

(130)  www.leukemia-net.org/content/home/eln_symposia/agendas/

(131)  www.leukemia-net.org/content/home/eln_symposia/

(127)  www.eutos.org/content/home

agendas/#e8151

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115

Although the project was by deﬁnition limited in 
time, the purpose was to make the dissemina-
tion of knowledge sustainable. With this aim, 
the website of the European LeukemiaNet (125) 
continues to actively place its knowledge at the 
disposal of physicians, patients, caregivers and 
the general public. The information is available 
in diﬀerent European languages and includes 
a variety of resources, such as meetings, con-
ferences, clinical trial registries, news, guidelines, 
printed materials, lists of patients’ organisations, 
etc. In 2010 only, the European LeukemiaNet 
website received around 48 000 visits from 148 
countries; this indicates the further need for such 
a knowledge tool.

A network with great perspectives

February 2011 was the last month of European 
Union funding within the 6th Framework Pro-
gramme, but not the last month of the Euro-
pean LeukemiaNet. Since then, the European 
Science Foundation (132) is funding the initiative 
and will continue this support until 2015.

Moreover, the European LeukemiaNet Founda-
tion (133), a charitable non-proﬁt organisation, is 

already supporting the European LeukemiaNet to 
address disparities in both access to treatment 
and quality of care, as well as to improve the 
care of leukaemia patients in Europe and glob-
ally. According to Prof. Hehlmann, Chairman of 
the European LeukemiaNet Foundation, this foun-
dation ‘oﬀers access to an alliance of researchers, 
industry, politicians, patient groups and the med-
ical profession to better understand origin and 
course of leukaemia and to reinvigorate the clini-
cal development of new strategies and drugs’ (134).

The  European  LeukemiaNet  is  expanding 
and  making  the  fragmentation  of  leukaemia 
research and management in Europe an issue 
of the past. According to the last activity report 
of the project, ‘The European LeukemiaNet facili-
tated for more than 8 years cooperative research 
in a network of excellence, including over 1 000 
leukaemia specialists from 182 institutions in 34 
countries across Europe. The European Leukae-
mia Net has become a landmark in the medical 
history of leukaemia’ (122).

For a detailed description of the achievements 
and perspectives of the European Leukemi-
aNet, please read the article written by the 
project consortium (124).

(132)  www.esf.org/

(133)  www.elnfoundation.org/content/home/

(134)  www.elnfoundation.org/content/about_us/

words_of_the_chairman/

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Further information:

Project website
http://www.leukemia-net.org/content/home/index_eng.html
www.leukemia-net.org/

Project team:

175 participating centres in 33 countries (1 000 researchers and associates) are cooperating in 
the European LeukemiaNet, the complete list is available here:
http://www.leukemia-net.org/content/home/the_project/participants/e7552/
infoboxContent8345/ELN-ParticipantsStand05_2010.pdf

EU contribution

This Network of Excellence has received co-funding from the European Union in the framework 
of the 6th Framework Programme.

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117

Transplantation Research Integration across Europe (TRIE)

This project has received co-funding from the European Union in the framework of the 6th Framework Programme.

The TRIE acronym stands for Transplantation 
Research Integration across Europe. This initia-
tive was a multinational project funded by the 
European Union under the 6th Framework Pro-
gramme. During 24 months, from March 2007 
to February 2009, TRIE brought together aca-
demic, clinicians, industry and patient groups 
with  the  aim  of  developing  a  coherent  and 
common strategy to deﬁne the future priori-
ties of transplantation research in Europe. The 
project was coordinated by Université Libre de 
Bruxelles (Belgium).

Our immune system protects our body from 
foreign substances. People who receive trans-
plants run the risk that their immune system 
rejects the transplant and causes the trans-
plant to fail. For this reason, these patients 
must receive immunosuppressive drugs, which 
prevent their immune system from rejecting 
the transplant. However, the rejection of donor 
organs remains a serious problem for trans-
plant patients; this is why further research is 
required to improve their long-term perspective.

Recent developments have opened new exciting 
perspectives for cell and organ transplantation, 
including the development of novel immuno-
suppressive  agents,  new  diagnostic  tools 
and validation of biomarkers to predict both 
transplant rejection and transplant tolerance. 
Transplant tolerance is an important issue for 
transplant patients. It can be deﬁned as the 
state in which the immune system of the recipi-
ent of a transplant accepts permanently the 
transplant in absence of chronic immunosup-
pression, so immunosuppressive drugs are not 
needed and the global functions of the immune 
system are preserved.

TRIE: deﬁning the priorities of 
transplantation research in Europe

The overall aim of TRIE was to identify impor-
tant questions in the ﬁeld of transplantation 
research, focusing on themes for which joint 
eﬀorts across multiple centres and countries in 
Europe would represent an added value. TRIE’s 
objectives were:

(cid:98)(cid:553) to identify current opportunities and 

challenges in the ﬁeld of transplantation 
research;

(cid:98)(cid:553) to suggest priority actions to be 

implemented in order to foster integration 
of research activities on transplantation.

The TRIE initiative worked on the identiﬁcation 
of priority topics on cell and organ transplan-
tation for further investigation. The selection 
of  these  priority  topics  was  based  on  three 
sources: a dedicated Advisory Council chaired 
by Prof. Kathryn Wood from the University of 
Oxford, a large electronic survey among 370 
key stakeholders (responses collected from 16 
European Union countries, the United States 
and  Canada),  and  a  high  level  workshop  in 
London gathering input from 60 leaders in the 
transplantation ﬁeld.

This forum was open to involvement of any 
organisation or individual with a direct inter-
est in transplantation research, e.g. National 
Societies for Solid Organ, Cell and Bone Mar-
row Transplantation, political representatives, 
research agencies and funding bodies, industry, 
patient organisations, etc (135).

The project team synthetised all these contri-
butions. Finally, consensus was reached on the 
following three priority topics for future initia-
tives in transplantation research (136).

Topic 1 — The identiﬁcation of biomarkers in 
the donor and in the recipient which could help 
doctors to deﬁne risk proﬁles for patients and 
tailor pre- and post-transplant therapies

A biomarker is a biological parameter that can 
be measured to predict a condition. In the con-
text of transplantation, it could be used to pre-
dict how the recipient will respond to the trans-
plantation, for example if the patient will be 
tolerant to the transplant received. This infor-
mation is useful as it would indicate how much 
immunosuppression each transplant recipient 
needs to take, which, in practical terms, will 

(135)  www.ont.es/publicaciones/Documents/RISET%20NEWSLET-

TER%2008.pdf

(136)  The TRIE (Transplantation Research Integration across Europe) 

project, Final report.

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allow to reduce the amount of immunosuppres-
sive drugs administered and, in consequence, 
their side eﬀects.

(cid:98)(cid:553) envisage public–private partnership models 

to implement this topic;

Topic 2 — The development of novel cell-based 
therapies for transplantation

Cell-based therapies are treatments contain-
ing viable cells. These highly innovative thera-
pies have a high potential in the treatment of 
various diseases as they restore tissues when 
the body’s own repair system is inadequate or 
absent. For this reason, the development of cell 
therapy products should be taken into consid-
eration as they might have positive implications 
for the transplantation process.

(cid:98)(cid:553) address ethical and regulatory 

considerations.

Topic 2 — The development of novel cell-based 
therapies for transplantation:

(cid:98)(cid:553) standardise cell therapy protocols in order 
to improve regulatory issues and industrial 
investment in this ﬁeld;

(cid:98)(cid:553) involve industry to guarantee that products 
will be translated into clinical application in 
a later phase.

Topic 3 — The establishment of innovative train-
ing programmes for scientists and healthcare 
staﬀ involved in research on transplantation

Topic 3 — The establishment of innovative train-
ing programmes for scientists and healthcare 
staﬀ involved in research on transplantation:

TRIE also undertook a comprehensive review of 
existing training resources in the ﬁeld of trans-
plantation in Europe (137).

TRIE formulated speciﬁc 
recommendations to address problems 
that cannot be solved independently

For  each  priority  topic  the  TRIE  consortium 
deﬁned a number of speciﬁc recommendations.

Topic 1 — The identiﬁcation of biomarkers in 
the donor and in the recipient which could help 
doctors to deﬁne risk proﬁles for patients and 
tailor pre- and post-transplant therapies:

(cid:98)(cid:553) develop standardised tests and techniques 

to achieve an agreement on valid 
biomarkers among the transplantation 
community;

(cid:98)(cid:553) in cooperation with the industry identify 

clinical trials that look at biomarkers using 
validated assays in multicentre studies;

(cid:98)(cid:553) set up uniform biobanking facilities and data 
collection procedures to compare patient 
data across countries;

(cid:98)(cid:553) develop biostatistics facilities and 

competencies to facilitate data analysis;

(cid:98)(cid:553) set up a coordinated network with identiﬁed 
high quality training centres; in association 
with the scientiﬁc societies and the industry, 
this network will contribute to integrate 
training needs in the transplantation 
research and facilitate the transmission 
of developments in the pharmaceutical 
industry to the clinical setting and vice 
versa;

(cid:98)(cid:553) set up a platform to promote scientiﬁc 

collaboration among the transplantation 
community (staﬀ exchange, promotion of 
techniques, discussion on projects, etc.).

Greater collaboration with the 
industry is required to accelerate 
the development of therapies for 
transplantation

It was agreed that a closer collaboration with 
the  industry  is  needed  to  ensure  that  the 
patients are the ﬁnal beneﬁciaries of research 
progress. For this reason, members of the Inno-
vative Medicines Initiative Joint Undertaking 
(IMI JU) (138) were invited to discuss the oppor-
tunities to speed up the development of better 
and safer medicines for patients in this ﬁeld.

(137)  www.ont.es/publicaciones/Documents/RISET %20NEWSLET-

TER %2008.pdf

(138)  www.imi.europa.eu

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119

Future actions derived from the TRIE 
initiative

The  TRIE  consortium  organised  a  high  level 
meeting  entitled  Integrating  transplantation 
research  in  Europe:  perspectives  for  public–
private partnerships, which was held in Brussels 
on 3 November 2008, just a few months before 
the end of the project. During the meeting, the 
conclusions, recommendations and future per-
spectives emerging from the TRIE initiative were 
highlighted to policymakers, scientists, industry 
and patient representatives.

According to the ﬁnal report of the project, sev-
eral opportunities were being explored at the 
end of the project to ensure that these recom-
mendations would be implemented in the form 
of concrete projects bringing scientists, clini-
cians and the industry more closely together 
with the ultimate goal of beneﬁting patients. 
Moreover, as stated by the project team, the 
TRIE initiative was open for consultation and 

transplant patients, people waiting for trans-
plants and patient organisations were requested 
to give feedback; early indications were that 
patients agreed with the priorities identiﬁed by 
the project partners (136).

The EU-funded project TRIE aspired to develop 
a united strategy to deﬁne the future priorities 
of transplantation research in Europe. It coordi-
nated clinicians, the academia, patient organi-
sations  and  the  industry  to  address  issues 
jointly  and  eﬀectively.  The  project  identiﬁed 
key themes on cell and organ transplantation 
to foster novel clinical therapies.

This initiative was the ﬁrst step to respond to 
speciﬁc  questions  that  cannot  be  addressed 
independently  but  that  require  a  scale  of 
research across multiples centres and coun-
tries. If the recommendations provided are fully 
implemented, the European Union may become 
a leader in the ﬁeld, thanks to the new syner-
gies created.

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Further information:

Project website
http://cordis.europa.eu/projects/rcn/86352_en.html

Project team:

Institut d’Immunolgie Medicale
Avenue F. D. Roosevelt 50
1050 Brussels 
BELGIUM
Tel. +32 71378560
Fax +32 71378562
E-mail: mgoldman@ulb.ac.be

Project partners:

(cid:97)(cid:149) ABU International Project Management Limited, Ireland
(cid:97)(cid:149) The Anthony Nolan Trust, United Kingdom
(cid:97)(cid:149) The Chancellor, Masters and Scholars of the University of Oxford, United Kingdom
(cid:97)(cid:149) Academisch Ziekenhuis Leiden, Netherlands

EU contribution

This project has received co-funding from the European Union in the framework of the 
6th Framework Programme.

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121

Comparative analysis of medically assisted reproduction in 
the EU: regulation and technologies (SANCO/2008/C6/051)

This service contract has been ﬁnanced from the European Union in the framework of the Public Health 
Programme 2003–2008 (Call for Tender: SANCO/2008/C6/051).

The European Society of Human Reproduction 
and Embryology (ESHRE) (139) was contracted by 
the European Union (DG SANCO) (140) in 2008 to 
outline the situation of fertility treatments in 
the European Union. The speciﬁc goals of the 
project were to compare among the European 
Union Member States:

(cid:98)(cid:553) the diﬀerent legal frameworks, as well as 

the eligibility and reimbursement criteria for 
fertility treatment;

(cid:98)(cid:553) the current practices of fertility clinics.

One out of six couples in Europe needs 
help conceiving

Infertility  means  not  being  able  to  conceive 
a  baby  within  12  months  of  regular  unpro-
tected  sexual  relations.  Taking  into  account 
that one in six couples experience infertility 
problems at least once during their reproduc-
tive  lifetime,  infertility  could  be  deﬁned  as 
a relevant problem.

There are treatments available to help women 
conceiving, o#en called fertility treatments or 
medically assisted reproduction. These include, 
for example, in vitro fertilisation (a process by 
which an ovum is fertilised by sperm outside 
the body), or intracytoplasmic sperm injection 
(in vitro procedure in which a single sperm is 
injected directly into an ovum). Around 5 million 
babies have been born worldwide since the ﬁrst 
in vitro fertilised baby was born in 1978 (141).

Europe leads the ﬁeld of medically assisted 
reproduction,  initiating  approximately  71  % 
of all reported treatments (Asia excluded) (139).

However, it is not clear that all couples with 
fertility problems in the European Union receive 

(139)  www.eshre.eu

(140)  http://ec.europa.eu/dgs/health_consumer/index_en.htm

the best possible management, or that fertility 
treatment is accessible to all of them. Adequate 
implementation,  legislation,  reimbursement 
schemes and clinical practice in all the Member 
States are crucial to achieve this goal.

Fertility treatment legislation in the 
then 27 EU Member States

According to a survey carried out for the pro-
ject, 25 out of the then 27 EU Member States 
had already implemented the EU Tissues and 
Cells Directive (142) in 2006, and in most of them 
a Competent Authority (143) had started inspec-
tions of the fertility clinics. Moreover, 19 EU 
Member States reported to have speciﬁc leg-
islation to regulate medically assisted repro-
duction in their countries, whereas eight coun-
tries reported to have only general legislation 
covering these kinds of procedures. There were 
national registries for the collection of clinical 
activities in more than 20 countries, and a few 
of them reported to have local registries as 
well. Regarding the establishment of national 
and local registries for donors, a clearly mosaic 
pattern  among  the  European  countries  was 
detected (144).

According  to  the  project,  the  eligibility  and 
reimbursement  criteria  for  fertility  treat-
ments in the then 27 EU Member States var-
ied, which implied that not all women in the 
European Union had the same access to treat-
ment. Almost all EU Member States had some 
reimbursement scheme in place, but for many 
countries  it  was  not  clear  which  arguments 
had been used to decide on a restrictive policy. 
For example, in most countries the reasons for 

(142)  Directive 2004/23/EC — ‘Setting standards of quality and 

safety for the donation, procurement, testing, processing, pres-
ervation, storage and distribution of human tissues and cells’.

(143)  According to the Directive 2004/23/EC each Member State must 
nominate at least one Competent Authority, which is responsible 
for implementing regulatory activities in the ﬁeld of human 
tissues and cells for transplantation and assisted reproduction.

(141)  Assisted Reproductive Technology (ART) fact sheet. 

www.eshre.eu/ESHRE/English/Guidelines-Legal/ART-fact-sheet/
page.aspx/1061

(144)  Comparative analysis of medically assisted reproduction in 
the EU: regulation and technologies. SANCO/2008/C6/051. 
Final report.

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treatments in the European Union; in this sense, 
recording activities (including procurement, test-
ing, preservation, processing, storage and dis-
tribution) become compulsory, and these clinics 
must submit an annual report to the Competent 
Authority summarising their activities. Further-
more, the Competent Authority should maintain 
a National Registry for fertility clinics, specify-
ing status on accreditation, authorisation and 
licensing. The project team highlighted that 21 
of the then 27 Member States had established 
a National Registry already in 2009 (reporting 
was compulsory in 13 of them, and voluntary in 
the remaining eight countries). Moreover, around 
60 % of EU countries had accreditation systems 
in place in 2006 (144).

Outcomes of medically assisted reproduc-
tion:  In  2006,  the  number  of  fertility  treat-
ments  carried  out  in  the  European  Union 
approached 0.4 million (the 812 clinics sur-
veyed reported a total of 374 986 treatment 
cycles performed that year). The mean num-
ber of treatments per million inhabitants var-
ied among countries ranging from 120 to more 
than 2 000. The data collected show that more 
than  100  000  European  citizizens  are  born 
in the European Union as a result of fertility 
treatments. In some countries like Denmark 
and Slovenia, on average at least one child in 
every school class is the result of this kind of 
treatment (144).

Looking at the success rates per country and 
per  technique,  the  pregnancy  rates  a#er  in 
vitro fertilisation ranged from 20 % to 30 % 
with similar rates between diﬀerent countries. 
The same situation was repeated for intracyto-
plasmic sperm injection, which showed slightly 
increased pregnancy rates compared to in vitro 
fertilisation (144).

A  substantial  number  of  couples  in  the 
European Union travel to another country to 
obtain fertility treatment: According to the 
project, the information available suggested 
that a substantial number of couples travel to 
another country to obtain medically assisted 
reproduction treatments. The main reasons for 
travelling abroad were the prohibition of the 
technique, the inaccessibility to the treatment 
due to the characteristics of the patients (such 
as age, sexual orientation or civil status), long 
waiting lists or high costs of the treatment in 
the country of origin. However, the project team 
highlighted  that  more  elaborate  research  is 
necessary to obtain a complete picture of this 
phenomenon in Europe (144).

Geographical distribution of institutes for medically assisted reproduction (MAR) in 

the 27 EU Member States in 2006

restrictions on treatments were based on their 
cost-ineﬀectiveness, although in many cases 
the evidence base for this decision was weak. 
The eligibility criteria on reimbursement varied, 
with marital status and the maximum age of 
the mother being the factors that represented 
the  most  common  limitations  on  access  to 
a fertility treatment (144).

Characteristics of fertility clinics in the 
European Union

Size  and  activity:  There  were  971  clinics 
executing fertility treatments in the European 
Union in 2006, most of them located in Ger-
many, France, Spain and Italy (with more than 
100 clinics in each of them). Around 56 % of 
the Member States had less than 16 clinics. The 
size of the clinics varied considerably among 
the diﬀerent countries (144).

Registries: The EU Tissues and Cells Directive (142) 
introduced  reporting  and  registration  obliga-
tions  for  establishments  performing  fertility 

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123

Registering key information within 
the ﬁeld of medically assisted 
reproduction is still required 

This study oﬀered a ﬁrst clear description of 
the situation of medically assisted reproduction 
in the European Union. However, according to 
the authors, there is still an urgent need in the 
Member States for registering key information 
within this ﬁeld. The correct and precise collec-
tion of this data will improve quality and safety 
in medically assisted reproduction in Europe (144).

The conclusions stated in the ﬁnal report of this 
project highlighted that ‘safety and quality are 
the main concerns when treating patients with 
medically  assisted  reproduction  techniques. 
Adequate legislation, reimbursement schemes 
and good clinical practice are crucial to achieve 
this goal. Reliable data collection regarding the 
results obtained should allow improvement in 
the ﬁeld’ (144).

According  to  ESHRE,  the  ability  to  organ-
ise data collection covering most of the then 
27 EU Member States was essential for this 
study (145). ESHRE was recognised by the Euro-
pean Union as ‘the expert’ European organisa-
tion in the area of medically assisted repro-
duction. The collaboration of ESHRE with the 
European Union has improved the quality and 
safety of fertility treatments in the European 
Union. Nowadays, this collaboration continues 
to be active and fruitful.

The ﬁnal report of this project is available in 
the website of DG SANCO (146) and ESHRE (147).

(145)  www.eshre.eu/guidelines_and_legal/page.aspx/16

(146)  http://ec.europa.eu/health/blood_tissues_organs/docs/study_

eshre_en.pdf

(147)  www.eshre.eu/guidelines_and_legal/page.aspx/16

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Further information:

Project website
http://www.eshre.eu/

Project team:

The European Society of Human Reproduction and Embryology (ESHRE)
Meerstraat 60
1852 Grimbergen (Beigem)
BELGIUM
Tel. +32 22690969
Fax +32 22695600

EU contribution

This service contract has been ﬁnanced from the European Union in the framework of the 
Public Health Programme 2003–2008 (Call for Tender: SANCO/2008/C6/051).

H U M A N   T I S S U E S   A N D   C E L L S   F O R   T R A N S P L A N T A T I O N 

125

Analysis and comparison of testing methods and testing 
laboratories in the EU and third countries for the biological 
markers speciﬁed in the blood and tissues and cells 
Directives (SANCO/2008/C6/012)

This service contract has been ﬁnanced from the European Union in the framework of the Public Health 
Programme 2003–2008 (Call for Tender: SANCO/2008/C6/012).

Medical  therapies  based  on  substances  of 
human origin (blood, tissues, cells and organs) 
are increasingly common and save many lives. 
However, care must be taken to eliminate any 
risk of patients being infected with diseases 
such as hepatitis and HIV through such thera-
pies. To ensure the quality and safety of blood, 
tissues and cells, all European Union Member 
States are obliged to comply with the stand-
ards laid down in EU legislation (148).

One strategic aim of the European Union is to 
develop and implement an import/export instru-
ment to assist Member States in the exchange 
of substances of human origin. To facilitate the 
achievement  of  this  objective,  the  European 
Union  (DG  SANCO) (149)  contracted  ALCIMED 
to carry out a project over the course of 12 
months, from January to December 2009. ALCI-
MED (150) is a biotechnology company based in 
Paris that had already participated in previous 
projects undertaken for the European Union.

The  project’s  general  goal  was  to  facilitate 
the exchange of substances of human origin 
between Member States as well as between 
Member States and non-EU countries (herein-
a#er referred to as ‘third countries’). This gen-
eral objective was concretised by deﬁning the 
following speciﬁc objectives:

(cid:98)(cid:553) to understand the limitations in the 

exchange of substances of human origin 
between Member States as well as between 
Member States and third countries;

(cid:98)(cid:553) to provide recommendations to facilitate 
the exchange of substances of human 
origin between Member States;

(cid:98)(cid:553) to provide recommendations to facilitate 
the exchange of substances of human 
origin between Member States and third 
countries (with a focus on the United 
States).

 The Commission may consider these strategies  

and measures in its evolving political and economic 
context. 

ALCIMED, Authorisation of testing laboratories, testing methods  

and kits for biological markers used in blood, tissue and cell establishments in the 

EU, A report to the Commission.

ALCIMED conducted a bibliographical research 
of documents published on relevant websites. 
Patient organisations also provided informa-
tion on the exchange of substances of human 
origin between countries and on the diﬃculties 
experienced. In addition, 38 key opinion leaders 
within Competent Authorities and within blood, 
tissues and cells establishments (151) were con-
tacted directly to discuss these issues. Finally, 
a scientiﬁc experts’ committee was established 
in collaboration with the European Commission 
for the veriﬁcation of all technical aspects of 
the project.

The project team focused on the situation of 
ﬁve European Member States (the United King-
dom, France, Italy, Netherlands and the Czech 
Republic) and three countries outside Europe 
(the United States, Australia and Brazil).

The ﬁrst phase of the project (Work Packages 1 
and 3), gave an overview of existing authorisa-
tion and validation systems and currently used 
diagnostic kits for blood, tissues and cells.

(148)  http://ec.europa.eu/health/blood_tissues_organs/policy/

index_en.htm

(149)  http://ec.europa.eu/dgs/health_consumer/index_en.htm

(150)  www.alcimed.com/

(151)  Blood, tissues and cells establishments are authorised centres 

that receive, test, process, store and distribute blood, tissues 
or cells (including gametes and embryos) for human applica-
tion in the European Union.

(cid:98)(cid:553) Self-suﬃciency policies: several European 
countries have declared self-suﬃciency 
policies for blood and blood components. As 
a result, these countries do not exchange 
the regulated substances or only to 
a limited extent.

(cid:98)(cid:553) Diﬀerences in national testing requirements: 
the European Directives set out minimal 
safety requirements for substances of 
human origin, which are followed by all 
Member States. However, the Directives 
allow any Member State to adopt additional 
safety measures, which in practice vary 
between Member States. Such diﬀerences 
can hinder the exchange of blood, tissues 
and cells.

(cid:98)(cid:553) Diﬀerences in national donation legislation: 
the legislation that regulates donations 
of human blood, tissues and cells varies 
between Member States, which restricts the 
exchange of substances of human origin.

(cid:98)(cid:553) Lack of matching standards between 

Member States: to a limited extent, new 
EU Member States reported problems in 
implementing the common quality and 
safety standards speciﬁed by the European 
Directives.

(cid:98)(cid:553) Lack of networking between establishments: 
networks of trusted tissue establishments 
remain small and do currently not extend 
across the whole European Union.

According to the project’s ﬁnal report, the diﬃ-
culties in the exchange of substances of human 
origin between Member States in the European 
Union do not arise through a lack in quality 
standards, but rather through diﬀerences in 
the regulatory environment. Therefore, regula-
tory issues should be the target to facilitate the 
exchange (152).

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Project structure

The second phase (Work Packages 2 and 4) 
identiﬁed the existing variability in diﬀerent 
national authorisation and validation systems 
as well as in testing methods, and analysed its 
implication for the exchange of substances of 
human origin.

Finally, a substantial time of the project was 
spent to formulate the recommendations to the 
European Commission (Work Package 5).

What factors hinder the exchange of 
substances of human origin between 
Member States in the European Union?

According to the ﬁnal report of the project (152), 
the following factors inﬂuence on the exchange 
of substances of human origin within the Euro-
pean Union.

(cid:98)(cid:553) The nature of the substance: for instance, 
there is a growing need for the exchange 
of haematopoietic stem cells between 
countries, which has prompted the 
establishment of systems to facilitate 
the exchange of stem cells. On the other 
hand, the exchange of other cells, such as 
reproductive cells, is usually limited.

(152)  ALCIMED, Authorisation of testing laboratories, testing 

methods and kits for biological markers used in blood, tissue 
and cell establishments in the EU, A report to the Commission.

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127

What factors hinder the exchange of 
substances of human origin between 
Member States and countries outside 
the European Union?

(cid:98)(cid:553) Litigation risks: the potential ﬁnancial 

consequences of lawsuits in third countries 
prevent small private establishments in 
Member States from exporting blood, 
tissues and cells to such third countries.

The following diﬃculties were highlighted (152).

(cid:98)(cid:553) Regulations limiting export: third countries, 
such as Australia, have deﬁned policies that 
ensure a suﬃcient supply of substances of 
human origin for the domestic population, 
which can lead to restrictions of exports to 
other countries.

(cid:98)(cid:553) Varying testing requirements: third 

countries have reported diﬃculties in 
meeting all testing requirements of Member 
States which go beyond the requirements 
speciﬁed in the European Directives. On 
the other hand, third countries may specify 
testing methods that diﬀer from the 
European practices.

