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 Tissues and Cells
Date: 2011-06-17
Institutions: European Commission
Subjects: cytology, organ transplantation, public awareness campaign, public health

EUROPEAN COMMISSION 

Brussels, 17.6.2011 
COM(2011) 352 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 Tissues and Cells 

 
 
 
 
  
 
TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

3. 

Introduction .................................................................................................................. 2 

Results .......................................................................................................................... 3 

Legislative provisions, guidelines and policies............................................................ 3 

Compensation and incentives....................................................................................... 4 

Promotion and advertising ........................................................................................... 5 

Procurement and supply............................................................................................... 6 

Summary and concluding remarks............................................................................... 8 

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1. 

INTRODUCTION 

The principles governing tissue and cell donation are set out in article 12 of Directive 
2004/23/EC1. It states that Member  States shall endeavour  to ensure voluntary  and 
unpaid  donations  of  tissues  and  cells.  Donors  may  receive  compensation,  which  is 
strictly  limited  to  making  good  the  expenses  and  inconveniences  related  to  the 
donation.  In  that  case,  Member  States  define  the  conditions  under  which 
compensation may be granted. 

In  addition,  Member  States  shall  take  all  necessary  measures  to  ensure  that  any 
promotion  and  publicity  activities  in  support  of  the  donation  of  human  tissues  and 
cells  comply  with  guidelines  or  legislative  provisions  laid  down  by  the  Member 
States.  Such  guidelines  or 
include  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 
advantage.  

legislative  provisions  shall 

Member States shall endeavour to ensure that the procurement of tissues and cells as 
such is carried out on a non-profit basis. 

Donated tissues and cells, such as skin, bones, tendons, corneas and haematopoietic 
stem  cells,  are  increasingly  used  in  medical  therapies  and  as  starting  material  for 
advanced  therapy  medicinal  products  (ATMP).  In  addition,  reproductive  cells2  are 
used in the field of medically  assisted  reproductive technology (ART),  e.g. in vitro 
fertilization  (IVF)  and  other  so-called  ART  techniques  to  achieve  pregnancy  by 
artificial or partially artificial means. 

In  accordance  with  Article  12-1  of  Directive  2004/23/EC,  Member  States  shall 
submit reports on the practice of voluntary and unpaid donation to the Commission 
every three years. The first Commission report on the promotion by Member States 
of voluntary unpaid donation of tissues and cells was published in 20063. 

This  Commission  report  is  based  on  the  Members  States'  responses  to  a  report 
template on voluntary and unpaid donation of tissues and cells, which was sent to the 
Competent Authorities for tissues and cells during the summer of 2010. All Member 
States submitted a report to the Commission. In addition, Liechtenstein and Norway 
submitted a report (in total 29 reporting countries). The main findings of this report 
have been presented to the Competent Authorities for tissues and cells4. 

This  report  aims  to  provide  an  overview  of  the  practice  of  voluntary  and  unpaid 
donation  of  tissues  and  cells,  focusing  on  (1)  legislative  provisions,  guidelines  and 

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4 

Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  on  setting 
standards of quality and safety for the donation, procurement, testing, processing, preservation, storage 
and distribution of human tissues and cells. 
Directive  2006/17/EC  defines  reproductive  cells  as  "all  tissues  and  cells  intended  to  be  used  for  the 
purpose of assisted reproduction". 
COM/2006/0593 final. 
http://ec.europa.eu/health/blood_tissues_organs/docs/ev_20101206_mi_en.pdf 

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policies,  (2)  compensation  and  incentives,  (3)  promotion  and  advertising,  and  (4) 
procurement and supply.  

2. 

RESULTS 

2.1. 

Legislative provisions, guidelines and policies 

27  of  the  29  reporting  countries  have  some  form  of  provisions  governing  the 
principle  of  voluntary  and  unpaid  donation  of  tissues  and  cells  (binding  or  non-
binding). 

Figure I  

Regulation of voluntary and unpaid donation of 
tissues and cells

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25

Legislation

Legislation and self-regulation

No data No regulation

As  shown  in  figure  I,  25  countries  have  binding  rules  concerning  voluntary  and 
unpaid donation of tissues and cells in their national regulations (Belgium, Bulgaria, 
Cyprus,  Czech  Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece, 
Hungary,  Italy,  Latvia,  Lithuania,  Luxembourg,  the  Netherlands,  Poland,  Portugal, 
Romania,  Slovakia,  Slovenia,  Spain,  Sweden,  the  United  Kingdom  and  Norway). 
Malta  has  a  dual  system  with  binding  rules  laid  down  by  national  regulation  and 
rules  set  by  the  sector  (self-regulatory),  while  Ireland  and  Liechtenstein  have  no 
legislative provisions governing this field. No data was reported from Austria on this 
point. 

