Report from the Commission to the Council and the European Parliament on the promotion by Member States of voluntary unpaid donation of tissues and cells
Date: 2006-10-16
Institutions: European Commission
Subjects: EU Member State, EU law - national law, indemnification, organ transplantation, public awareness campaign, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, xxx 
COM(2006) yyy final 

REPORT FROM THE COMMISSION TO THE COUNCIL 
AND THE EUROPEAN PARLIAMENT 

on the promotion by Member States of voluntary  
unpaid donation of tissues and cells 

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REPORT FROM THE COMMISSION TO THE COUNCIL  
AND THE EUROPEAN PARLIAMENT 

on the promotion by Member States of voluntary  
unpaid donation of tissues and cells 

1. 

INTRODUCTION 

In accordance with Article 12 of Directive 2004/23/EC of the European Parliament and of the 
Council  of  31  March  2004  setting  standards  of  quality  and  safety  for  the  donation, 
procurement, testing, processing, preservation, storage and distribution of human tissues and 
cells1, this report summarises the measures taken by Member States2 to endeavour to ensure 
voluntary  unpaid  donations  and  identifies  the  measures  the  Commission  intends  to  take  at 
Community level. The individual national reports can be consulted on the SANCO website: 
http://ec.europa.eu/health/ph_threats/human_substance/blood_tissues_organs_en.htm. 

This report covers the donation of tissues and cells in general. The donation of reproductive 
cells  more  specifically  has  been  the  object  of  a  separate  report.3  The  information  received 
from  the  Member  States  on  the  measures  taken  to  endeavour  to  ensure  voluntary  unpaid 
donations of tissues and cells has been complemented where appropriate with the findings of 
the report on reproductive cells.  

2. 

THE PRINCIPLE OF VOLUNTARY UNPAID DONATION 

The  principle  of  voluntary  unpaid  donation  of  tissues  and  cells  was  recognised  for  the  first 
time in Spain in 1979 and in Luxembourg, Belgium and Finland in the early 1980s. Although 
the principle of  voluntary  unpaid  donation for blood  has been an accepted  practice for over 
50 years  in  many  Member  States4,  most  Member  States  have  recognised  the  principle  for 
tissues and cells only since the 1990s or since 2000.  

Since 2006, the principle has been legally recognised by all 24 reporting Member States. The 
two  Member  States  (Cyprus  and  Malta)  that  had  no  regulation  governing  the  principle  of 
voluntary  unpaid  donation  of  tissues  and  cells  introduced  it  in  their  legislation  when 
transposing  the  Tissues  and  Cells  Directive.  The  UK  and  Ireland  have  now  introduced  the 
principle in legislation where it used to be in guidelines before (see Figures 1 and 25). 

No Member State is aware of cases where donors have been remunerated for the donation of 
tissues and cells.  

1 

2 

3 

4 

5 

OJ L 102, 7.4.2004. p. 48. 
Twenty-four Member States have sent in a national report, Greece has not done so yet.  
Report on the Regulation of Reproductive Cell Donation in the European Union,  
http://ec.europa.eu/health/ph_threats/human_substance/tissues_en.htm. 
Report on the voluntary and unpaid donation of blood, at: 
http://ec.europa.eu/health/ph_threats/human_substance/keydo_blood_en.htm. 
Figures 1 and 2: 100% refers to the 24 Member States that have sent in a report. 

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Figure 1: Recognition of principle of unpaid donation 
before Directive 2004/23

2
8%

2
8%

20
84%

regulated by law

regulated by
guidelines

not regulated

Figure 2: Recognition of principle of unpaid donation 
after Directive 2004/23/EC

regulated by law

24
100%

3. 