(cid:98)(cid:553) Self-suﬃciency policies: Competent 

Authorities in third countries (e.g. Australia) 
prefer self-suﬃciency policies to circumvent 
the need to test imported substances.

(cid:98)(cid:553) Remuneration of donations: Member 

States of the European Union that ban 
remunerated donations cannot import 
substances of human origin from third 
countries that allow such remunerations.

(cid:98)(cid:553) Matching quality and safety standards: 
particularly the United States does not 
consider their quality and safety standards 
to match with European standards, a fact 
that hampers severely the exchange of 
substances of human origin between 
the two zones. To overcome this barrier, 
according to the project, the focus should 
be put on these standards and on creating 
a common ground in the discussion 
between the United States and Europe.

How to facilitate exchange between 
Member States as well as between 
Member States and third countries

The following strategies and measures were 
suggested  to  facilitate  exchange  between 
Member States as well as between EU Mem-
bers and third countries (152).

(cid:98)(cid:553) Developing communication tools: 

communication tools which bridge the gap 
between regulatory systems with diﬀerent 
quality and safety requirements are 
currently the most developed measures to 
facilitate the exchange of blood, tissues and 
cells between countries.

(cid:98)(cid:553) Harmonising European standards: according 
to the project team, the harmonisation of 
European standards has a dual function: it 
facilitates the exchange of substances of 
human origin between Member States and 
it strengthens the visibility of a European 
quality and safety standard. Third countries 
perceive this harmonisation of European 
standards as positive, which promotes 
the exchange. Several projects for the 
harmonisation of European standards are 
currently under way in the European Union.

(cid:98)(cid:553) Developing accreditation schemes: an 

internationally recognised accreditation 
scheme for tissue establishments could 
facilitate the exchange of tissues between 
Member States and third countries. The 
beneﬁts of such schemes have been 
demonstrated by similar initiatives for cells 
establishments such as JACIE (www.jacie.
org/).

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(cid:98)(cid:553) Seeking alliances: strong alliances with 

stakeholders in the United States and in 
Europe will facilitate an agreement with 
the United States on quality and safety 
standards for blood, tissues and cells, 
which, in the medium term, will facilitate 
the exchange of these products.

The political and the economic context concern-
ing substances of human origin is dynamic and 
has seen substantial regulatory changes and 
commercial developments in the last years. It 
is therefore important to consider this evolv-
ing context for the eﬀective implementation of 
these recommendations.

(cid:98)(cid:553) Implementing regulation of imports and 

exports: the European Commission should 
seek negotiations with the US Food and 
Drug Administration (FDA) on a mutual 
acceptance of quality and safety standards.

Recommendations to the European Commission

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129

Project team:

ALCIMED
57, bvd de Montmorency
75016 Paris
FRANCE
Tel. +33 144301741
Fax +33 144304432
http://www.alcimed.com/

EU contribution

This service contract has been ﬁnanced from the European Union in the framework of the 
Public Health Programme 2003–2008 (Call for Tender: SANCO/2008/C6/012).

Organ donation  
and transplantation

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133

The availability of donor organs is o#en a ques-
tion of life and death for patients requiring a 
transplant. With transplantation now a com-
monplace technique, one of the main factors 
limiting the number of transplants is the short-
age of organs.

The  Communication  on  organ  donation  and 
transplantation adopted by the Commission in 
2007, and the undertaken impact assessment 
identiﬁed  major  policy  challenges  for  organ 
donation and transplantation. These included:

(cid:98)(cid:553) ensuring the quality and safety of human 

organs,

(cid:98)(cid:553) increasing organ availability,

(cid:98)(cid:553) enhancing the eﬃciency and accessibility 

of transplantation systems in the European 
Union.

A public consultation demonstrated wide sup-
port for EU initiatives in this ﬁeld.

Action Plan and legislation

In December 2008, the Commission adopted 
a proposal for a Directive that deﬁnes qual-
ity and safety requirements for human organs 
intended  for  transplantation,  and  an  Action 
Plan on Organ Donation and Transplantation 
(2009–2015) to support voluntary cooperation 
between Member States in this ﬁeld.

Under this Action Plan, several European pro-
jects were funded via the Research and Health 
Programmes,  to  support  the  cross-border 
cooperation  between  Member  States  in  the 
ﬁeld of organ donation and transplantation, in 
particular to help increase organ availability 
and enhance the eﬃciency and accessibility of 
transplant systems at national and EU levels.

The Directive on standards of quality and safety 
of human organs intended for transplantation 
(Directive  2010/53/EU)  was  adopted  by  the 
European Parliament and the Council on 7 July 
2010. It provides for the appointment of Com-
petent  Authorities  in  all  Member  States,  for 
authorisation of procurement and transplanta-
tion centres and activities, for traceability sys-
tems and for the reporting of serious adverse 
events and reactions. Moreover, the Directive 
will set requirements for the safe transportation 
of organs and for the characterisation of every 
donor and organ. Member States were required 
to transpose the requirements of the Directive by 

27 August 2012. Further to the transposition of 
the Dir ective, the European Commission is sup-
porting the Member States in its implementation.

It  is  also  foreseen  in  the  ‘Mother  Directive’ 
2010/53/EU that where organs are exchanged 
between Member States, detailed rules for its 
uniform implementation should be adopted by 
the Commission regarding procedures:

(a) for the transmission of information on 
organ and donor characterisation (for 
example type and size of organ, donor’s 
age, gender, health history);

(b) for the transmission of the necessary 

information to ensure the traceability of 
organs (in compliance with conﬁdentiality 
and data security measures);

(c)  for ensuring the reporting of serious 
adverse events and reactions (which 
allows the doctors to take appropriate 
measures if needed).

The  Commission  Implementing  Directive 
2012/25/EU laying down information procedures 
for the exchange, between Member States, of 
human organs intended for transplantation was 
adopted on 9 October 2012 and shall be trans-
posed in national laws by 10 April 2014.

Other cooperation activities

To raise the awareness of journalists from dif-
ferent EU countries on this important issue and 
to  foster  the  exchange  of  best  practices,  the 
European Commission has been also organis-
ing yearly since 2010 a journalists’ workshop on 
organ donation and transplantation. These work-
shops involve speakers from various national 
authorities and other experts in the ﬁeld.

The European Commission also has coopera-
tion activities with key global partners such 
as the Council of Europe and the World Health 
Organisation, and European Organ Exchanges 
Organisations  such  as  Eurotransplant  and 
Scandiatransplant.

Medical applications of organ 
transplantation

There are many types of organs that are cur-
rently being transplanted in order to cure mul-
tiple diseases, for example the following.

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(cid:98)(cid:553) Kidneys are the most frequently 

(cid:98)(cid:553) A heart-lung transplant is a procedure 

transplanted organs. Kidney transplantation 
is the organ transplant of a kidney in a 
patient with end-stage renal disease. 
Kidney transplantation is typically classiﬁed 
as deceased-donor (formerly known as 
cadaveric) or living-donor transplantation 
depending on the source of the recipient 
organ. As every deceased donor has two 
kidneys, two patients can be provided with a 
donor kidney. Living-donor renal transplants 
are further characterised as genetically 
related (living-related) or non-related (living-
unrelated) transplants, depending on whether 
a biological (family) relationship exists 
between the donor and recipient.

(cid:98)(cid:553) Liver transplantation is the replacement 
of a diseased liver with a healthy liver 
allogra#. Liver transplantation nowadays is 
a well-accepted treatment option for end-
stage liver disease and acute liver failure. 
In some cases, a liver can be split and 
therewith two patients can be provided with 
a new organ.

(cid:98)(cid:553) Heart transplantation is performed on 
patients with end-stage heart failure or 
severe coronary artery disease. The most 
common procedure is to take a working 
heart from a recently deceased organ 
donor (allogra#) and implant it into the 
patient. The patient’s own heart may either 
be removed (orthotopic procedure) or, less 
commonly, le# in to support the donor heart 
(heterotopic procedure).

(cid:98)(cid:553) While lung transplants carry certain 

associated risks, they can also extend life 
expectancy and enhance the quality of life 
for end-stage pulmonary patients.

carried out to replace both heart and lungs 
in a single operation. Due to a shortage of 
suitable donors, it is a rare procedure.

(cid:98)(cid:553) A pancreas transplant involves implanting 
a healthy pancreas (one that can produce 
insulin) into a person who has diabetes. The 
healthy pancreas comes from a donor who 
has just died or it may be a partial pancreas 
from a living donor. At present, pancreas 
transplants are usually performed in persons 
with insulin-dependent diabetes who have 
severe complications.

(cid:98)(cid:553) Small bowel transplant is still very rare 
but does take place in some EU Member 
States.

Treatments  based  on  substances  of  human 
origin are dependent on citizens who are will-
ing to donate organs. Citizens are all potential 
donors able to help patients in need, and in 
many cases donors are even able to save other 
people’s lives.

In the projects funded in this ﬁeld under the EU 
Health Programmes as well as in its own activi-
ties  and  in  its  cooperation  with  the  Member 
States’ National Competent Authorities and other 
international partners, the European Commission 
is continuously supporting activities in the vari-
ous and o#en complex issues related to organ 
donation and transplantation such as deceased 
donation  and  living  donation,  transplant  sys-
tems and quality improvement methods, follow-
up of transplanted patients and living donors, 
cross-border agreements to exchange organs or 
patients and communication activities.

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135

Overview of projects in this section

Acronym

DOPKI

ALLIANCE’O

ETPOD

EULID

Title

Page

Improving the knowledge and practice of Organ Donation 

European Group for Coordination of National Research 
Programmes on Organ Donation and Transplantation

European Training Programme on Organ Donation 

European Living Donation and Public Health 

EFRETOS

European Framework for the Evaluation of Organ Transplants 

ELIPSY

EDD

ODEQUS

COORENOR

ELPAT
Conference

MODE

European Living Donor Psychological Follow-up 

Developing Guidelines for the Organisation of a Public Organ 
Donation Day 

European Quality System Indicators and Methodology on Organ 
Donation 

Coordinating a European Initiative among National 
Organisations for Organ Transplantation 

2nd Conference on Organ Transplantation: Ethical, Legal and 
Psychosocial Aspects — Expanding the European Platform 

Mutual Organ Donation and Transplantation Exchanges: 
Improving and developing deceased organ donation and 
transplantation programmes (Joint Action)

ACCORD

Achieving comprehensive coordination in organ donation 
throughout the European Union (Joint Action)

European Training Course for Trainers in Transplant Donor 
Coordination in the European Union

Study on the set-up of organ donation and transplantation in 
the EU Member States, uptake and impact of the EU Action 
Plan on Organ Donation and Transplantation (2009–2015)

EULOD

Living Organ Donation in Europe 

136

141

146

151

156

162

166

173

177

184

188

193

199

204

208

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Improving the knowledge and practice of  
Organ Donation (DOPKI)

This project has received co-funding from the European Union in the framework of the 6th Research Framework 
Programme.

Many  patients  cannot  benefit  from  the 
improvements and advantages in transplan-
tation medicine as less organs are available 
for transplantation than there are patients on 
waiting lists. Increasing the number of avail-
able organs for transplantation is a permanent 
challenge for healthcare systems throughout 
Europe and globally. A way forward to improve 
this situation is to maximise the potentials of 
deceased organ donation.

The main objectives of the DOPKI project were 
to improve knowledge and develop a common 
method to determine the potential for deceased 
organ donation and its likely outcome, and to 
deﬁne the limits of organ safety and quality. 
The project aimed to use the knowledge gen-
erated to give recommendation for the gen-
eration of actions that could help to improve 
deceased  donation  activities  and  ultimately 
donation rates.

A consortium of 13 organisations covering 16 
European countries worked together in the pro-
ject from January 2006 to March 2009. Pro-
ject partner countries represented 80 % of the 
population and 80 % of all the donation and 
transplantation activities in Europe. DOPKI was 
coordinated by the Spanish National Transplant 
Organisation (ONT).

Knowledge, tools and  
methods generated by DOPKI

State-of-the-art overview on donation and 
transplantation practices and outcomes in 
DOPKI countries: As one of the main outcomes 
of the project, DOPKI compiled a comprehen-
sive  overview  of  donation  and  transplanta-
tion practices and outcomes on the basis of 
data collection from the participating coun-
tries:  Report  on  the  general  European  situ-
ation: technical, legal and socio-sanitary point 
of  view (153).  To  support  the  comprehensive 
overview, a cross-sectional study exploring the 
relationship between donation rates and demo-
graphic, economic and healthcare factors that 

(153)  www.ont.es/internacional/Documents/DOPKI.pdf

 Quality Assurance Programmes in the 
deceased donation process are essential internal 
tools for the countries, and if they are established 
under the umbrella of common definitions, they 
could be used to make international comparisons 
in the future. 

  (154)

Guide of recommendations for Quality Assurance Programmes in the Deceased 

Donation Process

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137

THE NEED FOR QUALITY ASSURANCE PROGRAMMES 
IN THE DECEASED DONATION PROCESS

Since the ﬁrst successful kidney transplantation was performed in 
1954, organ transplantation has progressively become a healthcare 
practice of unequivocal importance. Kidney transplantation 
represents the best therapeutic option for patients with end-stage 
renal disease as it provides better outcomes in terms of survival, 
quality of life and cost-eﬀectiveness than other renal replacement 
therapies. Liver, heart and lung transplantations represent an 
almost unique therapeutic alternative for patients with end-stage 
liver, heart and lung failure. The diﬀerent modalities of pancreas 
transplantation have become a solution to re-establish insulin 
secretion in selected diabetic patients in order to improve patient 
survival and quality of life. Small bowel transplantation, usually 
performed as a part of a multi-organ transplantation, is still a 
relatively uncommon procedure, but one aimed at solving life-
limiting conditions. Results of organ transplantation are excellent 
and have continued improving over the years, thanks to the 
advances in immunosuppression and the acquired experience and 
knowledge about surgical and medical procedures.

Despite these impressive advances, there are still many problems 
to be solved in the ﬁeld of organ transplantation: gra$s are 
mostly lost in the long term due to the so-called chronic rejection 
and death with a functioning gra$, mainly due to cardiovascular 
disease. Furthermore, short- and long-term consequences of 
immunosuppression decrease organ recipients’ longevity and quality 
of life. However, an even earlier obstacle has to be faced regarding 
organ transplantation, that is, the shortage of organs to cover the 
demand. The number of patients joining the waiting list has been 
progressively increasing over the years because of the excellent 
results of transplantation, while the number of donors and organs 
has not increased or has increased at a much lower rate. As a result, 
organs available for transplantation have not been keeping up with 
demand. In the European Union (EU), 57 343 patients were waiting 
for a kidney, a liver or a heart transplant at the end of the year 2007, 
while only 25 932 kidney, liver or heart transplant procedures were 
performed during that entire year. Similar ﬁgures can be found all 
over the world, thus making organ shortage a worldwide problem. In 
addition to the problem of organ shortage for transplantation, it is 
apparent that donation and transplantation activities diﬀer among 
the countries in general terms, and among EU countries, in particular. 
This means that the eﬀectiveness of our systems to face organ 
shortage is highly variable, which subsequently means high variability 
regarding donation and transplantation activities and therefore the 
possibilities of transplantation for EU citizens.

Guide of recommendations for Quality Assurance Programmes in the Deceased  

Donation Process

could have an impact on donation rates were 
also investigated.

The overview showed considerable variation 
in donation and transplantation practices and 
outcomes in the studied European countries. 
Furthermore, the report highlighted an impor-
tant barrier to measuring donor potential: ‘One 
of the major problems when it comes to the 
analysis of donor potential is the lack of data … 
Unless data collection is carried out according 
to standardised patterns it is very diﬃcult to 
make comparisons between the countries.’

Common methodology to estimate the poten-
tial of deceased donation and evaluate the 
performance  of  the  decease  donation  pro-
cess: DOPKI partners have developed a common 
methodology to estimate the potential of the (at 
that time so-called) ‘heart-beating’ deceased 
donation and to evaluate the performance and 
global eﬀectiveness of the deceased donation 
process and to identify areas for improvement.

In doing so, DOPKI partners deﬁned a set of 
indicators and collected data from 30 hospitals 
throughout Europe who participated in the pilot 
study to validate the methodology. Based on 
the data, DOPKI developed a basic set of indi-
cators in the following areas: potential of dona-
tion, areas of improvement and global eﬀec-
tiveness. Reference values were established for 
these indicators. A comparison of hospitals with 
this reference value helped identify areas of 
improvement in the deceased donation process.

Based  on  the  pilot  and  knowledge  exchange 
among project partners, DOPKI has developed 
a Guide of recommendations for Quality Assur-
ance  Programmes  in  the  Deceased  Donation 
Process (154) as one of the main outputs of the 
project.  The  report  sets  out  a  deﬁnition  and 
objectives of a quality assurance programme in 
deceased donation process, gives an overview 
of the state of the art of quality assurance pro-
grammes in the deceased donation process in 
DOPKI countries and ﬁnally it provides general 
recommendations  to  build  up  quality  assur-
ance programmes. Such quality assurance pro-
grammes are expected to help the design and 
implementation of targeted actions to improve 
the donation process and tackle organ shortage.

(154)  http://www.ont.es/publicaciones/Documents/DOPKI%20GUIA.pdf

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

General approach to the process of deceased donation a$er brain death (Guide of recommendations for Quality Assurance Programmes in the 

Deceased Donation Process)

DOPKI Registry for  
Expanded Criteria Donors

Based on the DOPKI deﬁnitions, the project 
created  a  registry  of  harmonised  informa-
tion from donors and recipients on outcome 
and survival. An internal web-based registry 
with high safety levels was created and made 
access ible to project partners who could upload 
the information on expanded criteria donors 
and the outcome of their recipients. The infor-
mation was analysed as a ﬁrst approach on 
the use of expanded criteria donors. By doing 
so, the project has managed to take the nec-
essary ﬁrst steps to provide a basis for devel-
oping quality and safety guidelines for using 
such donors.

DOPKI tool to estimate  
cost-eﬀectiveness of  
organ donation programmes

activities (155). In addition to the model, the tool 
includes a Model User Guide and a Literature 
Review  with  published  input  variables.  The 
model was developed for participant organisa-
tions of the DOPKI project in a way that it can 
be adapted to any DOPKI countries and it is able 
to capture the social value of other solid organ 
transplants. Additionally, the ﬁrst country adap-
tation was completed in Hungary during the pro-
ject’s lifetime.

In order to disseminate its results, the DOPKI 
project  organised  a  final  conference  on 
24  March  2009  in  Madrid  to  various  stake-
holders. DOPKI maintained a website during the 
project’s lifetime (156). Two DOPKI newsletters 
and a DOPKI leaﬂet helped to spread the infor-
mation about the project and its results in the 
beginning and at the end of the project (157).

(155)  DOPKI Newsletter 2009: http://www.ont.es/publicaciones/

Documents/DOPKI %20NEWSLETTER %2009.pdf

The project designed a statistical model that 
helped to estimate the present net value cost 
savings  and  additional  quality-adjusted  life 
years  (QALY)  in  renal  transplantation  that 
occur as the result of improved organ donation 

(156)  The main reports and the Guide are available on the Spanish 

National Transplant Organisation, www.ont.es

(157)  DOPKI Newsletter 2007: http://www.ont.es/publicaciones/
Documents/DOPKI %20NEWSLETTER %2007.pdf; DOPKI 
Newsletter 2009: http://www.ont.es/publicaciones/Documents/
DOPKI %20NEWSLETTER %2009.pdf

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139

The scientiﬁc community in organ donation and 
transplantation have been reached by presenta-
tions on national and international conferences 
and via scientiﬁc publications. Cooperation with 
other EU-funded projects in the same ﬁeld was 
maintained throughout the project’s lifetime.

Results of the project were channelled through 
a  link  created  with  the  WHO  via  the  Global 
Observatory  on  Donation  and  Transplanta-
tion (158),  an  observatory  developed  by  the 
Spanish National Transplant Organisation in 
cooperation with the WHO. The link allowed 
a bilateral information ﬂow. Information was 
available  on  donation  and  transplantation 
activities and organisational issues in Europe 
and in other WHO regions. At the same time, 
this  was  an  opportunity  to  disseminate  the 
knowledge and recommendations generated 
by the DOPKI on these issues.

The link with the WHO represented a unique 
opportunity  to  cooperate  with  the  initia-
tive  ‘Data  harmonisation  in  transplantation: 
measuring  the  potential  supply  of  organs 
from deceased donors’ organised by the WHO, 

the Transplantation Society and the Spanish 
National Transplant Organisation. The initia-
tive aimed to agree on a common methodol-
ogy to estimate the potential of donation and 
prospectively identify potential deceased organ 
donors. The experience of DOPKI supported the 
development of this global initiative.

 DOPKI is about why and what. Why aren’t 
there enough organs? What can we do to improve 
that? 
Guide of recommendations for Quality Assurance Programmes in the Deceased 

Donation Process

The DOPKI project developed knowledge and 
tools that in the future can help to increase 
deceased  donation  rates  and  hence  trans-
plantation activities. These tools help improve 
the way health systems tackle the universal 
and dramatic problem of organ shortage. The 
deﬁnitions and knowledge generated by DOPKI 
served  as  the  starting  point  for  many  later 
European projects.

(158)  http://www.transplant-observatory.org/

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Further information: 

Website at DG Research and innovation: 
http://ec.europa.eu/research/fp6/ssp/dopki_en.htm 

Project team: 

Project leader: 
Organización Nacional de Trasplantes (ONT)  
C/ Sinesio Delgado 6-8, Pabellón 3 
28029 Madrid 
SPAIN 
Tel. +34 902300224 
Fax +34 902300226 
E-mail: ont@msssi.es
Website: http://www.ont.es

Associated partners: 

(cid:97)(cid:149) Agence de la Biomédecine, France
(cid:97)(cid:149) Deutsche Sti$ung Organtransplantation, Germany
(cid:97)(cid:149) Hungarotransplant Public Service Cooperation, Hungary
(cid:97)(cid:149) Centro Nazionale Trapianti, Italy
(cid:97)(cid:149) Organizacão Portuguesa de Transplantação, Portugal
(cid:97)(cid:149) UK Transplant, United Kingdom
(cid:97)(cid:149) Eurotranplant International Foundation, based in the Netherlands, covering several 

European countries

(cid:97)(cid:149) Swisstransplant, Switzerland
(cid:97)(cid:149) Transplant Coordinating Centre of the Czech Republic, Czech Republic
(cid:97)(cid:149) Slovenija Transplant, Slovenia
(cid:97)(cid:149) Ministry of Health And Social Welfare, Croatia

EU contribution

This project has received co-funding from the European Union in the framework of the 
6th Research Framework Programme (Research priority: 2.2. Public health issues, including 
epidemiology contributing to disease prevention and responses to emerging rare and 
communicable diseases, allergies, procedures for secure blood and organ donations,  
non-animal test methods). 

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141

European Group for Coordination of National Research 
Programmes on Organ Donation and Transplantation 
(ALLIANCE-O)

Project reference: This project has received co-funding from the European Union in the framework of the 6th 
Research Framework Programme (CA-011853-ALLIANCE-O).

ALLIANCE-O,  the  European  Group  for  Coor-
dination of Research Programmes on Organ 
Donation and Transplantation was a Coordi-
nation Action (2004–2007) funded under the 
ERA-NET scheme of the Sixth Framework Pro-
gramme (159). ALLIANCE-O was one of the ﬁrst 
collaborations between national transplanta-
tion agencies in the organ transplantation ﬁeld 
funded by the European Commission. 

Coordinated by the Agence de la Biomédecine 
in France, ALLIANCE-O has brought together 
representatives of national public transplant 
organisations  from  seven  countries:  France, 
Germany, Hungary, Italy, Portugal, Spain and 
the United Kingdom.

The  main  objective  of  ALLIANCE-O  was  to 
set up a coordinated network of organ dona-
tion and transplantation. Further, the project 
aimed to identify existing programmes and to 
propose common strategies and joint initiatives 
for better coordination and eﬃciency of organ 
transplant systems in EU Member States.

ALLIANCE-O activities and results

The project has organised its activities along 
six  technical  work  packages  that  took  into 
account  the  following  aspects  of  organ 
transplantation: 

(cid:98)(cid:553) expanding the donor pool,

(cid:98)(cid:553) allocation rules and their impact on equity 

and eﬃciency,

Project summary at http://ec.europa.eu/research/fp7/pdf/era-net/fact_sheets/fp6/
alliance-o_en.pdf

(cid:98)(cid:553) increasing safety and quality of organ 

performance,

transplantation,

(cid:98)(cid:553) evaluation methods of transplantation 

(cid:98)(cid:553) fundamental research activities,

(cid:98)(cid:553) ethical and legal aspects.

(159)  The objective of the ERA-NET scheme (ERA: European Research 
Area) is to step up the cooperation and coordination of research 
activities carried out at national or regional level in the Member 
States and associated states through: the networking of re-
search activities conducted at national or regional level, and the 
mutual opening of national and regional research programmes.

Along these aspects, the ALLIANCE-O project 
has managed to review and compare the then 
existing national/regional transplantation pro-
grammes, their processes and outcomes. Based 
on the benchmarking analysis performed by the 

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project, state-of-the-art overviews were pro-
duced and recommendations were drawn up 
and piloted in selected ﬁelds.

The analysis regarding the possible 
expansion of the donor pool involved 
harmonised data collection for 
39 countries with respect to the 
year 2004

The results of this analysis pointed out impor-
tant variations in many aspects of the dona-
tion and transplantation activity, notably in 
living  donation  activities,  non-heart  beat-
ing  donation  and  the  size  of  waiting  lists, 
as  well  as  mortality  while  on  waiting  lists. 
To understand these diﬀerences in donation 
and transplantation activities and outcomes, 
the project analysed and compared the basic 
national characteristics and frameworks such 
as socio-demographic, economic, healthcare 
factors and mortality levels for every Euro-
pean country. The results suggested that fac-
tors of mainly organisational and structural 
nature may explain many of the diﬀerences 
between the countries.

 Additionally, the ALLIANCE-O project 

provided paramount information including 
on legal and ethical aspects that was available 
to policy-makers and experts involved in the 
preparation of the organ Directive. It can be 
considered as a strong basis that particularly 
inspired and allowed to build-up further EU 
projects and Joints Actions in the field. 
Agence de la Biomédecine, France

Based on the ﬁndings of the state-of-the-art 
and  benchmarking  analysis,  the  ALLIANCE-
O group developed a set of statements and 
recommendations about diﬀerent aspects of 
expanding the donor pool such as brain death 
donors, non-heart beating donors, living dona-
tion, promotion of organ donation and trans-
plantation.  Further,  the  ALLIANCE-O  made 
recommendations about common methods for 
donor pool estimation. A set of indicators to 
estimate the donation potential and to evalu-
ate the outcome of the donation process and 
the system’s global eﬀectiveness have been 
proposed by the ALLIANCE-O group.

The  project  has  also  reviewed  and  evaluated 
organ allocation rules and practices in the par-
ticipating countries and their impact on equity 
and eﬃcacy. The state-of-the-art analysis of cur-
rent organ allocation activities pointed out that 
a wide range of allocation systems, procedures, 
protocols and allocation criteria existed in the 
countries. ALLIANCE-O prepared a set of state-
ments and proposed general recommendations 
for best practices in organ allocation. It also made 
the ground for developing a common simulation 
tool. Such activity included the analysis of allo-
cation systems and building on the experiences 
of an experimental pilot study performed among 
selected partners using the organ allocation simu-
lation prototype that was developed by the pro-
ject coordinator. Based on these activities, ALLI-
ANCE-O managed to build a conceptual toolbox 
for health policymakers and institutions involved 
in organ allocation in Europe and proposed a com-
mon simulation tool for allocation policies.

