COMMISSION STAFF WORKING DOCUMENT on the implementation of the principle of voluntary and unpaid donation for human blood and blood components as foreseen in 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 and amending Directive 2001/83/EC Accompanying the document Report from the commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components
Date: 2016-04-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, blood transfusion, health control, health risk, national implementing measure, quality standard, safety standard, summarising

EUROPEAN 
COMMISSION 

Brussels, 21.4.2016  
SWD(2016) 130 final 

COMMISSION STAFF WORKING DOCUMENT 

on the implementation of the principle of voluntary and unpaid donation for human 
blood and blood components as foreseen in 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 and amending Directive 2001/83/EC 

Accompanying the document 

Report from the commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions 

on the implementation of Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 
2005/62/EC setting standards of quality and safety for human blood and blood 
components 

{COM(2016) 224 final} 
{SWD(2016) 129 final} 

EN 

   EN 

 
 
 
 
  
 
Contents 
1. INTRODUCTION ................................................................................................................................... 4 

2. IMPLEMENTATION OF THE PRINCIPLE OF VOLUNTARY AND UNPAID DONATION OF BLOOD AND 
BLOOD COMPONENTS............................................................................................................................. 5 

2.1. Legislative provisions, guidelines and policies concerning donation........................................... 5 

2.1.1. Provisions and guidelines on VUD at national level and their application ........................... 5 

2.1.2. Recent and planned changes of legislative provisions or guidelines .................................... 5 

2.1.3. Replacement donors ............................................................................................................. 6 

2.1.4. Trans-border donation .......................................................................................................... 6 

2.2. Practices vis-à-vis donors and collectors...................................................................................... 7 

2.2.1. Occurrence of practices vis-à-vis donors............................................................................... 7 

2.2.2. Values of practices vis-à-vis donors .................................................................................... 10 

2.2.3. Perception of practices vis-à-vis donors.............................................................................. 11 

2.2.4. Practices vis-à-vis collectors ................................................................................................ 12 

2.3. Ensuring sufficient supply of blood, blood components and derivatives .................................. 12 

2.3.1. Supply of blood, blood components and derivatives.......................................................... 12 

2.3.2. Policies to promote (self-) sufficiency of blood and derivatives ......................................... 13 

2.3.3. Promotion of VUD ............................................................................................................... 14 

2.3.4. Policies and audits on clinical use of blood, blood components and derivatives as a means 
to achieve sufficiency .................................................................................................................... 16 

2.4. Organisation of collection and supply........................................................................................ 18 

2.4.1. Main collectors and suppliers of blood and blood components......................................... 18 

2.4.2. Plasma fractionation ........................................................................................................... 18 

2 

 
 
 
 
ABBREVIATIONS 

Aph. = Apheresis  

BE = Blood establishment  

EEA = European Economic Area 

EU = European Union 

EUR = Euro 

VUD = Voluntary and unpaid donation 

WB = Whole blood 

Member States abbreviations:  http://publications.europa.eu/code/en/en-370100.htm 

3 

 
 
 
 
 
 
1. INTRODUCTION 

This  Staff  Working  Document  summarises  the  results  of  a  questionnaire  survey  of  Member 
States on the implementation of the principle of voluntary and unpaid donation for blood and 
blood components.  The survey was conducted in 2014. Results of a separate survey on the 
implementation of the blood legislation in general are summarised in a separate Staff Working 
Document,  prepared  in  parallel  with  this  one.  These  two  documents  accompany  the  Report 
from the Commission to the European Parliament, the Council, the European Economic and 
Social  Committee  and  the  Committee  of  the  Regions  on  the  implementation  of  Directives 
2002/98/EC,  2004/33/EC,  2004/33/EC,  2005/61/EC  and  2005/62/EC  setting  standards  of 
quality and safety for human blood and blood components. 

According  to  recital  (23)  the  Directive  takes  account  of  the  definition  of  the  Council  of 
Europe1  on  what  is  considered  voluntary  and  non-remunerated  donation.  However,  no 
definitions  of  the  terms  compensation,  incentive,  sufficiency  or  shortage  are  defined.    To 
allow  for  comparable  replies,  and  only  for  the  purpose  of  this  survey,  the  following 
definitions were provided: 

•  Compensation  means  reparation  strictly  limited  to  making  good  the  expenses  and 

inconveniences related to the donation;  

• 

Incentive  means  inducement/stimulus  for  donation  with  a  view  to  seeking  financial 
gain or comparable advantage;  

•  National  self-sufficiency  means  fulfilling  the  needs  of  human  blood,  blood 
components and plasma derivatives for medical application of the resident population 
by accessing resources from within the country’s population; 

•  National  sufficiency  means  fulfilling  the  needs  of  blood,  blood  components  and 
plasma  derivatives  for  medical  application  of  the  resident  population  by  accessing 
resources from within the country and through regional/international cooperation; 

•  Shortage means a relative deficiency in the supply with blood, blood components and 
plasma derivatives for medical application, which requires creation of waiting lists or 
makes a certain therapy temporarily unavailable at national level. 