COMPENSATION FOR THE DONATION OF TISSUES AND CELLS 

Under  the  principle  of  voluntary  unpaid  donation  of  tissues  and  cells,  donors  cannot  be 
remunerated but may receive compensation strictly limited to making good the expenses and 
inconvenience related to the donation. The Member States define the conditions under which 
compensation may be granted.6 

Fifteen  Member  States  currently  allow  for  donors  to  be  compensated,  but  nine  do  not 
(Austria, Estonia7, Latvia, Lithuania, Malta, Poland, Portugal, Slovakia and the Netherlands). 
Of the countries allowing donors to be compensated, the majority have defined the conditions 
for  granting  compensation  by  law  or  government  rules.  Denmark,  Ireland  and  Sweden  state 
that they have not defined such conditions, see Figure 3.8  

Figure 3: type of regulation covering 
compensation

law

3
20%

2
13%

1
7%

1
7%

binding guidelines

non binding
guidelines

none

not specified

8
53%

6 

7 

8 

Article 12 of Directive 2004/23/EC. 
Compensation can only be given for the donation of gametes. 
Figure 3: 100% refers to the 15 Member States that allow for compensation.  

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Some countries only allow for compensation of the expenses or inconveniences related to the 
donation  of  certain  types  of  tissues  or  cells.  In  Estonia,  only  gamete  donors  can  be 
compensated  for  their  expenses.  The  UK  only  allows  compensation  in  some  limited  live 
donor situations, such as the donation of bone marrow.  

The type of expenses compensated differs amongst Member States. Member States sometimes 
specify  that  only  those  expenses  that  are  not  reimbursed  by  social  insurance  can  be 
compensated  (Hungary).  Several  Member  States  indicate  that  expenses  can  be  reimbursed 
only if documented and only at actual cost (Cyprus, Denmark, Hungary, Italy). 

3.1. 

Travel expenses 

All 15 Member States that allow compensation reimburse travel expenses.  

The Czech Republic only reimburses travel expenses for public transportation, Finland allows 
for  reimbursement  of  travel  costs  when  they  are  related  to  treatment  for  illness  or 
rehabilitation.  In  the  UK,  compensation  for  the  donation  of  haematopoietic  stem  cells  also 
covers the travel expenses of one family member or friend accompanying the donor. France 
has a similar system for reimbursing the accommodation costs of an accompanying person. 

3.2. 

Loss of earnings 

The  second  type  of  compensation  commonly  allowed  is  compensation  for  loss  of  earnings 
(see Figure 4)9. The conditions under which such compensation is paid differ. In the Czech 
Republic, lost pay is reimbursed up to a maximum of 92 hours. In Finland, the donor of an 
organ or tissue who loses income for at least an entire day because of the removal of an organ 
or tissue to meet a vital transplantation need10 and does not otherwise receive compensation 
for this period is entitled to a daily allowance. Spain only provides compensation for loss of 
earnings in the case of self-employed persons who do not have a basic salary.  

Figure 4: type of com pensation: loss of 
earnings

4
27%

1
7%

yes

no

not specified

10
66%

3.3. 

Time off work 

Time  off  work  is  given  in  about  half  of  the  Member  States  that  allow  for  compensation 
(see Figure  5)11.  However,  this  result  should  be  read  together  with  the  findings  regarding 
compensation for loss of earnings. In most cases, one or the other is provided.12 

9 

10 

11 

Figure  4:  100%  refers  to  the  15  Member  States  that  allow  for  compensation.  Belgium,  Cyprus,  the 
Czech  Republic,  Finland,  France, Hungary,  Luxemburg,  Spain  and  the  UK  provide  compensation  for 
loss of earnings, Italy does not.  
Or for essential related tests and examinations. 
Figure 5: 100% refers to the 15 Member States that allow for compensation. Denmark, Finland, France, 
Germany, Italy, Slovenia, Spain and Sweden give time off work, Hungary does not.  

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Whether time off work is given depends on the case and the medical opinion of the physician 
(Finland,  Germany,  Slovenia  and  Spain).  France  provides  time  off  work  for  donors  during 
their  hospitalisation,  which  is  two  to  six  weeks  for  kidney  donation  and  a  few  days  for 
haematopoietic stem cell donation. Giving time off work would be considered acceptable in 
Denmark, but the situation rarely arises, because many donors are in-house patients, deceased 
donors or students. 

