COMMISSION STAFF WORKING DOCUMENT on the implementation of the principle of voluntary and unpaid donation for human tissues and cells 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 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells
Date: 2016-04-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, blood transfusion, cytology, health control, health risk, national implementing measure, organ transplantation, quality standard, safety standard, summarising

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 21.4.2016  SWD(2016) 128 final   COMMISSION STAFF WORKING DOCUMENT on the implementation of the principle of voluntary and unpaid donation for human tissues and cells 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 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells {COM(2016) 223 final} {SWD(2016) 127 final}  
 
 
Contents 

1. 

INTRODUCTION ............................................................................................................. 4 

IMPLEMENTATION OF THE PRINCIPLE OF VOLUNTARY AND UNPAID 
2. 
DONATION FOR HUMAN TISSUES AND CELLS ........................................................... 4 

2.1. 

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

2.2. 

Practices vis-à-vis donors ........................................................................................................ 8 

2.2.1. 

Practices vis-à-vis living donors of non-reproductive tissues and cells ........................... 9 

2.2.2. 

Practices vis-à-vis donors of reproductive cells ............................................................ 15 

2.2.3. 

Practices vis-à-vis relatives of deceased donors of tissues and cells ............................ 25 

2.3. 

Tissue and cell donation and anonymity ............................................................................... 26 

2.4. 

Promotion and advertising .................................................................................................... 27 

2.5. 

Donation-related practices in the healthcare system ........................................................... 29 

2.6.  National sufficiency and shortages of tissues and cells ........................................................ 32 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABBREVIATIONS 

ART   = Assisted reproductive technologies 

BM  

= Bone marrow 

EC  

= European Commission 

EEA   = European Economic Area 

EU  

= European Union 

IFA  

= Illegal and fraudulent activities 

HFEA   = Human Fertility and Embryology Authority 

HSC   = Haematopoietic stem cells 

HTA   = Human Tissue Authority 

PBA   = Price base amount 

PBSC   = Peripheral blood stem cells 

SOP  

= Standard operating procedures 

VUD   = Voluntary and unpaid donation 

WMDA  = World Marrow Donor Association 

Member State and country codes: http://publications.europa.eu/code/en/en-370100.htm  

3 

 
 
 
 
 
 
 
 
 
 
 
 
1. INTRODUCTION 

This  Staff  Working  Document  accompanying  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 2004/23/EC, 2006/17/EC and 
2006/86/EC setting standards of quality and safety for human tissues and cells, is based on the 
responses to a questionnaire sent to the Members States' tissue and cell competent authorities 
in  2014.  All  Member  States  submitted  their  replies  to  the  Commission.  In  addition, 
Liechtenstein and Norway provided answers to the survey.  

This  document  aims  to  map  the  implementation  of  the  principle  of  voluntary  and  unpaid 
donation (VUD) of tissues and cells in the European Union. Besides addressing the legislative 
provisions  and  guidelines  existing  at  national  level,  the  report  presents  the  Member  States’ 
practices  vis-à-vis  donors  and  provides  data  on  tissue  and  cell  donation  and  anonymity,  on 
promotion and advertising, as well as on donation-related practices in the national healthcare 
systems.  The  main  findings  of  the  VUD  survey  have  been  presented  to  the  Member  States' 
tissue and cell competent authorities during their regular meetings with the Commission.  

2. IMPLEMENTATION OF THE PRINCIPLE OF VOLUNTARY AND 

UNPAID DONATION FOR HUMAN TISSUES AND CELLS 

2.1. Legislative provisions, guidelines and policies 

Twenty-seven of the 30 reporting countries reported that VUD of human tissues and cells is 
mandatory in their countries (AT, BE, BG, CY, CZ, DE, DK, EL, ES, FI, FR, HR, HU, IT, 
LT,  LU,  LV,  MT,  NL,  PL,  PT,  RO,  SE,  SI,  SK,  UK  and  NO)  (Figure  1).  Ireland  and 
Liechtenstein  reported  that  the  VUD  of  human  tissues  and  cells  is  not  mandatory  in  their 
countries. Additionally, one Member State (Estonia) indicated that payment for reproductive 
cells  is  not  prohibited  and  there  are  no  national  requirements  on  the  amount  of  the 
remuneration, which is merely decided by the operators. 