This  document  aims  to  map  the  implementation  of  the  principle  of  voluntary  and  unpaid 
donation  (VUD)  of  blood  in  the  Union.  It  mainly  focuses  on  practices  vis-à-vis  donors  and 
collectors (chapter 2.2). It also covers provisions and policies related to VUD (chapter 2.1.) 
and addresses the efforts to ensure sufficient supply through VUD (chapter 2.3.), as well as 
the organisation of collection and supply of blood, blood components and derivatives (chapter 
2.4.).  The  main  findings  of  this  document  have  been  presented  to  the  blood  competent 
authorities during their regular meetings with the Commission. 

1 Recommendation No R(95)14 of the Committee of Ministers to member states on the protection of the health 
of donors and recipients in the area of blood transfusion, Appendix, Article 2 states "if the person gives blood, 
plasma or cellular components of his or her own free will and receives no payment for it, either in the form of 
cash or in kind which could be considered a substitute for money. This would include time off work other than 
that  reasonably  needed  for  the  donation  and  travel.  Small  tokens,  refreshments  and  reimbursements  of  direct 
travel costs are compatible with voluntary, non-remunerated donation." 
. 

4 

 
 
 
                                                            
2. IMPLEMENTATION OF THE PRINCIPLE OF VOLUNTARY AND 
UNPAID DONATION OF BLOOD AND BLOOD COMPONENTS 

2.1. Legislative provisions, guidelines and policies concerning donation 

2.1.1. Provisions and guidelines on VUD at national level and their application  

The  principle  of  VUD  of  blood  and  blood  components  is  recognised  in  all  Member 
States, albeit enforced to different degrees. The large majority of Member States (25) and 
Norway  reported  that  VUD  of  human  blood  and  blood  components  was  mandatory  in 
their country. Due to divergent interpretations of the term "mandatory", it has to be noted 
that in some of these 25 Member States, the national legal provisions rather "encourage" 
VUD.  On  the  other  hand,  VUD  may  be  the  common  practice  or  strongly  recommended 
also  in  those  Member  States  (Czech  Republic,  Lithuania,  and  United  Kingdom)  and 
Liechtenstein which reported that it was not legally mandated.  

Seventeen  Member  States  have  defined  penalties  for  infringements  of  their  legislative 
provisions  related  to  VUD  of  blood  and  blood  components  (AT,  BE,  BG,  CY,  EE,  EL, 
ES, FI, FR, HR, IT, LU, NL, PT, RO, SE, UK). The nature of the penalties, the actions 
for  which  they  are  defined  and  the  persons  on  whom  they  are  imposed  (hospital  or 
company  managers,  legal  persons  such  as  hospitals  and  companies  or  any  individual) 
vary  among  these  Member  States.  For  instance,  there  are  penalties  for  collecting  blood 
without  consent  of  the  donor  or  for  taking  part  in  blood  transactions  to  make  financial 
gain. Eleven Member States allow the intervention of supervising bodies, for example to 
revoke  or  suspend  authorisations,  17  Member  States  have  defined  fines  with  maximum 
amounts from EUR 62 to 25 million euros and 10 Member States allow imprisonment for 
maximum  terms  from  six  months  to  five  years.  So  far,  none  of  these  penalties  has  ever 
been imposed.  

Nine  Member  States  reported  taking  additional  measures  to  ensure  that  donations  are 
voluntary  and  unpaid  (BE,  BG,  CZ,  EE,  FI,  FR,  LT,  PL,  RO).  All  of  them  examine  or 
inspect advertising material provided by blood establishments, collection sites and blood 
donor associations (flyers, website information etc.). In addition, the Czech Republic and 
Romania  ensure  that  the  principle  of  VUD  is  also  respected  for  imported  blood  and  its 
components.  In  Bulgaria  and  Romania,  professionals  are  trained  to  detect  illegal  and 
fraudulent activities. 

2.1.2. Recent and planned changes of legislative provisions or guidelines  

Since the last survey on VUD of blood and blood components, five Member States (CZ, IE, 
LV, LT, SK) have implemented binding national rules concerning VUD. The Czech Republic, 
Latvia  and  Slovakia  have  regulated  the  forms  or  amounts  of  compensation  for  donation  of 
blood that are allowed. Lithuania and Ireland have established rules concerning the promotion 
of VUD.  

Four Member States (EL, IE, RO, SI) mentioned having plans to change their guidelines for 
the donation of blood and its components in a manner that will further promote VUD. Greece 
plans  new  policies  such  as  school  education  and  strategies  for  social  recognition  of  donors, 
and for donor registration and maintenance. Furthermore, it wants to improve the distribution 
of  blood  and  blood  components.  Ireland  is  considering  implementing  guidelines  on  VUD. 
Slovenia  is  considering  adopting  guidelines  for  incoming  trans-border  donors  and  Romania 
plans to ask donors about their donations in other countries.  

5 

 
 
2.1.3. Replacement donors 

A  replacement  blood  donor  is  a  person  who  gives  a  donation  of  blood  on  request,  to 
replace donations that have been used for their family member or friend. A replacement 
donation is likely to be inconsistent with the principle of VUD. Five Member States (BG, 
CY,  EL,  LV,  RO)  reported  being  aware  of  replacement  donations  in  their  countries. 
Bulgaria  and  Greece  indicated  that  replacement  donation  often  occurred,  while  Latvia 
reported occasional occurrence. Romania reported replacement donation on the initiative 
of  family  and  friends.  Cyprus  stated  that  replacement  donation  only  occurred  in 
authorised exceptional circumstances.  