These legislative provisions or guidelines have been subject to change in a number of 
countries. Since 2006, when the first report on the promotion by Member States of 
voluntary and unpaid donations of tissues and cells was issued by the Commission, 
Bulgaria,  Czech  Republic,  Poland,  Portugal  and  the  United  Kingdom  have  updated 
or changed their provisions on voluntary and unpaid donation of tissues and cells. In 
addition,  Bulgaria,  Ireland,  Malta  and  Liechtenstein  state  that  they  are  planning  to 
update or change their legislative provisions or guidelines in the field.  

Penalties  for  infringements  of  the  legislative  provisions  on  voluntary  and  unpaid 
donation  of  tissues  and  cells  have  been  defined  in  23  countries  (Austria,  Bulgaria, 
Belgium,  Cyprus,  Czech  Republic,  Denmark,  Estonia,  Finland,  France,  Germany, 

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Greece,  Hungary,  Italy,  Lithuania,  Luxembourg,  the  Netherlands,  Poland,  Portugal, 
Romania,  Slovenia,  Sweden,  the  United  Kingdom  and  Norway).  1  country  has 
imposed such penalties (Czech Republic).  

2.2. 

Compensation and incentives 

13  countries  have  guiding  principles  regarding  the  possibility  of  giving  forms  of 
compensation or incentives to donors of tissues and cells (Bulgaria, Czech Republic, 
Denmark,  Finland,  Hungary,  Greece,  Italy,  Lithuania,  Malta,  the  Netherlands, 
Slovenia, Spain and the United Kingdom).  

19  countries  report  providing  some  form  of  compensation  or  incentives  for  living 
donors  of  tissues  and  cells  (excluding  reproductive  cells),  namely  Belgium,  Czech 
Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy, 
Latvia, Lithuania, Luxembourg, the Netherlands, Slovakia, Slovenia, Spain, Sweden 
and the United Kingdom.  

The  following  14  countries  give  some  form  of  compensation  or  incentives  for  the 
donation  of  reproductive  cells:  Austria,  Belgium,  Bulgaria,  Denmark,  Estonia, 
Finland, France, Hungary, the Netherlands, Portugal, Slovakia, Slovenia, Spain and 
Norway.  

4  countries  provide  forms  of  compensation  or  incentives  to  relatives  of  deceased 
donors (Bulgaria, Romania, Slovenia, and Spain) (see figures II-IV).  

Figure II 

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0

Compensation and incentives - tissues and cells 
(excluding reproductive cells) 

Reimbursement  of  cost s for t ravel

Reimbursement  of  medical costs

Compensat ion linked to loss of earnings

Ref reshment s

Time of f work (public sector)

Time of f work (private sect or)

Small tokens, e.g. pens or towels

Food vouchers

Free physical check-up

Ot her

As  shown  by  figure  II,  the  main  forms  of  compensation  and  incentives  given  to 
donors of tissues and cells (excluding reproductive cells) are reimbursement of costs 
of  travel,  reimbursement  of  medical  costs,  compensation  linked  to  loss  of  earnings 
and refreshments.  

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Figure III 

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Compensation and incentives - reproductive cells

Reimbursement of costs for t ravel

Refreshments

Compensation linked t o loss of earnings

Reimbursement of medical costs

Time off  work (privat e sect or)

Small t okens, e.g. pens or towels

Free physical check-up

Time off  work (public sector)

Food vouchers

Figure III demonstrates major forms of compensation and incentives given to donors 
of reproductive cells, including reimbursement of travel costs and refreshments.  

Figure IV 

Compensation and incentives - relatives to deceased donors

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Other 

Cost of
burial

Figure  IV  illustrates  the  main  forms  of  compensation  and  incentives  given  to 
relatives of deceased donors.  

2.3. 

Promotion and advertising 

The  following  countries  report  having  taken  measures  to  promote  voluntary  and 
unpaid donation of tissues and cells: Belgium, Bulgaria, Cyprus, Denmark, Finland, 
France, Germany, Greece, Ireland, Italy, Lithuania, Malta, the Netherlands, Poland, 
Portugal, Slovenia, Spain, Sweden and the United Kingdom.  

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Figure V 

Promotion and advertising - voluntary and unpaid 
donation of tissues and cells

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

As demonstrated by the figure above, the most commonly used measures to promote 
voluntary and unpaid donation of tissues and cells are events focusing on donation, 
awareness  raising  and  information  campaigns.  11  countries  have  specific  target 
groups  for  promotion  and  advertisements,  such  as  students,  medical  professionals, 
hospital employees, the police and army forces, blood donors and certain minorities 
(for cord blood banks). 

As  set  out  in  article  12-2  of  Directive  2004/23/EC,  Member  States  shall  take  all 
necessary measures to ensure that any promotion and publicity activities in support 
of  the  donation  of  human  tissues  and  cells  comply  with  guidelines  or  legislative 
provisions laid down by the Member States. Such guidelines or legislative provisions 
shall  include  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  advantage.  The  following  23  countries  report  having  such 
restrictions on advertisements: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, 
Denmark,  Estonia,  Finland,  France,  Germany,  Hungary, 
Italy,  Lithuania, 
Luxembourg,  the  Netherlands,  Poland,  Portugal,  Romania,  Slovakia,  Slovenia, 
Spain,  Sweden  and  the  United  Kingdom.  Penalties  for  infringements  of  these 
restrictions have been defined in 20 countries.  