Fig. 1. The application of the VUD principle by EU and EEA countries (2014 data) 

4 

 
 
 
Legislative provisions or guidelines regarding VUD of tissues and cells have been subject to 
change  in  a  number  of  countries.  Since  the  last  report,  six  Member  States  made  changes  in 
their legislation on VUD of tissues and cells:  

  Bulgaria  (2011)  –  prohibition  of  commercialisation  of  donated  reproductive  cells, 
prohibition of financial gain for donating reproductive cells, provisions allowing donor 
compensation  (reimbursement  of  costs  related  to  travel  and  accommodation  and 
compensation for potential temporary disability, pain/discomfort and for specific loss 
of time and daily income); 

  Greece  (2011)  –  provisions  regarding  compensation  of  donors,  prohibition  of  donor 
remuneration, penalties for illegal removal of human tissue and organs, for offering for 
sale  human  tissue  and  organs  or  mediating  transactions  involving  human  tissues and 
cells; 

  Lithuania (2013) – prohibition of commercial transactions involving tissues, cells and 
organs, penalties for illegal removal or for offering for sale human tissue and organs; 
  Latvia (2012, 2013) – provisions concerning consent for donating reproductive cells, 

provisions regarding anonymity of donations;  

  Slovakia  (2012)  –  provisions  allowing  donor  compensation  and  prohibiting  any 
financial  profit  related  to  the  procurement  and  transplantation  of  tissues,  cells  and 
organs; 

  United  Kingdom  (2012)  –  provisions  regarding  donation  of  gametes  and  embryos 
(compensation  provided  to  oocyte  and  sperm  donors,  benefits  in  kind  in  the  case  of 
oocyte donation). 

In  addition,  six  Member  States  declared  having  plans  to  update  or  change  their  legislative 
provisions,  guidelines  or  administrative  practices  regarding  the  application  of  the  VUD 
principle. Four Member States indicated that new legislative provisions are under preparation: 
a  national  interpretation  of  “compensation”  and  “incentive”  (Bulgaria);  clarifications  and 
transposition  of  Directive  2012/25/EU  (Estonia);  definitions  of  donor  compensation  in  the 
assisted  reproductive  technologies  (ART)  sector  (Spain);  implementation  of  Directive 
2012/39/EU (Sweden). Ireland specified that guidelines for tissue and cell donations need to 
be drafted, whereas Slovenia reported planning an administrative change. 

Penalties  for  infringements  of  the  legislative  provisions  on  VUD  of  tissues  and  cells  have 
been introduced in 25 Member States (AT, BE, BG, CY, CZ, DE, DK, EE, ES, FR, HR, HU, 
IT,  LT,  LU,  LV,  MT,  NL,  PL,  PT,  RO,  SE,  SI,  SK,  UK).  One  country  (Latvia)  defined 
penalties  after  2009  when  the  second  VUD  survey  was  launched.  Ireland  and  Liechtenstein 
have not defined such penalties.  

A summary of the type of penalties for infringements of the legislative provisions on VUD of 
tissues  and  cells  included  in  the  national  legislations  is  presented  in  Figure  2.  Of  the  13 
countries in which penalties include fines for the hospital/company not respecting the national 
legal provisions, 11 also provided the amounts of these fines, which range from EUR 25 to 1 
000 000 (Figure 3). Spain reported that regional health authorities are competent to establish 
the penalties and sanction procedures, including the amount of fines and Denmark specified 
that  the  amount  is  decided  by  the  police  or  courts.  All  countries  which  penalise  hospital  or 
company managers also provided the amount of the fines established at national level, which 
vary from EUR 500 to 300 000 (Figure 4). 

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Fig. 2. Type of penalties defined by the EU and EEA countries for infringements of the 
legislative provisions on VUD of tissues and cells (2014 data) 

Fig. 3. Fines for the hospital/company not respecting the national legal provisions concerning 
VUD of tissues and cells (2014 data) 

6 

 
 
 
 
 
 
 
 
Fig. 4. Fines for the hospital/company manager not respecting the national legal provisions 
concerning VUD of tissues and cells (2014 data) 

It  should  be  underlined  that,  as  of  now,  only  one  country  (Germany)  has  reported  having 
imposed penalties for the infringement of criminal provisions laid down in the national law. 
Individual  convictions  related  to  organ  and  tissue  trafficking  however  are  not  recorded 
separately. 

In terms of planned changes, Slovenia reported planning to adopt new legislative provisions 
defining penalties when the application of the VUD principle is not respected. 

As regards measures taken at national level to ensure that donations are voluntary and unpaid, 
half of the reporting countries (AT, BG, DE, DK, HU, IE, LT, LU, LV, NL, PL, RO, SK and 
LI,  NO)  acknowledged  that  no  additional  measures  are  in  place  besides  verifying  donor 
consent.  