Member States seem to have different views on replacement donation. This can partly be 
explained by the lack of a common definition of this term at the European level: 

• 

• 

• 

In  Greece,  blood  donor  programmes  make  a  concerted  effort,  with  a  resulting 
change  in  hospital  practice,  in  order  to  convert  replacement  donors  to  voluntary 
blood donors. Also some Romanian replacement donors become repeat or regular 
donors.  Greece  and  Romania  therefore  consider  replacement  donors  to  be 
contributing to the national blood supply and to be prospective regular, voluntary 
and  unpaid  donors  and,  consequently,  they  have  dedicated  policies  or  guidelines 
for this practice; 

Ireland,  Spain  and  the  United  Kingdom,  which  are  not  aware  of  replacement 
donors  in  their  countries,  have  policies  that  forbid  or  strongly  discourage 
replacement donation; 

In  the  Czech  Republic,  according  to  a  recommendation  of  the  Czech  medical 
society,  directed  donation  for  a  specific  patient  is  exceptionally  acceptable  if  it 
bears  lower  risks  for  the  recipient  or  if  the  donation  of  the  specific  blood 
component needed carries increased risks for the donor. 

2.1.4. Trans-border donation  

Trans-border donors can be described as individuals who donate in a country where they are 
not living. Five Member States (AT, EE, HU, LU, NL) are aware of individuals who are not 
living  in  their  countries  and  who  come  to  their  countries  to  donate  blood  or  blood 
components. Six Member States (CY, HU, LU, PL, SI, SK) are aware of individuals who are 
living  in  their  countries  and  who  go  to  donate  blood  or  blood  components  outside  their 
country.  Among  these  later  ones,  Cyprus,  Hungary  and  Luxembourg  have  reported  local 
shortages within their countries. 

In  a  number  of  Member  States,  policies  or  practices  are  in  place  related  to  trans-border 
donation. 

In 10 Member States (AT, BG, CY, FI, LT, LU, NL, PT, SI, SK), the donor questionnaire is 
available not only in the native language but also in English, which can significantly facilitate 
trans-border  donation.  In  Austria,  Finland  and  in  some  private  collection  sites  in  Germany, 
donor questionnaires are available in additional languages.  

Policies or practices which discourage or inhibit donation by persons who are not living in the 
country of donation are to be found in 16 Member States (CY, CZ, DK, EE, EL, FI, FR, HR, 
IT, LV, MT, PL, RO, SE, SI, SK) and in Norway: 

6 

 
 
• 

• 

In  eight  Member  States  (DK,  EL,  FI,  HR,  IT,  LV,  MT,  SE),  donors  must  have  an 
identity document issued by the country of donation;  

In Cyprus, the Czech Republic and Romania, donors are usually accepted only if they 
had been living for some time in the country of donation. This is also the practice in 
Slovakia  and  Slovenia,  which  both  pointed  out  that  they  accept  as  donors  also  their 
citizens  who  live  and  work  abroad  but  donate  in  their  country  of  origin  during  their 
holidays;  

•  Five Member States (CZ, DK, FR, PL, RO) and Norway pointed out that donors were 
required  to  understand  the  language  of  the  country  of  donation,  at  least  to  a  certain 
level. 

Trans-border  donation  is  mainly  considered  to be  an individual  practice. Only Hungary and 
Slovakia  reported  that,  apart  from  individual  trans-border  donors,  near  the  border  with 
Austria, there were also organised groups leaving Hungary and Slovakia in order to undergo 
plasmapheresis donation in Austria. Poland reported that mainly young first time donors who 
live  near  to  the  border  with  Germany  go  there  to  donate  plasma  in  private  establishments. 
Austria and Germany have no further information available on this topic. 

2.2. Practices vis-à-vis donors and collectors 

2.2.1. Occurrence of practices vis-à-vis donors 

The  practices  vis-à-vis  donors  vary  from  one  Member  State  to  another  (see  Figure  1)  and 
there may also be different practices within one country. 

It  is  common  practice  to  give  donors  refreshments  (25  Member  States,  Liechtenstein  and, 
Norway) and small tokens (such as pins, pens, towels, t-shirts and mugs) (22 Member States, 
Liechtenstein and Norway). In around half of the Member States, donors are reimbursed their 
travel costs and get time off work in the public and private sector.  

Thirteen Member States (BG, CZ, DE, EE, FI, IE, HU, LT, LU, LV, NL, PL, RO) reported 
having guiding principles regarding the possibility of giving compensation to donors of blood 
and blood components. In general, these principles, set out in national laws, decrees or non-
binding  recommendations,  appear  to  define  what  form  of  compensation  or  other  practice  is 
allowed and under which circumstances.  