The ALLIANCE-O project was also able 
to collect and analyse the then existing 
safety and quality aspects of donation 
and transplantation systems in the 
countries of consortium members

The project also analysed existing programmes 
that aimed at expanding organ donation and 
retrieval in ALLIANCE-O countries. The pro-
ject found common approaches to increase the 
donor pool, but also substantial diﬀerences with 
regards to the legal, technical, organisational, 
training, educational, promotional and ﬁnan-
cial initiatives and human resources. Overall, 
the project has established that while organi-
sational  diﬀerences  were  relatively  small,  in 
terms of technical aspects important diﬀer-
ences  existed,  especially  with  regard  to  the 
use  of  expanded  criteria  donors  and  special 
techniques.

An inventory and comparison of existing safety 
and quality procedures were prepared. In terms 
of  safety  practices,  the  overview  focused  on 
transmittable diseases and the relevant tests 
thereof. While with the quality systems, the pro-
ject, in addition to the existence of such systems, 
focused on the approach applied to the dona-
tion and transplantation process. The project has 
managed to elaborate safety recommendations 
and recommendations to increase quality. It also 
developed ‘common best practices for a qual-
ity management system in the transplantation 
process’ (ALLIANCE-O White Paper). In relation 
to safety and quality issues, the group worked 

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143

out the ﬁrst dra# of a single European donation 
form that would include the same data set all 
over Europe to give impetus to future collabora-
tion in harmonisation eﬀorts.

The ALLIANCE-O work on evaluation of trans-
plantation performance involved a state-of-the-
art review of transplant methods and a summary 
of ﬁndings related to a wide range of issues of 
performance measurement such as data collec-
tion process, funding arrangements for data col-
lection, statistical analysis and audit, so#ware 
used in data analysis and how statistical results 
are made available to the public. By providing a 
summary of methods that have proved to be help-
ful in the analysis of transplant data in Europe, it 
served as a guide to units who were about to set 
up methods for monitoring and analysis trans-
plant  outcomes.  Further,  the  project  was  able 
to draw a proposal for standardised methods to 
monitor the performance of diﬀerent transplanta-
tion teams and standardised risk factors. 

The ALLIANCE-O project has managed 
to build an inventory of the then 
existing research projects/programmes 
in the domain of organ transplantation

strategies  to  enhance  the  performance  of 
research and avoid duplications. Based on this 
overview, the project developed recommenda-
tions on key functions, tasks and responsibili-
ties of a national body dedicated to research 
in  the  ﬁeld  of  donation,  procurement  and 
transplantation.

Furthermore,  legal  and  ethical  aspects  of 
organ  donation  and  transplantation  were 
identiﬁed and analysed by the project. Based 
on the ﬁndings, the ALLIANCE-O elaborated 
general recommendations to help focus the 
then  upcoming  EU  legislation  on  deceased 
organ donation and on living donation.

ALLIANCE-O  organised  a  ﬁnal  workshop  on 
24 October 2007 to disseminate its main results 
to  a  European  audience  of  representatives 
from competent authorities and from research 
bodies, transplant professionals and journalists. 
The summary of the project’s main activities 
and  results  were  published  among  other 
communications in the ALLIANCE-O White Paper 
(www.agence-biomedecine.fr).

ALLIANCE-O outcomes

The overview identiﬁed the main focuses and 
needs in basic research and presented possible 

The project highlighted areas of improvement 
in  organ  donation  and  transplantation,  set 
the needs and encouraged Member States to 

Organ donation rates in 2003, when the project was initiated  

(http://ec.europa.eu/research/fp7/pdf/era-net/fact_sheets/fp6/alliance-o_en.pdf)

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Making systems compatible: in 2004 several countries had launched national research 
programmes to look into ways to help organ supply meet demand. Projects tended to focus 
on how to expand the donor pool, improve organ allocation, ensure the safety and quality of 
transplants, and evaluate and disseminate results. Yet there was little coordination between the 
diﬀerent national research programmes in Member States. One of the main barriers to joint activity 
was the variation in organisational structures. Some countries had a national transplantation 
agency, under the control of the Ministry of Health, while others had appointed an independent 
foundation. Several countries had joined together to create a supranational organisation, such as 
Eurotransplant and Scandiatransplant — but many Member States had no central body at all.

Despite their diﬀerences, the organ transplant community in Europe recognised the need for greater 
transnational coordination of research programmes to expand the overall donor pool within the EU, 
to provide a transparent allocation system and enable the movement of organs and/or patients 
across borders in order to minimise shortages and avoid the waste of any transplant material.

The European Group for Coordination of Research Programmes on Organ Donation and 
Transplantation (ALLIANCE-O) had been established to bring together representatives from the 
organisational bodies of seven Member States, and coordinated by the Etablissement Français 
des Greﬀes — an institution now replaced by the Agence de la Biomédecine.

http://ec.europa.eu/research/fp7/pdf/era-net/fact_sheets/fp6/alliance-o_en.pdf

develop shared structures, deﬁnition and meth-
ods as well as common frameworks for data 
collection, training and evaluation.

Based on the overview of diﬀerent aspects of 
organ transplantation, the project was able to 
point out — as a result — important variations 
in most of the aspects of post-mortem donation, 
living donation, allocation programmes, safety 
and quality criteria, and describe the transplant 
organisation system at national/regional/local 
levels of the seven participating Member States. 
Based on this global state-of-the-art analysis, 
a conceptual toolbox for organ allocation was 
generated. This led to the ﬁrst outline of the EU 
donation form and made medical and organi-
sational information available to countries and 
transplant  agencies  initiating  transplant  pro-
grammes or developing their system. 

ALLIANCE-O fostered networking

The Alliance Consortium also recommended 
better interaction between all professionals of 
the ﬁeld and called for a better sharing of tools 
and expertise.

As set out in the ALLIANCE-O conclusions in the 
project’s White Paper: ‘Many of the proposals 
imply collaboration between countries. The goal 
is to establish more powerful strategies but not 
to reach a unique uniform system:

(cid:98)(cid:553) common deﬁnition of terms is mandatory to 

share experience and results,

(cid:98)(cid:553) common approach in tools used for 

organisation, training, education, allocation, 
safety, quality and evaluation, could avoid 
duplication of work and save time.’

In doing so, ALLIANCE-O facilitated the expan-
sion and reinforcement of the network of trans-
plant agencies.

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145

Further information: 

Project website 
http://ec.europa.eu/research/fp7/pdf/era-net/fact_sheets/fp6/alliance-o_en.pdf 

More information and communication on the project 
www.agence-biomedecine.fr 

http://www.agence-biomedecine.fr/IMG/pdf/dp-allianceo.pdf 

Project team: 

Coordinator:
Agence de la Biomédecine 
1 avenue du stade de France  
93212 Saint-Denis La Plaine Cedex 
FRANCE 
Fax +33 155936550
Contact: http://www.agence-biomedecine.fr/Contact-us
Website: http://www.agence-biomedecine.fr/About-us

Partners:

Istituto Superior di Sanità, National Transplant Centre, Italy

(cid:97)(cid:149) Ministry of Health, Deutsche Sti$ung Organtransplantation, Germany
(cid:97)(cid:149) Ministry of Health, Hungarotransplant Psc., Hungary
(cid:97)(cid:149)
(cid:97)(cid:149) Ministry of Health, Organizaçao Portugesa de Transplantaçao, Portugal
(cid:97)(cid:149) Centro Nacional de Trasplantes y Medicina Regenerativa, Spain
(cid:97)(cid:149) Ministry of Health, United Kingdom Transplant, United Kingdom

EU contribution

Project reference: This project has received co-funding from the European Union in the 
framework of the 6th Research Framework Programme (CA-011853-ALLIANCE-O)

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European Training Programme on Organ Donation (ETPOD)

This project has received co-funding from the European Union in the framework of the Public Health  
Programme 2003–2008 (Grant: 2005205).

Diﬀerent levels of professional staﬀ are involved in 
the process of organ donation and transplantation, 
such as: (1) healthcare professionals in targeted 
donor units such as intensive care, recovery and 
emergency room departments; (2) healthcare pro-
fessionals in charge of organising the generation 
of donors or those due to join a Transplant Coor-
dination Oﬃce (TCO) and key donation profession-
als (KDP) wishing to update their know ledge and 
reinforce their competences; (3) donor programme 
managers responsible for national, regional, local 
and/ or hospital organisations with high activity in 
organ procurement and transplantation.

Increasing organ donation rates to its maxi-
mum potential requires that all those levels of 
professional staﬀ have a comprehensive know-
ledge  and  reliable  information  available  on 
most aspects of organisation and procedures 
of organ donation and transplantation. The pro-
ject ‘European Training Programme on Organ 
Donation’ (ETPOD) aimed at disseminating such 
knowledge by means of a multi-module train-
ing programme.

The project started in January 2007 for 3 years 
and involved 20 organisations from 17 coun-
tries. Through its activities the project reached 
25 target areas (TA’s) of organ donation and 

transplantation. ETPOD was coordinated by the 
University Hospital of Barcelona and its Cen-
tre for Transfer of Knowledge, Technology and 
Innovation (TPM).

ETPOD developed four training modules 
for the various levels of professionals 
involved in organ donation

ETPOD started with a comparative analysis to 
assess organ donation rates before and a#er 
the  implementation  of  the  ETPOD  training 
programmes as well as a study of the train-
ing needs of the various levels of healthcare 
professionals involved in the process of organ 
donation, in accordance with the organisation 
structure and resources of each TA. The ETPOD 
training programme was developed and imple-
mented in four course modules, addressing the 
various professional levels.

(1) A Training for Trainers Programme aimed 

to train Key Donation Professionals (KDPs) 
as multipliers of training actions, providing 
them with skills required so that they 
could replicate the training programme 
within the target areas (TAs) in an accurate 
manner so as to successfully carry out the 
‘Essentials in Organ Donation Training’.

(2) An Essentials in Organ Donation Training 
aimed at providing fundamental training 
related to the donation-procurement 
process, in order to promote among 
healthcare professionals the active 
detection of possible donors and to obtain 
their cooperation.

(3) The Professional Training on Organ 

Donation Programme aimed at training 
healthcare professionals in charge of 
organising the generation of donors and/or 
those due to join a Transplant Coordination 
Oﬃce as well as Key Donation Professionals 
wishing to update their knowledge and 
reinforce their competences.

(4) The Organ Donation Quality Managers 

Training aimed to provide participants with 
the theoretical, technical and practical 
know-how required to eﬃciently organise 

ETPOD website

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

147

and manage a transplant procurement 
oﬃce concerning the quality indicators of 
the organ donation process success. This 
programme is addressed to responsible 
of national, regional, local and hospital 
organisations with high activity in organ 
procurement and transplantation.

Within this framework, the learning 
methodology to implement the ETPOD 
was based on two modalities: blended 
learning and face-to-face training

The methodology of the project followed the cycle 
of: (1) analysis of the country’s current situation, 
(2) designing an adapted training programme to 
the needs, (3) validation and implementation of 
the programme, (4) follow-up, (5) evaluation and, 
ﬁnally, (6) analysis its transferability observing 
again the country’s current situation. The strat-
egy was based on the awareness that each par-
ticipant country has diﬀerent donation rates per 
million inhabitants (pmp); therefore the project 
included the following actions:

(cid:98)(cid:553) transfer of the gained expertise 
between countries with higher 
organisational development and those 
with less organisational development 
in the respective processes by training 
programmes with international faculty staﬀ 
from diﬀerent partner countries;

(cid:98)(cid:553) development of a European training 

programme on organ donation addressed to 
diﬀerent professionals’ proﬁles involved in 
the donation process at national, regional, 
local and hospital levels;

(cid:98)(cid:553) design and adaptation of speciﬁc contents 
to be developed in accordance with the 
analysis of educational needs previously 
identiﬁed in each target area (TA).

Within this framework, the learning method-
ology to implement the ETPOD was based on 
two modalities: blended learning and face-to-
face training. Learning occurs when a series 
of processes takes place ending with the new 
knowledge assimilation and objectives accom-
plishment. The ETPOD trainings used a train-
ing approach called experience-based learning 
action,  that the Institute for LifeLong Learning 
(IL3) has successfully used in similar trainings 
before. It allows participants to acquire up-to-
date focused knowledge, to develop the know-
how into professional competences and skills, 

to develop the performance of good practices 
by ‘show-how’, and to ﬁnally enable them to 
apply the newly acquired knowledge and expe-
rience adapted to their own reality.

The execution of the project was carried out 
through  four  working  groups  (WGs)  involv-
ing 17 countries and 20 partner organisation 
representatives.

WG1 — Database Source Group was respon-
sible for obtaining information on the target 
areas before and a#er the implementation of 
the ETPOD courses in order to evaluate their 
inﬂuence on the organ donation rates and the 
staﬀ training requirements.

WG2 — Basic Training Group coordinated and 
followed up the Training For Trainers and Essen-
tials in Organ Donation Training Programmes.

WG3 — Professional Training Group coordi-
nated and followed up the Professional Train-
ing on Organ Donation Programme plus the 
E-learning Virtual Modules.

WG4 — Managers Training Group coordinated 
and  followed  up  the  Managers  Training  On 
Organ Donation.

Basic Training Group to prepare Senior 
Transplant Coordinators

The Training for Trainers programme allows 
preparing  Senior  Transplant  Coordinators  to 

CD-ROM for dissemination of ETPOD results

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

implement in their own Target Area the Essen-
tials  in  Organ  Donation  Training.  The  Train-
ing for Trainers programme is based on the 
blended learning methodology, which considers 
both the online and the face-to-face training. 
Courses were designed, developed and imple-
mented in English.

The Essentials in Organ Donation Training is 
the basis of WG2. Its aim is to provide training 
related to the donation-transplant process, in 
order to provide healthcare professionals with 
the knowledge and skills needed to be in charge 
of an organ donation-procurement programme 
in a competent and successful way.

Professional Training Group for Junior 
Transplant Coordinator with experience 
of up to 2 years

The aim of the Professional Training on Organ 
Donation  Programme  is  to  train  Transplant 
Coordinators in charge of organising the gen-
eration of donors. The participant’s proﬁle of 
this programme is that of a Junior Transplant 
Coordinator (experience up to 2 years) or with 
an  interest  in  transplant  coordination  with 
possibilities to be a future Transplant Coordi-
nator. Communication and computer skills are 
essential.

The Professional Training on Organ Donation 
programme is based on the blended learning, 

which considers both the online and the face-
to-face training. Courses are designed, devel-
oped and implemented in English language and 
consist of modules such as: Donor Management 
and Organ Viability e-learning module; Organ 
Retrieval, Preservation and Distribution e-learn-
ing module; and the Professional Training on 
Organ Donation face-to-face programme.

Managers Training Group for 
organising, managing and evaluating a 
transplant area

The aim of the Organ Donation Quality Manag-
ers Training is to provide the skills required for 
organising, managing and evaluating a trans-
plant area and promote the implementation 
and evaluation of quality and safety measures 
to hospital, regional or national donation oﬃce 
responsible included in the Target Areas. 

ETPOD project achievements

The  collaborative  partnership  and  network-
ing has been accomplished by means of the 
ETPOD  Partners  Community  hosted  on  the 
website http://etpod.il3.ub.edu/. In addition, par-
ticipants built a professional relationship during 
the online modules and had the opportunity to 
meet in person during the face-to-face courses. 
This allowed them to create a solid networking 
that has gone further than the scope of ETPOD.

The new vital cycle: Donation and transplantation process (transplant procurement management: transplant 

coordination organisation model for the generation of donors)

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

149

Stars of the donation-transplantation process (transplant procurement management: transplant coordination 

organisation model for the generation of donors)

A survey was carried out in the 25 target areas 
in order to determine the training needs con-
cerning the whole process of the organ dona-
tion according to each level. The courses were 
developed in accordance with the results.

As the conducted surveys indicated, the pro-
cured brain death donors in the 25 target areas 
showed a rise of 27.8 % (p=0.01). The ETPOD 
Project has further been presented in several 
scientiﬁc forums.

All  the  planned  courses  have  been  created 
and implemented at the three diﬀerent train-
ing levels. Furthermore, all the courses were 
evaluated by the participants a#er their imple-
mentation.  The  average  score  was  4.35  on  
a 1–5 scale.

To reach a relevant number of direct beneﬁ-
ciaries, each target area responsible person 
selected  the  ﬁve  candidates  to  be  directly 
trained  within  ETPOD.  Moreover,  the  EOD 
seminars  trained  around  120  participants 
in each target areas. Fi#y-one participants 
attended the Training for Trainers (both online 
and face-to-face training) of which 49 par-
ticipants attended the Professional Training 
on Organ Donation (both online and face-to-
face training); 23 participants attended the 
Organ Donation Quality Managers (face-to-
face training).

3 163 participants attended  
the EOD seminars in the 
25 target areas. 

 Altogether,  

ETPOD  has  created 
quality  educational 
materials that count 
with  the  support  of 
t he  par ticipating 
organisations.  The 
EOD  seminars  are 
being  carried  out  in 
several TA and non-partner countries which 
have shown interest in the developed training 
courses. Moreover, the European Commission 
mentioned ETPOD in the Action plan on Organ 
Donation and Transplantation (2009–2015).

The ETPOD Project built a public access website 
in order to provide information about the project 
and also about the results. It is available at http://
etpod.il3.ub.edu/. In order to keep track of all the 
diﬀerent outputs of the project, the ETPOD team 
has created a web application to compile all the 
information that is available at http://www.etpod-
dissemination.eu upon registration. The project 
deliverables can also be accessed through the 
project database of EAHC (see Infobox).

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Further information: 

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=2005205 

Project website 
http://etpod.il3.ub.edu/ 

Dissemination page: 
http://www.etpod-dissemination.eu 

Project team: 

Fundació Bosch i Gimpera  
Ciutat de Granada 131  
08018 Barcelona  
SPAIN  
Tel. +34 935677410 
Fax +34 934279798 

Associated partners: 

(cid:97)(cid:149)
Institutul Roman de Training (NAT), Romania
(cid:97)(cid:149) Universistat de Barcelona Virtual (UBV), Spain
(cid:97)(cid:149) Organización Nacional de Transplantes (ONT), Spain
(cid:97)(cid:149) Medicinische Universitat Wien (UHV), Austria
(cid:97)(cid:149) Agence de la Biomedicine (ABM), France
(cid:97)(cid:149) Deutsche Sti$ung Organtransplantation (DSO), Germany
(cid:97)(cid:149)
(cid:97)(cid:149) Fondazione per l’Incremento dei Trapianti d’Organo (FITO), Italy
(cid:97)(cid:149) Hungarotransplant Egeszsegugyi Koordinalo Kozhasznu Tarsasag (Hungarotransplant), 

Instituto Superiore di Sanità(ISS), Italy

Hungary

(cid:97)(cid:149) Nacionalinis Organu Transplantacijos Biuras (NBOT), Lithuania
(cid:97)(cid:149) Organizaçao Portuguesa de Transplantaçao (OPT), Portugal
(cid:97)(cid:149) Dolnoslaska Fundacja Transplantacji (LSF), Poland
(cid:97)(cid:149) Akademi Medycznej w Warszawie (MUW), Poland
(cid:97)(cid:149) Centrum Organizacyjno Koordynacyjne Transplantacjni, Poland
(cid:97)(cid:149) Paraskevaidion Surgical and Transplant Centre (PSTC), Cyprus
(cid:97)(cid:149) Hellenic National Transplant Organisation, Hellenic Department of Health (EOM), Greece
(cid:97)(cid:149) Martinska Fakultna Nemocnica (UHM), Slovakia
Zavod Republike Slovenije za Presaditve Organov in Tkiv Slovenija Transplant, Slovenia
(cid:97)(cid:149)
(cid:97)(cid:149) Akdeniz Universitesi Organ Nakli Egitim, Arastirma ve Uygulama Merkezi (AUTC), Turkey
(cid:97)(cid:149) Executive agency for Transplantation Bultransplant (EAT), Bulgaria
(cid:97)(cid:149) Skane Lands Landsting, County Concil of Skane, Sweden
(cid:97)(cid:149) Sihtasutus Tartu Ulikooli Kiilikim (TUC), Estonia

EU contribution

This project has received co-funding from the European Union in the framework of the Public 
Health Programme 2003–2008 (Grant: 2005205).

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151

European Living Donation and Public Health (EULID)

This project has received co-funding from the European Union in the framework of the Public Health  
Programme 2003–2008 (Grant: 2006211).

Live donation has been growing in recent years 
due to the advances in the ﬁeld of organ trans-
plantation and its success as a treatment to 
procure quality-adjusted life years for many 
patients with end-stage diseases. The choice 
of transplantation from a living donors’ oﬀers 
some  advantages  compared  to  that  from  a 
deceased donor. However, it also carries disad-
vantages related to the donors’ risks in terms 
of health and safety. Several controversial ethi-
cal aspects are also to be considered.

standards and recommendations that guaran-
tee the living donor health and safety.

Twelve partners from 11 countries worked for 
30 months (May 2007 to October 2009) to 
reach a consensus on the main requirements 
for the protection of living donors by focus-
ing on the diﬀerent issues related to the main 
objective of the project. The project was coor-
dinated by Hospital Clínic of Barcelona (Spain).

There is a great heterogeneity among 
European countries’ legislations, 
ethical concerns, protection systems  
and donor’s data registries on the topic

In Directive 2004/23/EC of the European Par-
liament and of the Council it was recognised 
that ‘… it is necessary to increase conﬁdence 
among  the  Members  States  in  the  quality 
and safety of donated tissues and cells, in the 
health protection of living donors and respect 
for deceased donors and in the safety of the 
application process…’

Additionally, the Action Plan on Organ Donation 
and Transplantation (2009–2015): Strength-
ened  Cooperation  between  Member  States 
encourages  Member  States  to  promote  the 
exchange of best practices on living donation 
programmes (Priority Action 3). Furthermore, 
the Commission states that it ‘… will help to 
develop adequate tools to facilitate the proper 
collection of information on the medical, psy-
chological, ﬁnancial and social consequences 
of  a  living  donation  —  in  the  short  and  the 
long term. This information, coupled with the 
exchange of best practices on living donation 
programmes among the Member States, should 
help to develop evidence-based guidelines and 
consensus documents, and address the selec-
tion,  evaluation  and  follow-up  of  the  living 
donor.’

The main objective of the project European Liv-
ing Donation and Public Health (EULID) was to 
analyse the European situation regarding legal, 
ethical, protection and registration practices 
related to living organ donation, in order to set 

Legislation and ethical concerns 
regarding living donation

The work package on legislation and ethical 
concerns regarding living donation analysed 
and compared the diﬀerent European countries’ 
legal and ethical frameworks on living donor’s 
health and safety in order to establish Euro-
pean legal and ethical recommendations.

The  partners  have  collaborated  through 
answering  the  sur-
vey with data related 
to their own country 
and  discussed  and 
reached  consensus 
about  ethical  con-
cerns regarding living 
donation. The follow-
ing reports have been 
dra#ed: (1) Report on 
ethical  concerns;  (2) 
Report on current leg-
islation practices; and 
(3) Recommendations 
report  of  standard 
procedures  on  living 
donor donations.

Great  heterogene-
ity  between  partner 
countries’ 
legisla-
tions regarding living 
donation  has  been 
encountered.

Organ Donation and Transplantation — Public 

Policy and Clinical Perspectives, Edited by Gurch 

Randhawa, ISBN 978-953-51-0039-3, Hard cover, 

284 pages, Publisher: InTech, Published: 8 February, 

2012 under CC BY 3.0 license, in subject Medicine, 

doi:10.5772/1486

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LANGUAGE LEAFLET COVER.qxp:EULID leaflet  24/11/09  12:13  Página 3

Informative leaflet
to the public about
Living Donation

EULID leaﬂet for dissemination

Protection of the living donor in 
European countries

The work package on protection of the living donor 
in European countries determined the potential 
risks for the living donor and analysed whether 
there are speciﬁc legislative or non-legislative 
systems or practices for living donor’s protec-
tion. The work package developed and wrote an 
informative leaﬂet directed to the general public 
and conducted a survey on living donor’s satis-
faction in the project partners’ European coun-
tries. The following reports have been produced: 
(1) Report on risks for living donors; (2) Current 
protection practices and ﬁnal recommendations 
for the protection of living donors; (3) Informative 
leaﬂet translated into all partners’ languages; (4) 
Guidelines: What information an informative leaf-
let for living donors should contain; (5) Report on 
living donor’s satisfaction survey results.

E-registry database model on living 
organ-donors’ data

living organ-donors’ data that allows having 
a  common  European  database  registry  and 
common national registries on the issue. The 
partners contributed the list of hospitals with 
living donor activity, tested the online data-
base  model  and  entered  living  donor  cases 
in the database. The following reports have 
been produced under the umbrella of this work 
package: (1) List of hospitals with a living donor 
programme; (2) Report on current registration 
practices; (3) Report on the recommended data 
to be collected about living donors; (4) Report 
on the implementation and use of the e-regis-
try model; and (4) Recommended strategy to 
monitor living donors. 

Laws and some institutions’ rules on data pro-
tection limit the availability of all donors’ data. 
The online registry, once created, required a long 
period of testing before the partners could start 
entering  real  cases.  Therefore,  three  levels  of 
data to be registered were created: basic, recom-
mended and excellence data. The database design 
furthermore recognises the need for data protec-
tion: access to the database requires speciﬁc-
person authorisation and a password is needed 
to log in. Furthermore, the data collected makes 
impossible the identiﬁcation of donors, since no 
personal data is collected. Finally real cases were 
entered, with more than 700 donors registered.

Minimum set of ﬁnal recommendations

The project’s ﬁnal recommendations were elab-
orated with a consensus among project part-
ners, even though there is a great heterogeneity 
among the diﬀerent countries on the diﬀerent 
issues discussed. At the same time, this hetero-
geneity leads to an agreement on the minimum 
recommendations necessary to guarantee living 
donors’ health and safety. The ﬁnal minimum set 
of recommendations are as follows.

With respect to legislation:

(cid:98)(cid:553) prohibition and penalisation of organ 
traﬃcking, transplant tourism and 
commercialism, including incentives;

(cid:98)(cid:553) prohibition of minors and persons unable to 

give consent;

(cid:98)(cid:553) authorisation of transplant centres and 

registry of living donors under the control of 
authorities;

This Registry work package established and 
validated  an  e-registry  database  model  on 

(cid:98)(cid:553) regulation of independent commissions 

(evaluation, information, approval);

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153

(cid:98)(cid:553) reimbursement of expenses related to 

donations and provisions to protect donors 
and their families from discrimination, 
permanent injury or death.