Fig. 5. Additional measures taken by the reporting countries to ensure that donations are 
voluntary and unpaid (2014 data) 

7 

 
 
 
 
 
Additional measures  to ensure that donations are voluntary and unpaid were  reported by 15 
Member States (BE, CY, CZ, EE, EL, ES, FI, FR, HR, IT, MT, PT, SI, SE, UK) (Figure 5). 
These  measures  include  training  of  professionals  to  spot  illegal  and  fraudulent  activities 
(IFA), verification that the VUD principle is also respected for imported tissues and cells (e.g. 
through  inspection  of  the  documentation),  examination/inspection/approval  of  advertising 
materials (e.g. flyers, website information) provided by tissue establishments. Verification of 
the  standard  operating  procedures  (SOPs)  prepared  by  the  tissue  establishments  during 
inspections (Czech Republic, France), and inspecting patient and donor information provided 
by licensed fertility clinics (UK-HFEA) were also reported. 

2.2. Practices vis-à-vis donors 

In  order  to  have  a  better  understanding  of  the  practices  vis-à-vis  donors  across  the  EU,  the 
questionnaire proposed definitions for compensation and incentive, which are not defined in 
Directive  2004/23/EC.  Compensation  was  defined  as  reparation  strictly  limited  to  making 
good the expenses and inconveniences related to the donation, whereas incentive was defined 
as an inducement/stimulus for donation, with a view to seeking financial gain or comparable 
advantage.  The  abovementioned  definitions  do  not  constitute  an  interpretation  of  the  EU 
Tissues  and  Cells  Directives,  and  were  proposed  in  order  to  facilitate  a  consistent 
interpretation of these concepts for the purpose of this survey. 

Nineteen Member States reported having guiding principles regarding the possibility of giving 
compensation to donors of tissues and cells (BE, BG, CZ, DE, EL, ES, FI, FR, HU, IT, LT, 
LU,  MT,  NL,  PL,  PT,  SI,  SK,  UK)  (Figure  6).  Compared  with  the  situation  in  2009,  six 
additional Member States (BE, BG, LU, PL, PT, SK) have introduced such guiding principles. 

Fig. 6. Guiding principles for giving compensation to donors of tissues and cells in EU and 
EEA countries (2014 data) 

There  is  a  large  variation  between  Member  States  regarding  the  content  of  the  guiding 
principles. Malta reported following WHO guidelines and nine Member States (BE, CZ, DE, 
EL,  FR,  HU,  LU,  NL,  UK/HTA)  stated  that  compensation  is  provided  for  costs  directly 
related to  the  donation. France indicated  that guiding principles are included in  the national 
legislation. Italy indicated that according to their national legislation, stem cell donors cannot 
be  remunerated,  but  they  are  allowed  to  take  time-off  from  work  on  donation  day(s),  with 
costs being covered by the public social security system. In addition, for unrelated donors, an 

8 

 
 
 
insurance coverage is provided for cases in which donation-related serious adverse reactions 
(including invalidity or death) occur. Lithuania mentioned that donors are entitled to medical 
leave for the day(s) required for donating cells, tissues or organs. Poland specified that donors 
are  given  awards  (Transplant  Donor  or  Distinguished  Transplant  Donor  Award).  Portugal 
reported that the compensation for loss of earnings and inconvenience for gamete donation is 
set  in  relation  to  the  social  support  index  (1/10  for  sperm  donors  and  1.5/10  for  oocyte 
donors).  Slovakia  indicated  that  compensation  is  based  upon  the  principle  that  the  donor 
should not lose money. France also indicated financial neutrality as a legal principle.  

As set out in Article 12(1) of Directive 2004/23/EC, donors may receive compensation, which 
is  strictly  limited  to  making  good  the  expenses  and  inconveniences  related  to  the  donation. 
Sixteen  countries  confirmed  having  a  national  interpretation  of  what  is  meant  by  “making 
good  the  expenses  and  inconveniencies  related  to  the  donation”  (Figure  7).  Most  of  these 
countries  consider  it  acceptable  to  provide  a  financial  compensation  covering  the  justifiable 
expenses  related  to  the  donation  (e.g.  travel,  loss  of  income,  medical  expenses).  Estonia 
specified  that  both  donors  and  recipients  are  entitled  to  subsidies  for  temporary  incapacity 
from work by the Estonian Health Insurance. Italy referred to their national law which allows 
time off work and provides insurance coverage for stem cell donors. Lithuania reiterated that 
donors are entitled to medical leave for day(s) required for donating cells, tissues or organs. 

Fig. 7. National interpretation of what is meant by “making good the expenses and 
inconveniences related to the donation” (2014 data) 

2.2.1. Practices vis-à-vis living donors of non-reproductive tissues and cells  

Twenty-two countries reported providing some form of  compensation for living donors of 
non-reproductive tissues and cells (e.g. peripheral blood stem cells, bone marrow, cord blood) 
(Figure 8).  

9 

 
 
 
 
 
Fig. 8. Countries providing compensation to tissue and cell living donors (2014 data) 

An overview of the practices vis-à-vis donors of non-reproductive tissues and cells is detailed 
in Figure 9.  

