REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS 2nd Report on Voluntary and Unpaid Donation of Blood and Blood Components
Date: 2011-03-23
Institutions: European Commission
Subjects: blood transfusion, health control, health policy, member country, public health, quality standard, research report, safety standard

EN 

EN 

   EN 

 
EUROPEAN COMMISSION 

Brussels, 23.3.2011 
COM(2011) 138 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE 
COMMITTEE OF THE REGIONS 

2nd Report on Voluntary and Unpaid Donation of Blood and Blood Components 

EN 

   EN 

 
 
TABLE OF CONTENTS 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE 
COMMITTEE OF THE REGIONS 2nd Report on Voluntary and Unpaid Donation of Blood 
and Blood Components .............................................................................................................. 1 

1. 

2. 

Introduction .................................................................................................................. 3 

Results .......................................................................................................................... 4 

2.1. 

Legislative provisions, guidelines and policies............................................................ 4 

2.1.1.  Replacement donors ..................................................................................................... 5 

2.1.2.  Trans-border blood donation........................................................................................ 5 

2.2. 

Incentives ..................................................................................................................... 5 

2.2.1. 

Incentives for whole blood donors............................................................................... 5 

2.2.2. 

Incentives for apheresis donors.................................................................................... 6 

2.3. 

2.4. 

Promotion..................................................................................................................... 6 

Collection and supply................................................................................................... 7 

2.4.1.  Collection ..................................................................................................................... 7 

2.4.2.  Plasma fractionation..................................................................................................... 8 

2.4.3.  Supply of blood and blood components....................................................................... 8 

2.4.4.  Clinical use................................................................................................................... 9 

2.4.5.  Self-sufficiency ............................................................................................................ 9 

3. 

Summary and concluding remarks............................................................................. 10 

EN 

2 

   EN 

1. 

INTRODUCTION 

The  principles  governing  voluntary  and  unpaid  donation  of  blood  and  blood 
components are set out in article 20 of Directive 2002/98/EC1. It states that Member 
States  shall  take  the  necessary  measures  to  encourage  voluntary  and  unpaid  blood 
donations with a view to ensuring that blood and blood components are in so far as 
possible provided from such donations.  

Donors  can  give  whole  blood  or  just  some  components  of  the  blood,  e.g.  plasma. 
During donations of blood components,  the needed  components  are  separated  from 
the  blood  and  the  remainder  is  thereafter  returned  to  the  donors  in  a  so-called 
apheresis process. Such apheresis donations take longer in time but can be organised 
more  frequently.  While  plasma  can  be  separated  from  whole  blood  after  the 
donation, much plasma is obtained through apheresis (plasmapheresis). 

Donated  blood  and  blood  components  are  essential  bases  for  therapies,  either  as 
direct  transfusions  e.g.  during  surgery,  or  as  starting  materials  for  plasma  derived 
medicinal products, e.g. to treat factor VIII deficient haemophilia patients.  

In accordance with Article 20(2) of the Directive, Member States shall submit reports 
on  the  practice  of  voluntary  and  unpaid  blood  donation  to  the  Commission  every 
three years. The first report on the promotion by Member States of voluntary unpaid 
blood donations was published in 20062.  

This  Commission  report  is  based  on  the  Members  States'  responses  to  a  report 
template  on  voluntary  and  unpaid  donation  of  blood  and  blood  components,  which 
was  sent  to  the  Competent  Authorities  for  blood  and  blood  components  during  the 
spring  of  2010.  All  Member  States  submitted  a  report  to  the  Commission.  In 
addition,  Croatia  and  Norway  submitted  a  report  (in  total  29  reporting  countries). 
The  main  findings  of  this  report  have  been  presented  to  the  Competent  Authorities 
for blood and blood components3. 

This  second  report  aims  to  provide  an  overview  of  the  practice  of  voluntary  and 
unpaid  donation  of  blood  and  blood  components  in  the  EU,  focusing  on  (1) 
legislative provisions/guidelines and policies, (2) incentives, (3) promotion, and (4) 
collection and supply. It should, however, be noted that although this report touches 
on areas related to pharmaceuticals, its focus is on blood and blood components4.  