With respect to ethical aspects:

(cid:98)(cid:553) the altruism of living donors should be 

object of the most elevated consideration 
by the community;

(cid:98)(cid:553) the promotion of living donation should 
not impede cadaveric donation and its 
development to its maximal potential;

(cid:98)(cid:553) organ traﬃcking, commercialism or 

incentives are ethically unacceptable and 
should be banned;

(cid:98)(cid:553) living donor candidates should be protected 
from any form of physical, psychological, 
social or economic disadvantage;

(cid:98)(cid:553) the autonomy of potential living donors 

should be respected if there is not a greater 
risk;

(cid:98)(cid:553) the reimbursement model should be 
implemented by health authorities to 
protect donors;

With respect to the protection of living donors:

(cid:98)(cid:553) careful selection of information to the 

living donor is crucial for donor safety; not 
everyone who wants can become a donor;

(cid:98)(cid:553) sick leave with 100 % payment and socio-

medical and protective support if sick leave 
is prolonged;

EU living donor CD-ROM for dissemination of results  

(available at http://www.eulivingdonor.eu/eulid/results.html)

(cid:98)(cid:553) registration of all living donors is obligated 
for the purpose of traceability, safety and 
transparency of activity and procedure 
outcome;

(cid:98)(cid:553) collection of living donor data has to 

be done through an established central 
database system, accessible by appropriately 
authorised persons;

(cid:98)(cid:553) data on identiﬁcation, country of residency, 
nationality, type of donation, healthcare 
institutions and outcome must be registered, 
with protection of the donor’s proper privacy; 
an oﬃcial point of contact must be registered 
at the embassy of the donor’s country of 
residence;

(cid:98)(cid:553) full economic reimbursement during 

(cid:98)(cid:553) a regulatory audit is mandatory and data 

investigation and procedure;

(cid:98)(cid:553) ﬁnancial coverage in case of unforeseen events 

related with the procedure;

(cid:98)(cid:553) medical follow-up obligated and 
psychosocial support if needed;

(cid:98)(cid:553) living donation should not be a limitation 

for getting a life insurance, mortgage or any 
other social assistance or beneﬁt;

(cid:98)(cid:553) homogenous protection systems within the 
European Union with a deﬁned minimum 
standard.

With respect to registration practices:

should be both monitored on a national and 
institutional level.

The ﬁnal complete set of results and outputs of 
EULID are disseminated on the EULID website 
(EULID CD) (http://www.eulivingdonor.eu) for the 
public and professionals. EULID has prepared an 
informative leaﬂet about living donation. The 
leaﬂet is addressed to the general public and is 
available in 12 diﬀerent languages.

Project results have also been widely dissemi-
nated to the professional community at vari-
ous international conferences, and presented 
in  Competent  Authority  meetings  to  reach 
national level. Additionally, the Living Donor 

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Registry is available through the EULID website 
for professionals a#er registration.

Final results have also been published in diﬀer-
ent scientiﬁc journals (Manyalich, Ricart, Martínez 
et al. EULID Project: European Living Donation 
and Public Health. Transplantation Proceedings, 
41,2021–2024 (2009)). The results of the EULID 
Project have also been included in a chapter enti-
tled ‘European Living Donation and Public Health 
(EULID Project)’ in the book ‘Organ Donation and 
transplantation — Public Policy and Clinical Per-
spectives’ (ISBN 978-953-51-0039-3), edited by 
Gurch Randhawa.

Future perspectives

Among the tools developed, the EULID partners 
validated a living donor satisfaction survey that 
examines three spheres: information, perception 
and acceptance of the donation process; qual-
ity of life; and psychological well-being. Living 
donors’ opinions through a satisfaction survey 
can be one of the tools to monitor the quality 

and safety of the living donation programmes 
and the key to detect all the potential negative 
consequences of becoming an organ donor. With 
the idea of a Living Donor Observatory (LIDOBS), 
researchers give continuity to these activities 
and at present the satisfaction survey is avail-
able online with more than 200 surveys collected 
through interviews from 11 countries and the 
data included in the database. The survey has 
been translated into 12 European languages.

Registry and follow-up are tools that allow bench-
marks for quality control and implementation of 
improvement measures. Registry, when regulated, 
is one of the scarce tools that Member States have 
in order to detect unethical or forbidden practices, 
taking into account that, when obligated, the non-
registration is by itself an infraction. It is necessary 
that registration models are developed by scien-
tists themselves so that Member States have a 
reference to implement for the beneﬁt of living 
donation health and safety.

The project ELIPSY and the Joint Action ACCORD take 
up these activities and bring them steps further.

Concept of the living donor satisfaction survey.

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Further information: 

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=2006211 

Project website 
http://www.eulivingdonor.eu 

Project team: 

Hospital Clinic i Provincial Barcelona 
C/ Villaroel, 170  
08036 Barcelona  
SPAIN  
Tel. +34 932275400 
Fax +34 934515272

Associated partners: 

Institute for transplantation of organs and tissues of the Republic of Slovenia, Slovenia

Instituto Superiore di Sanita, Italy

(cid:97)(cid:149) Paraskevaidion Surgical and Transplant Centre of Cyprus, Cyprus
(cid:97)(cid:149)
(cid:97)(cid:149) Fundació Bosch i Gimpera, Spain
(cid:97)(cid:149) Service de Transplantation Rénale Adulte, France
(cid:97)(cid:149)
(cid:97)(cid:149) The University Hospital Rikshospitalet-Radiumhospitalet Trust, Norway
(cid:97)(cid:149) Polish Transplant Coordinating Centre, Poland
(cid:97)(cid:149) Hospital Geral Santo Antonio, Portugal
(cid:97)(cid:149) National Agency for Transplantation, Romania
(cid:97)(cid:149) Sahlgrenska University Hospital, Sweden
(cid:97)(cid:149) NHS Blood and Transplant, United Kingdom

EU contribution

This project has received co-funding from the European Union in the framework of the  
Public Health Programme 2003–2008 (Grant: 2006211).

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European Framework for the Evaluation of Organ Transplants 
(EFRETOS)

This project has received co-funding from the European Union in the framework of the Health  
Programme 2008–2013 (Grant: 20081101).

In  the  Action  Plan  on  Organ  Donation  and 
Transplantation (2009–2015): Strengthened 
Cooperation between Member States (160), the 
Commission sets out, as one of the three main 
challenges in the ﬁeld of organ transplantation, 
the importance of improving quality and safety 
of  transplantation,  among  others  through 
compiling  the  information  concerning  organ 
donations and transplantation in registers to 
facilitate the evaluation of post-transplantation 
results (Priority Action 9). As suggested by the 
Action Plan, this evaluation of post-transplant 
results would be facilitated through common 
deﬁnitions  of  terms  and  methodology  and 
supported by compatible follow-up registers, 
or even EU-wide registers. Furthermore, the 
Action Plan recommends promoting common 
deﬁnitions of terms and methodology to help 
determine acceptable levels of risk in the use 
of expanded donors.

Common deﬁnitions of terms 
and methodology for the future 
establishment of a European Registry 
of Registries on pre- and post-
transplant outcome data

The objective of the project European Frame-
work for the Evaluation of Organ Transplants 
(EFRETOS)  was  to  provide  such  common 

What is the 5-year post-transplant survival rate for all patients treated 
in Europe with a renal allogra$? How many patients were transplanted 
in Europe who suﬀered from the Hemolytic Uremic Syndrome? 
What donor and recipient factors inﬂuence the outcome a$er 
organ transplantation? Are there diﬀerent strategies towards organ 
replacement therapies and related outcomes between the diﬀerent 
countries in Europe? At present we cannot answer questions such as 
these, but a European Transplant Registry will enable us to do so.

http://www.eurotransplant.org/cms/mediaobject.php?ﬁle=brochure_
efretos_def.pdf

deﬁnitions of terms and methodology for the 
future establishment of a European Registry of 
Registries on pre- and post-transplant outcome 
data. The aim of such a European Registry of 
Registries is to be able to monitor patients and 
evaluate the results of transplantation, thereby 
to  contribute  to  an  improved  eﬀectiveness, 
quality and safety of organ transplantation.

In  practical  terms,  ‘the  EFRETOS  project  was 
to describe the optimal content of a European 
Transplant Registry, based on the existing regis-
tries in Europe and current expertise. In addition, 
an appropriate functional framework, a feasible 
technical approach and the organisational prereq-
uisites for realising a pan- European Registry had 
to be designed’, states the project summary (161).

The project EFRETOS was coordinated by the 
Eurotransplant  International  Foundation,  a 
non-proﬁt service organisation for allocation 
of donor organs, which is active for transplant 
centres and their associated tissue typing lab-
oratories and donor hospitals in seven Euro-
pean countries. The work implemented during 
the EFRETOS project was based on the joint 
eﬀorts of seven partner institutions and sev-
eral collaborating organisations from 20 Mem-
ber States of the European Union. The project 
was implemented in 2 years from May 2009 
to May 2011.

EFRETOS was articulated around work pack-
ages focusing on diﬀerent, but related issues 
such  as  common  deﬁnitions,  methodology, 
safety management and quality insurance.

Development of a data dictionary

The aim of this work package was to develop a 
common data dictionary and deﬁnitions for all 
the variables that will be included in the registry. 
To be able to select and provide state-of-the-
art  deﬁnitions  of  the  registry  variables,  three 
European  expert  groups  were  formed  within 
the European Society for Organ Transplantation 

(160)  Communication from the Commission — Action Plan on Or-

gan Donation and Transplantation (2009-2015): Strengthened 
Cooperation between Member States, http://eur-lex.europa.eu/
LexUriServ/LexUriServ.do?uri=CELEX:52008DC0819:EN:NOT 

(161)  http://www.eurotransplant.org/cms/mediaobject.

php?ﬁle=brochure_efretos_def.pdf 

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157

(ESOT) — EFRETOS partner — to overview the 
existing international data sets and collect all 
possible variables related to donors, recipients, 
organs  and  the  donation  and  transplantation 
procedure.

Based on multiple expert reviews and discussions, 
a ﬁnal set of variables has been agreed upon. 
The ﬁnal set of variables and the data dictionary 
included the list of mandatory and optional vari-
ables per organ that are necessary to evaluate 
outcome and risk factors for quality and safety 
in deceased donation and organ transplantation 
and the respective deﬁnitions thereof.

 The European Registry designed by the 
EFRETOS project is able to hold activity and 
outcome data on the transplantation of solid 
organs. The basic data set of the registry consists 
of all variables that are acknowledged to be of 
importance for a comprehensive evaluation of 
transplant outcomes. 

EFRETOS Report on the use of the European Registry of Registries, May 2011 (162)

Methods as well as legal  
and technical requirements

The  aims  of  this  work  package  were:  (1)  to 
develop data analysis methods for organ trans-
plantation outcomes, and (2) to develop legal, 
functional and technical requirements for set-
ting up and managing a future registry as well 
as to propose an organisation structure. The 
work in relation with these tasks mainly com-
prised an overview of existing statistical meth-
ods building also on previous project results on 
related  topics  and  collecting  the  necessary 
system information via surveys to consortium 
members.

A#er developing the main features and ele-
ments, the EFRETOS project tested the techni-
cal feasibility of the proposed registry of reg-
istries. The purpose of the pilot study was to 
get an indication about how the diﬀerent coun-
tries may be able to contribute to the European 
Registry, to identify possible problems and also 
provide  evidence  that  such  a  pan- European 
registry can be created. The pilot study design 
focused on the evaluation of 1- and 5-year gra# 
survival rates following kidney transplantation 
from deceased or live donation. Altogether ﬁve 
countries participated in the pilot, i.e. were able 
to provide national level data. The results of the 
pilot study provided further useful insights for 
the design of a European Registry and demon-
strated its potentials.

Cumulative data 
per country

relational database

analysis database

Schematic overview of the European Registry
(http://www.eurotransplant.org/cms/mediaobject.php?ﬁle=brochure_efretos_def.pdf)

(162)   (http://www.efretos.org/images/EFRETOS_Deliverable %20

11_FINAL.pdf)

 
158TRANSPLANTATION AND TRANSFUSIONCommon safety management procedure in two speciﬁc areasThe objective of this work package was to develop a common safety management proce-dure in two speciﬁc areas: (1) the safety limits of the donation and transplantation process when non-standard-risk donors are consid-ered for transplantation, and (2) the develop-ment of recommendations on how to build a European organ vigilance system. In order to make a state-of-the-art overview of the cur-rent practices, the work package designed and distributed a speciﬁc questionnaire among the EFRETOS consortium. Building on the survey results, the review of published literature and expert discussions, this work package devel-oped recommendations on how to establish a comprehensive system that is also able to adapt to national transplant systems for safety management and organ donation and trans-plantation. Furthermore, it provided recom-mendations on how to use non-standard-risk donors and the necessary data set to follow-up the recipients.Quality assurance system for obtaining high quality data on transplantation outcomesThe aim here was to set up a quality assurance system for obtaining high-quality data on trans-plantation outcomes. The project has overviewed the performance indicators used in existing reg-istries, and gathered information from EFRETOS partners through a survey on presently adopted quality assurance systems. The results of this work led to a common shared methodology that enables the quality of post-transplant outcomes to be assessed and for these data sources and their handling to be validated.Main features and beneﬁts  of the RegistryThe European Registry developed by EFRE-TOS is designed in a way to allow for a sim-pliﬁed reporting of such essential outcome data at national and European level that had not been available previously. ‘The European Registry designed by the EFRETOS project is able to hold activity and outcome data on the transplantation of solid organs. The basic data set of the registry consists of all variables that are acknowledged to be of importance for a comprehensive evaluation of transplant outcomes’ (163).Furthermore, the EFRETOS project sees many advantages and beneﬁts of having such a pan-European registry on transplantation. Among others, ‘it will lead to the ability to investigate outcomes following transplantation for rare conditions, to explore outcomes following the transplantation from extended criteria donors, to identify factors associated with the occur-rence of rare adverse events and to establish a European vigilance system’, as pointed out in the report. (163) EFRETOS  Report on the use of the European Registry of Registries, May 2011, http://www.efretos.org/images/EFRE-TOS_Deliverable %2011_FINAL.pdf EFRETOSEUROPEAN FRAMEWORK FOR THE EVALUATION OF ORGAN TRANSPLANTS ∙1EFRETOS  Report on the use of the European Registry of RegistriesEFRETOS White Paper (http://www.eurotransplant.org/cms/mediaobject.php?file=EFRETOS-White_paper.pdf)159ORGAN DONATION AND TRANSPLANTATIONWho can beneﬁt from the European Registry and what has been done to reach them?The main stakeholders and beneﬁciaries of the EFRETOS project are medical experts in the ﬁeld of organ donation and transplantation, the European Commission and the national com-petent authorities in charge of organ donation and transplantation in the EU countries, and of course patients.The project had used various dissemination methods to reach its target groupsThe ﬁnal results of the EFRETOS project were summarised in the ‘Report on the use of the European Registry of Registries’. This compre-hensive report gives a detailed description of the optimal content of a pan-European trans-plant registry, based on the existing registries and current expertise. Additionally, the report presents an appropriate functional framework, a feasible technical approach and the organisa-tional prerequisites and key recommendations for its development and management.A ﬁnal EFRETOS symposium was organised in Brussels on 17 May 2011, entitled Unifying Data Collection — Creating New Knowledge, for a wide audience: scientists, researchers and medical professionals, politicians, policy-makers, patients and representatives of organisations in the ﬁeld of organ transplantation. During the EFRETOS symposium, among other topics, the diﬀerent stakeholders pointed out and discussed the main advantages of the Registry of Regis-tries. The added value for European citizens of the Registry of Registries was emphasised as being the improved patient care and outcomes, improved information for patients and the pub-lic and increased transparency and accountabil-ity (164). The main EFRETOS objectives and activi-ties were ﬁrst introduced in a layman brochure; regular updates on progress and results were disseminated via EFRETOS newsletters.(164) Report on the Symposium EFRETOS Unifying data collection, creating new knowledge. May 17, 2011, www.eurotransplant.org/cms/index.php?page=efretos_report_sympoThe ﬁnal major recommendations for setting up a European Transplant RegistryThe executive summary (165) outlines the 10 major recommendations from the EFRETOS project as following.(165) http://www.eurotransplant.org/cms/mediaobject.php?ﬁle=brochure_efretos_def.pdf  = coordinating and associated partners = collaborating partner = not covered by EFRETOS*EU council of Europe 2009Countries covered by EFRETOS1. National or supranational registries on organ transplantation should be established in all countries. The structure of these registries should allow data delivery to the European Registry.2. Besides collection of data on waiting list and transplant activities, data on the outcome of transplanted patients should be collected. National legislation ensuring that transplant programmes report on a mandatory and regular basis on the outcome of their patients would facilitate the data collection and reporting process.3. The necessary funding for setting up and maintaining this national registry should be made available by the competent authorities.160

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

4.  Although the format of the required data set will be 
tightly speciﬁed, ﬂexibility will be needed in the early 
phase in accepting and converting submitted data 
to the required formats. It is recommended that 
any such conversion is performed by the European 
Registry itself.

5.  A#er data have been submitted to the European 
Registry, quality assurance procedures should be 
performed before data are uploaded to the Registry 
itself.

6.  The quality of the Registry data will need to be 

maintained by updating existing records on a regular 
basis and making any necessary corrections to the 
data.

7.  A relational database will be required to 

accommodate the data and website produced that 
will allow data submission through the Internet.

8.  Regular reports that summarise the data held in 

the European Registry will need to be produced and 
disseminated.

9.  All proposals for audit and research projects based 
on data held in the European Registry should be 
scrutinised by a Review Committee set up for this 
purpose.

10.   In the early stages of the formation of the European 
Registry, a greater number of staﬀ will be needed 
for setting up the Registry and accepting the ﬁrst 
submissions of data from participating countries, but 
there will be a continuing need for staﬀ to facilitate 
the uploading of data from countries that join the 
Registry at a later stage.

Report on the ﬁnal symposium in Brussel 2011 for presenting the results and conclusions
(http://www.eurotransplant.org/cms/index.php?page=efretos)

Final Results are available at 

(http://www.efretos.org/images/EFRETOS_Deliverable%2011_FINAL.pdf)

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161

S

TS ∙
N
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S
N
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N
A

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E F

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T

Further information: 

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=20081101 

Project website 
http://www.efretos.org 

Towards a European 
Registry of Registries

Final Report and Results: 
http://www.efretos.org/images/EFRETOS_Deliverable%2011_FINAL.pdf 

Project team: 

Stichting Eurotransplant International Foundation  
Plesmanlaan 100  
PO-BOX  
2332 CB Leiden  
NETHERLANDS  
Tel. +31 715795704  
Fax +31 715790057 

Associated partners: 

(cid:97)(cid:149) Agence de la Biomédecine — ABM, France
(cid:97)(cid:149) European Society for Organ Transplantation — ESOT, Netherlands
(cid:97)(cid:149) NHS Blood and Transplant — NHSBT, United Kingdom
(cid:97)(cid:149) Organizisacion Nacional de Transplantes — ONT, Spain
(cid:97)(cid:149)
(cid:97)(cid:149) Scandiatransplant — SKT, Denmark

Instituto Superiore di Sanità — ISS/Centro Nazionale Trapianti — CNT, Italy

Other partners from the Czech Republic, Germany, Greece, Italy, the Netherlands, Poland, 
Portugal, Slovakia and Slovenia also collaborated in EFRETOS.

EU contribution

This project has received co-funding from the European Union in the framework of the  
Health Programme 2008–2013 (Grant: 20081101).

 
 
 
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European Living Donor Psychological Follow-up (ELIPSY)

This project has received co-funding from the European Union in the framework of the Health  
Programme 2008–2013 (Grant: 20081104).

 From December 2009 to 
October 2012, a consortium of 
seven partner organisations from 
six different countries joined 
their efforts to fulfil the objectives 
and tasks of the project. 

Information on living donor follow-up is scarce as 
only a few studies in Europe have been carried 
out. Furthermore, the interpretation of results is 
limited due to diﬀerent methodologies, tools and 
focuses. The recipient’s outcome is an important 
factor to be analysed, because the psychosocial 
evolution of living donors could be related to 
the recipient’s outcome. If so, attention should 
focus on giving the best information to potential 
donors in the future to prevent that their decision 
to become a donor may aﬀect in a negative way 
their quality of life and psychosocial well-being. 
It is therefore important to study the long-term 
(1, 3 and 5 years) outcomes of donors and recipi-
ent outcomes because most donors make the act 
of donation for a genetically or non-genetically 
related  recipient  for 
emotional  reasons. 
The  knowledge  of 
negative psychosocial 
impact in living donors 
could  contribute  to 
better donor selection.

Having a good know-
ledge  and  under-
standing  about  the 
living  donors’  psy-
chosocial  outcomes  in  the  long  term  in  the 
European area that is based on a sound and 
validated methodology could have an improve-
ment in living donation.

The main objective of the ELIPSY project is 
to contribute to a high quality of living organ 
donation  programmes  by  creating  a  follow-
up model for the living donors’ psychosocial 
well-being and quality of life. The impact of 
the recipient’s outcome on the donor and the 
donor’s perception of the process will also be 
evaluated in the follow-up model.

The project has organised its activities in diﬀer-
ent working groups: WP 4 — Donor Follow-up, 
WP 5 — Recipient Follow-up, WP 6 — Imple-
mentation  of  the  follow-up  strategy,  and 
WP 7 — Data analysis and results. 

In order to achieve its main objectives, the pro-
ject carried out the following tasks.

of current practices, considered the 
psychosocial well-being, quality of life 
and perception of the process to evaluate 
the impact of the donation process on the 
donor.

(cid:98)(cid:553) It designed a recipient follow-up 

methodology, based on a survey of current 
practices, using the best indicators with the 
purpose to link the recipient’s outcome to 
the living donor’s follow-up.

(cid:98)(cid:553) It tested the methodology and tools 

developed in the partners’ countries in 
a prospective study during a period of 
15 months. The study was designed to 
compare the psychosocial well-being and 
quality of life of the donors before and a#er 
donation, and in this way study the impact 
of the donation process. The impact of the 
recipient’s outcome on the well-being of the 
donor was also addressed.

(cid:98)(cid:553) It tested the methodology and tools 
developed in a retrospective study, 
assessed the long-term impact of donation 
and the impact of the recipient’s outcome 
on the donor. Psychosocial well-being, 
quality of life and the impact of the 
recipient’s outcome data were collected for 
a period of 15 months from donors who 
donated 1, 3 and 5 years ago.

Main outcomes of the project

The main outcomes of the project will include:

(cid:98)(cid:553) knowledge of current living donor (LD) 

follow-up practices;

(cid:98)(cid:553) a standardised LD assessment and follow-up 

methodology, analysing the donors’ 
perception of the donation process as well as 
their psychosocial well-being and quality of 
life;

(cid:98)(cid:553) a standardised recipient’s follow-up 

methodology, to relate the recipient’s 
outcome in donor’s psychosocial well-being 
and quality of life;

(cid:98)(cid:553) It designed living donor follow-up tools 
and methodologies, based on a survey 

(cid:98)(cid:553) a strategy for living donor evaluation;

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

163

ELIPSY website at http://www.eulivingdonor.eu/elipsy/

(cid:98)(cid:553) contribution to the harmonisation in 

the European area of Living Donation 
assessment/follow-up studies that 
contribute to a high quality of living 
donation programmes.

Expected project impact, as seen by the project 
partners, emphasises that developing stand-
ard tools and methods will harmonise in the 
European area the living donor follow-up stud-
ies. The tools and methodology will allow the 
detection  of  possible  negative  psychosocial 
consequences of the living donor related to the 
recipient’s outcome. Knowing the risks, in return, 
will make it possible to act and take measures 
to prevent them. This will contribute to guar-
antee health and safety in psychosocial terms 

of living donors through the contribution to the 
harmonisation of such activities in Europe.

The ﬁnal meeting of the ELIPSY project was 
held in Barcelona on 17–19 October 2012. The 
ELIPSY project website has been set up and 
included in the platform, which was created 
for the EULID project. The project results have 
been disseminated in international conferences 
inside and outside of Europe such as:

(cid:98)(cid:553) 2nd ELPAT Congress, April 2010, Rotterdam, 

the Netherlands;

(cid:98)(cid:553) Living kidney donor follow-up: State of the 
art and future directions, September 2010, 
Washington, United States;

164

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

(cid:98)(cid:553) EEUU, European Organ Donation Congress, 

22nd ETCO, September 2010;

(cid:98)(cid:553) ELPAT Meeting, October 2010, Soﬁa, 

Bulgaria. 

The project was also been invited to present its 
interim results during the Competent Authori-
ties meeting in Brussels that was held from 
28 February–1 March 2011. Please visit the 
ELIPSY project website for further information 
at www.eulivingdonor.eu where reports will be 
made available a#er ﬁnalisation.

Results and Conclusions

•

•

•

•

•

The study used the EULID registry, an on-line databa-
se developed within a project during 2007-2009 with
more than 1400 living donors registered. 

The first survey showed no previous consensus in the
Living  donors  psychosocial  assessment  and  follow-
up practices among the studied transplant centres. 

There was an unification of the most relevant psycho-
social variables to be assessed and follow-up.  

The  same  tools  will  be  used  to  evaluate  the  Living
donors aspects Quality of life, Psychosocial wellbeing
and Satisfaction with the donation process. 

Each of the centres translated the tools in their own
language and adapted the methodology to their cha-
racteristics and resources. 

•

•

•

•

•

The  prospective  study  linked  post  donation  mental
health  and  psychosocial  wellbeing  of  living  donors
and their satisfaction one year after donation to their
psychosocial profile before donation. 

The  retrospective  study  identified  the  long  term
impact  of  living  donation  in  terms  of  mental  health,
psychosocial  wellbeing  and  satisfaction  after  dona-
tion process. 

The impact of recipient outcome in the living donor is
evaluated in both studies. 

The donors assessed demonstrate to have absolute
Psychosocial well-being and Quality of Life.

All  the  centres  who  follow  similar  methodology  are
considered as excellence level centres. 

Acknowledgments

The ﬁrst gratitude goes to all the Living donors who participate in this study. Their participation allowed the realization
of the project. A very special thanks goes out to all participants in all the stages of the project. We hope to have con-
tributed with this project to a better care of Living donors. 

Project results and conclusions (ELIPSY leaﬂet, English)

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

165

Further information: 

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=20081104 

Project website 
http://www.eulivingdonor.eu/elipsy/ 

Project team: 

Hospital Clinic i Provincial Barcelona  
C/ Villaroel, 170  
PO-BOX  
08036 Barcelona  
SPAIN  
Tel. +34 932275713

Associated partners: 

(cid:97)(cid:149) Hopital Geral de Santo Antonio, Portugal
(cid:97)(cid:149) Hopital Necker, France
(cid:97)(cid:149) Paraskevaidion Surgical and Transplant Service (until 31 December 2010), Cyprus
(cid:97)(cid:149) Rikshospitalet-Radiumhospitalet Medical Center (until 1 January 2010), Norway
(cid:97)(cid:149) Sahlgrenska Universitetssjukhuset Hospital, Sweden
(cid:97)(cid:149) Charity Universtätsmedizin Berlin (from 1 January 2010), Germany

EU contribution

This project has received co-funding from the European Union in the framework of the  
Health Programme 2008–2013 (Grant: 20081104).