Fig. 9. Overview of the practices vis-à-vis donors and their interpretation by the responding 
countries (2014 data) 

10 

 
 
 
 
As reported by 19 Member States (AT, BG, CZ, DE, DK, EE, EL, ES, FR, HR, HU, IT, LT, 
NL,  PT,  SE,  SI,  SK,  UK)  and  Norway,  the  most  common  practice  vis-à-vis  donors  of  non-
reproductive cells is the reimbursement of the costs linked to travel to and from the place of 
donation.  In  second  place,  compensation  linked  to  loss  of  earnings  was  reported  by  15 
Member States (BE, CZ, DE, DK, EE, EL, FI, FR, HR, HU, LU, NL, SE, SK, UK). Third, in 
13 reporting Member States, is the full exemption of donation-related medical costs of living 
donors (AT, CZ, DE, EL, FI, FR, HR, HU, LT, SE, SI, SK, UK). Nine Member States (CZ, 
DK, EL, ES, IT, PT, SE, SI, UK) and Norway reported offering refreshments. With regard to 
time off work, ten Member States (CZ, DE, DK, EL, FR, IT, LT, LU, NL, SI) reported that 
this practice is used in both public and private sectors and only one Member State (Slovakia) 
reported that time off work is accepted only in the public sector.  

items  (small 

Other  practices,  such  as  providing  non-cash 
tokens,  T-shirts,  etc.), 
reimbursement of medical costs based on actual costs/receipts and granting time off work, are 
allowed in less than a third of the Member States. For instance, small tokens are provided to 
donors  in  five  Member  States  (CZ,  DK,  PT,  SE,  UK)  and  Norway,  whereas  nine  Member 
States  (DE,  DK,  EL,  FR,  HR,  HU,  LT,  PT,  SK)  reimburse  medical  costs  connected  with 
donation based on receipts. Additionally, food vouchers are provided in four Member States 
(CZ,  DK,  ES,  UK),  a  free  physical  check-up  for  donors  is  provided  in  one  Member  State 
(Czech  Republic),  and  two  Member  States  (Greece,  Italy)  compensate  donors  for  the 
inconveniences  related  to  donation  (e.g.  pain).  Additional  practices  were  reported  by  three 
Member States: reimbursement of hotel  costs (Netherlands),  accommodation  fees which are 
not included in the hospitalisation cost and travel expenses the donor has sometimes to pay to 
express  his  consent  (France)  and  costs  associated  with  the  recovery  period  (Germany).  No 
Member States reported practices such as providing a lump sum irrespective of actual costs, 
either established locally or at national level.  

Of  the  21  countries  compensating  donors  of  non-reproductive  tissues  and  cells,  only  three 
Member States and Norway were able to provide data on the value of the practices allowed at 
national level (Table I).  

Furthermore,  it  has  to  be  emphasised  that  in  a  few  cases  the  same  practice  has  a  different 
interpretation from one country to another (Figure 10). Providing refreshments, food vouchers 
or small tokens was interpreted either as compensation or other type of practice. 

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Croatia 

Lithuania 

Norway 
average 5€  

Spain 

average 2€ 
maximum 2€ 

average 7€ 
maximum 7€ 

average 5€ 

average 4000€; 
maximum 
6400€ 

NAV 

average 230€; 
maximum 
470€ 

maximum 100€ 

average 75€ 

average 20€; 
maximum 30€ 

Practices 

a) Refreshments 

b) Food voucher(s) 

c) Small tokens, such as pins, 
pens, towels, t-shirts, mugs 

d) Free physical check-up 
(beyond what is required for the 
donation) 
e) Reimbursement of medical 
costs (e.g. hospitalisation, 
medication, etc.) based on actual 
costs/receipts 
f) Reimbursement of costs linked 
to traverageel (to and from place 
of donation) based on actual 
costs/receipts 
g) Time off work – public sector 

h) Time off work – private sector 

100% coverage 
by health 
insurance system 
according to the 
rules of the health 
insurance system 

100% coverage 
by health 
insurance system 

i) Full exemption for the medical 
costs  

NAV 

NAV 

j) Compensation linked to loss of 
earnings 
k) Compensation for the 
inconveniences related to 
donation (e.g. pain) 
l) Fixed sum of money, 
irrespective of actual costs – 
established at national level 
m) Fixed sum of money, 
irrespective of actual costs – 
established by the TE 
n) Other 
Table I. Average and the maximum value of the practices vis-à-vis donors of non-reproductive tissues 
and cells (2014 data; NAV = data not available) 