Figure 5: type of com pensation: tim e off w ork

6
40%

1
7%

8
53%

yes

no

not specified

3.4. 

Compensation for inconvenience 

Only one Member State, Denmark, indicates that compensation for discomfort endured during 
the donation of tissues and cells would be considered acceptable (see Figure 613). However, 
the  Danish  National  Board  of  Health  is  not  aware  that  this  practice  is  generally  employed, 
except for reproductive cells. From the information received for the report on the donation of 
reproductive cells, it appears that the Czech Republic also takes into account the discomfort 
endured when donating reproductive cells.  

Sweden argues that no compensation should be given for discomfort or inconvenience, as this 
would come close to paying donors.  

Figure 6: type of com pensation: 
inconveniences

1
7%

14
93%

yes

no

3.5. 

Other types of compensation 

Several  Member  States  indicate  that  the  medical  costs  of  donation  are  covered  by  social 
security (Austria, Belgium, France, and Poland). 

12 

13 

Only Ireland did not give information in this regard.  
Figure 6: 100% refers to the 15 Member States that allow for compensation. 

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Other types of compensation include accommodation (Cyprus, France, Hungary, Ireland and 
Spain), refreshments (the Czech Republic, Denmark, Ireland, Sweden and the UK), a formal 
letter given to cell donors or their employers (Czech Republic), compensation for a medical 
accident  connected  with  donation  in  France,  or  acknowledgements  such  as  titles.  Polish 
donors of bone marrow or other regenerating tissues or cells are for example awarded the title 
of “Graft Donor” or “Meritorious Graft Donor” if they have donated more than once, together 
with a membership card and a special badge. These donors also enjoy the privilege of using 
outpatient public health care services without appointment.  

4. 

PROMOTION OF VOLUNTARY UNPAID DONATION OF TISSUES AND CELLS 

4.1. 

Promotion of the donation of tissues and cells 

Most  Member  States  undertake  activities  to  promote  the  donation  of  tissues  and  cells 
(see Figure  7)14.  The  measures  range  from  information  campaigns,  making  use  of 
advertisements,  conferences,  posters,  TV/radio  spots,  info  telephones  and  websites,  to  the 
production  of  booklets,  the  funding  of  registers  of  volunteers  or  the  organisation  of  student 
awareness  programmes  or  donor  days.  Authorities  also  organise  training  for  transplant 
coordinators and collaborate with patients’ associations on awareness raising. They use both 
the  mass  media  for  the  broad  distribution  of  messages  and  local  initiatives  to  improve 
procurement. Some promotional measures are directed towards specific subpopulations such 
as ethnic groups15, students, judges or minority groups. The possibility to register online as a 
donor is also used as a means to encourage donation.  

In the Czech Republic, Hungary and Portugal, promotional measures seem to focus on bone 
marrow  donation,  while  in  other  countries  (Lithuania,  Sweden,  UK)  the  promotion  of 
donation is generally linked to organ donation, not so much to tissues and cells. The UK has 
also  organised  a  specific  campaign  to  promote  the  donation  of  gametes  to  prepare  for  the 
removal of anonymity.  

Figure 7: prom otion of donation

1
4%

5
21%

yes

no

in discussion

18
75%

14 

15 

Figure  7:  100%  refers  to  the  24  Member  States  that  sent  in  a  report.  Estonia,  Ireland,  Latvia, 
Luxemburg and Slovakia have not taken measures to promote donation. The promotion of donation is 
under discussion in Austria. 
To improve the availability of various HLA types, it is important to target ethnic groups because they 
have different HLA types. 

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4.2. 

Promotion of the unpaid character of donation 

Most Member States undertake activities to promote the donation of tissues and cells, but not 
all  organise  activities  in  order  to  advertise  specifically  the  unpaid  character  of  the  donation 
(see  Figure  8).16  One  reason  advanced  for  this  is  the  fact  that  the  unpaid  character  of  the 
donation is fixed by law (Finland). The UK on the other hand sees the legislation as an added 
advantage in its campaigns to make it perfectly clear that donation should be unpaid. 