166TRANSPLANTATION AND TRANSFUSIONTransplantation medicine is dynamically devel-oping with enormous progress and great suc-cesses in recent decades. The major challenge however in this ﬁeld is the shortage of avail-able organs. According to the estimates of the Council of Europe, more than 56 000 people are on diﬀerent transplantation waiting lists. The donation rate greatly varies among EU Member States. The Action Plan on Organ Donation and Trans-plantation by the European Commission states a number of priorities to improve donation rates, among others public awareness. The European Donation Day is increasingly seen as one primary European awareness-raising event about organ and tissue donation and transplantation.The Council of Europe organises the European Day of Organ Donation and Transplantation each year in diﬀerent host countries amongst its member statesThe Council of Europe organises the European Day of Organ Donation and Transplantation each year in diﬀerent host countries amongst its member states. The concept of accompa-nying so-called satellite celebrations grew into equally important simultaneous events. Tradi-tionally, the European Donation Day has been held in October.The project EDD was coordinated by Slovenia-Transplant, the associated and collaborated partner organisations were from Austria, Cro-atia, Slovakia, the Czech Republic, Montenegro, Republic of Serbia, the Federation of Bosnia and Herzegovina and Georgia, and two supra-national organisations, the European Directo-rate for the Quality of the Medicines — Council of Europe — and Eurotransplant International Developing Guidelines for the Organisation of a Public Organ Donation Day (EDD)This project has received co-funding from the European Union in the framework of the Health  Programme 2008–2013 (Grant: 20081109).WORKING MEETINGS3 months before eventweekly 1 week before eventEDAY DDatePlaceEquipmentEinterteinersDocument List of tasksUpdate List of tasksUpdate List of tasksTasks completed (cid:258)(cid:374)(cid:282)(cid:3)(cid:302)(cid:374)(cid:258)(cid:367)(cid:3)agenda of event (s)STARTACTION PLAN DONE 6–9 monthsbefore eventFIRST MEETING 9–12 monthsbefore eventFigure 4Timeplanning for the organisers of an awareness-raising day, such as the EDD Transplantation is a unique moment in the medicine, where life of the patient depends on a wish or will of another person. Prof. Philippe Morel, founder of European Donation DayFoundation. The EDD project started in Septem-
ber 2009 and lasted for 20 months.

The main partner of the EDD project in 2008 
organised an event on behalf of the Council of 
Europe in Ljubljana. Slovenia-Transplant devel-
oped a model on how to organise such a Euro-
pean Donation Day and which components to 
organise based on its own experiences in organ-
ising this event in 2008. This model is proposed 
to be modiﬁed according to diﬀerent cultural 
circumstances  and  formulated  into  general 
guidelines that can help organise future Euro-
pean Donation Days in European Member States 
with less developed organ donation awareness.

The main objective of the EDD project 
was to develop and disseminate 
guidelines for the organisation of 
future European Donation Days

The main objective of the EDD project was to 
develop and disseminate guidelines for the organi-
sation of future European Donation Days, elabo-
rated by consultation of experts and considering 
the guidance of the Council of Europe, the initiator 
of the main event. Furthermore, the idea was to  
test, whether satellite European Donation Days in 
parallel to the main event are beneﬁcial for rais-
ing awareness on organ donation in the speciﬁc 
circumstances of small countries.

The project activities were organised 
in three major work packages

The ﬁrst aimed to outline the guidelines for 
organising European Donation Days in a way 
to include practical recommendations and tips 
on the organisation and on a methodology for 
measuring  the  awareness-raising  potential 
of such events. In order to fulﬁl these tasks, 
expert meetings together with a ﬁnal consen-
sus conference were held to ﬁnalise the guide-
lines and the methodology.

The second was to test the feasibility of the 
guidelines  by  organising  satellite  European 
Donation Days in diﬀerent locations. These sat-
ellite events were organised during the project in 
Slovenia, Austria, Croatia, the Czech Republic and 
Slovakia in parallel with the main event. 

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

167

 A unified European Donation Day on organ 

and tissue transplantation could help raise public 
awareness, enhance a positive attitude towards 
organ donation and potentially augment the 
number of organ donors. 
EDD toolkit

SATELITSKO 
PRAZNOVANJE 
EVROPSKEGA DNEVA 
DAROVANJA V SLOVENIJI

Toplo Vabljeni v Tivoli

Dobrodelni tek, hoja in ustvarjalne delavnice 
(cid:93)(cid:68)(cid:3)(cid:231)(cid:76)vljenje in radost

Sobota,16. oktober 2010
(cid:45)(cid:68)(cid:78)(cid:82)(cid:83)(cid:76)(cid:262)(cid:72)(cid:89)(cid:3)(cid:71)(cid:85)(cid:72)(cid:89)(cid:82)(cid:85)(cid:72)(cid:71)(cid:3)(cid:89)(cid:3)(cid:55)(cid:76)(cid:89)(cid:82)(cid:79)(cid:76)(cid:77)(cid:88)(cid:3)
(cid:47)(cid:77)(cid:88)(cid:69)(cid:79)(cid:77)(cid:68)(cid:81)(cid:68) 

Tecimo in hodimo!
10.30 Zadnje prijave za tek
11.30 Start teka na 8 km
11.30 Start hoje na 2 km

Ustvarjajmo!
10:30 - 14:00 otroci ustvarjajo...

Podrobnejše informacije na
Podrobnejše informacije na
Podrobnejše informacije na
Podrobnejše informacije na
Podrobnejše informacije na
Podrobnejše informacije na
Podrobnejše informacije na
www.Slovenija-transplant.si
www.Slovenija-transplant.si
www.Slovenija-transplant.si
www.Slovenija-transplant.si
www.Slovenija-transplant.si
www.Slovenija-transplant.si
www.Slovenija-transplant.si

 © EDQM, Council of Europe. 
(cid:57)(cid:86)(cid:72)(cid:3)(cid:83)(cid:85)(cid:68)(cid:89)(cid:76)(cid:70)(cid:72)(cid:3)(cid:83)(cid:85)(cid:76)(cid:71)(cid:85)(cid:231)(cid:68)(cid:81)(cid:72)(cid:17)

(cid:55)(cid:68)(cid:3)(cid:71)(cid:82)(cid:78)(cid:88)(cid:80)(cid:72)(cid:81)(cid:87)(cid:18)(cid:71)(cid:82)(cid:74)(cid:82)(cid:71)(cid:72)(cid:78)(cid:3)(cid:77)(cid:72)(cid:3)(cid:71)(cid:72)(cid:79)(cid:3)(cid:83)(cid:85)(cid:82)(cid:77)(cid:72)(cid:78)(cid:87)(cid:68)(cid:3)(cid:170)(cid:53)(cid:68)(cid:93)(cid:89)(cid:76)(cid:77)(cid:68)(cid:81)(cid:77)(cid:72)(cid:3)(cid:86)(cid:80)(cid:72)(cid:85)(cid:81)(cid:76)(cid:70)(cid:3)(cid:93)(cid:68)(cid:3)(cid:82)(cid:85)(cid:74)(cid:68)(cid:81)(cid:76)(cid:93)(cid:68)(cid:70)(cid:76)(cid:77)(cid:82)(cid:3)(cid:40)(cid:89)(cid:85)(cid:82)(cid:83)(cid:86)(cid:78)(cid:72)(cid:74)(cid:68)(cid:3)(cid:71)(cid:81)(cid:72)(cid:89)(cid:68)(cid:3)(cid:71)(cid:68)(cid:85)(cid:82)(cid:89)(cid:68)(cid:81)(cid:77)(cid:68)(cid:169)(cid:15)(cid:3)(cid:78)(cid:76)(cid:3)(cid:74)(cid:68)(cid:3)(cid:192)(cid:3)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:85)(cid:68)(cid:3)(cid:40)(cid:89)(cid:85)(cid:82)(cid:83)(cid:86)(cid:78)(cid:68)(cid:3)(cid:56)(cid:81)(cid:76)(cid:77)(cid:68)(cid:3)
v okviru Zdravstvenega programa (http://ec.europa.eu/eahc/). Svet Evrope je pobudnik ideje praznovanja Evropskega dneva darovanja 
(cid:82)(cid:85)(cid:74)(cid:68)(cid:81)(cid:82)(cid:89)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:85)(cid:68)(cid:81)(cid:86)(cid:83)(cid:79)(cid:68)(cid:81)(cid:87)(cid:68)(cid:70)(cid:76)(cid:77)(cid:15)(cid:3)(cid:78)(cid:76)(cid:3)(cid:77)(cid:72)(cid:3)(cid:81)(cid:68)(cid:80)(cid:72)(cid:81)(cid:77)(cid:72)(cid:81)(cid:3)(cid:86)(cid:83)(cid:82)(cid:71)(cid:69)(cid:88)(cid:77)(cid:68)(cid:81)(cid:77)(cid:88)(cid:3)(cid:85)(cid:68)(cid:93)(cid:83)(cid:85)(cid:68)(cid:89)(cid:3)(cid:81)(cid:68)(cid:3)(cid:87)(cid:72)(cid:80)(cid:3)(cid:83)(cid:82)(cid:71)(cid:85)(cid:82)(cid:262)(cid:77)(cid:88)(cid:3)(cid:76)(cid:81)(cid:3)(cid:82)(cid:93)(cid:68)(cid:89)(cid:72)(cid:229)(cid:262)(cid:68)(cid:81)(cid:77)(cid:88)(cid:3)(cid:87)(cid:72)(cid:85)(cid:3)(cid:81)(cid:68)(cid:83)(cid:85)(cid:72)(cid:71)(cid:78)(cid:88)(cid:3)(cid:81)(cid:68)(cid:3)(cid:83)(cid:82)(cid:71)(cid:85)(cid:82)(cid:262)(cid:77)(cid:88)(cid:3)(cid:71)(cid:68)(cid:85)(cid:82)(cid:89)(cid:68)(cid:81)(cid:77)(cid:68)(cid:3)(cid:76)(cid:81)(cid:3)
presajanja organov. (www.edqm.eu in www.coe.int)

Poster for the EDD Satellite day in Slovenia, 2010

 
 
168TRANSPLANTATION AND TRANSFUSIONThe experiences of organising these events were drawn up in a report and provided further informa-tion to the ﬁnalisation process of the guidelines.The third was to measure the awareness-raising potential of the applied guidelines. The project partners designed a survey which was administered by a professional opinion research organisation IPSOS Marketing in the above ﬁve countries before and a#er the satellite European Donation Days. Questions about the public infor-mation, knowledge and opinions on organ dona-tion and awareness of the European Donation Day celebration were asked. In each country a sample of 700 respondents, representative of gender, age and region, was used. In each participating country a sample of 700 respondents, representative of gender, age and region, was interviewed twiceThe EDD project has managed to further develop and validate the protocol that Slove-nia Transplant successfully implemented dur-ing the European Donation Day organised in Ljubljana in 2008. During the EDD project the eﬀects on populations of various states inside and outside of the EU were measured and compared, leading to useful conclusions and recommendations.The results of the European Donation Day sur-veys conducted in 2010 by the project showed that the celebration not only sensitised the public, but also informed them in signiﬁcant ways about organ donation.Selected works of the high-school children produced during the art competition (EDD toolkit) ‘Monolith’ by Cornelia Brandstetter. Without title. Daniela Wöckinger. Man, enveloped by darkness, crouching, threatened, in need of help.  The artist depicts man, ornamentally disintegrated as a symbol of dejection and despair. The heart as a symbol of love gives trust. Living love by donating a heart. Life conquers death. One of the most important factors that influences the organ donation rate is social awareness. EDD toolkitO R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

169

The major ﬁndings of the survey showed that 
a#er the European Donation Day in 2010:

(cid:98)(cid:553) the public received more information on 

organ donation;

(cid:98)(cid:553) information on some particular subjects 
regarding organ donation was better 
disseminated;

(cid:98)(cid:553) awareness of the European Donation Day 
celebration among the general public was 
higher;

(cid:98)(cid:553) a part of the general public obtained new 
and interesting information about organ 
donation; new information inﬂuenced their 
opinions, feelings and decision-making in a 
positive way.

The main output of the project is the 
EDD Guideline — European Donation 
Day Toolkit for Event Organisers

As no extensive guidelines for the organisation 
of the European Donation Day existed before, the 
toolkit developed by the project ﬁlls this gap and 
shares important lessons learned.

The guidelines and toolkit are intended to help 
and support future organisers of the European 
Donation  Day  events.  The  toolkit  has  been 
developed for healthcare professionals, edu-
cational organisations, institutions and govern-
mental agencies interested in organising Euro-
pean Donation Day. Policymakers at all levels 
will also ﬁnd the guide useful when spreading 
the message regarding organ and tissue trans-
plantation and donation.

The toolkit gives plenty of practical sugges-
tions, ideas and possible strategies to adapt a 
European Donation Day to the organisational 
needs and ﬁnancial possibilities of the event 
future organisers. During the development of 
the guidelines, the political, economical and cul-
tural speciﬁcs of diﬀerent countries have been 
taken into consideration as well.

According to the toolkit, the main objectives of 
a uniﬁed European Donation Day are:

(cid:98)(cid:553) to raise public awareness in the ﬁeld 
of organ and tissue donation and 
transplantation;

(cid:98)(cid:553) to acknowledge all the people involved in 

the transplant process (transplant patients 

The amount of information received on organ donation and transplantation in the last year: comparison of the results (before ﬁrst wave/a$er 

second wave) in all participating countries (EDD Toolkit)

170

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

EUROPEAN
DONATION 
DAY

ORGAN

TISSU E

To o l k i t   fo r   Eve nt   O rga n i ze rs

funding from the European Union in the framework of the Health 
Programme.”

The Toolkit for Event Organisers — European Organ and Tissues Donation Day.  

The brochure is available in print and electronic format.

and their families, organ donor families, 
healthcare professionals);

non-commercial and professional organ and 
tissue donation and transplantation;

(cid:98)(cid:553) to establish trust among the general 
public towards responsible, ethical, 

 Promotion of the European Donation Day 
event should stress the fundamental principles of 
organ donation and transplantation: solidarity, 
non-profit orientation, social awareness, gratitude 
and compassion. 
EDD toolkit

(cid:98)(cid:553) to share and discuss challenges and 

innovations in transplant medicine among 
healthcare professionals;

(cid:98)(cid:553) over the long term to increase the number 

of organ and tissue donors.

‘This publication presents guidelines, instruc-
tions and recommendations for organising an 
EDD. It ﬁlls an important gap in this ﬁeld at 
the European level. The publication addresses, 
in an appropriate and up-to-date way, social 
actors who ought to be acquainted with the 

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

171

importance  of  celebrating  European  Dona-
tion Day as well as of donor activities them-
selves. Through this publication on EDD and the 
organisation of events, the trust, importance, 
and humanity of organ donation is addition-
ally emphasised. The toolkit is a professionally 
prepared and well-designed booklet which will 
also be of interest to other organisers of similar 
events,’ explains Prof. Dr Eldar M. Gadžijev as an 
introduction at the webpage, where the toolkit 
can be downloaded for free (see infobox below).

Dissemination of project results to 
stakeholders

The  toolkit  was  printed  and  distributed  in 
750 copies, while electronic copies were dis-
tributed to an international group of approxi-
mately 1 400 stakeholders. The project has set 
up and maintains a website where all project 
related documents and resources are available 
(www.europeandonationday.org) for those who 
are planning to organise a Public Awareness-
Raising  Day  in  Organ  Donation,  such  as  the 
European Donation Day.

Slovenian Prime Minister Borut Pahor (centre) expressed his commitment and support to organ donation by participating in the event ‘Run for life 

and joy’ (EDD Toolkit)

172

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

EUROPEAN
DONATION 
DAY

ORGAN

TIS SU E

To o l k i t   fo r   Eve nt   O rga n i ze rs

Further information: 

funding from the European Union in the framework of the Health 
Programme.”

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=20081109 

Project website 
http://www.europeandonationday.org/ 

The toolkit: 
http://www.europeandonationday.org/index.php?option=com_content&view=article&id=5&Itemid=7 

Project team: 

Zavod R Slovenije za presaditve organov in tkiv Slovenija-transplant  
Zaloška Cesta 7  
PO-BOX  
1000 Ljubljana  
SLOVENIA  
Tel. +386 13006862  
Fax +386 13006866  
E-mail: danica.avsec@slovenija-transplant.si 

Associated partners: 

(cid:97)(cid:149) Austria Transplant, Austria
(cid:97)(cid:149) Czech National Coordinating Centre, Institut Klinicke a Experimentalni Mediciny, Czech 

Republic

(cid:97)(cid:149) Ministry of health and social welfare Republic of Croatia, Croatia
(cid:97)(cid:149) Martin Faculty Hospital Dept of Transplant and Vascular Surgery, Slovakia

EU contribution

This project has received co-funding from the European Union in the framework of the  
Health Programme 2008–2013 (Grant: 20081109).

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

173

European Quality System Indicators and methodology on 
Organ Donation (ODEQUS)

This project has received co-funding from the European Union in the framework of the  
Health Programme 2008–2013 (Grant: 20091103).

Important  diﬀerences  exist  in  the  national 
donation deceased and live donation rates and 
in the eﬀectiveness of donation programmes 
among the European countries.

This implies that European citizens have diﬀer-
ent chances to undergo organ transplantation 
depending on where they live. These diﬀerences 
can be partly explained by the type of donation 
programmes implemented but other issues such 
as the organisational structure of their donation 
services, their eﬃciency and social factors have 
also been seen to have considerable impact.

Previous best practices analysis in organ donation 
show that evaluation tools are an important part 
of quality systems. Their utilisation should ulti-
mately increase the number of citizens attending 
the European donation programmes, regardless 
of economic, legal or cultural diﬀerences.

ODEQUS intends to increase the 
eﬃciency of organ donation in 
European hospitals by creating 
useful evaluation tools

The ODEQUS — Organ Donation European Qual-
ity System — project intends to increase the eﬃ-
ciency of organ donation in all European countries 
by creating useful evaluation tools. The project 
is the joint eﬀort of 14 associated partners and 
ﬁve collaborating partners, including altogether 
16 countries from Europe. It is coordinated by the 
University of Barcelona. The project spans from 
October 2010 until September 2013.

Therefore the general objective of ODEQUS is 
to determine the standards of best practices 
and to develop quality indicators for donation 
a#er brain death (DBD), donation a#er cardiac 
death (DCD) and living donation (LD) in order 
to create tools to evaluate the overall quality 
in organ donation.

The project is working in the following areas to 
set up the quality indicator system:

(DBD, DCD and LD) focused mainly at 
hospital level;

(cid:98)(cid:553) to create quality indicators in order to 

assess organisational structures, clinical 
procedures and outcomes on the three 
types of organ donation;

(cid:98)(cid:553) to develop auditing tools in order to 
evaluate the implementation of best 
practices described in the quality criteria 
and used by the quality indicators;

(cid:98)(cid:553) to train healthcare professionals on how to 
use the quality indicators and the auditing 
tools.

(cid:1)

(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)
(cid:1)

(cid:1)
(cid:1)
(cid:1)
(cid:1)

(cid:1)

Quality Criteria 

(cid:21)(cid:27)(cid:40)(cid:41)(cid:31)(cid:37)(cid:36)(cid:1)(cid:12)(cid:23)(cid:47)(cid:1)(cid:63)(cid:61)(cid:62)(cid:64)(cid:1)

(cid:98)(cid:553) to identify and develop quality criteria in 

the three diﬀerent types of organ donation 

A dra$ of the quality criteria developed by ODEQUS is already available on the 

project website (http://www.odequs.eu/pdf/odequs_quality_criteria.pdf)

174

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

The ODEQUS tools created are designed to be 
wide enough to be implemented in diﬀerent 
target hospitals and may be later exported to 
other European countries.

The ODEQUS tools created are designed 
to be wide enough to be implemented 
in diﬀerent target hospitals

The ODEQUS activities so far have identiﬁed and 
systematised the standards on best practices in 
the three types of organ donation, through litera-
ture review, research for evidence based on best 
practices and the performance of a comparative/
benchmarking study. Results have been compiled 
in the comparative study report and on a quality 
criteria document. A dra# of the quality criteria 
developed by ODEQUS is already available on 
the project website (http://www.odequs.eu/pdf/
odequs_quality_criteria.pdf).

ODEQUS has developed and created 
the quality indicators on organ 
donation services organisational 
structures and clinical procedures

ODEQUS has developed and created the qual-
ity indicators (QIs) on organ donation services 

organisational  structures  and  clinical  proce-
dures,  based  on  the  comparative  study  and 
quality  criteria  (QCs).  The  ﬁelds  taken  into 
account for measuring the organisational struc-
tures have been: legal framework, accreditation 
and certiﬁcation, organisation, human resources 
(job description — core competences), mate-
rial resources (oﬃce, equipment, etc.), ﬁnances 
(sources/payment), services oﬀered, marketing 
for improving outcomes, media/dissemination 
(information systems), education and research.

Clinical process related to the three types of 
organ donation have been considered as fol-
lowing:  donor  identiﬁcation;  clinical  evalua-
tion; death diagnosis; family/personal consent; 
donor maintenance; organ viability evaluation 
and placement, surgical organ recovery; organ 
preservation; number of donors, organs and 
number of transplants.

A 2-day training course on quality 
indicators has been developed

A 2-day training course on quality indicators was 
developed and implemented for 11 people in Lis-
bon (Portugal) on April 2011. The trainings are 
to enable them to document the QS, to create 
the QI, and use the evaluation tools. A#er the 
implementation of QS and QI in the respective 

ODEQUS website at http://www.odequs.eu/

Flyer ODEQUS:v3  11/03/11  18:03  Página 1

Q!

ODEQUS

Organ Donation European Quality System

There are wide differences in the effectiveness of donation programs among the European countries. The national

donation rates may range, for example, from 1.5 deceased donors pmp* in Bulgaria to 34.4 deceased donors pmp in

Spain. Kidney living donation rates vary from 1.2 pmp in Poland to 25.3 pmp in the Netherlands (data from 2009). 

Such data reveal that the possibilities of European citizens getting an organ graft differ notably, depending on where
they live. These differences can be partly explained by the type of donation programs implemented, but other issues
such as the structure of their donation services, their efficiency and social factors have a big impact. 

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

175

hospitals, an external evaluation will be done in 
at least one participating donation service.

For this reason, the ODEQUS Project (Organ
Donation  European  Quality  System)  aims  at
creating useful evaluation tools meant to incre-
ase  the  efficiency  of  organ  donation  in  all
European countries. 

A further step in the ODEQUS project is to organ-
ise the next training course in October in Lisbon, 
Portugal. The audits are planned to be imple-
mented from October to December in 2012.

rences.

According to an analysis of the the best practi-
ces in organ donation, such tools are going to be
designed  and  included  in  a  Quality  System.
They should help to increase the number of citi-
zens  attended  by  the  European  donation  pro-
grams, despite economic, legal or cultural diffe-

The ODEQUS project targets a wide 
range of stakeholders and target 
groups with its results

The ODEQUS project targets a wide range of 
stakeholders and target groups with its results: 
national health authorities, NGOs, donor hospi-
tals, transplant centres and coordinators, tissue 
banks, critical care members, ethicists, physi-
cians, patient associations, pharmaceuticals, 
insurance companies, specialised and general 
media, donors, donor’s families, waiting candi-
dates, recipients and citizenship.

ODEQUS Project involves 12 associated part-
ners  and  5  collaborating  partners  and  it  is  co-
financed  by  the  European  Agency  for  Health
and Consumers (EAHC 20091108).
* per million population

The project website is available at www.odequs.eu 
where main outputs will be available. A layman 
brochure has been developed and distributed. 
The ODEQUS project has been introduced and its 
results disseminated in diﬀerent congresses and 
international meetings, as well as in competent 
authority meetings. The ﬁnal meeting of ODEQUS 
was held at the end of May 2013 in Barcelona.

(cid:2)

(cid:2)
(cid:2)

(cid:2)
(cid:2)
(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)
(cid:2)

Associated partners              
Collaborating partners

Partners in the ODEQUS project

Flyer ODEQUS:v3  11/03/11  18:03  Página 2

Associated Partners

Collaborating Partners

Objectives

Medical University of Vienna – Austria
Ministry of Health and Social Welfare – Croatia
Agence de la Biomedecine – France
Deutsche Stiftung Organtrasplantation – Germany
Fondazione per l’Incremento dei Trapianti d’Organo e
Tessuti – Italy
Poltransplant – Poland
Autoridade para os Serviços de Sangue e da Transplantação
– Portugal
Fundatia Pentru Transplant – Romania
Donation and Transplantation Institute – Spain
Fundación Investigación Biomédica Hospital Gregorio
Marañón – Spain
Karolinska Institutet – Sweden
NHS Blood and Transplant – United Kingdom

dures.

Helenic Transplant Organisation – Greece
Hungarian National Blood Transfusion
Service – Hungary
Mater Dei Hospital – Malta
Slovenija Transplant – Slovenia
Medicalpark Antalya Hospital Complex –
Turkey

The main objective of the ODEQUS Project is to define a methodology to assess the per-
formance of organ procurement at hospital level.

More specifically, other objectives of the project are:

! to identify and develop Quality Criteria (QC) in the 3 different types of organ dona-

tion (DBD, DCD and LD)  focused mainly at hospital level;

! to create Quality Indicators (QI) in order to assess the organizational structures, clini-

cal procedures and outcomes on the 3 types of organ donation;

! to develop auditing tools in order to evaluate the implementation of best practices

described in the QC and used by the QI;

! to train healthcare professionals on how to use the QI, checklists and auditing proce-

Objectives of the project

Methods and means 

The standards of best practices will be identified according to:

! Expert’s opinion

! Literature review and research for evidence, whenever possible

! Survey sent to the European countries to know about the current use of QI at hospital level

The main fields to be considered to assess the organizational structures will be: legal frame-

work, accreditation and certification, organization, human and material resources, education

and research. 

As for the clinical procedures, the main fields to be considered will be: donor identification,

clinical evaluation, death diagnosis, donor maintenance, family/personal consent, organ via-

bility, surgical recovery and preservation, number of donors/organs/transplants. 

Two types of training will be designed:

! Creation of QC and QI

conducted in selected hospitals.

! Use of the evaluation tools derived from the QC and QI. External evaluations will be

Strategic relevance 

With the aim of representing the European countries’ diversity, the following criteria have

been considered for the selection of partners: 

! Expertise on some type of donation

! Experience in previous collaborative European projects such as Alliance-O, ETPOD,

DOPKI, EQSTB, EULID

! Diverse efficiency of the donation programs in their countries

! Geographical and social situation

The tools to be created should be wide enough to be implemented in different target hos-

pitals and may be later exported to other European Countries.

Q!

ODEQUS

www.odequs.eu 

odequs@odequs.eu

ODEQUS Project Coordination 

Transplant Procurement Management - TPM

Parc Científic de Barcelona

Baldiri Reixac, 4-8. Torre I, planta 8

08028 Barcelona - Spain

176

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Flyer ODEQUS:v3  11/03/11  18:03  Página 1

Q!

ODEQUS

Organ Donation European Quality System

Further information: 

There are wide differences in the effectiveness of donation programs among the European countries. The national
donation rates may range, for example, from 1.5 deceased donors pmp* in Bulgaria to 34.4 deceased donors pmp in
Spain. Kidney living donation rates vary from 1.2 pmp in Poland to 25.3 pmp in the Netherlands (data from 2009). 

Such data reveal that the possibilities of European citizens getting an organ graft differ notably, depending on where
they live. These differences can be partly explained by the type of donation programs implemented, but other issues
such as the structure of their donation services, their efficiency and social factors have a big impact. 

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=20091108 

For this reason, the ODEQUS Project (Organ
Project website 
Donation  European  Quality  System)  aims  at
creating useful evaluation tools meant to incre-
http://www.odequs.eu/ 
ase  the  efficiency  of  organ  donation  in  all
European countries. 

Project team: 

According to an analysis of the the best practi-
ces in organ donation, such tools are going to be
designed  and  included  in  a  Quality  System.
They should help to increase the number of citi-
zens  attended  by  the  European  donation  pro-
grams, despite economic, legal or cultural diffe-
rences.