1 

2 
3 
4 

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. 
COM(2006)217 final, Report on the promotion by Member States of voluntary unpaid blood donations. 
http://ec.europa.eu/health/blood_tissues_organs/docs/blood_mi_20101027_en.pdf. 
Directive 2002/98/EC defines  blood  as  "whole  blood  collected  from  a  donor  and  processed  either for 
transfusion  or  for  further  manufacturing",  and  blood  components  as  "therapeutic  constituent  of  blood 
(red cells, white cells, platelets, plasma) that can be prepared by various methods".  

EN 

3 

   EN 

                                                 
2. 

RESULTS 

2.1. 

Legislative provisions, guidelines and policies 

All but one of the reporting countries have some form of provisions (binding or non-
binding)  governing  the  principle  of  voluntary  and  unpaid  donation  of  blood  and 
blood components (Figure I).  

Figure I 

Regulation of voluntary and unpaid blood 
donation

1

1

2

1

24

Legislation 
Legislation and self-regulation
Other

Self-regulation
No regulation

As  shown  in  figure  I,  24  countries  have  binding  rules  concerning  voluntary  and 
unpaid  blood  donation,  laid  down  in  national  regulations  (Austria,  Belgium, 
Bulgaria,  Cyprus,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Italy, 
Latvia,  Lithuania,  Luxembourg,  the  Netherlands,  Portugal,  Poland,  Romania, 
Slovenia, Slovakia, Spain, Sweden, Norway and Croatia). Hungary and the UK have 
a dual system with binding rules laid down by national regulations and rules set by 
the  sector  (self-regulatory),  and  in  Malta,  binding  rules  concerning  voluntary  and 
unpaid blood donation are set by the sector (self-regulatory). The Czech Republic has 
a  non  binding  declaration  in  its  national  law  (in  line  with  Directive  2002/98/EC), 
while  Ireland  has  no  legislative  provisions  or  guidelines  governing  the  principle  of 
voluntary and unpaid donation of blood and blood components. 

These legal provisions and guidelines appear to have remained relatively stable over 
time.  Since  2006,  when  the  1st  Report  on  the  promotion  by  Member  States  of 
voluntary  and  unpaid  blood  donations  was  issued  by  the  Commission,  the  Czech 
Republic,  Croatia  and  Sweden  have  changed  their  provisions  on  voluntary  and 
unpaid blood donation. However, two countries (Czech Republic and Estonia) state 
that they are planning to change their existing legal provisions or guidelines.  

Austria,  Belgium,  Bulgaria,  Cyprus,  Estonia,  Finland,  France,  Greece,  Italy, 
Luxembourg, the Netherlands, Spain, Sweden, the United Kingdom and Croatia have 
defined  penalties  for  infringements  of  the  legislative  provisions  on  voluntary  and 
unpaid  donation  of  blood  and  blood  components.  None  of  these  countries  have 
imposed such penalties.  

EN 

4 

   EN 

 
2.1.1.  Replacement donors 

A replacement blood donor could be described as a person who gives a replacement 
unit of blood only when a family member or friend requires transfusion.  

Only 6 Member States have specific policies concerning the practice of replacement 
donors (Czech Republic, France, Hungary, Spain, Sweden and the United Kingdom). 
In these countries the practice of replacement donors is generally discouraged.  

2.1.2.  Trans-border blood donation 

In  certain  parts  of  the  EU,  there  seems  to  exist  a  practice  of  individuals  donating 
blood  and  blood  components  outside  their  country  of  residence,  e.g.  in  another 
Member State.  

Six countries (Czech Republic, Estonia, Luxembourg, Poland, Sweden and Norway) 
report  having  some  form  of  policy  or  guidelines  concerning  the  practice  of  trans-
border blood donation.  

2.2. 

Incentives 

Belgium,  Bulgaria,  Estonia,  Finland,  France,  Germany,  Greece,  Italy,  Lithuania, 
Luxembourg,  the  Netherlands,  Poland,  Romania,  Spain,  Slovakia  and  the  United 
Kingdom  as  well  as  Norway  and  Croatia  (18  countries)  reported  some  form  of 
guiding principles concerning the possibility of giving incentives to donors of blood 
and blood components. 

2.2.1. 