The  unpaid  character  of  donation  is  promoted  by  means  similar  to  those  mentioned  for  the 
promotion of donation as such.  

Figure 8: prom otion of unpaid donation

1
4%

8
33%

yes

no

in discussion

15
63%

4.3. 

Promotion of the non-profit procurement of tissues and cells 

Most  Member  States  also  take  measures  to  endeavour  to  ensure  that  procurement 
organisations and procurement teams work on a non-profit basis (see Figure 917). Denmark, 
Italy,  Latvia,  Lithuania  and  Slovakia  mention  only  their  legislation  prohibiting  for  profit 
procurement as measures they have taken. In contrast, Belgium, Cyprus, the Czech Republic, 
Finland, France, Germany, Hungary, Poland, Portugal, Slovenia, Spain, Sweden and the UK 
implement a broader range of measures. Some Member States focus on the annual financial 
reporting  of  procurement  organisations  to  the  authorities  and  on  financial  (Belgium)  or 
general  (France)  inspections,  while  in  other  Member  States  the  fact  that  procurement  is 
carried  out  by  institutions  that  are  part  of  the  national  health  system  or  by  institutions 
receiving public funding ensures that the procurement of tissues and cells is on a non-profit 
basis (Czech Republic, Hungary, Poland, Portugal, Sweden).  

Estonia,  Ireland,  Luxemburg,  Malta  and  the  Netherlands  have  not  taken  measures  to 
endeavour  to  ensure  that  the  procurement  of  tissues  and  cells  is  carried  out  on  a  non-profit 
basis.  

16 

17 

Figure 8: 100% refers to the 24 Member States that sent in a report. Denmark, Finland and Malta have 
taken measures to promote donation, but not specifically to promote unpaid donation. 
Figure 9: 100% refers to the 24 Member States that sent in a report. 

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Figure 9: prom otion of non-profit procurem ent

1
4%

5
21%

5
21%

yes via promotional
activities

yes via legislation

13
54%

no

in discussion

5. 

ADVERTISING 

Before  the  transposition  of  the  Tissues  and  Cells  Directive,  half  of  the  Member  States 
(see Figure 1018) had regulation in place restricting or prohibiting the advertising of the need 
for or availability of human tissues and cells with a view to offering or seeking financial gain 
or comparable advantages.  

Figure 10: regulation on advertising - 
before Directive 2004/23/EC

1
4%

11
46%

12
50%

yes

no

not specif ied

Austria, Cyprus, Ireland, Malta, Slovakia and the UK have introduced or will introduce such 
regulation  upon  transposing  the  Tissues  and  Cells  Directive  (see  Figure  1119).  Denmark, 
Finland, Latvia and Portugal have no such regulation yet.  

Figure 11: regulation of advertising - 
after Directive 2004/23/EC

5
21%

1
4%

yes

no

not specified

18
75%

Denmark  states  that  although  it  has  no  specific  legislation  imposing  restrictions  or 
prohibitions on advertising in relation to tissues and cells, its law on the marketing of health 
services  prohibits  the  marketing  of  health  services  on  TV,  film,  video  or  the  like.  Also,  the 
general regulation prohibiting for profit procurement would most likely apply.20 Estonia only 

18 

19 

20 

Figure 10: 100% refers to the 24 Member States that sent in a report. 
Figure 11: 100% refers to the 24 Member States that sent in a report. 
The Danish Health Act, § 268(2).  

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has  specific  legislation  concerning  advertising  for  artificial  insemination,  while  for  other 
activities  the  general  legislation  on  the  advertising  of  health  services  applies.  Luxemburg21 
and  Lithuania22  refer  to  the  general  principle  of  free  donation  and  the  prohibition  of 
commercial transactions relating to tissues and cells enacted in their legislation.  