NAV 

Concerning  the  responsibility  for  establishing  the  form  and  value  of  the  compensation  for 
living  donors  of  non-reproductive  tissues  and  cells,  the  survey  shows  that  the  responding 
countries  have  varied  approaches,  with  some  countries  entrusting  this  task  to  operators  (i.e. 
tissue establishments) and others where the decisions are taken by the national government or 
national/local  government  or  by  authorities  in  collaboration  with  health  insurance  schemes 
(Figure 10). In three Member States other bodies are also involved in the decisional process: 
the private insurance scheme (Germany), the hospital where the donation and transplantation 
occurs  (Lithuania)  or  the  employer  and  the  social  insurance  agency  (Sweden).  In  some 
Member  States,  the  decision  process  is  shared  between  national  organisations  and  tissue 
establishments. For example, in Denmark, donation-related travel costs are decided at national 

12 

 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
level, costs of food and accommodation are covered by the hospital and small tokens (flowers, 
chocolate) are offered by the tissue establishment. In Austria, travel costs are reimbursed by 
the tissue establishments and the cost of medical service is covered by the national insurance 
scheme. Only in four Member States (BE, NL, PT, UK) and Norway do tissue establishments 
have  the  sole  responsibility  for  deciding  on  the  form  and  value  of  compensation  for  living 
donors of non-reproductive tissues and cells. 

Five Member States impose specific conditions for providing compensation to living donors 
of  tissues  and  cells  (DK,  FR,  HR,  SI,  UK).  Four  Member  States  (DK,  FR,  HR,  SI)  require 
donors to provide supporting documents when claiming reimbursement of expenses related to 
donation.  In  addition,  the  United  Kingdom  (HTA)  further  specified  that  compensation  is 
restricted to expenses and inconveniences related to the donation. 

Fig.10.  Institutions/organisations  responsible  for  establishing  the  form  and  value  of  the 
compensation provided to living donors of non-reproductive tissues and cells (2014 data) 

Eighteen  Member  States  (CY,  CZ,  DK,  ES,  FI,  FR,  HR,  HU,  IE,  IT,  LT,  LV,  NL,  PL,  PT, 
RO, SI, SK) and Norway reported having a follow-up registry or a database of bone marrow 
and peripheral blood stem cell (PBSC) donors. 

The  information  provided  is  presented  in  Table  II,  which  shows  that  Member  States  have 
differing  approaches,  with  donor  follow-up  performed  in  the  five  to  ten  years  following 
donation,  with  examinations  performed  at  the  donor/transplantation  centre,  by  the  general 
practitioner or via a questionnaire. The other reporting countries indicated that such registries 
are  not  required  by  law  (Austria,  Bulgaria)  or  that  follow-up  of  donors  is  ensured  in  a 
different manner. For  instance, in  Belgium, donors  are followed for one year after donation 
and  notification  of  serious  adverse  reactions  to  the  competent  authorities  is  mandatory. 
Estonia reported that its haematopoietic stem cell donors are registered with the Finnish Bone 
Marrow  Donor  Registry.  Germany  indicated  that  a  follow-up  registry  is  not  in  place  but 
traceability  is  ensured  by  allocating  a  unique  number  to  each  donation.  In  Sweden, 
regional/university  hospitals  are  responsible  for  the  follow-up  schemes  of  living  donors. 
United  Kingdom  specified  that  individual  licensed  tissue  establishments  may  have 
arrangements in place to follow-up donors. 

13 

 
 
 
 
Member State 

Information on the registry(ies) for the follow-up of PBSC and BM donors  

Croatia 

Cyprus 
Czech Republic 
Denmark 

Finland 
France 

Hungary 

Ireland 

Italy 

Latvia 
Lithuania 

Netherlands 
Poland 

Portugal 

Romania 
Slovakia 

Slovenia 

Spain 

Clinical and laboratory evaluation of the donor on the day of discharge from the hospital, on 
the last day of apheresis and 30 days after donation. 
Complete blood count to be performed one year and five years after donation.  
Ten years after the donation the Register must contact donors through questionnaires. SARs 
and SAEs must be reported immediately. 
According to WMDA guidelines 
Regular check-ups: after 1 week, 1 month, 6 moths, 1 year, 4 years blood tests 
The registry contacts donors 1 week after donation by telephone. If they have symptoms the 
follow-up is continued on individual basis. After 6 weeks blood tests are performed 
(haemoglobin, leukocytes, platelets, liver and kidney parameters). The two tissue 
establishments in Denmark where donation takes place have not yet implemented long-term 
follow-up, but they are planning to do this in accordance to WMDA standards.  
For the bone marrow registry, the licence holder is the Finnish Red Cross Blood Service 
The follow-up of related donors is directly managed by transplant physicians.  
The follow-up of unrelated donors is managed by the national registry and the correlated donor 
centres: since 1994 for BM donations and since 2000 for PBSC donations (yearly follow up). 
The Hungarian Bone Marrow Donor Registry is maintained by the Hungarian National Blood 
Transfusion Service (HNBTS). 
Historically PBSC donors were followed up annually for 10 years and BM donors were 
followed up until fully recovered. In accordance with WMDA, guidelines were amended by 
the national establishment as follows:  