7 

 
 
e

el

el 

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enien

ney, irrespective of actual 
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dical costs 
arnings
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ork - private sector
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Small tokens, such as pins, pe
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ork - public sector
nt of m
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nsation linke
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d to donation
dditional m
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m of m
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Other forms
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e off w
Refreshm
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d su
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relate
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Fixe
Fixe
Tim
Tim
Fre
C
Days/donation Maximum value in EUR/donation
Days/donation Maximum value in EUR/donation
X
25

Maximum value in EUR/donation
Maximum value in EUR/donation

pe
om
C

ugs

Fre

e
m

X
25

w

1
X

o

o

e

e

FI

IE

EL

ES

EE

CZ

BE

FR

CY

DE

AT

DK

HR

BG

HU

X
WB
X
Aph.
X
WB
X
Aph.
4,09
WB
Aph. 4,09
X
WB
X
Aph.
X
WB
X
Aph.
X
WB
X
Aph.
1
WB
1
Aph.
X
WB
X
Aph.
1
WB
1
Aph.
X
WB
X
Aph.
X
WB
X
Aph.
X
WB
X
Aph.
3
WB
3
Aph.
1,58
WB
X
Aph.
X
WB
X
Aph.
WB
2.50
Aph. 2.50
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
Total EU
WB
LI
Aph.
WB
Aph.

X
10
4
4
X
X
X
X
25
2.70
X
X
X

4
4
2
2
X
X
2
2

MT

NO

X
X

UK

RO

NL

LU

PT

SK

LV

SE

PL

LT

IT

SI

X
X
X
X
3,06
3,06
X
X
X
X
X
X
10
10
X
X
1
1
X
X
1.50
1.50

3
3

X
X

X
X

8
8
3.50
3.50
X
X
2
2

X
10
8
8
X
X
X
X
22
3

X
X

4,09
4.09

X
X

X
X

1,42
1,42

15
15

2
2

6
2.70
X

X
X

16
16
27
27

X
X

X
X
X
X

X

X
X

20
20
X
X

X
X
2/10km
2/10km

X
X

2
2

<1
<1

<1
<1
2
2

1
1

1
1
1
1
<1
<1
1
1
<1
<1
<1
<1
1
1

1
1

1
1
1
1

2
2

<1
<1

<1
<1

1
1
1
1
<1
<1
1
1
<1
<1
<1
<1
1
1

1
1

1
1
1
1

13

16

13

X
X

X
X
X
X
X
X

X
X

5

X
X

X
X

30
30

X
X

4

X
X

X
X

X
16-30
27
27

X
16-30
27
27

12
12

4.27
28.46

X
X

X
X

X
X

X
X

3
9

5

4

4

1

X
X
X
X

X
X

4

Fig. 1: Practices vis-à-vis 
donors 

Aph.: apheresis, BE: blood 
establishment, WB: whole blood X: 
regular or exceptional practice, but 
value not available or not specified 

Note 1: The column 'Free or 
reimbursement of medical costs' refers 
only to costs incurred following 
adverse reactions associated with 
donation. 

Note 2: Where a MS has reported 
monetary reimbursement or 
compensation of more than one type, 
the sums given should not be added 
together, e.g. for DE, a total of EUR 27 
is given. 

Note 3: The free physical check-up 
provided in RO is annual and

8 

 
 
 
 
 
 
 
el 

ney, irrespective of actual 
ney, irrespective of actual 
nt of medical costs 
d to loss of earnings
eniences 
d to trav
what is required for the donation)
(e. g. additional medication, etc.)
Small tokens, such as pins, pens, 
d at national lev
Free physical check-up (beyond 
nation)
nt of costs linke
Time off work - private sector
Compensation for the inconv
Time off work - public sector
(to and from place of do
d by BE
towels, t-shirts, mugs
Free or reimburseme
Compensation linke
related to donation
m of mo
m of mo
costs, establishe
costs, establishe
Reimburseme
Other forms
Fixed su
Fixed su

Total

el

oucher(s)
Refreshments
Food v

Maximum value in EUR/donation
Maximum value in EUR/donation

Days/donation Maximum value in EUR/donation
Days/donation Maximum value in EUR/donation

X
X

X
25

X
30
27
27

12
12

4.27
28.46

5

2

7

3

9

5

2

5

5

3

3

1

3

2

3

3

6

2

4

4

X
X

X
X

11

X
X

X
25

X
30
27
27

X
X

3
9

FI

IE

EL

ES

EE

CZ

BE

FR

CY

DE

AT

DK

HR

BG

HU

WB
Aph.
WB
Aph.

X
X
X
X
WB
4.09
Aph. 4.09
X
WB
X
Aph.
X
WB
X
Aph.
X
WB
X
Aph.
1
WB
1
Aph.
X
WB
X
Aph.
1
WB
1
Aph.
X
WB
X
Aph.
X
WB
X
Aph.
X
WB
X
Aph.
3
WB
3
Aph.
1.58
WB
X
Aph.
X
WB
X
Aph.
WB
2.50
Aph. 2.50
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
WB
Aph.
Total EU
LI
WB
Aph.
WB
Aph.