(cid:2)

ODEQUS Project involves 12 associated part-
ners  and  5  collaborating  partners  and  it  is  co-
financed  by  the  European  Agency  for  Health
and Consumers (EAHC 20091108).
* per million population

Universitat de Barcelona — UB  
(cid:2)(cid:2)
Gran Via de les Corts Catalanes 585  
PO-BOX  
08007 Barcelona  
SPAIN  
Tel. +34 934037687  
Fax +34 931986076
Associated Partners

(cid:2)
(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)
(cid:2)

(cid:2)
(cid:2)
(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)

(cid:2)

Associated partners              
Collaborating partners

Collaborating Partners

Helenic Transplant Organisation – Greece
Hungarian National Blood Transfusion
Service – Hungary
Mater Dei Hospital – Malta
Slovenija Transplant – Slovenia
Medicalpark Antalya Hospital Complex –
Turkey

Associated partners: 

Medical University of Vienna – Austria
Ministry of Health and Social Welfare – Croatia
Agence de la Biomedecine – France
Deutsche Stiftung Organtrasplantation – Germany
Fondazione per l’Incremento dei Trapianti d’Organo e
Tessuti – Italy
Poltransplant – Poland
Autoridade para os Serviços de Sangue e da Transplantação
– Portugal
Fundatia Pentru Transplant – Romania
Donation and Transplantation Institute – Spain
Fundación Investigación Biomédica Hospital Gregorio
Marañón – Spain
Karolinska Institutet – Sweden
NHS Blood and Transplant – United Kingdom

(cid:97)(cid:149) Agence de la Biomèdecine, France
(cid:97)(cid:149) Autoridade para os Serviços de Sangue e da transplantação — ASST, Portugal
(cid:97)(cid:149) Deutsche Sti$ung Organtransplantation — DSO, Germany
(cid:97)(cid:149) Donation Transplant Institute, Spain
(cid:97)(cid:149) Fondazione per l’incremento dei Trapianti d’Organo e Tessuti Onlus, Italy
(cid:97)(cid:149) Fundatia Pentru Transplant Romania, Romania
(cid:97)(cid:149) Karolinska Institute, Sweden
(cid:97)(cid:149) Medizinische Sti$ung Universität Wien — MUW, Austria
(cid:97)(cid:149) Ministry of Heath and Social Welfare Republic of Croatia, Croatia
(cid:97)(cid:149) NHS Blood and Transplant, United Kingdom
(cid:97)(cid:149) Polish Transplant Coordinating Centre, Poland
(cid:97)(cid:149) Fundacion Investigacion Biomedica Hospital Gregorio Maranon, Spain
(cid:97)(cid:149) Fundació Bosch I Gimpera — FBG (from 16 December 2010), Spain
(cid:97)(cid:149) Servicio Madrileño de Salud — SERMAS (from 16 August 2010), Spain

EU contribution

This project has received co-funding from the European Union in the framework of the  
Health Programme 2008–2013 (Grant: 20091108).

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

177

Coordinating a European Initiative among National 
Organisations for Organ Transplantation (COORENOR)

This project has received co-funding from the European Union in the framework of the Health  
Programme 2008–2013 (Grant: 20091103).

Donation and transplant programmes and rates 
greatly diﬀer in the Member States of the Euro-
pean Union. Some countries have established 
systems, other have less experience in this ﬁeld. 
Furthermore, not all programmes are available 
in all countries. This creates inequality in access 
to transplantation for patients in the various 
countries. The diﬀerences in the way the coun-
tries organise their donation and transplanta-
tion processes could be a reason for such a 
varying picture in accessibility and outcomes.

in organ transplantation in the participating 
EU countries, focusing on speciﬁc activities in 
major issues such as deceased donation, living 
donation and cross-border organ exchange. 

Altogether 13 organisations from 10 diﬀerent 
countries, the majority of which are from the 
new EU Member States, have joined their eﬀorts 
to implement the COORENOR project from June 
2010 until December 2012. The project was coor-
dinated by the Italian National Transplant Centre. 

To face such challenges, the COORENOR pro-
ject’s general aim was to establish a coordi-
nated network between national programmes 

In order to reach the project objectives, part-
ners have organised project activities in four 
core work packages.

Figure 1: Representative transplant systems: main organisational and responsibility levels (systems A, B: B1/B2, C and D). *: Delegated body 

is also in charge of cross-border exchanges out of members, when required. #: National transplant organisation being more or less involved, 

depending on the Member State concerned. Tx C: Transplant coordinator. MD: Medical doctor. PhD: Doctor in science. The coordination of organ 

proposal stands for a common action of actors involved. Cross-border organ exchanges being dealt either with national or supranational 

transplant organisations (Agence de la biomédecine, COORENOR, 2012, ESRI).

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Investigating, comparing and 
benchmarking national/regional 
transplantation programmes

Building on the main outcomes of earlier pro-
jects  such  as  the  ALLIANCE-O  project  (see 
pages 141–145), partners surveyed the Mem-
ber States, acceding states and other selected 
countries, altogether 35, on their existing trans-
plant programmes. A comprehensive overview 
is on the way to help create a complete pic-
ture of some fundamental mechanisms in the 
organisation  of  transplantation  systems  in 
these countries with a special focus on the new 
EU Member States.

A proﬁle for each country is under preparation 
where,  in  addition  to  general  country  infor-
mation, all the pivotal details on transplant 
programmes such as how countries organise, 
regulate and fund their transplant system will 
be included. ‘The overview also gives useful 
information  on  the  implementation  and  the 
transposition of the Directive 2010/53/EU and 
the Action Plan,’ says Paola Di Ciaccio, project 
coordinator, Head of Foreign Aﬀairs Division at 
the Italian National Transplant Centre (Fig. 1).

Additionally,  a  European  benchmarking  pro-
gramme  is  being  developed  by  the  project. 
This process started with identifying a set of 
indicators, along which the programmes can be 
compared and achievable benchmark models 
can be identiﬁed (Fig. 2, 3).

Finally,  recommendations  on  further  initia-
tives and future work are being prepared on 
the challenges of issuing common European 
Guidelines on diﬀerent aspects of organ dona-
tion  and  transplantation  (i.e.  organisational 
strategies and educational methodologies).

Deceased donation: cerebral death 
assessment, procurement, safety and 
quality, allocation and outcomes

This work has focused on the analysis of exist-
ing  systems  regarding  scientiﬁc  aspects  of 
deceased donation. The starting points of this 
work were the results of earlier projects such 
as  the  ALLIANCE-O  and  DOPKI.  Information 
was collected via three questionnaires from the 
then 27 European Union Member States and two 
international organisations (Eurotransplant and 
Scandiatransplant).

Figure 2: Number of hospitals performing transplantation in 2010 (including those 

authorised for such activities but that were non-active that year; Agence de la 

biomédecine, COORENOR, 2012, ESRI).

Figure 3: Number of transplant teams/programmes in 2010 (including those 

authorised for such activities but that were non-active that year; Agence de la 

biomédecine, COORENOR, 2012, ESRI).

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

179

 The project could successfully reach competent 

authorities, who are managing the Action Plan, 
on different subjects to work together and build 
a network among them. We expect that sharing 
possible solutions for common problems and  
good practices can bring the desired  
improvements. 

Alessandro Nanni Costa, scientiﬁc project leader, general director at the Italian 

National Transplant Centre

The ﬁrst survey and analysis focused on laws 
and/or  protocols  concerning  the  diagnosis 
of brain and cardiac death and critical steps 
related to deceased donation in all EU coun-
tries. Special eﬀort was made to highlight pos-
sible diﬀerences in daily practice of the identi-
ﬁcation of potential donors and the diagnosis 
of death. ‘This work will give useful information 
to a new joint action named ACCORD, which has 
a work package devoted to the end of life care 
pathways  that  can  lead  to  organ  donation,’ 
explains Paola Di Ciaccio.

The second survey and analysis have focused 
on  public  awareness  campaigns  regarding 
deceased organ donation and their impact on 
organ donation.

The  third  survey  and  analysis  assessed  the 
organisational aspects of existing programmes. 
The output here was an overview of medical 
centres accredited to organ transplantation, the 
training of healthcare professionals and exist-
ing quality assurance programmes.  

Figure 4: IT portal for cross-border organ exchange

180

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Figure 5: COORENOR main deliverables

Living donation: maximising the safety 
of living donors

The  main  goal  of  this  work  is  to  develop  a 
common European strategy aiming to increase 
living kidney donor transplantation. The then 
27 EU Member States were surveyed about 
many diﬀerent aspects of living donation to be 
able to give a comprehensive overview of liv-
ing organ donation practices. Issues included 
legal regulations, organisational structure and 
medical providers, evaluation of living donor, 
the use of extended categories of living donors, 
methods to reduce surgical donor’s complica-
tions, long-term follow-up of living donor, risk 
assessment and pre-emptive management to 
prevent donors complications, ethical and social 
consideration regarding living organ donation.

The work performed also included the organi-
sation of a scientiﬁc expert meeting in June 
2011 in Warsaw where the results of the sur-
vey was presented and participants discussed 
the possible recommendations for the strategy.

Cross-border organ exchanges

In European countries where no supranational 
organisations are devoted to organ exchange 
practices,  organ  exchange  takes  place  on 
a voluntary basis or through bilateral agree-
ments. Additionally, no information is collected 
about organ exchange activities, on surplus and 
demand on international level. 

The aim of this COORENOR work package was 
therefore to provide a comprehensive overview 
of cross-border organ exchange for transplan-
tation with a special focus on existing legal 
 regulations on organ exchange and the ﬁnan-
cial, organisational and logistical aspects. This 
work package also aimed to develop the main 
outline of an IT registry tool to serve interna-
tional collaboration in organ exchanges. 

The project asked the then 27 EU Member States 
and international organisations to provide data 
on  a  wide  range  of  issues  in  organ  exchange 
activities such as cross-border and international 
organ  exchange  policies;  number  and  type  of 
organs exchanged and features of donors and 
recipients; existing organ exchange agreements; 
and presence and role of national/international 
organisations responsible for cross-border organ 
exchanges.

In addition to providing the ﬁrst comprehen-
sive picture of the international organ exchange 
practices  in  Europe,  the  work  highlights  the 
 various  problematic  aspects  of  the  present 
cross-border organ exchange practices.

In  order  to  support  international  organ 
exchange, the main features of an IT platform 
were identiﬁed. The IT application is presently 
running among project partners. The platform 
was designed to be user-friendly, to be able to 
connect organ supply with demand in a quick 
and safe electronic manner, and to be cheap 
as far as costs for maintenance are concerned. 

A  basic  set  of  necessary  information  to  be 
uploaded on organ oﬀers and possible demand 
was also identiﬁed by the project (Fig. 4). The IT 
platform for cross-border organ exchange will 
be further developed in the framework of the 
Joint Action FOEDUS..

Spreading the results of the COORENOR 
project to the main stakeholders

Information on the project is available on the 
project  website  www.coorenor.eu.  The  main 
COORENOR results and outputs are available 
here for the public. The COORENOR Laymen 
Brochure (166),  available  both  electronically 
and in printed format, has been disseminated 
among partners for local information provision. 
Two layman’s brochures on deceased organ 
donation and living kidney donation were pre-
pared and translated to national languages in 
countries where organ donation is less devel-
oped, namely Latvia, Lithuania and Romania. 

The general structure of the IT portal for organ 
exchanges and the preliminary results of the 
whole project have been widely disseminated 
during  Competent  Authority  and  CD-P-TO 
meetings. Furthermore, the COORENOR project 
was presented among the success stories of 
the Public Health Programme at the High-Level 
Conference ‘EU Health Programmes: results and 
perspectives, in Brussels, 3 May 2012, organ-
ised by the European Commission’s DG SANCO 
and its Executive Agency. ‘Several posters have 
been prepared for the European Health Forum 
Gastein and for other international meetings, 
to  disseminate  COORENOR  results  to  high-
level policymakers and to the general public’, 
explains Paola Di Ciaccio.

The project ended on 24 December 2012 and 
all the results were presented during the ﬁnal 
meeting which was hosted in Budapest by the 
leader of the dissemination WP.

Main results, expected impact and 
added value for EU citizens

COORENOR  has  generated  comprehensive 
knowledge on the current situation of organ 
donation  and  transplantation  in  the  wider 

(166)  Available on the project website: http://coorenor.eu/images/

stories/download/coorenor.pdf

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181

Organ exchanged through the web portal,  
20 November 2012

The COORENOR portal started running on 1 July 2012 and some 
partners have successfully started using this tool for oﬀering surplus 
organs to all involved organ exchange organisations working in Europe, 
thus increasing the possibility to avoid wasting useful resources and the 
chances of patients to be transplanted.
The ﬁrst success of the portal was the exchange of a heart of an infant 
from Prague that saved the life of a baby girl in Rome in last August, 
thanks to this European system of quick sharing of information on 
available human organs.
When a 1-year-old child died in Prague in early August, his parents gave 
consent to his organs being donated to patients who may need them 
and since no suitable recipient was present on the national waiting 
list, the doctors entered the relevant data in the COORENOR Internet-
based system presenting oﬀers and demands for human organs from 
participating countries.
The Italians were the ﬁrst to react through the Italian Gate to Europe oﬃce.
‘We received an answer from Rome in a minute a#er publishing our 
oﬀer,’ told Pavel Brezovsky, head of the Czech Transplant Coordinating 
Centre (KST). On Monday night, a private plane with a surgical team 
arrived in Prague, and on Tuesday morning the Czech infant’s heart 
was given to an 11-month-old patient in Rome who had waited for a 
heart since April. A mere 27 hours elapsed between the oﬀer’s entry in 
COORENOR and the surgery in Rome.
A new successful exchange was performed on October 30, 2012. 
A COORENOR donation alert was launched by Polish transplant 
organisation, Poltransplant. The donor was a 4-year-old male that had 
died in Krakow due to a brain hemorrage. The Italian Gate to Europe 
coordination staﬀ reacted ﬁrst to the alert and the liver and two lungs 
were accepted by some Italian transplant centres. The Bergamo 
Transplant Centre split the liver to allow two transplants: the le$ liver 
part was transplanted in a 1-year-old baby and the right part in a 
4-year-old child, both patients on a waiting list at Bergamo Transplant 
Centre. The lungs were retrieved by the Padua Transplant Centre and the 
same team transplanted them in a 9-year-old child. All the transplants 
were successfully performed with the functional recovery of the organs.

News from the COORENOR website on the successful start of the organ exchange platform 

(http://www.coorenor.eu/)

Europe and identiﬁed possible common Euro-
pean pathways for improvement. Project results 
are expected to contribute to the improvement 
of overall quality and safety of transplants in 
the European Union, to better traceability of 
international exchanges and visibility of com-
petent authorities in Member States.

‘The project could successfully reach competent 
authorities, who are managing the Action Plan, 
on diﬀerent subjects to work together and build 
a network among them,’ says Alessandro Nanni 
Costa, scientiﬁc project leader, general director 

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at the Italian National Transplant Centre. ‘We 
expect that sharing possible solutions for com-
mon problems and good practices can bring the 
desired improvements’ (Fig. 5).

Furthermore, ‘In Europe, organ donation and 
exchange  is  part  of  public  life  under  public 
rules. The results of COORENOR — respecting 
the  various organisations, agencies and authori-
ties — can contribute to these public rules and 
help  raising  better  public  awareness  about 
national transplantation programmes, the prob-
lems and possible solutions,’ shared Mr Nanni 
Costa on his thoughts on the added value of 
COORENOR for European citizens.

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183

Further information: 

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=20091103 

Project website 
http://www.coorenor.eu/ 

Project team: 

Centro Nazionale Trapianti (CNT)  
Istituto Superiore di Sanità — ISS  
Viale Regina Elena 299  
00161 Rome RM  
ITALY  
Tel. +39 0649904040 
Fax +39 0649904101 
E-mail: centronazionale.trapianti@iss.it 

Associated partners: 

(cid:97)(cid:149) Agence de la biomedecine — ABM, France
(cid:97)(cid:149) Eurotransplant International Foundation — ETI, Netherlands
(cid:97)(cid:149) Gesundheit Österreich GmbH — ÖBIG (until 15/11/2010), Austria
(cid:97)(cid:149) Fundeni Clinical Institute — FCI, Romania
(cid:97)(cid:149) Koordinaní stedisko transplantací — KST, Czech Republic
(cid:97)(cid:149) Lithuanian National Transplantation Bureau — NTB, Lithuania
(cid:97)(cid:149) Univerzitna Nemocnica Martin — UNM, Slovakia
(cid:97)(cid:149) Medical University Of Warsaw — MUW, Poland
(cid:97)(cid:149) Országos Vérellátó Szolgálat — HNBTS, Hungary
(cid:97)(cid:149) Paraskevaidion Surgical and Transplant Center of Cyprus — PSTC (until 31 December 

2010), Cyprus

(cid:97)(cid:149) Pauls Stradins Clinical University Hospital, Latvian Transplantation Centre — PSCUH, 

Latvia

(cid:97)(cid:149) Polish Transplant Coordinating Centre — POLTRANSPLANT, Poland

EU contribution

This project has received co-funding from the European Union in the framework of the  
Health Programme 2008–2013 (Grant: 20091103).

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2ND Conference on Organ Transplantation: Ethical,  
Legal and Psychosocial Aspects — Expanding the  
European Platform (ELPAT)

This project has received co-funding from the European Union in the framework of the Health  
Programme 2008–2013 (Grant: 20094102).

The  general  objective  of  the  conference  was 
to expand the Ethical, Legal and Psychosocial 
Aspects of organ Transplantation (ELPAT) plat-
form towards the new EU Member States, can-
didate  countries  and  other  eastern  European 
countries; and to foster improvement in donation 
policies and practices. The conference holder was 
the European Society for Organ Transplantation.

Speciﬁcally, the conference aimed to provide an 
opportunity to increase ELPAT members from 
eastern European countries and their partici-
pation in study projects, gaining insight in the 
diﬀerences  between  national  organ  donation 

Conference Proceedings Book, available through PABST publishers

policies and increasing knowledge and aware-
ness of the problems faced in the area of dona-
tion and transplantation in EU Member States 
with a focus on the new MS.

The conference ‘Organ Transplantation: Ethical, 
Legal and Psychosocial Aspects — Expanding 
the European Platform’ took place on 17–20 
April 2010 in the World Trade Centre Rotterdam, 
the Netherlands.

‘ELPAT attempts to be the movement from which 
research  groups  can  structure  their  eﬀorts  by 
working together. Especially the rapid expansion of 
the European Union creates vast opportunities for 
cooperation between the various nations, although 
at the same time it may create problems that we 
have  to  face,  e.g.  equal  access  to  healthcare,’ 
Prof. Willem Weimar, Chair, Professor of Internal 
Medicine at the Erasmus University Rotterdam, 
the Netherlands, welcomed the conference par-
ticipants on behalf of the organising committee.

The conference addressed a wide range of dif-
ferent types of stakeholders such as medical 
scientists; experts in (bio-)ethics, law and psy-
chology; medical practitioners in transplanta-
tion; students; public health professionals and 
health policymakers; civil society and interna-
tional organisations.

The overriding theme of the 
conference (167) was crossing borders 
in organ transplantation

Topics  during  plenary  and  parallel  sessions 
reﬂected the focus topics of the ELPAT Work-
ing Groups: organ tourism and paid donation; 
diverse populations; legal and ethical bounda-
ries; deceased donation; psychological care for 
living  donors  and  recipients;  and  Samaritan/
unrelated donation. The Conference programme 
included plenary morning sessions, late-morning 

(167)  The Programme and abstract book of the Conference is 

available here: http://www.esot.org/Meetings/PublicPlatform/
MeetingPlatform.aspx?MeetingPlatformUI=6

meet-the-expert sessions, free communications 
and a#ernoon workshops and discussions.

The interest in the conference was high as indi-
cated by the total number of registrations and 
the higher than expected number of abstracts 
received  prior  to  the  conference.  Altogether 
297 people registered for the conference from 
44 diﬀerent countries: 30 European and 14 non-
European. Due to the volcanic eruptions in Iceland, 
a total of 175 people managed to attend, out of 
which 162 people from 12 European countries.

Successful expansion of the ELPAT 
platform and strengthened cooperation 
with new EU Member States

One of the main objectives of the conference 
was the expansion of the ELPAT platform to 
countries from eastern Europe. As a result of 
the conference, the ELPAT platform successfully 
expanded with about 23 new members from the 
new EU Member States and candidate countries.

Additionally, a new project was launched under 
the Seventh Framework Programme titled ‘Liv-
ing Organ Donation in Europe’ (see page 208). 
Half of the participating partners in this pro-
ject were from the new EU Member States and 
almost all of the project partners were involved 
in the ELPAT conference either as organiser, 
chair speaker or delegate. 

As a further direct post-conference achieve-
ment, a follow-up expert working group meet-
ing took place in October 2011 in Soﬁa, Bul-
garia. The Bulgarian Centre for Bioethics invited 
ELPAT experts from ‘old’ EU Member States to 
share information and knowledge with the aim 
to improve donation and transplantation in Bul-
garia. The contacts established for this meeting 
were a direct result from personal meetings at 
the 2nd ELPAT conference.

Sharing experiences and knowledge 
for improved donation policies and 
practices in the future

The conference had contributed to the improve-
ment  of  knowledge  on  the  various  ethical, 
legal  and  psychosocial  aspects  of  donation 
and  transplantation  through  its  wide  range 
of innovative topics presented in the scientiﬁc 
programme and through the participation inter-
nationally renowned experts during and a#er 
the conference.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

185

 ELPAT attempts to be the movement from 

which research groups can structure their efforts by 
working together. Especially the rapid expansion of 
the European Union creates vast opportunities for 
cooperation between the various nations, although 
at the same time it may create problems that we 
have to face, e.g. equal access to healthcare. 
Prof. Willem Weimar

How Eyja%allajokull endangered the conference

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ELPAT conference proceedings book

A book on the 2nd ELPAT Conference proceed-
ings was compiled a#er the event with the aim 
to share novel information and increase know-
ledge in the ﬁeld of ethical, legal and psycho-
social aspects of organ transplantation. The 
book, entitled ‘Organ Transplantation: Ethical, 
Legal  and  Psychosocial  Aspects.  Expanding 
the European Platform’ (edited by W. Weimar, 
M.A. Bos and JJ Busschbach), was published 
by  Pabst  Science  Publisher  in  2011.  It  con-
tains over 50 papers from conference partici-
pants on a range of subjects that dominated 

contemporary policy and practice in the ethical, 
legal and psychological aspects of transplanta-
tion medicine.

All those who registered for the 2nd ELPAT Confer-
ence and ﬁrst authors of the publication received 
a free copy of the book. Additionally, ‘the publica-
tion of the book was announced through ELPAT/
ESOT dissemination channels such as the ELPAT/
ESOT  Newsletter  to  around  9  000  transplant 
professionals in the world,’ explained Frederike 
Ambastsheer,  ELPAT  coordinator,  at  Erasmus 
University Rotterdam. The book can be ordered 
through the ELPAT website (www.elpat.org).

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187

Further information: 

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=20094102 

Conference booklet: 
http://www.esot.org/Files/Elpat/Content_Files/txmed_1-2007.pdf 

Project team:

European Society for Organ Transplantation — ESOT  
Hanzeplein 1  
9713 GZ Groningen  
NETHERLANDS  
Tel. +31 642668336  
Fax +31 104366372

EU contribution

This project has received co-funding from the European Union in the framework of the  
Health Programme 2008–2013 (Grant: 20094102).

188TRANSPLANTATION AND TRANSFUSIONJoint Action on Mutual Organ Donation and Transplantation Exchanges: Improving and developing deceased organ donation and transplantation programmes (MODE)This joint action has received co-funding from the European Union in the framework of the Health Programme 2008–2013 (Grant: 20102101).Eleven partners, the majority of them from the new EU Member States, have worked together to implement MODE between January 2011 and June 2012. The project was coordinated by the Italian National Transplant Centre. The main objective of MODE was to promote the transfer of best practices in the ﬁeld of deceased organ donation and transplantation in light of the implementation of Directive 2010/53/EC on quality and safety of human organs. It aimed to facilitate the creation of positive synergies among participating Mem-ber States to support decision-making.Paola Di Ciaccio, project manager, at the Italian National Transplant Centre, explains the main concepts of MODE: ‘Organ dona-tion and transplantation have diﬀerent prac-tices and diﬀerent levels in the countries of Europe. Sharing knowledge and skills in selected ﬁelds of interest could be an incen-tive to overall progress in organ donation and transplantation.’The MODE partners have identiﬁed best prac-tices in deceased organ donation and trans-plantation. Based on their ﬁndings they facili-tated the sharing of best practices via organ-ising on-site visits in ﬁve countries and they provided specialised trainings. Identifying best practices  in deceased organ donationThe MODE partners self-assessed their respective national donation and transplanta-tion systems in a SWOT analysis with respect to the implementation of the Action Plan on Organ Donation and Transplantation (2009–2015). The project also mapped the interests and training needs of partners. Three prior-ity action areas were ﬁnally selected for the purposes of best practice sharing: promot-ing quality programmes to improve organ donation; organisational models for donation and transplantation; and evaluation of post-transplantation results. MUTUAL ORGAN DONATION AND TRANSPLANTATION EXCHANGESIMPROVING AND DEVELOPING CADAVERIC ORGAN DONATION AND TRANSPLANTATION PROGRAMSThe ﬁnal brochure summarising the results of MODE Joint Action The preparatory phase was an opportunity for all partner countries to analyse the organisational situations of donation and transplantation in their respective country from the point of view of the implementation of Directive 53/2010. Dr Alessandro Nanni Costa, scientiﬁc leader of the project (Italian National Transplant Centre)Dr Alessandro Nanni Costa, scientiﬁc leader of 
the project (Italian National Transplant Centre) 
(MODE White Paper) (168), explains the added 
value of MODE: ‘The preparatory phase was 
an opportunity for all partner countries to ana-
lyse the organisational situations of donation 
and transplantation in their respective country 
from the point of view of the implementation of 
Directive 53/2010.’

Using the ﬁndings of the assessments, MODE 
partners have developed and organised best 
practice transfer activities, namely the ﬁve on-
site visits and a set of specialised short- and/
or medium-term training courses.

On-site visits to facilitate  
best-practice transfer

Altogether ﬁve on-site visits took place during 
the MODE project. The visits were structured in 
a way that gave an opportunity to the hosting 
partners to present their organ donation and 
transplantation  systems  and  discuss  some 
speciﬁc practical areas in more detail. A#er 
each on-site event, the visiting partners evalu-
ated the programme and the implementation 
potentials of the presented best practices with 
respect to their own countries.

These on-site visits were considered as impor-
tant initial points for future bi- or multi-lateral 
cooperation  among  those  partner  countries 
and organisations who in the future wished 
to  improve  their  donation  practices  through 

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

189

 Organ donation and transplantation 

have different practices and different levels in 
the countries of Europe. Sharing knowledge and 
skills in selected fields of interest could be an 
incentive to overall progress in organ donation and 
transplantation. 

Paola Di Ciaccio, project manager,  

Italian National Transplant Centre

adapting best practices in their national con-
texts and health systems.