Incentives for whole blood donors 

The  following  countries  provide  some  form  of  incentives  to  whole  blood  donors: 
Austria,  Belgium,  Bulgaria,  Czech  Republic,  Cyprus,  Denmark,  Estonia,  Finland, 
France,  Germany,  Greece,  Ireland,  Italy,  Lithuania,  Luxembourg,  the  Netherlands, 
Malta,  Poland,  Romania,  Spain,  Slovakia,  Slovenia,  Sweden,  the  United  Kingdom, 
Norway and Croatia (Figure II). 

Figure II 

Incentives - whole blood

0

5

10

15

20

25

Reporting countries

Reimbursement of medical costs

Compensation linked to loss of
earnings
Food vouchers

Other forms of incentives

Free physical check-up

Time off w ork, private sector

Reimbursement of travel costs

Time of w ork, public sector

Small tokens

Refreshments 

EN 

5 

   EN 

 
As  illustrated  by  the  figure  above,  the  most  commonly  used  incentives  in  these  26 
countries  include  refreshments,  small  tokens,  such  as  mugs  and  t-shirts,  time  off 
work (in the public sector), and reimbursement of travel costs. 

2.2.2. 

Incentives for apheresis donors 

As  regards  apheresis  (plasma,  platelets…),  the  following  countries  provide  some 
form of incentives to donors: Austria, Belgium, Czech Republic, Denmark, Estonia, 
Finland,  France,  Germany,  Greece,  Ireland,  Italy,  Latvia,  Lithuania,  Luxembourg, 
the  Netherlands,  Malta,  Poland,  Romania,  Spain,  Slovenia,  Sweden,  the  United 
Kingdom, Norway and Croatia (Figure III). 

Figure III 

Incentives - apheresis (plasma, platelets...)

0

5

10

15

20

25

Reporting countries

Reimbursement of medical costs

Compensation linked to loss of
earnings
Other forms of incentives

Free physical check-up

Food vouchers

Time off w ork, private sector

Time of w ork, public sector

Reimbursement of travel costs

Small tokens

Refreshments 

Figure  III  shows  that  the  most  commonly  used  incentives  in  these  24  countries 
include  refreshments,  small  tokens,  such  as  mugs  and  t-shirts,  reimbursement  of 
travel costs and time off work (in the public sector). 

In  sum,  the  undertaken  study  indicates  that  there  are  no  major  differences  in 
incentives for whole blood and apheresis donors in the EU, Norway and Croatia.  

The values of these incentives are determined by governments and/or operators in the 
reporting  countries.  For  whole  blood,  this  value  is  set  by  national  or  local 
governments in 10 countries, by operators/blood establishments in 10 countries, and 
by a combination of both or other in 5 countries. Similarly for apheresis, the value of 
incentives  is  defined  by  national  or  local  governments  in  10  countries,  by 
operators/blood or apheresis establishments in 9 countries, and by a combination of 
both or other in 4 countries. No data was provided by Ireland on this point. 

2.3. 

Promotion 

The  following  countries  have  undertaken  some  form  of  measures  to  promote 
voluntary  and  unpaid  blood  donation:  Austria,  Belgium,  Bulgaria,  Czech  Republic, 
Cyprus,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy, 
Lithuania,  Luxembourg,  the  Netherlands, Malta,  Poland,  Portugal,  Romania,  Spain, 
Slovakia, Slovenia, Sweden, the United Kingdom, Norway and Croatia. 

EN 

6 

   EN 

 
Figure IV 

Promotion of voluntary and unpaid blood donation

n
o
i
t
o
m
o
r
P

s
e
r
u
s
a
e
m

1

0

5

10

15

20

25

30

Reporting countries

Other
Aw areness raising or information campaign(s)
Events focusing on donation, such as donor day

As demonstrated by the figure above, the most commonly used measures to promote 
voluntary  and  unpaid  blood  donation  in  the  EU,  Croatia  and  Norway  are  events 
focusing  on  donation,  awareness  raising  and  information  campaigns.  More 
specifically, the listed measures include: (1) public advertisement, (2) personal phone 
calls,  e-mails,  letters  and  text  messages  to  donors,  (3)  concerts  and  other 
performances,  (4)  media  events,  (5)  campaigns  and  other  social  events  (nationally, 
regionally  and  locally)  e.g.  at  the  World  Donor  Day,  (6)  online  information  and 
campaigns, booklets and flyers, (7) seminars and lectures at schools, universities and 
churches,  (8)  student  visits  to  blood  establishments,  and  (9)  other  measures  in 
cooperation with blood establishments, associations and other organisations. 