X
10
4
4
X
X
X
X
25
2.70
X
X
X

4
4
2
2
X
X
2
2

MT

NO

X
X

UK

RO

NL

LU

PT

SK

LV

SE

PL

LT

IT

SI

1
X

2
2

<1
<1

<1
<1
2
2

1
1

1
1
1
1
<1
<1
1
1
<1
<1
<1
<1
1
1

1
1

1
1
1
1

X
X

16
16
27
27

X
X

X
X
X
X

X

X
X

20
20
X
X

X
X
2/10km
2/10km

X
X

2
2

<1
<1

<1
<1

1
1
1
1
<1
<1
1
1
<1
<1
<1
<1
1
1

1
1

1
1
1
1

13

16

13

X
X

X
X
X
X
X
X

X
X

5

X
X

X
X
X
X

X
X

4

X
X
X
X
3.06
3.06
X
X
X
X
X
X
10
10
X
X
1
1
X
X
1.50
1.50

3
3

X
X

X
X

8
8
3.50
3.50
X
X
2
2

X
10
8
8
X
X
X
X
22
3

X
X

4.09
4.09

X
X

X
X

1.42
1.42

15
15

2
2

6
2.70
X

X
X

X
X

30
30

X
X

4

7

3

5

4

4

9

2

3

2

9 

5

4

4

1

 
 
 
2.2.2. Values of practices vis-à-vis donors 

In most Member States, only fragmented data are available as regards the monetary values of 
their practices vis-à-vis donors (Figure I). Where values were reported, they were sometimes 
the  same  for  donation  of  whole  blood  and  for  apheresis  donation  of  blood  components. 
Apheresis donation is not practised in all Member States.  

The highest maximum values reported lie between EUR 25 and EUR 30 (AT, CZ, DE, LV, 
RO). In Bulgaria and the Czech Republic, the maximum values are defined as a percentage of 
the national minimum wage. The reported maximum values of refreshments and small tokens 
range between EUR 1 and EUR 10. Food vouchers are available in six Member States (BG, 
CZ,  LV,  HU,  RO,  SK)  and  in  Liechtenstein.  The  reported  maximum  values  usually  lie 
between  EUR  1.4  (Latvia)  and  EUR  4.1  (Bulgaria).  However,  in  Romania  a  fixed  value  of 
EUR 15 is established for food vouchers. 

As regards reimbursement of the costs incurred by the donor to travel to and from the place of 
donation, in some Member States the actually incurred costs (Finland, Romania) or a certain 
sum  per  kilometre  (Sweden)  are  reimbursed  whereas  other  Member  States  have  fixed  a 
maximum value for the reimbursement (Netherlands) or cover it with a maximum lump sum, 
irrespective of the actually incurred costs (Czech Republic and Germany). 

In most Member States where donors get time off work from the public sector, this is also the 
case  for  the  private  sector.  In  nine  Member  States,  donors  are  given  one  day  off,  in  six 
Member States less than one day or only the time needed for the donation and in two Member 
States, donors get two days off. 

Nine  Member  States  (AT,  BG,  CZ,  DE,  LV,  LT,  NL,  PL,  SE)  reported  practices  which 
involve the transfer of money other than for reimbursement of travel or medical costs. Such 
practices aim at compensating loss of earnings or for the inconveniences related to donation 
or  consist  in  the  transfer  of  fixed  sums  of  money.  These  fixed  sums  are  irrespective  of  the 
costs actually incurred by the donor for the donation. 

In  Austria,  Bulgaria  and  Poland,  the  transfer  of  money  is  only  allowed  under  certain 
circumstances, such as: 

• 

In emergency cases (AT; BG: EUR 23 per donation);  

•  For donation of rare blood groups (PL); 

•  For  donation  through  apheresis  of  plasma  and  platelets (AT), of platelets (BG:  EUR 

46 per litre of blood passed through the apparatus), or of anti-D plasma (PL); 

•  For  donations  intended  for  the  production  of  vaccines,  sera  and  immunoglobulins  or 

for research and diagnostic purposes in medicine (BG: EUR 40 per donation). 

In  the  Czech  Republic,  compensation  may  exceptionally  exceed  the  demonstrably  incurred 
costs and the maximum value fixed as 5 % of the minimum wage for standard donations. This 
can be the case if the blood from a specific donor is needed in order to provide individual care 
to a specific patient, or if special preparation or selection of the donor is required according to 
the  blood  group  systems  of  the  recipient.  In  such  cases,  the  maximum  is  not  defined  but 
typically might reach EUR 30. 

In 15 Member States, operators or blood establishments are involved in defining the values of 
what is given to donors (15 Member States: AT, CZ, DE, EE, EL, ES, FI, HU, IE, LT, MT, 
10 

 
 
NL, PL, SE, UK), while national governments are involved in 10 Member States (BG, CY, 
CZ,  IT,  LT,  LV,  PL,  PT,  RO,  SK).  Other  bodies  involved  are  health  insurance  schemes 
(Finland, Croatia, Slovenia), regional and local governments (Italy, Sweden), the Red Cross 
(Croatia, Liechtenstein) or specific bodies such as the association of local donors in Denmark, 
a  working  group  on  blood  in  Germany,  the  hospital  transfusion  committee  in  Greece  and 
blood donor associations in Italy. In Luxemburg, there are agreements between employers and 
employees on the time off work given to donors. 