Speciﬁc trainings to promote  
best-practice transfer

The training topics were linked to the topics 
that  were  selected  for  the  on-site  visits,  so 
that all project eﬀorts aiming at the transfer of 
best practices were more eﬀective and focused 
on well-deﬁned items. Based on the training 
needs assessment and on the experiences of 
the on-site visits, the following Action Plan pri-
ority areas were selected for the specialised 
training courses:

(cid:98)(cid:553) traceability and bio-vigilance in 

organ transplantation, analysing how 
organisations perform in Europe and in 

MODE on-site visits and the presented best practices 

Date

7 June
2011

9 June
2011

20 June
2011

7 July
2011
12 July
2011

Hosting 
partner

ONT
Spain

Action plan goal

Priority action

Best practice

Increasing organ availability

Quality improvement 
programmes

Quality improvement,
quality management,
safety management

KST
Czech Rep.

Enhancing eﬃciency 
and availability of 
transplantation (TX) systems

Supporting and guiding 
organisational models

Protection against transmissible and 
neoplastic diseases, traceability

ASST 
Portugal

ST
Slovenia

CNT Italy

Enhancing eﬃciency and 
availability of TX systems

Enhancing eﬃciency and 
availability of TX systems

Supporting international 
exchange of organs for 
transplantations
Increasing deceased donation  
to their full potential

Interchange of organs  
between Member States

Multi-organ donors,  
international organ exchange

Improving quality and  
safety of TX

Evaluation of post-
transplantation results

Accreditation of TX centres, 
evaluation and auditing of TX results

Source: MODE White Paper, 2012.

(168)  MODE White Paper is available on the project website:  

www.mode-ja.org

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other developed countries, and what tools 
can be useful to implement to comply with 
the mandate of Directive 2010/45/EU on 
standards of quality and safety of human 
organs intended for transplantation;

(cid:98)(cid:553) quality assurance in the donation process as 
a means to evaluate the potential for organ 
donation and standardise the procedures 
and guidelines for improving the donation of 
organs from brain death donors;

(cid:98)(cid:553) accreditation of transplant centres and 

how to improve safety and quality in the 
allocation of organs and evaluation the 
outcomes of the transplantation process.

The specialised courses started with an e- learning 
session  that  took  place  between  27  April  and 
3 May 2012. This was followed by three 1-day 
face-to-face training courses in Spain, organised 
by the Organización Nacional de Trasplantes. The 
faculty of the training courses were experts who 
had European project experience related to the 
Action Plan in the selected ﬁelds.

The day-to-day sessions and their 
focus areas

7 May 2012: Reporting on adverse events and 
reactions

Altogether  20  people  (staﬀ  from  national 
organisations/competent authorities) partici-
pated from eight countries.

8 May 2012: The Quality Assurance Programme 
of the Donation Process in Spain: Key Factors to 
Improve (Workshop)

Eighteen  competent  authority  staﬀ  or  their 
appointed national experts took part in this 
workshop from nine diﬀerent countries.

9 May 2012: Quality assurance of the trans-
plantation process

Altogether, 18 people participated from eight 
diﬀerent countries on this specialised training 
course.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

191

Information about  
the project and its results

Information about the project and its results 
were drawn up in a ﬁnal document called the 
MODE White Paper. This document is publicly 
available on the project website: www.mode-ja.
org. The project has also published a Layman 
Brochure that summarises the main aspects 
of the MODE joint action (www.mode-ja.org). 
Five hundred copies of this brochure have been 
distributed  in  diﬀerent  events  by  partners. 
National  authorities  and  policymakers  have 
been informed about the activities and results 
of MODE in two competent authority meetings 
in 2011 and at the High-Level Conference — 
EU Health Programmes: results and perspec-
tives, organised by the European Commission 
on 3 May 2012. A wide range of target groups 
were reached through international events: 24 
presentations in four countries provided oppor-
tunity to present and discuss the status and 
results of the projects.

‘The innovative aspect of the project was, how-
ever, to allow partners to highlight their ﬁelds 
of interest through an analysis of strengths and 
weaknesses and to specify their training needs 

 Due to the complexity of the process and the 

variables in the organisational situations, each 
country has something to “offer” and much to learn 
from others. In our action such comparison has 
always been constructive, allowing the knowledge 
and understanding of “ different worlds” and 
the acquisition of new skills that, maybe, cannot 
be imported tout court, but are however a great 
stimulus for our mutual growth. 

Dr Nanni Costa about the MODE Joint Action

in those speciﬁc ﬁelds,’ concludes Dr Alessan-
dro Nanni Costa, scientiﬁc leader of the project 
(Italian National Transplant Centre).

‘MODE will also provide useful inputs to and 
have  its  ideal  continuation  in  the  ongoing 
ACCORD joint action that is planning to imple-
ment twinning arrangements for best practice 
sharing in selected countries,’ concludes Paola 
Di Ciaccio, project manager.

Kick-oﬀ meeting of the Joint Action MODE

192TRANSPLANTATION AND TRANSFUSIONFurther information: EAHC Project Database: http://ec.europa.eu/eahc/projects/database.html?prjno=20102101 Project website http://www.mode-ja.org Project team: Centro Nazionale Trapianti, Istituto Superiore di Sanità  Viale Regina Elena, 299  00161 Rome RM ITALY  Tel. +39 0649904040  Fax +39 0649904101 E-mail: centronazionale.trapianti@iss.it Associated partners: (cid:97)(cid:149)Autoridade para os Serviços de Sangue e da Transplantação, Portugal(cid:97)(cid:149)Bulgarian Executive Agency for Transplantation (BEAT), Bulgaria(cid:97)(cid:149)Department of Health of Malta, Malta(cid:97)(cid:149)Institute for Transplantation of organs and tissues of the Republic of Slovenia — Slovenija Transplant, Slovenia(cid:97)(cid:149)Koordinaní stedisko transplantací, Czech Republic(cid:97)(cid:149)National Transplant Bureau, Lithuania(cid:97)(cid:149)Organisacion Nacional de Trasplantes, Spain(cid:97)(cid:149)Országos Vérellátó Szolgálat, Hungary(cid:97)(cid:149)Pauls Stradins Clinical University Hospital, Latvia(cid:97)(cid:149)Tartu University Hospital, EstoniaEU contributionThis joint action has received co-funding from the European Union in the framework of the Health Programme 2008–2013 (Grant: 20102101).O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

193

Achieving Comprehensive Coordination in Organ Donation 
throughout the European Union (Joint Action ACCORD)

This joint action has received co-funding from the European Union in the framework of the Health Programme 
2008–2013 (Grant: 20102101).

In order to improve the situation of substantial 
heterogeneity among the European countries in 
donation and transplantation activities, a con-
sortium of 23 national transplantation authori-
ties and 10 collaborative partners, mostly major 
international  organisations,  have  joined  their 
eﬀorts to implement the ACCORD Joint Action.

ACCORD —  ‘Achieving  Comprehensive  Coor-
dination  in  Organ  Donation  throughout  the 
European Union’ — is co-funded by the Euro-
pean Commission under the Health Programme 
(2008–2013). The project is initiated and coor-
dinated  by  the  Spanish  National  Transplant 
Organisation (ONT) and started in May 2012 
with the kick-oﬀ meeting in Madrid, The project 
is expected to run until November 2015.

The general objective of ACCORD is to strengthen 
the full potentials of EU Member States in the 
ﬁeld of organ donation and transplantation and 
to improve cooperation between them. There-
fore,  this  Joint  Action  is  a  further  necessary 

step to assist EU Member States for a consist-
ent implementation of Directive 2010/53/EU of 
the European Parliament and of the Council of 7 
July 2010 on standards of quality and safety of 
human organs intended for transplantation and 
the Action Plan on Organ Donation and Trans-
plantation (2009–2015): Strengthened Coopera-
tion between Member States.

The countries participating in the Joint Action 
ACCORD have identiﬁed six speciﬁc objectives 
as currently most vital to work on during this 
project. These are:

(cid:98)(cid:553) improving Member States’ information 

systems on live organ donation;

(cid:98)(cid:553) improving the deceased donation process 
in the EU countries through describing the 
most common pathways applied to patients 
with devastating brain injury and their 
impact on the potential of donation;

The relation of the Joint Action ACCORD to Directive 2010/53/EU and Action Plan (www.accord-ja.eu)

194

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

(cid:98)(cid:553) improving end-of-life management in a way 
to promote donation through developing a 
rapid improvement toolkit adapted to the 
identiﬁed end-of-life care models;

(cid:98)(cid:553) providing concrete assistance through collab-
orations and trainings between EU Member 
States in speciﬁc areas related to Directive 
2010/53/EU and the Action Plan on Organ 
Donation and Transplantation;

(cid:98)(cid:553) providing useful insights and 

recommendations for future twinning 
initiatives; and

(cid:98)(cid:553) disseminating and rendering sustainable 
the results and outputs of the project.

The Joint Action ACCORD has organised its work 
in three work packages focusing on three spe-
ciﬁc ﬁelds and activities.

Living donor registries

Live donation is an important source of organs. 
As living donors are facing evident risks it is 
paramount to ensure that living donors receive 

appropriate  and  comprehensive  care  (live 
donor care) that is in compliance with univer-
sal medical, ethical and psychosocial standards 
throughout Europe. Living donor registries are 
an  essential  component  of  such  appropri-
ate and comprehensive care and increase the 
safety of living donation.

The aims of this work package are to improve 
information  systems  on  live  organ  donation 
through the provision of recommendations for 
designing and managing structured live donor 
registries and through setting down a model 
for  supranational  data  sharing  (‘registry  of 
registries’).

The institutions that are working in this work 
package will review and analyse existing live 
donor registries in partner countries and pro-
duce a comprehensive state-of-the-art over-
view.  This  expert  review  and  analysis  shall 
form the basis for recommendations about the 
ne cessary governing rules as well as minimum 
requirements of data sets of future registries. 
Additionally, the feasibility of setting up a Euro-
pean live donor registry is planned to be piloted 
among those partner countries that already 
have established registration systems.

The website of the Joint Action ACCORD (www.accord-ja.eu)

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

195

The ﬁnal set of recommendations for developing 
a live donor registry and a common European 
registry will aid EU Member States, particularly 
those who are without a functioning live regis-
try, in the set-up and design of European-wide 
coordinated registries. It will also facilitate inter-
national data sharing and provide comparable 
information in the area of live donors available 
for improved services in Europe. These activities 
will not only contribute to a safer live donor care 
in Europe, but also will increase coherence to 
existing regulations in this ﬁeld.

 Very sensitive changes are taking place in the 

management of critical care patients at the end 
of life … and it is not to describe how to make the 
process, but what is the point(s) considered the key 
for success … 

Rafael Matesanz, Director, Organizacion Nacional de Trasplantes, Coordinator of 

ACCORD at the kick-oﬀ meeting of ACCORD on 31 May 2012 in Madrid, Spain

Cooperation between intensive 
care units and donor transplant 
coordination

end-of-life care pathways in order to promote 
and optimise the deceased organ donation pro-
cesses will be the output of this work.

Many  factors  inﬂuence  the  organ  donation 
rate,  such  as  the  way  that  possible  donors 
are being identiﬁed in the hospital setting, or 
how eﬀectively the clinical decision-making 
process is organised in the hospital’s end-of-
life practices (e.g. intensive care units). These 
end-of-life practices are organised in diﬀerent 
ways across hospitals, regions and countries 
in Europe. This varying organisation leads also 
to the variation in deceased donation rates 
among countries.

The second technical work package of the Joint 
Action ACCORD therefore works on increas-
ing the availability of organs from deceased 
donors  by  strengthening  the  cooperation 
between intensive care units and the donor 
transplant  coordinators.  In  focusing  on  the 
potential  role  of  end-of-life  care  pathways 
in the deceased donation process, this work 
package  is  analysing  end-of-life  practices 
and clinical decision-making processes in the 
participating Member States and is exploring 
their impact on the potential and actual donor 
pool. The critical goal is to identify areas for 
improvement.

A clinical reference group will review the varia-
tions in end-of-life care pathways for patients 
with brain injury in a selected sample of hos-
pitals. In this area, the project team is using a 
benchmarking approach, which is an eﬀective 
way to identify improvements in the process of 
when and how a possible donor is becoming an 
actual donor. The work shall guide the building 
of an eﬀective connection between intensive 
care units and donor transplant coordinators, 
which in turn increases available organs derived 
from deceased donation. A set of recommenda-
tions and a toolkit methodology to improve the 

Twinning programmes on organ 
donation and transplantation

Direct exchange of speciﬁc national experience 
can eﬀectively meet the needs of other coun-
tries. Twinning activities further promote that 
speciﬁc knowledge acquired in one country is 
transferred and implemented in others hospi-
tals, regions and countries.

Therefore, the third technical work package of 
the Joint Action ACCORD is working on organising 
the exchange of best practices and consolidated 
expertise and tools through speciﬁc twinning 
programmes. The topics and speciﬁc areas which 
these twinning programmes focus on are either 
topics covered by Directive 2010/53/EU or topics 
recommended by the Action Plan on organ dona-
tion and transplantation. Building on the twinning 
experiences not only from this work package, but 
also from past twinning experiences, this work 
package will also provide recommendations for 
future twinning initiatives in the ﬁeld of organ 
donation and transplantation.

The institutions participating in this work pack-
age of the Joint Action ACCORD are planning 
and  organising  the  following  twinning  pro-
grammes with detailed protocols:

(cid:98)(cid:553) the organisation of the national 

procurement system, the data collection 
and analysis as well as support of 
paediatric kidney transplantations is 
addressed to Bulgaria with the support of 
France;

(cid:98)(cid:553) setting up a national accreditation system 

for transplant centres is addressed to 

196

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Cyprus, the Czech Republic, Malta and 
Lithuania with the support of Italy;

(cid:98)(cid:553) the testing of a training platform in organ 
recovery for surgeons will be performed 
in Hungary with the support of the 
Netherlands.

The experiences gained in these three twin-
ning projects will allow setting up a potential 
European Union tool for the accreditation of 
transplant centres, training in organ recovery 
and one-to-one support for the development 
of transplant systems. This work package also 
develops a guideline for further twinning initia-
tives in the ﬁeld.

Expected outcome and its added value

The  expectations  towards  the  Joint  Action 
ACCORD as a whole are to help in the consist-
ent implementation of Directive 2010/53/EU of 
the European Parliament and of the Council of 
7 July 2010 on standards of quality and safety 
of  human  organs  intended  for  transplanta-
tion across the European Member States, and 
to provide concrete assistance in meeting the 
objectives of the Action Plan.

It represents a strategic opportunity in time as 
the national provisions of the recent Directive 
are being worded and ACCORD can support the 
alignment of such provisions and procedures, 
which  overall  shall  lead  to  a  safe  and  high-
quality  organ  donation  and  transplantation 
process with the ultimate and concrete goals of 

1.

2.

3.

WP4

MAPPING
The action will perform a state-of-art on existing living donor registries in par-
tner countries.

SHARING
A living donor registry of European living donor registries is one final goal of this
ACCORD core Work package .

BUILDING
Putting expertise in common and defining clinical parameters for building up a
living donor registry will be discussed and agreed. Living donor registries are
essential components of national strategies targeted to increase the safety of
living donation in the European Union.

WP5

MAPPING
A review of existing end-of-life care pathways in different Member States will be
carried out, with special focus on practices relevant to organ donation.

SHARING
Best practices for facilitating the identification of potential donors and their con-
version into actual donors will be shared, to guide on the establishment of an
effective connection between intensive care units and donor transplant coordina-
tors that facilitates deceased donation.

BUILDING
New tailored-to local needs tools that will allow Member States to improve
performance in the donation rocess and to increase the number of deceased
donors will be supplied..

MAPPING
Expertise of a given Member State can meet the needs of others.Three twinning
programmes will be performed in ACCORD with the final aim of improving per-
formance, quality and safety of the supported countries' transplant systems.

WP6

SHARING
The organization of the national procurement system, data collection and analysis
and the support of kidney paediatric transplantations will be addressed in Bulgaria.
Setting up a national accreditation system for transplant centres will be the area
covered in Cyprus, Czech Republic, Malta and Lithuania testing a training platform
in organ recovery for surgeons will be covered by the cooperation with Hungary.

BUILDING
Setting up potential EU tools for the accreditation of Transplant Centres, training
in organ recovery, and one-to-one support for the development of a Transplant
system will be addressed by capitalizing on experience. Guideline for further
Twinning models in the field Is another goal of this ACCORD work package.

WP4
LIVING DONOR
REGISTRIES

WP leader: Dutch Transplant Foundation

WP5
COOPERATION BETWEEN ICU
PROFESSIONALS AND DTCS

WP leader: National Health Service Blood and Transplant

WP6
TWINNING

WP leader: Agence de la biomédecine

The brochure ACCORD — A unique opportunity in time (www.accord-ja.eu).

saving the lives of those patients, which are in 
urgent need of an organ transplant, wherever in 
Europe. This context also sets the subtitle of the 
project ‘ACCORD — a unique opportunity in time’.

Moreover, the project introduces elements of 
innovation in the ﬁeld of donation and trans-
plantation, for instance, in the form of a Euro-
pean-wide common foundation for the devel-
opment of live donor registries, in the form of a 
unique description on the diﬀerent approaches 
to end-of-life practices and a tailored model to 
optimise the realisation of the deceased dona-
tion process, and in the form of a guidance 
approach for future twinning initiatives.

The  main  target  groups  of  the  project  are 
national and regional institutions, which are 
involved in organising and setting the political 
framework of organ donation and transplanta-
tion in respective EU Member States. Further 
target groups are professionals, patient asso-
ciations and the public.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

197

 Every country should make a diagnosis of 

the situation and find the most adequate way 
towards self-sufficiency; there is not a single way 
to self-sufficiency, well-proven successful models 
should be taken as reference … 

Rafael Matesanz, Director, Organizacion Nacional de Trasplantes, Coordinator of 

ACCORD at the kick-oﬀ meeting of ACCORD on 31 May 2012 in Madrid, Spain

To ensure that the project’s approach, strategy, 
results  and  outputs  are  accessible  to  all  tar-
get groups, the project has: produced a layman 
brochure; is issuing regular newsletters for dis-
seminating progress and results; will organise a 
ﬁnal dissemination event at the end of the Joint 
Action project; and will maintain a close link with 
the World Health Organisation and the Council of 
Europe to ensure that the results of the project 
are made available also outside the European 
Union. The project website is already available 
at the following link: www.accord-ja.eu.

Pilar Farjas, General Secretary of the Spanish Ministry of Health, Social Services and Equity, and Rafael Matesanz, Director of the Spanish 
National Organisation for Organ Transplantation (ONT), open the ACCORD Joint Action on 31 May 2012 in Madrid, Spain

198

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ASSOCIATED PARTNERS
Organización Nacional de Trasplantes - ONT (Spain, coordina-
tor and WP3 leader); Italian National Transplant Centre, Italian
Institute of Health - CNT-ISS (Italy, WP2 leader);
National
Dutch Transplant Foundation - DTF (Netherlands, WP4 lea-
der); National Health Service Blood and Transplant - NHSBT
(UK, WP5 leader); Agence de la biomédecine - ABM (France,
WP6 leader); Executive Agency for Transplantation - BEAT
(Bulgaria); Ministry of Health and Social Welfare of
the
Republic of Croatia - MOHSW (Croatia); Ministry of Health of
the Republic of Cyprus
- MoH CY (Cyprus); Czech
Transplantation Coordinating Center - KST (Czech Republic);
Tartu University Hospital - TUH (Estonia); German Organ
Transplantation Foundation - DSO (Germany); Hellenic
Transplant Organization - HTO (Greece); Hungarian National
Transfusion Service - HNBTS (Hungary); Health Service
Executive - HSE (Ireland); Pauls Stradins Clinical University
Hospital - PSCUH (Latvia); Lithuanian National Transplantation
Bureau - NTB (Lithuania); Ministry for Social Policy, Health, the
Elderly and Community Care - MHEC (Malta);The Norwegian
Directoreate of Health - HDIR (Norway); Polish Transplant
Coordinating Centre “Poltransplant” (Poland);
Instituto
Português do Sangue e da Transplantação - IPST (Portugal);
National Transplant Agency - ANT (Romania);
Institute for
transplantation of Organs and Tissues of the Republic of
Slovenia - Slovenija Transplant (Slovenia); The National Board
of Health and Welfare - SoS (Sweden).

COLLABORATING PARTNERS
European Directorate for
the Quality of Medicines and
Healthcare - EDQM ; World Health Organization; European
Hospital and healthcare federation - HOPE; European Society
of
Intensive Care Medicine - ESICM; European Transplant
Coordinators Organizations-European Donation Committee
Eurotransplant;
(ETCO-EDC)
Scandiatransplant; Organisation des Etablissements de Soins
(Belgium); Hospital Clínic de Barcelona (Spain).

section

ESOT;

of

a

Funded by the

Grant Agreement no. 2011 21 02
May 23rd 2012 - Apr 22nd 2015
“This publication arises from the Joint Action ACCORD which has received fun-
ding from the European Union, in the framework of the Health Programme.
The sole responsibility lies with the author, the Executive Agency is not respon-
sible for any use that may be made of the information contained therein”.

www.accord-ja.eu

Further information: 

A UNIQUE OPPORTUNITY IN TIME

EAHC Project Database: 
http://ec.europa.eu/eahc/projects/database.html?prjno=20112102 

Project website 
http://www.accord-ja.eu/ 

Project team: 

Organización Nacional de Trasplantes (ONT) 
C/ Sinesio Delgado, 6-8  
PO-BOX  
28029 Madrid  
SPAIN  
Tel. +34 902300224 
Fax +34 902300226 
E-mail: http://www.accord-ja.eu/contact 

Associated partners: 

Istituto Superiore Di Sanità — ISS, Italy

(cid:97)(cid:149) Agence de la Biomédecine — ABM, France
(cid:97)(cid:149) Autoridade para os Serviços de Sangue e da Transplantação, ASST, Portugal
(cid:97)(cid:149) Deutsche Sti$ung Organtransplantation — DSO, Germany
(cid:97)(cid:149) Helsedirektoratet — HDIR, Norway
(cid:97)(cid:149) Dutch Transplantation Foudation — DTF, Netherlands
(cid:97)(cid:149) Executive Agency for Transplantation — BEAT, Bulgaria
(cid:97)(cid:149) Feidhmeannacht na Seirbhíse Sláinte — HSE, Ireland
(cid:97)(cid:149) Hellenic Transplant Organisation — HTO, Greece
(cid:97)(cid:149) Zavod Republike Slovenije za presaditve organov in tkiv Slovenija Transplant, Slovenia
(cid:97)(cid:149)
(cid:97)(cid:149) Koordinační středisko transplantací — KST, Czech Republic
(cid:97)(cid:149) Ministry for Social Policy, Helath, the Elderly and Community Care — MHEC, Malta
(cid:97)(cid:149) Ministry of Health of the Republic of Cyprus — MOH CY, Cyprus
(cid:97)(cid:149) Ministarstvo zdravlja Republika Hrvatska — MOHSW, Croatia
(cid:97)(cid:149) Agenţia Naţională de Transplant — ANT, Romania
(cid:97)(cid:149) Nacionalinis transplantacijos biuras — NTB, Lithuania
(cid:97)(cid:149) National Health Service Blood and Transplant — NHSBT, United Kingdom
(cid:97)(cid:149) Országos Vérellátó Szolgálat — HNBTS, Hungary
(cid:97)(cid:149) Paula Stradiņa Klīniskā universitātes slimnīca — PSCUH, Latvia
(cid:97)(cid:149) Sihtasutus Tartu Ülikooli Kliinikum — TUH, Estonia
(cid:97)(cid:149) Náradná transplantacná organizácia — NTO, Slovakia
(cid:97)(cid:149) Centrum Organizacyjno-Koordynacyjne ds. Transplantacji ‘Poltransplant’, Poland

EU contribution

This joint action has received co-funding from the European Union in the framework of the 
Health Programme 2008–2013 (Grant: 20112102).

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

199

European Training Course for Trainers in Transplant Donor 
Coordination in the European Union

This training course has been funded by the European Union in the framework of the Health Programme 2008–
2013 (Service Contract: 20106102).

In 2011, DG SANCO of the European Commis-
sion provided teacher training to a total of 79 
healthcare professionals from 24 EU Member 
States (all of them experts in the donation and 
transplant process) in order to promote the ﬁg-
ure of ‘Transplant Coordinator’, which is a key 
success factor of the internationally recognised 
Spanish donation and transplantation model — 
one that has given such good results year a#er 
year in Spain.

This  course  addressed  part  of  the  Priority 
Action Number 1 of the European Action Plan 
on Organ Donation and Transplantation (2009–
2015) which is the ‘Promotion of the role of 
transplant donor coordinators in every hospital 
where there is potential for organ donation’. It 
was funded by the European Union under the 
EU  Health  Programme  in  the  framework  of 
a service contract.

The course was developed in Spain, designed 
and executed by the IAVANTE Foundation, an 
organisation based in Granada/Spain and spe-
cialised in healthcare training, in collaboration 
with the Spanish National Transplant Organisa-
tion (ONT).

STAGES OF TRAINING

Spain’s leadership in donation and trans-
plantation and its capacity for continuing 
improvement.

   PRIOR E-LEARNING STAGE

The students will have access to information including content 
and simple activities via the Iavante distance learning platform 
for 10 days prior to the face-to-face stage of the training event. 
This will help them achieve the course objectives and will facili-
tate the learning of the doctors involved.

   FACE-TO-FACE STAGE 

The platform consists of 8 blocs corresponding to the 8 main 
thematic training units of the training event. These are:

Objectives of the Training Course 
for Trainers in transplant donor 
coordination in the European Union

- U.1 Unit 1: Donor identification, selection and evaluation.
- U.2 Unit 2: Diagnosis of brain death.
- U.3 Unit 3: Donor maintenance. 
- U.4 Unit 4: Retrieval and distribution of organs. 
- U.5 Unit 5: Non-beating heart donation.
- U.6 Unit 6: Communication skills and relating to the family.
- U.7 Unit 7: Ethics, legislation and organisational models. The 
role of coordinator.
- U.8 Unit 8: Introduction to teaching methodology and skills.

The classroom-based stage of the training event will follow 10 
days of distance learning with 5 hours of classes spread over the 
morning and afternoon (except for the last day which will have 
only a morning session).

The ‘delivery of teaching units’ section will specify the content, 
objectives,  documentation  and  activities  for  each  unit  in  their 
online and face-to-face stages.

The course platform (Moodle Environment) will provide the stu-
dent with a tool for ongoing communication with the organisation 
and the teaching team. This system allows students to partici-
pate in chat sessions led by individuals trained to resolve any is-
sues that may arise. Asynchronous support may also be sought 
by students using a blank form to provide their contact details 
and describe the issue they need resolved in order for it to be 
dealt with as soon as possible.

DG SANCO of the European Commission 
ﬁnanced  this  training  course  through  a 
public  call  for  tenders;  the  design  and 
INTERNATIONAL TRAINING COURSE  FOR 
running of the course was the result of 
TRAINERS IN 
collaboration between the IAVANTE Foun-
TRANSPLANT 
dation with the Spanish National Trans-
DONOR 
plant Organisation (ONT). The training pro-
COORDINATION 
gramme was based on the consortium’s 
IN THE EUROPEAN 
wide experience in this ﬁeld and in health-
UNION
care training using simulation techniques. 
It followed the course model that the ONT 
and the IAVANTE Foundation have been 
running  since  2006  in  the  CMAT  Medi-
cal Simulation Centre, Granada, in which 
more than 240 healthcare professionals 
from Spain and Latin America have been 
trained to date, with a satisfaction rate 
of 93 %.