21  of  the  reporting  countries  have  defined  target  groups  for  their  promotion 
activities.  The  main  target  groups  identified  are  young  people,  students,  military 
personnel and first time donors. 

2.4. 

Collection and supply 

2.4.1.  Collection 

The collectors/suppliers of whole blood and plasma are predominately public in the 
29 countries participating in this survey.  

25  countries  report  that  the  main  collectors/suppliers  for  whole  blood  are  public  or 
non  for  profit,  whereas  1  country  has  private  suppliers/collectors  and  3  countries 
have  a  mixture  of  public-private  and/or  other  collectors/suppliers.  The  following 
countries  report  having  public  or  non  for  profit  collectors/suppliers:  Belgium, 
Bulgaria,  Czech  Republic,  Cyprus,  Denmark,  Estonia,  France,  Greece,  Hungary, 
Ireland,  Italy,  Latvia,  Luxembourg,  the  Netherlands,  Malta,  Poland,  Portugal, 
Romania,  Spain,  Slovakia,  Slovenia,  Sweden,  the  United  Kingdom,  Norway  and 
Croatia.  In  addition,  Austria  report  having  private  suppliers/collectors  and  Finland, 
Germany  and  Lithuania  have  a  mixture  of  public-private  and/or  other 
collectors/suppliers.  

EN 

7 

   EN 

 
 
Similarly for plasma, 23 countries have public or non for profit collectors/suppliers, 
whereas  6  Member  States  have  private  or  a  mixture  of  public-private  and/or  other 
collectors/suppliers.  The  following  countries  report  having  public  or  non  for  profit 
collectors/suppliers: Belgium, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, 
Hungary,  Ireland,  Italy,  Luxembourg,  the  Netherlands,  Malta,  Poland,  Portugal, 
Romania,  Spain,  Slovakia,  Slovenia,  Sweden,  the  United  Kingdom,  Norway  and 
Croatia.  In  addition,  Austria,  Czech  Republic,  Finland,  Germany,  Latvia  and 
Lithuania  have  private  or 
and/or  other 
collectors/suppliers. 

a  mixture  of  public-private 

Furthermore, the participants in this study were asked whether they provide financial 
or other incentives for  the  collection of blood and blood components, e.g. to blood 
establishments,  hospitals  and  health  care  personnel.  About  10%  of  the  countries 
report  giving  some  form  of  incentives  to  collectors/suppliers  of  blood  and  blood 
components. 

2.4.2.  Plasma fractionation 

Plasma fractionation refers to the processes of separating the various fractions out of 
blood  plasma.  It  includes  manufacturing  steps  that  are  subject  to  pharmaceutical 
legislation and results in plasma derived medicinal products. 

About half of the 29 reporting countries have the capacity (pharmaceutical plants) for 
such  plasma  fractionation  (Austria,  Belgium,  Bulgaria,  France,  Germany,  Hungary, 
Italy,  the  Netherlands,  Poland,  Spain,  Slovakia,  Sweden,  the  UK  and  Croatia).  In 
these  countries,  about  71%  of  the  actors  are  private  and  the  remaining  29%  are 
public.  

2.4.3. 

Supply of blood and blood components 

In  the  undertaken  study,  the  participating  countries  were  asked  whether  they  have 
experienced  regular  shortage  of  blood  and  blood  components,  and  in  particular  for 
whole blood, fresh frozen plasma (for transfusion), red blood cells, white blood cells, 
platelets  and  plasma  fractions,  such  as  immunoglobulin,  factor  VIII,  factor  IX, 
albumin, lipoprotein, fibrinogen and antithrombine III (Figure V).  

EN 

8 

   EN 

Figure V 

Regular shortage of blood 
and blood components

0

1

2
Reporting countries

3

4

White blo o d cells

Fibrino gen

Other

Lipo pro tein

A lbumin

Facto r IX

Fresh fro zen plasma (fo r transfusio n)

Facto r VIII

A ntithro mbine III

Immuno glo bulin 

P latelets 

Red blo o d cells

Who le blo o d

In accordance with this figure, it appears that few countries have experienced regular 
shortage  of  blood  and  blood  components,  ranging  from  around  14%  (for  whole 
blood) to 0% for white blood cells. 