In 10 Member States (CZ, DE, EL, FI, HR, IT, LT, LU, PL, SE), more than one stakeholder is 
involved  in  taking  the  decision  on  the  values  of  what  is  given  to  donors.  For  example, 
maximum  values  can  be  decided  at  the  national  level  but  the  decision  on  the  actual  value 
might be taken on the local level (Czech Republic, Germany, Finland). Other Member States 
pointed out that different stakeholders agreed on  a common decision on the values (EL, IT, 
HR, LU, SE). 

2.2.3. Perception of practices vis-à-vis donors 

Fig. 2: Perception of practices vis-à-vis donors 

11 

 
 
 
 
Figure 2 shows that the same practice vis-à-vis donors may be classified as compensation by 
some  Member  States,  as  incentive  by  others  and  as  other  practice  by  a  third  group.  For 
example, among the countries which chose the option "other practice", 12 explained to give 
refreshments to donors for medical reasons and seven stated that small tokens were given to 
to  different 
express  appreciation.  These  divergent  perceptions  seem 
interpretations  of  the  given  definitions  of  compensation  and  incentive.  In  addition,  there 
seems to be no common understanding of what practices are compatible with VUD.  

to  be 

linked 

2.2.4. Practices vis-à-vis collectors  

Ten Member States (DK, EL, HU, IT, LT, LV, PL, PT, SI, SK) reported to provide financial 
incentives to blood establishments, recruitment organisations or professionals in their Member 
States for one or more activities related to collection, processing, storage and distribution of 
whole  blood  and  of  blood  components  (Fig.  3).  More  Member  States  provide  financial 
incentives for activities relating to whole blood than for activities relating to apheresis. 

Fig. 3: Activities for which Member States provide financial incentives to blood establishments and 
others (Member States in brackets provide incentives only for activities related to whole blood). 

2.3. Ensuring sufficient supply of blood, blood components and derivatives 

2.3.1. Supply of blood, blood components and derivatives  

Shortage  can  be  defined  as  a  deficiency  in  the  supply  with  blood,  blood  components  and 
plasma derivatives for medical application. Eight Member States (BG, CY, CZ, EL, HU, LV, 
PT, SE) reported having experienced regular shortage of whole blood, blood components or 
plasma fractions (Figure 4). In Slovenia there is a seasonal possibility of shortage of certain 
blood groups of red blood cells and of platelets.  

12 

 
 
 
 
 
Fig. 4: Regular shortage 

Shortage occurs mainly during the summer and other holiday periods, and is mainly due to an 
insufficient  number  of  donors  (seven  Member  States:  BG,  CZ,  EL,  HU,  PT,  SE,  SI)  and  to 
high rates of use (three Member States: Bulgaria, Czech Republic and Sweden). Overall, the 
shortages seem to have no serious impacts on healthcare. In five Member States (BG, CY, EL, 
HU,  PT),  as  a  result  of  shortage,  planned  surgeries  which  were  not  urgent  have  been 
postponed for around four days (Bulgaria, Cyprus, Hungary) up to 20 days in Greece, where 
summer  holidays  coincide  with  the  West  Nile  Virus  seasonal  activity.  The  shortages  of 
immunoglobulin  (intravenous  IgG  and  anti-D  IgG)  and  fibrinogen  in  the  Czech  Republic, 
which  occur  only  occasionally  and  the  shortage  of  albumin  and  immunoglobulins  in  Latvia 
seem to have had no impact on healthcare. In Sweden, where shortage occurs in particular in 
larger  cities,  it  can  be  covered  through  collaboration  of  neighbouring  blood  establishments. 
This  is  also  the  case  in  Cyprus.  Both  Hungary  and  Sweden  reported  that  in  2014,  there  has 
been less shortage than previously.  

2.3.2. Policies to promote (self-) sufficiency of blood and derivatives 

Member  States  have  set  the  objectives  of  self-sufficiency  in  human  blood  and  blood 
components  and  of  ensuring  that  blood  and  blood  components  are  in  so  far  as  possible 
provided from voluntary and unpaid donations2.  

(Self-) sufficiency can be measured not only at the national, but also at a local or at European 
Union level. Self-sufficiency at European Union level can be obtained through cooperation of 
Member States without requiring all Member States to be self-sufficient at their national level. 

Twenty-five  Member  States  (all  except  Austria,  Cyprus,  Finland)  and  Liechtenstein  and 
Norway have policies in place to endeavour to achieve self-sufficiency and or sufficiency of 
blood and blood derivatives. In Cyprus, such a policy was in preparation at the time of this 
survey. Austria stated that it was self-sufficient in blood and derivatives, Finland declared to 

2 Recitals 4, 23, 32 and Article 20(1) of  Directive 2002/98/EC of the European Parliament and of the Council of 
27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and 
distribution of human blood and blood components and amending Directive 2001/83/EC, (OJ L 33, 8.2.2003, pp. 
30-40). 

13 

 
 
 
                                                            
be  self-sufficient  in  blood  and  blood  components  and  to  be  sufficient  in  imported  plasma 
products.  