- 
- 

PBSC donors - one week, one month, one year and annually for 10 years  
BM donors - one week, one month, one year and annually for 10 years  

The registry/database has been in place since 09/01/2013 and has a compliance rate of 
approximately 95%. 
The follow-up of unrelated donors is carried out by the Donors Centre at periodic intervals 
after donation.  
After PBSC donation controls are performed after 2 and 7 days, after 1 month, 6 months and 
one year. After BM donation controls are performed at 1 month, 3 months, 6 months and 1 
year. For both types of donations an annual check-up is expected in the next 10 years. These 
controls include a physical examination, blood tests and other exams. 
Tissue establishments keep the register for autologous stem cells transplantations. 
The donor is invited for check-up (interview and full blood test) at the donation and 
transplantation centre 1 month after donation. Then donor is contacted by phone once per year 
with questions about his health condition, and if needed he is invited again for check-up. 
Duration of follow-up is 5 years. 
Guidelines/protocols are locally implemented and maintained 
The frequency, duration and parameters followed of check-ups are not established at national 
level. Each bone marrow donor centre has its own standard operating procedures created 
usually in co-operation with the procurement centre and accepted by the National Consultant 
in Haematology and the National Centre for Tissue and Cell Banking. The Unrelated bone 
marrow and cord blood donors’ registry has been created in its present form in 2010 and is 
continuously developed and upgraded. 
Follow-up inquiry one day after donation. Testing and written inquiry one month after 
donation. Written inquiry one year after donation. Data are centralized on the CEDACE 
(national registry of bone marrow donors) database 
National Registry of HSC Donors 
Bone marrow donor registry performs the follow-up at 3months intervals, 1 year up to 
minimum 5 years at the general practitioner and data are sent to registry. 
Regular examination after donation (6 months, 1 year, more if necessary). All steps shall be in 
accordance with legislative provisions and expert standards. 
The Spanish Register of Bone Marrow (REDMO) is responsible for the donor follow up, via 
telephone, few days after the donation. Each donation centre has their own rules to monitor the 
donors. The REDMO accepts this fact when the minimum checks are ensured in those centres, 
i.e. one month after the donation and once a year during five years (for PBSC); and one month 
and one year after the donation (for bone marrow). 

Table II. Follow-up of haematopoietic stem cell donors (2014 data) 

14 

 
 
 
 
One  Member  State  (Malta)  and  Liechtenstein  explained  that  patients  in  need  of  stem  cell 
transplantations are referred to other countries, so follow-up of both donors and recipients is 
expected to be performed abroad.  

2.2.2. Practices vis-à-vis donors of reproductive cells 

Regarding reproductive cells, 17 Member States (AT, BE, BG, CZ, DK, EE, ES, FI, FR, HU, 
LV, NL, PT, SE, SI, SK, UK) and Norway reported providing some form of compensation for 
living donors of reproductive cells. Greece did not provide replies to the section concerning 
donors of reproductive cells (Figure 11). Of the 11 countries not providing compensation to 
gametes donors, four Member States (DE, IT, LT, LU, MT) and Liechtenstein indicated that, 
at  the  time  of  the  survey,  non-partner  donation  is  not  allowed  at  national  level  and  one 
Member  State  (Germany)  reported  allowing  non-partner  donation  of  sperm,  but  not  oocyte 
donation. One Member State (Poland) reported that gamete donation was not yet regulated. 

Fig. 11. Countries providing compensation to donors of reproductive cells (2014 data) 

An outline of the practices vis-à-vis donors of reproductive cells is presented in Figure 12.  

In ranked order, the most common practices are the reimbursement of costs related to travel to 
and from the place of donation (BE, BG, CZ, DK, FI, FR, HU, SI, SK, and NO), providing 
compensation  related  to  loss  of  earnings  (BE,  BG,  CZ,  EE,  FR,  NL,  SE,  SK),  providing 
donors a fixed sum of money/lump sum irrespective of actual costs, either established/decided 
by the tissue establishments themselves (AT, BE, CZ, EE, NL, SE, SK) or at national level 
(CZ, DK, FI, HU, SI, UK), reimbursing medical costs (e.g. hospitalisation, medication) (DK, 
ES, FI, PT, UK) and compensating for the inconveniences related to donation (BG, CZ, DK, 
LV). 