2.4.4.  Clinical use 

About  75%  of  the  responding  countries  have  policies  in  place  to  contain  or  ensure 
the  effective  clinical  use  of  blood  and  blood  components  (Austria,  Belgium, 
Bulgaria,  Czech  Republic,  Cyprus,  Denmark,  Estonia,  Finland,  France,  Hungary, 
Italy,  Lithuania,  Luxembourg,  the  Netherlands,  Malta,  Poland,  Portugal,  Romania, 
Spain, Sweden, the U.K. and Norway).  

2.4.5. 

Self-sufficiency 

The  following  countries  have  policies  in  place  to  endeavour  to  promote  self-
sufficiency  of  blood  and  blood  components:  Austria,  Belgium,  Bulgaria,  Czech 
Republic,  Cyprus,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Latvia, 
Lithuania, Malta, Poland, Portugal, Romania, Spain, Slovenia, Sweden, Norway and 
Croatia. These policies appear to have remained more or less stable over time. Since 
2006,  France,  Lithuania  and  Poland  have  changed  their  policies  in  the  field. 
However,  3  countries  (France,  Greece  and  Ireland)  state  that  they  are  planning  to 
change their existing policies.  

Although 22 countries have national policies for self-sufficiency of blood and blood 
components,  only  13  of  them  seem  in  fact  to  have  defined  the  concept  of  self-
sufficiency  (Austria,  Bulgaria,  Czech  Republic,  Cyprus,  France,  Hungary,  Italy, 
Malta, Portugal, Romania, Spain, Sweden and Croatia). 

In addition, France, Greece, Luxembourg, Malta, Slovakia and Norway report having 
bilateral or other forms of agreements/collaboration structures to ensure appropriate 
supply of blood and blood components at a national level.  

EN 

9 

   EN 

 
3. 

SUMMARY AND CONCLUDING REMARKS 

This report shows that Member States overall comply with Article 20(1) of Directive 
2002/98/EC,  requiring  Member  States  to  take  the  necessary  measures  to  encourage 
voluntary  and  unpaid  blood  donations  with  a  view  to  ensure  that  blood  and  blood 
components are in so far as possible provided from such donation.  

Largely  in  line  with  the  findings  of  the  first  report  on  voluntary  and  unpaid  blood 
donation  (issued  2006),  this  report  shows  that  legislative  provisions  and  guidelines 
on voluntary and unpaid blood donation are well established across the EU. All but 
one of the 29 reporting countries have such provisions in place.  

Most  reporting  countries  have  some  form  of  incentive  structures  for  blood  donors, 
such  as  refreshments,  small  token  and  reimbursement  of  travel  costs.  Several 
countries also offer blood donors employed in the public sector time off work. The 
study  indicates  that  there  are  no  major  differences  in  incentives  for  whole  blood 
donors and apheresis (plasma, platelets…) donors. 

27  out  of  the  29  reporting  countries  have  undertaken  some  form  of  measures  to 
promote  voluntary  and  unpaid  blood  donation,  such  as  awareness  raising  and 
information campaigns.  

Concerning collection and supply of blood and blood components, the report shows 
that collectors/suppliers of whole blood and plasma are predominately public in the 
EU, Norway and Croatia. About half of the reporting countries have the capacity for 
plasma fractionation. In these countries, actors in the field of plasma fractionation are 
mainly private (71%). With regards to supply, the Competent Authorities for blood 
and  blood  components  report  relatively  limited  shortages  of  blood  and  blood 
components,  ranging  from  around  14%  (for  whole  blood)  to  0%  for  white  blood 
cells.  About  75%  of  the  countries  have  policies  in  place  to  contain  or  ensure  the 
effective  clinical  use  of  blood,  as  well  as  to  promote  self-sufficiency  of  blood  and 
blood components.  

Based  on  the  findings  of  the  report,  the  Commission  will  now,  together  with  the 
Member  States, reflect on the  potential need  for  further  measures,  keeping  in  mind 
that  the  Commission's  mandate  is  limited  to  quality  and  safety  of  blood  and  blood 
components. 

EN 

10 

   EN