In  order  to  achieve  (self-)  sufficiency,  there  is  a  variety  of  policies  in  place  among  the 
Member States. These policies aim either at increasing the supply of blood, blood components 
and  derivatives,  for  example  through  promotion  of  donation  (cf.  below  chapter  2.3.4.)  or 
through export restrictions or at decreasing the demand, in particular through the promotion of 
rational  or  efficient  use  (cf.  below  chapter  2.3.5.).  Some  Member  States  reported 
centralisation,  in  order  to  have  an  overview  of  the  national  stock,  or  cooperation  of  blood 
establishments within their country. Overall, Member States seem to have more strategies for 
the promotion of (self-) sufficiency in blood than for the promotion of (self-) sufficiency in 
derivatives. 

These  policies  appear  to  be  stable  over  the  time.  However,  some  countries  are  recently 
increasing their activities in the plasma sector. Four Member States (DK, EL, ES, SK) have 
launched  projects  to  increase  apheresis  donations,  mainly  for  plasma,  which  might  also 
increase in Norway. At the time of the survey, Portugal planned to start a programme to use 
plasma from whole blood donation via an international tender for the manufacture of plasma 
derived  medicinal  products.  Greece  reported  new  provisions  on  the  optimisation  of  clinical 
use  of  blood  components  and,  in  Norway,  there  is  an  initiative  to  introduce  patient  blood 
management.  

2.3.3. Promotion of VUD 

All Member States and Liechtenstein with the exception of Hungary, the Netherlands and 
also  Norway  reported  to  have  taken  measures  to  promote  VUD  of  blood  and  blood 
components.  Often  it  was  not  clear  if  the  reported  measures  were  intended  to  promote 
donation  of  blood  and  blood  components  as  such  or  if  they  focused  on  VUD.  However, 
since VUD is mandatory in the large majority of Member States, promotion of donation 
as such is likely to coincide with promotion of VUD. 

A variety of different measures are used to promote donation (Figure 5).  

14 

 
 
Fig. 5: Measures to promote (voluntary and unpaid) donation 

The  most  common  ones  are  awareness  and  information  campaigns,  which  are  run  in  26 
Member States and Liechtenstein, as well as events focusing on donation, such as donor 
days  (25  Member  States).  Fourteen  Member  States  (AT,  BG,  CZ,  EE,  ES,  HR,  IE,  IT, 
LT, LV, PL, PT, RO, UK) and Liechtenstein reported the involvement of the mass media 
in such campaigns. A large number of Member States noted the importance of honouring 
frequent  donors.  Ireland,  Italy,  Slovenia  and  the  United  Kingdom  mentioned  the  use  of 
social  media  (social  networks,  smartphone  applications).  Six  Member  States  (BG,  CZ, 
ES,  FR,  PL,  RO)  specified  that  various  stakeholders  cooperated  in  the  campaigns,  for 
example governmental institutions, non-governmental organisations and companies.  

As  regards  patient  specific  donor  drives,  Greece  explained  that  it  carries  out  campaigns 
for  the  promotion  of  VUD  on  the  International Thalassemia day (8th May).  Austria and 
Ireland  noted  that  registered  donors  are  called  if  special  blood  groups  or  types  are 
urgently needed. The United Kingdom stated that individual patient stories could be used 
within its marketing and that such patient specific drives tended to be community driven.  

Other measures described included, for example, training of staff of blood establishments 
and of volunteers for promotional measures in Lithuania and Poland.  

Among  the  26  Member  States  and  Liechtenstein  which  have  taken  measures  to  promote 
VUD, all but four Member States (Belgium, Czech Republic as regards the national level, 
Croatia, Malta) have defined specific target groups for these promotion measures (Figure 
6). 

15 

 
 
 
  
 
Fig. 6: Target groups for promotional measures 

Around two thirds of the Member States target youth and young adults, in particular through 
promotion measures at schools and universities.  

Other  target  groups  are,  for  example,  first  time  donors  in  Germany,  the  rural  population  in 
Romania,  defined  blood  groups  in  Liechtenstein  or  members  of  certain  professions,  such  as 
firemen in Austria and Poland, the public service in Cyprus, athletes in Spain and policemen 
in Poland. Italy and Spain reported providing training seminars to the media and Spain also 
medical seminars to general practitioners. 

2.3.4.  Policies  and  audits  on  clinical  use  of  blood,  blood  components  and  derivatives  as  a 
means to achieve sufficiency 

Member States were asked about policies and practices to support appropriate clinical use of 
blood,  blood  components  and  derivatives  as  these  initiatives  could  support  achieving 
sufficiency  through  VUD,  without  relying  on  importation  from  countries  where  the  VUD 
principle might not be followed. 

All  Member  States,  and  Norway,  with  the  exception  of  Estonia,  Slovakia  and  Liechtenstein 
have policies in place to contain or ensure the effective use of blood and blood components 
for clinical use. Policies to contain or ensure the effective use of plasma derivatives are less 
common, but 21 Member States have such policies (BE, BG, CY, CZ, DE, DK, EL, ES, FR, 
HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, RO, UK). Most common are national policies and 
policies  on  the  level  of  operators  and  blood  establishments  (Figure  7).  Five  Member  States 
(DE, CZ, EL, FR, IT) pointed out that specific bodies were involved in policy-making, such 
as  the  German  Medical  Association  (Bundesärztekammer),  the  French  Haute  Autorité  de  la 
Santé and medical scientific societies in Czech Republic, Greece and Italy. 