15 

 
 
 
 
Fig. 12. Practices vis-à-vis living donors of reproductive cells and their interpretation by the 
responding Member States (2014 data) 

Some practices were reported by just two or three Member States. For instance, offering time 
off work in both private and public sectors and providing refreshments was reported by three 
Member  States  (Bulgaria,  Latvia,  Slovenia),  whereas  two  Member  States  (Bulgaria,  Latvia) 
described  providing  small  tokens.  A  physical  check-up  beyond  what  is  required  for  the 
donation  was  reported  by  two  Member  States  (Bulgaria,  Slovenia).  Two  Member  States 
(Czech Republic, France) indicated fully exempting donors from the medical costs associated 
with donation. 

Only  one  Member  State  (United  Kingdom)  reported  that  donors  may  receive  a  discount  for 
to  another 
their  own  fertility 
individual/couple  (described  as  egg  or  embryo  sharing).  Food  vouchers  are  not  given  to 

if  unused  oocytes/embryos  are  donated 

treatment 

16 

 
 
 
donors  of  reproductive  cells  in  any  of  the  reporting  countries.  No  “other  practices”  were 
reported. 

As is the case for living donors of non-reproductive tissues and cells, it has to be underlined 
that  the  same  practice  may  have  different  interpretations  across  the  EU  (Figure  12).  For 
example  practices  such  as  providing  a  free  physical  check-up,  reimbursement  or  full 
exemption  of  medical  costs,  reimbursement  of  costs  associated  with  travel  to  the  donation 
centre, and providing time off work were considered either compensations or incentives.  

A small number of Member States provided information on the average/maximum equivalent 
of  money  corresponding  to  each  practice  applied  at  national  level.  For  instance,  Slovenia 
reported  that  medical  costs  covered  by  health  insurance  per  single  medical  procedure  were 
estimated to range from EUR 900 to 1800 for oocyte donation and up to EUR 135 for sperm 
donation.  In  Bulgaria,  expenses  related  to  travel  to  and  from  the  site  of  donation  are 
reimbursed  up  to  EUR  40  for  oocyte  donors.  In  Slovenia,  this  can  be  up  to  EUR  250  for 
oocyte  donors  and  EUR  125  for  sperm  donors.  Latvia  indicated  that  compensation  for  the 
inconveniences related to donation ranges from EUR 751 to 854 for oocyte donors and from 
EUR 113 to 280 for sperm donors. In addition, the figures reported by eight Member States 
regarding the lump sums provided to oocyte and sperm donors established both locally (by the 
tissue  establishments  responsible  for  procurement)  and  at  national  level  are  presented  in 
Figure 13.  

a) 

b) 

Fixed sum of money (lump sum) established at national level 

COUNTRY 

OOCYTE DONATION 

SPERM DONATION 

Average 
amount (€) 

Maximum 
amount (€) 

Average 
amount(€) 

Maximum 
amount(€) 

Denmark 
Finland 
Portugal 
Spain 
United Kingdom 

320 
250 
628,83 

320 
250 
628,83 
900 
898 

40 

67 

41,92 

41,92 
100 
42 

Fixed sum of money (lump sum) established at local level 

COUNTRY 

OOCYTE DONATION 

SPERM DONATION 

Average 
amount (€) 

Maximum 
amount (€) 

Average 
amount(€) 

Maximum 
amount(€) 

Slovakia 
Sweden* 
Bulgaria 

500 
700 
1000 

500 
1200 
1500 

50 
200 
50 

50 
400 
200 

* The maximum value provided by Sweden refers to an on-going project in the Skåne region offering a higher 
compensation for oocyte donation (25 % of the PBA) than the other regions. The lump sum for sperm donation is 
provided for 4 to10 donations 

Fig. 13. The average and maximum amount of the lump sums provided as compensation to 
oocyte and sperm donors: a) established locally (by the tissue establishments responsible for 
procurement) and b) decided at national level (2014 data) 

With reference to the responsibility for taking decisions specifying the form and value of such 
compensations,  in  half  of  the  reporting  countries  this  task  was  entrusted  to  the  tissue 

17 

 
 
 
 
 
 
 
 
 
establishments (Figure 14). A small number of Member States described the decision-making 
process  for  establishing  the  form  and  value  of  the  compensation  for  donors  of  reproductive 
cells.  