2.4. 

Procurement and supply 

The majority of the reporting countries have public collectors/suppliers of tissues and 
cells  (Belgium,  Hungary,  Italy,  Lithuania,  the  Netherlands,  Poland,  Portugal, 
Slovakia,  Spain,  Sweden  and  Norway)  or  a  dual  system  of  private  and  public 
collectors/suppliers (Austria, Bulgaria, Czech Republic, Denmark, Estonia, Finland, 
France, Germany, Greece, Ireland, Luxembourg,  Malta, Romania, Slovenia and the 
United  Kingdom).  The  remaining  three  countries  have  private  and/or  other 
collectors/suppliers  of  tissues  and  cells  (Cyprus,  Latvia  and  Liechtenstein)  (see 
figure VI). 

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Figure VI 

Collectors/suppliers of tissues and cells

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11

Public

Public and private

Private and/or other

Around 30% of the reporting countries provide some form of financial incentives for 
the procurement of tissues and cells, e.g. to hospitals, health care personnel or tissue 
establishments.  

Regarding  self-sufficiency,  11  countries  have  policies  in  place  to  endeavour  to 
promote  self-sufficiency  of  tissues  and  cells  (Bulgaria,  Czech  Republic,  France, 
Italy,  the  Netherlands,  Poland,  Portugal,  Slovakia,  Slovenia,  Sweden  and  Norway). 
In  addition,  17  countries  have  bilateral  or  other  forms  of  agreements/collaboration 
structures  to  ensure  national  supply  of  tissues  and  cells  (Belgium,  Bulgaria,  Czech 
Republic,  Denmark,  Estonia,  Greece,  Ireland,  Italy,  Lithuania,  Luxembourg,  Malta, 
Portugal, Slovakia, Slovenia, Spain, Sweden and Liechtenstein). 

Finally, in relation to supply, several countries report regular shortages of tissues and 
cells on a national level (see figure VII). 

Figure VII 

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Regular shortages of tissues and cells

Bone marrow

Other

Sperm

Oocytes

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As  demonstrated  in  the  figure  above,  almost  half  of  the  reporting  countries 
experience  regular  shortages  of  bone  marrow,  and  nine  countries  report  regular 
shortages of sperm and oocytes. Other tissues and cells subject to shortages include 
corneas, bones, tendons and skin. 

3. 

SUMMARY AND CONCLUDING REMARKS 

This  report  shows  that  Member  States  overall  comply  with  Article  12  of  Directive 
2004/23/EC, requiring Member States to take  the  necessary  measures  to  endeavour 
to ensure voluntary and unpaid donations of tissues and cells.  

Largely in line with the findings of the first report on voluntary and unpaid donation 
of  tissues  and  cells  (issued  2006),  this  report  shows  that  legislative  provisions  and 
guidelines on voluntary and unpaid donation of tissues and cells are well established 
across the EU. 27 out of the 29 reporting countries have such legislative provisions 
or guidelines in place.  

19 of the reporting countries have some form of compensation or incentive structures 
for donors of tissues and cells (excluding reproductive cells), such as reimbursement 
of  travel  and  medical  costs.  For  reproductive  cells,  about  half  of  the  countries 
provide  some  forms  of  compensation  or  incentives,  including  reimbursement  of 
travel  costs,  refreshments  and  compensation  linked  to  loss  of  earnings.  In  addition, 
four countries give some form of compensation or incentives to relatives of deceased 
donors. 

19  countries  have  undertaken  some  form  of  measures  to  promote  voluntary  and 
unpaid  donation  of  tissues  and  cells,  such  as  awareness  raising  and  information 
campaigns. In addition, 23 countries have 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 advantage (in line with article 12 of Directive 
2004/23/EC). 

Concerning  the  procurement  and  supply  of  tissues  and  cells,  this  report  shows  that 
the  majority  of  the  countries  have  public  collectors/suppliers  or  a  dual  system  of 
public  and  private  collectors/suppliers.  With  regards  to  supply,  11  countries  report 
having policies in place to endeavour to promote self-sufficiency of tissues and cells, 
and 17 countries have bilateral or other forms of agreements/collaboration structures 
to ensure national supply of tissues and cells. However, almost half of the countries 
report  some  form  of  shortages  of  tissues  and  cells,  including  bone  marrow  and 
gametes.  

As set out in Article 12 of Directive 2004/23/EC, the Commission shall inform the 
European Parliament and the Council of any necessary further measures it intends to 
take in the field of voluntary and unpaid donation of tissues and cells. Based on the 
findings of this 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 legal mandate is limited to quality and safety of tissues and cells. 

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