16 

 
 
 
 
Fig. 7: Policy setting to ensure effective use of blood, blood components and plasma derivatives 

Austria,  the  Czech  Republic  and  Italy  stressed  the  importance  of  having  policies  on  several 
levels in order to ensure the effective use of blood, blood components and derivatives and of 
involving  multiple  stakeholders,  such  as  patient  organisations,  health  insurance  companies, 
hospitals and  single physicians. In order to contain or ensure the effective  use of blood and 
blood components, 17 Member States (AT, BG, CZ, DK, EL, ES, FR, HU, IE, IT, LU, LV, 
MT, NL, PL, SI, UK) have policies in place on more than one level and 12 Member States 
(CZ, DK, EL, ES, FR, HU, IE, IT, LU, LV, PL, UK) to contain or ensure the effective use of 
plasma derivatives. 

Examples of such policies are: 

•  Patient blood management programmes in AT and IT, which contributed, according to 
Italian  data  and  together  with  improvement  in  transfusion  practice,  to  the  reduced 
consumption of red blood cells and fresh frozen plasma in 2013;  

•  Policies for the use of recombinant factor VIII in EL; 

•  National  clinical  guidelines  on  the  appropriate  use  of  blood  components  for  certain 

indications such as trauma in PT. 

Audits on the clinical use of blood, blood components and plasma derivatives can be carried 
out at national, regional or local level or on the level of hospitals and operators. 16 Member 
States reported having carried out regular audits on clinical blood use (BE, BG, CY, CZ, DK, 
EL,  FR,  HU,  IE,  IT,  LT,  LU,  MT,  PL,  PT,  UK),  but  only  eight  Member  States  reported 
carrying out regular audits on clinical use of plasma derivatives (BG, CZ, EL, IE, IT, LU, PL, 
PT). Audits of clinical blood use take place mainly at the level of hospitals and operators (14 
Member States) and at the national level (10 Member States). Audits of clinical use of plasma 
derivatives are mainly carried out at the hospital or operator level (five Member States) and at 
the local level (four Member States). 

17 

 
 
 
Most Member States that carry out regular audits of clinical use do so on more than one level, 
both as regards the clinical use of blood and blood components (12 Member States: DK, EL, 
FR,  HU,  IE,  IT,  LT,  LU,  MT,  PL,  PT,  UK)  and  of  plasma  derivatives  (six  Member  States: 
BG, CZ, EL, IE, IT, LU).  

2.4. Organisation of collection and supply 

2.4.1. Main collectors and suppliers of blood and blood components 

Public  national  establishments  are  the  main  collectors  of  whole  blood  in  22  Member  States 
(BG, CY, CZ, DK, EE, EL, ES, FR, HR, HU, IE, IT, LT, LV, MT, PL, PT, RO, SE, SI, SK, 
UK) and of plasma in the same Member States with the exception of Latvia and Portugal. 

Private national establishments (including not for profit organisations such as the Red Cross) 
are  main  suppliers  of  both  whole  blood  and  plasma  in  seven  Member  States  (AT,  BE,  CZ, 
DE, FI, LU, NL, SE) and of plasma in Latvia. Establishments from other countries are also 
the main suppliers for Ireland as regards solvent/detergent-treated plasma and for the United 
Kingdom as regards variant Creutzfeldt Jacob disease free plasma. 

2.4.2. Plasma fractionation 

Twelve  Member  States  (AT,  BE,  BG,  DE,  ES,  FR,  HU,  IT,  NL,  PL,  SE,  UK)  have  the 
capacity  for  plasma  fractionation.  The  plasma 
is  mainly  fractionated  by  private 
establishments, which include both for profit organisations (in AT, DE, ES, HU, IT, PL, SE, 
UK)  and  non-profit  organisations  (in  Belgium  and  Netherlands).  In  Bulgaria  and  France, 
plasma  is  fractionated  by  public  national  establishments.  The  fractionation  plant  situated  in 
the  United  Kingdom  does  not  fractionate  plasma  from  within  the  country,  due  to  risk  of 
variant Creutzfeldt Jacob disease, and was privatised in 2013. 

Nine  Member  States  (CZ,  EE,  EL,  FI,  LT,  LU,  LV,  SI,  SK)  and  also  Liechtenstein  and 
Norway send the plasma collected in their country for fractionation in other Member States, 
mainly in Austria. Plasma from Denmark is fractionated in Switzerland.  

Seven Member States (CY, IE, HR, MT, PT, RO, UK) reported that the plasma collected in 
their  country  was  not  fractionated.  Ireland  and  the  United  Kingdom  explained  that  this  was 
due  to  risk  of  variant  Creutzfeldt-Jacob  disease.  Croatia  and  Portugal  noted  that  there  are 
plans for plasma fractionation in the future. Lithuania reported an open procedure for contract 
fractionation.   

18