The prohibitions can be broad or more specific. They range from prohibiting any advertising 
relating  to  organs,  tissues  and  cells,  except  for  the  general  promotion  of  donation,  to 
prohibiting advertising in favour of a specific person or institution or advertising with a view 
to offering or seeking financial gain or comparable advantage.  

6. 

CONCLUSIONS 

Although the principle of voluntary unpaid donation is recognised by the Member States, the 
concrete  interpretation  of  this  principle  differs  across  Member  States.  Most  Member  States 
(62.5%) allow compensation to be offered to donors of tissues and cells. Of these countries, 
most  allow  only  for  the  compensation  of  expenses.  Even  though  the  Tissues  and  Cells 
Directive  allows  for  compensation  to  be  given  for  inconvenience,  only  one  Member  State 
states,  for  the  donation  of  tissues  and  cells  in  general,23  that  this  would  also  be  considered 
acceptable.  The  question  seems  to  be  whether  giving  compensation  for  the  inconvenience 
associated  with  the  donation  should  be  considered  as  an  incentive  or  not.  It  is  also  more 
difficult to quantify compensation for inconvenience objectively than for expenses incurred.  

Several  Member  States  mention  the  need  to  justify  the  expenses  for  which  compensation  is 
sought.  Expenses  should  be  documented,  which  implies  that  no  flat-rate  reimbursement 
should be offered.  

Very little information is given on the actual amounts reimbursed24, because the amount of the 
compensation paid will depend on the individual circumstances of the donor: number of times 
the donor has to visit the hospital, length of the stay at the hospital, distance from the donor’s 
home to the hospital, treatments to be undergone, effects of the donation on capacity to work 
etc. Practices may also vary according to the clinic concerned.  

Different  initiatives  exist  to  promote  the  principle  of  voluntary  unpaid  donations,  using 
techniques  as  diverse  as  advertising,  student  information  programmes  and  donor  days.  The 
measures taken do not always cover both the donation as such and the unpaid character of the 
donation. More attention is given to the need to increase donation of tissues and cells than to 
the promotion of the non-profit character of the donation.  

Not all Member States have regulation imposing restrictions or prohibitions on advertising of 
tissues and cells with a view to offering or seeking financial gain or comparable advantages. 
The restrictions or prohibitions that are in place also vary in scope.  

21 

22 

23 

24 

Loi du 25 novembre 1982 réglant le prélèvement de substances d’origine humaine. 
Law  of  25  March  2004  on  the  Amendment  on  Human  Tissues,  Cells  and  Organ  Donation  and 
Transplantation. 
Two Member States allow compensation for inconvenience when reproductive cells are donated.  
For the donation of reproductive cells, some Member States have maximum limits for reimbursement 
(Spain,  UK)  while  others  indicate  the  range  within  which  compensation  can  be  paid.  Report  on  the 
Regulation of Reproductive Cell Donation in the European Union, 
http://ec.europa.eu/health/ph_threats/human_substance/tissues_en.htm. 

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7. 

ACTION PLAN 

The Commission suggests the following actions: 

1.  Member  States  should  collect  more  detailed  information  on  the  day-to-day  practice  of 
compensation  at  different  hospitals  or  procurement  organisations,  which  they  can  then 
communicate to the Commission.  

2.  On  the  basis  of  the  information  collected,  the  Commission  will  investigate  with  Member 
States  the  need  for  issuing  guidelines  to  implement  the  principle  of  unpaid  donation.  Such 
guidelines  could  concern,  for  Member  States  allowing  compensation,  the  need  for 
transparency regarding the type of compensation offered and regarding the composition of the 
amount paid, or the need to document the expenses to be reimbursed.  

3.  On  the  basis  of  the  information  collected,  the  Commission  will  investigate  with  Member 
States the need for issuing guidelines for interpreting the requirement of Article 12(2) of the 
Tissues and Cells Directive to have appropriate restrictions or prohibitions on advertising the 
need for or availability of human tissues and cells with a view to offering or seeking financial 
gain or comparable advantages. 

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