Parque Tecnológico de Ciencias de la Salud 
Avda. de las Ciencias s/n 
18.100 Armilla - Granada – España
Tl: +34 958 00 22 50 
E-mail: formacion.gr@iavante.es 
www.iavante.es

MORE INFO:
CMAT, Advanced Multifunctional Centre for 
Simulation and Technological Innovation
Iavante Centre in Granada

During the 10 days following the face-to-face stage of the training 
event, the students will have access to information on the con-
tent and the answers to the post-course activity on the Iavante 
online training platform.

   POST FACE-TO-FACE E-LEARNING STAGE

INTERNATIONAL TRAINING COURSE  FOR 
TRAINERS IN TRANSPLANT 
DONOR COORDINATION IN 
THE EUROPEAN UNION

   LEARNING OBJECTIVES

General: 
Obtain the knowledge and skills needed to train trainers in pro-
tocols  for  the  organ  and  tissue  transplantation  and  donation 
process, from the identification of potential donors to transplan-
tation.

Specific:
-Able to provide training in the techniques needed for the diag-
nosis of brain death.
-Trained in knowledge of general donor selection and evaluation 
criteria in order to assess the viability of organs.
-Able to provide training on donor maintenance techniques.
-Able to manage the family interview and communication tech-
niques.
-Equipped with the communication skills needed to deliver bad 
news and to request organ and tissue donation.
-Obtain  sufficient  knowledge  and  ability  to  obtain  the  greatest 
possible  involvement  of  all  professionals  involved  in  the  organ 
and tissue retrieval process. 
-Obtain the knowledge and skills needed in the process for the 
reception of organs and tissue for transplants.
-Obtain knowledge of the legal framework, the various national 
and  international  transplant  models  and  their  differences  and 
similarities as the basis for unification of criteria.

   TEACHING HOURS AND DURATION

Total hours: 56 hours over 25 days
E-learning stage: 22 hours
   - E-learning prior to face-to-face stage: 10 days
   - E-learning after face-to-face stage: 10 days
Face-to-face stage: 34 hours over 5 days.

   DATES:

Prior E-learning stage: 5th-16th September, 2011
Face-to-face stage: 19th-23rd September, 2011
Post  face-to-face  E-learning  stage:  26th  September  -  7th 
October 2011

   PLACE:

CMAT, Advanced Multifunctional Centre for Simulation 
and Technological Innovation, Iavante Centre in Granada
Parque Tecnológico de Ciencias de la Salud 
Avda. de las Ciencias s/n 
18.100 Armilla - Granada – España
Tl: +34 958 00 22 50 
E-mail: formacion.gr@iavante.es 
www.iavante.es

Health Programme
2008-2013
Together for Health

INTERNATIONAL TRAINING COURSE  FOR 
TRAINERS IN 
TRANSPLANT 
DONOR 
COORDINATION 
IN THE EUROPEAN 
UNION

!"##$%&’()*’+,-

Course announcement  

for the training course  

(http://www.etc.iavante.es/)

The Spanish donation and 
transplantation model

The extraordinary performance of the trans-
plant  coordinators,  along  with  the  excellent 
organisational system and the generosity of 
the citizens, have permitted Spain to beat its 
own record for donation and transplantation 
in 2011 with a total of 1 667 donors allowing 
a total of 4 218 transplants to be performed. 
This represents an increase of 11.8 % com-
pared with the previous years, and a further 
445 patients transplanted. These ﬁgures are 
ground-breaking, both in absolute ﬁgures as 
well as in relation to the number of inhabit-
ants, which has raised the donation rate to 35.3 
donors per million population (donation rate in 
the European countries was 18.7 donors per 
million population in 2010). It should also be 
noted that the rate of refusal by family mem-
bers to donate has fallen by 4 points and was 
15  %  in  2011.  Once  again  this  represents 

Training in the Intensive Care Unit Simulation Theatre of  

the IAVANTE CMAT foundation

200

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

The transplant coordinator is the 
healthcare professional responsible 
for preparing the complex transplant 
process logistics between hospitals

Competent Authorities on organ donation and 
transplantation from the EU Member States 
selected  the  most  suitable  professionals  in 
their respective countries to attend this train-
ing programme. The goal of this initiative is to 
train professionals in the EU to develop training 
courses in their respective countries or to inte-
grate new elements into their existing training 
courses, in order to teach other professionals in 
all or part of the transplant coordination tasks, 
depending on each country’s reality and needs. 
The ﬁnal aim was to improve the results of the 
donation activity in Europe, thus increasing the 
possibility of transplantation for the citizens 
who need it.

Content of the programme

The selection process was opened from Decem-
ber 2010 to February 2011. By the end of the 
deadline, 103 nominees had registered from 
25 Member States. Finally, altogether 79 stu-
dents attended the course: 41 students on the 
ﬁrst course and 38 on the second. Twenty-ﬁve 
out of the then 27 Member States were repre-
sented on the course.

Two editions of the course took place between 
5 September and 7 October as well as between 
24  October  and  25  November  2011.  Each 
edition  of  the  course  consisted  of  an  initial 
e-learning phase of 10 days, followed by face-
to-face training with theoretical lessons and 
practical workshops of 5 days, ending with a 
post-course assignment of 10 days, where the 
students had to design a training course for 
coordinators  taking  into  account  the  reality 
and needs of their own countries. The face-
to-face phases of the two courses were held 
at the IAVANTE CMAT medical simulation cen-
tre in Granada (Spain), which is managed by 
the Andalusian Regional Health Ministry. For 
the  online  part  of  the  course  a  tailor-made 
e-learning platform was designed to facilitate 
communication among all participants and to 
access content materials.

The participants reviewed the diﬀerent phases 
of the donation process from a didactic per-
spective, ranging from the detection of poten-
tial  donors  to  the  maintenance  of  the  vital 
signs of the donor until organ extraction as 

Simulation methodologies involved the use of advanced robotic simulators of the 

IAVANTE CMAT foundation, which react to the medicines administered

The training programme was designed within 
the framework of the European Directive on 
Quality and Safety of Organs for Transplanta-
tion and was based on the Spanish model of 
donation and transplantation. In this organisa-
tional model of the process of donation and 
transplantation, the coordinator is the ﬁgure 
responsible for the detection of possible donors, 
as well as the care of the relatives of the donor 
and for the communication needed to obtain 
authorisation for the donation. The transplant 
coordinator is also the healthcare professional 
responsible for preparing the complex trans-
plant process logistics between diﬀerent hospi-
tals as well as the management of waiting lists 
and donation promotion. The terms ‘transplant 
coordinators’, ‘transplant donor coordinators’ 
and ‘key donation personnel’ might cover diﬀer-
ent tasks, realities and organisational systems 
in the various EU Member States, but these 
key persons are all involved in activities cov-
ering the chain from organ donation to organ 
transplantation.

 The best way to learn about these topics is 
making workshops, making a practice, because 
you can read about these topics in every book. But 
we make this practice with an actor, it is better 
than a mechanical robot, and they can see the 
reflexes, and we teach them about the pathological 
responses ... We can play any kind of situation that 
happens in real life. 
Diego Mora, Transplant Coordinator at the Juan Ramon Jimenez Hospital, Huelva, 

Spain

well as the family interview in which donation 
consent is requested. There was speciﬁc train-
ing in didactic methodologies and also a review 
of the legal and ethical framework applicable in 
the EU setting. These activities were carried out 
using the simulated scenarios in CMAT which 
include  critical  care  units  and  consultation 
rooms, providing the coordinators with high-
ﬁdelity simulated scenarios to re create real-
istic work environments. Workshops were also 
included using role-play as well as simulation 
methodologies involving the use of advanced 
robotic simulators which react to the medicines 
administered.

During the course, the participants were trained 
in  the  necessary  knowledge,  materials  and 
didactic methodology so that, on returning to 
their respective countries, they would be able 
to adapt what they learned in order to set up 
coordinator training courses according to their 
local requirements. As participants had diﬀer-
ent proﬁles and ﬁelds of expertise (including 
deceased donation/living donation, national/
regional/local coordinators, intensivists, neph-
rologists and nurses), they could also highly 
beneﬁt from the exchanges within the group, 
with the speakers and during the workshops.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

201

 There is always something to learn, in this 
case making the comparison with other countries 
with different options and legislation, and also 
different possibilities for carrying out donor 
transplant surgery. 

Daniela Maretti, Regional Transplant Coordinator, Lombardy, Italy

(cid:98)(cid:553) Unit 1: Donor identiﬁcation, selection and 

evaluation

(cid:98)(cid:553) Unit 2: Diagnosis of brain death

(cid:98)(cid:553) Unit 3: Donor maintenance

(cid:98)(cid:553) Unit 4: Retrieval and distribution of organs

(cid:98)(cid:553) Unit 5: Non-beating heart donation

(cid:98)(cid:553) Unit 6: Communication skills and relating to 

the family

(cid:98)(cid:553) Unit 7: Ethics, legislation and organisational 

models. The role of coordinator

The courses consisted of eight blocks:

(cid:98)(cid:553) Unit 8: Introduction to teaching 

methodology and skills

‘Passing the worst message ... ’ — Trainers for Transplant Donor Coordination train the interaction with relatives 

of deceased donors, which in this simulation are being played by professional actors

202

T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Results of the training course

A  total  number  of  79  health  professionals 
involved in donation and transplantation activi-
ties from 24 EU countries have been trained to 
train transplant coordinators in their respec-
tive countries. The average level of satisfac-
tion of the participants for each of the courses 
was respectively 8.1 and 9 of a maximum of 
10 points, which has demonstrated the overall 
high degree of quality in the courses, including 
scientiﬁc and organisational aspects.

 The ultimate goal of the project was to increase 
the quality and quantity of donation and transplant 
coordination in the EU through training transplant 
coordinators to be able to go back to their countries 
and in turn train professionals there … From the 
train-the-trainer approach we expected a multiplied 
effect with which we could increase the impact. 

David Riley, project manager, IAVANTE Foundation

self-assessment  survey  for  all  course  par-
ticipants,  asking  questions  on  transference 
of knowledge and impact. In this assessment, 
the indicator of ‘impact’ was deﬁned as put-
ting into practice the knowledge acquired dur-
ing the course, i.e. the planning, designing and 
implementing of training courses for transplant 
coordinators in the respective regions of the 
course participants. According to David Riley, 
‘70 % of Member States responded; the major-
ity of course participants were directly apply-
ing the knowledge gained during the course 
for training in their countries, either by setting 
up new training or improving the existing ones 
using the knowledge gained in the course.’

‘Many participants pointed out in their course 
evaluation that the course gave them a unique 
opportunity  to  come  together  to  share  and 
exchange knowledge in transplantation coordi-
nation from all over Europe,’ explained Mr Riley. 
Participants also emphasised that meeting other 
professionals and knowing how transplants are 
coordinated in other countries was very useful. ‘It 
opts towards making transplant coordination on a 
European level a reality which can have an enor-
mous impact on the health of European citizens.’

One  month  after  completing  the  course, 
an  impact  assessment  on  the  two  courses 
was  conducted  through  a  post-course 

This  course  can  be  seen  as  a  role  model  in 
mutual learning among EU Member States.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

203

Further information: 

Project website 
http://www.etc.iavante.es/ 

Project consortium: 

CMAT, Advanced Multifunctional Centre for Simulation and Technological Innovation 
Iavante Centre in Granada Parque Tecnológico de Ciencias de la Salud 
Avda. de las Ciencias s/n 
18 100 Armilla (Granada) 
SPAIN
Tel. +34 958002250 
E-mail: formacion.gr@iavante.es 
Webpage: http://www.iavante.es

Consortium partners: 

(cid:97)(cid:149) Organización Nacional de Trasplantes (ONT), Spain 
(cid:97)(cid:149) Spanish Ministry of Health, Madrid, Spain

EU contribution

This training course has been funded by the European Union in the framework of the  
Health Programme 2008–2013 (Service Contract: 20106102).

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Study on the set-up of organ donation and transplantation in 
the EU Member States, uptake and impact of the EU Action 
Plan on Organ Donation and Transplantation (2009–2015)

This study has been funded by the European Union in the framework of the EU Health Programme 2008–2013 
(Service Contract: 20116141).

The  study  on  the  set-up  of  organ  donation 
and transplantation in the EU Member States, 
uptake and impact of the EU Action Plan on 
Organ Donation and Transplantation (2009–
2015)  is  ﬁnanced  by  the  European  Union 
under  a  service  contract  and  carried  out  by 
the Netherlands Institute for Health Services 
Research (NIVEL). The implementation of the 
study started on 1 January 2012 and ﬁnished 
in February 2013.

Organ shortages are observed in all Member 
States and form an acute problem for patients 
in urgent need of an organ transplant. Since the 
early 1990s the European Union has recognised 
organ shortages as a subject that necessitates 
joint eﬀorts from European Member States and 
the European Commission. In 2007 the Com-
mission adopted a Communication to the Euro-
pean Parliament on organ donation and trans-
plantation outlining a set of actions. This was 
followed by an Impact Assessment identifying 
major policy challenges for organ donation and 

transplantation in Europe. In December 2008, 
the Commission adopted an Action Plan and a 
proposal for a Directive.

The Action Plan on Organ donation and trans-
plantation (2009–2015) is a non-binding instru-
ment that has been established in accordance 
with Article 168(2) and (4) of the Treaty on the 
Functioning of the European Union (TFEU) to 
help the Member States address three main 
challenges: the shortage of organ donations 
and the increase organ availability (Challenge 1 
of the Action Plan), to make transplant systems 
eﬃcient and accessible (Challenge 2) as well as 
to ensure quality and safety of donation and 
transplant procedures (Challenge 3). The Action 
Plan identiﬁes 10 priority actions, most of them 
being supported by several actions.

The  ACTOR  study,  conducted  over  the  year 
2012, is a mid-term research on the uptake 
and impact of the Action Plan (2009–2015). It 
results in a comprehensive analysis and over-
view of the organisation of organ donation and 
transplantation  systems  in  every  European 
Member State as well as at EU level. It will also 
provide an in-depth review of the implementa-
tion of the Action Plan in Member States with 
recommendations for further steps to be taken.

The study will consist of a systematic analysis 
of the available scientiﬁc and non-scientiﬁc lit-
erature on each of the 10 priority actions and 
its implementation. This data will be supple-
mented, corrected and contextualised through 
the consultation of Competent Authorities in 
the Member States and European institutions, 
through  structured  questionnaires  and  the 
use of an online database. Existing indicators 
or data will be evaluated and supplemented 
so that strengths, weaknesses, opportunities 
and threats of and for the implementation of 
the Action Plan can be determined. Based on 
this analysis, Member State speciﬁc, ‘priority 
action’-speciﬁc and general recommendations 
for the second-half period of the Action Plan 
implementation can be formulated.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

205

Expected outputs of the ACTOR study

Two  major  outputs  are  expected  from  this 
study: ﬁrstly, a comprehensive overview of the 
organisation of organ donation and transplan-
tation systems in every EU Member State as 
well as at EU level, providing a general picture 
as well as detailed elements for each of the 
priority actions of the Action Plan; and sec-
ondly, an in-depth assessment of the imple-
mentation of the Action Plan in Member States 
with recommendations for further implemen-
tation,  based  on  the  analysis  of  strengths, 
weaknesses, opportunities and threats (SWOT 
analysis).

The activities of the study consisted of four 
major steps. The research group started with 
an assessment of organ donation and trans-
plantation activities in each of the European 
Member States, including the general set-up 
and organisation at central and hospital level. 
This includes a description of background infor-
mation on organ donation and transplantation 
activities through deﬁning background indica-
tors. A detailed description of the organ dona-
tion and transplantation system in each of the 
EU Member States and Croatia, Iceland, Liech-
tenstein, Norway, the former Yugoslav Repub-
lic of Macedonia, Montenegro, Switzerland and 
Turkey is the expected result from this work.

The 10 priority actions of the Action Plan on Organ Donation and Transplantation (2009–2015):  

Strengthened cooperation between Member States (http://ec.europa.eu/health/archive/ph_threats/

human_substance/oc_organs/docs/organs_action_en.pdf)

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Therea#er, an assessment of the state of imple-
mentation for the 10 priority actions in each of 
the EU Member States has been carried out. As 
a result of this work, a state-speciﬁc mapping, 
analysis and assessment of the implementation 
process of the priority actions in each of the EU 
Member States is drawn up. The mapping analy-
sis for the state of aﬀairs of the implementa-
tion of the Action Plan shall be presented as a 
separate chapter in the ﬁnal report.

Furthermore, an assessment of the engage-
ment  of  Member  States  and  the  European 
Commission  in  common  European-wide  ini-
tiatives and projects as well as the outcome 
of these initiatives in relation to the 10 prior-
ity actions has been carried out. The focus of 
this work has been on searching, ﬁnding and 
organising all relevant project information. The 
study will furthermore include an overview and 
assessment of interaction of the Commission’s 
Action Plan with other international initiatives 
undertaken by the WHO, the Council of Europe, 
Eurotransplant and Scandiatransplan and Euro-
pean professional organisations.

The ACTOR survey/database

For the ACTOR study, NIVEL has developed a 
survey database. It is an online digital survey 
instrument with an option to upload PDF docu-
ments, which makes it a unique research tool. It 
shall also leave room for both researchers and 
Competent Authorities to comment and react 
to the answers and data given.

The  survey  is  first  filled  in  by  the  NIVEL 
researchers,  on  the  basis  of  the  research 
team’s  initial  data  gathering  stage.  Compe-
tent Authorities can subsequently verify, add 
and change the answers to the questions and 
leave  comments  and  documents  to  support 
their answers.

Finally,  an  assessment  of  strengths,  weak-
nesses, opportunities and threats of and for the 
implementation of the Action Plan and recom-
mendations for the second half-period of the 
Action Plan, both at EU and national level has 
been carried out and shall provide a summary 
of the complete study for each of the 10 priority 
areas. The analysis will indicate open spots, such 
as which of the 10 priority actions have not been 
well addressed yet and suggest ways to address 
them by 2015. An analysis of opportunities and 
threats to the successful implementation of the 
Action Plan at EU and national level will provide 
new information. Based on this analysis, recom-
mendations for the second half-period of the 
Action Plan will be dra#ed. The ﬁnal report shall 
include a list of Member State-speciﬁc recom-
mendations on how respective Member States 
can improve their Action Plan implementation, 
as well as further recommendations concerning 
the work at EU level, for the Commission and the 
whole European group of Competent Authorities 
in the ﬁeld.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

207

Published ACTOR study:

http://ec.europa.eu/health/blood_tissues_organs/docs/organs_actor_study_2013_en.pdf

Project consortium: 

NIVEL, Netherlands institute for health services research 
Otterstraat 118–124 
3513 CR Utrecht 
NETHERLANDS 
Tel. +31 302729-700/647 
Fax +31 302729729 
E-mail: r.friele@nivel.nlConsortium 

Partners: 

(cid:97)(cid:149) Katholieke Universiteit Leuven (KULeuven), Leuven, Belgium
(cid:97)(cid:149) Spanish Ministry of Health, Madrid, Spain

EC contribution

This study has been funded by the European Union in the framework of the  
Health Programme 2008–2013 (Service Contract: 20116141).

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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

Living Organ Donation in Europe (EULOD)

This coordinated action has received co-funding from the European Union in the framework of  
the 7th Research Framework Programme.

Organ scarcity is a serious problem in most 
EU Member States and results in long waiting 
times and high waiting list mortality in respect 
of  all  organs.  Living  donation  is  a  valuable 
alternative to increase the amount of avail-
able organs for donation. Living organ dona-
tion means opportunities but also poses spe-
ciﬁc ethical, legal and psychosocial implications 
and challenges such as inequality in access to 
care, the risks for living donors and the growing 
problem of commercialism in organ transplan-
tation and medical tourism.

European  countries  vary  in  terms  of  living 
organ donation practices, rates and ethical 
concerns, as well as legislation and protection 
systems for living donors. The Action Plan on 
Organ Donation and transplantation (2009–
2015): Strengthened Cooperation between the 
Member States, put forward by the European 
Commission,  emphasises  the  potentials  of 
sharing experiences between Member states 
and  promotes  the  exchange  of  best  prac-
tices on living donation programmes (Priority 
Action 3).

The  objectives  of  the  EULOD  project  are  to 
establish an inventory of living donation prac-
tices in European Member States; to explore 
and  promote  living  donation  as  a  way  to 
increase  organ  availability;  and  to  develop 
tools that improve the quality and safety of 
living organ donation in Europe. The project 
aims to focus on the new EU Member States. 
Eleven partners from 10 diﬀerent countries are 
involved in EULOD, where more than half of 
the participating organisations are from new 
EU Member States.

The  project  draws  upon  the  support,  know-
ledge and network of ELPAT — The European 
Platform on Ethical, Legal and Psychological 
Aspects of Organ Transplantation and ESOT — 
the European Society for Organ Transplantation. 

The EULOD project started in April 2010 and 
ﬁnished  in  March  2012.  It  was  managed  by 
Erasmus University Medical Centre Rotterdam. 
To achieve these objectives, the activities were 
divided into two scientiﬁc research packages 
focusing on living unrelated donation practices 
and on the legal restriction and safeguards of 
living donation.

Living unrelated organ donation 
practices in Europe

This work package collected data via an online 
survey on a wide range of aspects connected 
to  living  donation  practices,  such  as  preva-
lence and types of living organ donation; legal, 
ethical, ﬁnancial and practical barriers. Data 
came  from  kidney  and  liver  transplant  cen-
tres in 40 European countries. Out of the then 
27 EU countries, 25 were presented by kidney 

The EULOD Project Living Organ Donation in Europe — Results and 

Recommendations, by Ambagtsheer, F.; Weimar, W. (Eds.)

transplant units and 18 countries by liver trans-
plant units. The study resulted in a review of 
the  various  practices  of  organ  donation  in 
Europe. Almost all centres had a donor follow-
up. National or European living donor registers 
were kept in 66 % of the kidney transplant cen-
tres and in 46 % of the liver transplant centres.

Attitudes, barriers and opportunities: 
results from focus groups conducted 
in four European countries

Furthermore, the project performed a literature 
review to explore the ethical, legal, political, 
cultural, religious and profession-based argu-
ments for and against living donation. Addition-
ally, it conducted altogether four focus groups 
in Estonia, Bulgaria and Romania (all countries 
with low living donation rates), as well as in 
Belgium to better understand potential barriers 
towards living organ donation. The ﬁndings are 
being published in scientiﬁc publications.

Legal restrictions and safeguards for 
living donation in Europe

A second major strand of the EULOD project 
focused  on  research  about  unrelated  organ 
donation  as  well  as  organ  traﬃcking  and 
transplant tourism. With the help of ELPAT it 
identiﬁed and contacted legal experts on liv-
ing  organ  donation  in  almost  all  European 
countries. These experts were asked to provide 
information on national living organ donation 
laws, anti-organ-traﬃcking laws, living dona-
tion practices and national legal systems. This 
information  then  was  analysed,  and  results 
compiled in reports. 

The report ‘Comparative analysis of European 
transplant laws on living organ donation’ pro-
vides an overview of these laws and recon-
siders all legal requirements for living organ 
donation such as the concept and requirements 
of informed consent, classes of donors, restric-
tive measures, subsidiarity, procedural issues 
and social security regulations for donors. The 
report outlines that overall, almost all of the 
countries considered have established speciﬁc 
rules for Living Organ Donation, but only some 
regulations are comparable and great diﬀer-
ences exist.

Furthermore,  a  ﬁnal  report  is  available  on 
the  EULOD  website  entitled  ‘Improving  the 
Eﬀectiveness  of  the  Organ  Trade  Prohibi-
tion’. The report gives an overview of the role 

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

209

 We also want to investigate the obstacles that 
prevent the use of living donors, to highlight living 
donation as a way of increasing the availability of 
organs for transplants, and to produce guidelines 
that improve the quality and safety of living organ 
donation in Europe. 
Annette Lennerling, Institute of Health and Care Sciences, Sahlgrenska Academy, 
Goteborg, Sweden (169)

of international organisations and their legal 
instruments against organ traﬃcking, trans-
plant commercialism and transplant tourism. 
It furthermore describes the implementations 
of laws in these ﬁelds into national legislation 
in selected countries such as Hungary, Mol-
dova, the Netherlands, Romania and Serbia. 
It also presents empirical data of ﬁeld stud-
ies conducted in selected European countries, 
namely  Moldova,  the  Netherlands,  Romania 
and Kosovo, through stakeholder interviews, 
media analysis and archival research. Finally, 
the report provides a set of recommendations 
to improve organ trade prohibition in relation 
to diﬀerent areas such as law enforcement, 
healthcare professionals, ethics committees 
and incentives. 169

Better insights in the way European 
societies deal with the option of living 
unrelated donation

EULOD used various dissemination methods 
to reach its wide range of targeted stakehold-
ers. Scientiﬁc articles were submitted for pub-
lication in peer-reviewed journals. EULOD has 
delivered numerous presentations about the 
project and its results have been presented at 
various national and international conferences.

Furthermore, the EULOD project is compiling 
the project reports into a book to be published 
and  disseminated  towards  its  main  target 
groups such as competent authorities, trans-
plant organisations and professionals, policy-
makers and further relevant stakeholders in 
living donations. 

As all participating project partners are ELPAT 
members, the project devoted special attention 

(169)  http://www.sahlgrenska.gu.se/english/news_and_events/news/
News_Detail/eu-funding-for-european-living-organ-donation.
cid948345

 
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T R A N S P L A N T A T I O N   A N D   T R A N S F U S I O N

to  integrate  its  work  into  the  larger  ELPAT 
(European  Platform  for  Ethical,  Legal  and 
Psychosocial Aspects of Organ Transplanta-
tion) and ESOT (European Society for Organ 
Transplantation) networks. As part of this, two 
ELPAT working group meetings were organised 
in Soﬁa in October 2010 and in Berlin 2011 to 
discuss project plans and processes, evaluation 
and dissemination eﬀorts.

Information on the project and its results have 
been published in four ELPAT newsletters to its 
contacts of around 9 000 people in the world. 
These newsletters can be found on the EULOD 
project website.

The ﬁnal results of the project are expected 
to  lead  to  a  better  understanding  of  the 
comprehensive  aspects  of  living  unrelated 
donation  in  Europe.  EULOD  therefore  is 
expected  to  contribute  generally  to  the 
improvement  of  the  quality  and  safety  for 
human  organs,  promotion  of  good  medical 
practices  and  the  identiﬁcation  of  relevant 
research areas and future needs.

The project also responded to the need to com-
municate and exchange best practices on living 
organ donation programmes among EU Mem-
ber States, and the need to enhance organisa-
tional models of organ donation and transplan-
tation in order to relieve the current shortage.

O R G A N   D O N A T I O N   A N D   T R A N S P L A N T A T I O N

211

Further information: 

Project website 
http://www.eulod.eu 

DG Research and Innovation 
http://ec.europa.eu/research/health/public-health/health-systems/projects/living-donation_en.html 

Project team:

Kidney Transplant Unit, Internal Medicine,  
Erasmus Medical Centre 
Rotterdam 
NETHERLANDS 
E-mail: j.ambagtsheer@erasmusmc.nl 
Tel. +31 642668336  
Fax +31 104366372

EU contribution

This coordinated action has received co-funding from the European Union in the framework of 
the 7th Research Framework Programme.

European Commission

Transplantation and Transfusion — Projects and Actions for saving and improving the quality of life 
of citizens by facilitating transplantation and blood transfusion in the European Union

Luxembourg: Publications Oﬃce of the European Union

2013 — 211 pp. — 21 × 29.7 cm

ISBN 978-92-9200-020-2

doi:10.2818/14909

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