  Latvia and Slovenia indicated that compensation is established on a case by case basis 

 

by either the tissue establishments or the national ART Committee, respectively; 
In  Sweden,  the  decision-making  process  varies  from  county  to  county.  In  2013,  a 
recommendation  was  produced  by  the  National  Tissue  Council  in  cooperation  with 
representatives from all university hospitals. The recommendation targets non partner 
donors  and  urges  that  compensation  is  only  offered  for  the  expenses  linked  to  the 
donation.  This  compensation  is  connected  to  the  price  base  amount  (PBA)  which  is 
updated annually. For sperm, the compensation was set at 1.25 % of the PBA and for 
egg donation the sum is 15 % of the PBA. If the donor has expenses that exceed these 
amounts,  the  compensation  can  be  increased  to  cover  these  extra  expenses.  The 
compensation is paid after performing a donation including handing in a screening test 
180  days  after  the  donation.  The  United  Kingdom  specified  that  the  form  of 
compensation  was  decided  by  the  competent  authority  (HFEA)  following  a  public 
consultation. 

Fig. 14. Institutions/organisations responsible for deciding the form and value of the 
compensation given to donors of reproductive cells (2014 data) 

As regards the possibility for couples/individuals requesting fertility treatments with donated 
oocytes or sperm to bring/recruit potential donors, 12 Member States (AT, BE, BG, DE, DK, 
EE, FI, NL, RO, SE, SK, UK) reported allowing such a practice. In five Member States (BG, 
DK, NL, SE, UK), bringing a potential oocyte donor gives some advantages to the recruiting 
couple/individual.  In  four  of  these  countries  (BG,  DK,  NL,  SE),  this  practice  moves  the 
recruiting  couples/individuals  up  the  waiting  list.  Bulgaria  further  specified  that  when 
recipients  are  not  in  a  position  to  wait  to  find  an  anonymous  non-partner  oocyte,  oocyte 
donors can be recruited among relatives (e.g. siblings, cousins). Denmark reported that oocyte 
donors  recruited  by  a  couple/individual  are  included  in  an  oocyte  donor  pool,  while  the 
recruiting  couple/woman  will  receive  an  oocyte  from  another  donor  in  the  pool  ("cross-
donation"). Cross-donation was also reported by Sweden. Furthermore, Bulgaria and Sweden 
admitted  having  difficulties  in  ensuring  that  in  such  cases  donation  remains  voluntary  and 

18 

 
 
 
unpaid.  United  Kingdom  (HFEA)  informed  that  recruiting  couples/individuals  can  benefit 
from certain advantages but these are decided at clinic level in line with the HFEA Direction 
0001. 

Three  Member  States  (Croatia,  Netherlands  and  Slovenia)  declared  imposing  specific 
conditions  to  couples/individuals  from  other  EU  MS/non-EU  countries  requesting  fertility 
treatments  with  donated  sperm  or  oocytes  on  their  territory.  Croatia  specified  that  in 
accordance with the national Medically Assisted Fertilisation Act, a child conceived and born 
by  means  of  ART  with  donated  sperm,  oocytes  or  embryos,  is  entitled  to  review  the  data 
concerning  his  biological  origin  after  he  or  she  has  reached  the  age  of  18,  including  the 
identity of the sperm/oocyte/embryo donor(s). The latter information is recorded in the State 
Register of Medically Assisted Reproduction maintained by the national competent authority. 
The  Netherlands  indicated  that  only  gametes  from  non-anonymous  donations  can  be  used. 
Slovenia underlines that the special conditions refer only to pricing and reimbursement from 
the  health  insurance  company(ies)  in  the  patients’  countries  of  origin.  Additionally,  Malta 
reiterated that according to the Embryo Protection Act 2012, non-partner donation of gametes 
is not allowed. 

Three  Member  States  (Finland,  Netherlands  and  Slovenia)  and  Norway  reported  having  a 
national registry or database for the follow-up of donors of oocyte and/or sperm intended for 
non-partner donation. In this context, the Netherlands explained that in case  of a child born 
through  IVF,  data  on  the  sperm/egg  donor  and  mother  are  kept  in  a  central  database  and 
specific  data  can  be  requested  by  general  practitioners,  the  child  and  the  parents.  France 
indicated that the Biomedicine Agency has the mission to follow oocyte donors and children 
born subsequent to ART procedures through the public national health insurance database.  

2.2.2.1. Special provisions for non-partner oocyte donation 

In regard to non-partner oocyte donation, the vast majority of countries reported having some 
restrictions  in  place,  as  defined  by  Directive  2006/17/EC  (Figure  15).  However,  nine 
Member States (BE, CY, CZ, DK, FI, IE, PL, RO und UK) stated having no such restrictions. 

Fig. 15. Member States and EEA countries’ approaches towards non-partner oocyte donation 
(2014 data) 

Most  of  the  respondents  noted  that  the  restrictions  for  non-partner  oocyte  donation  are  laid 
down in the national legislation (Figure 16).  

19 

 
 
 
 
Fig. 16. Legal status of the restrictions put in place for non-partner oocyte donation by the 
reporting Member States and EEA countries (2014 data) 

In  addition,  Liechtenstein  reported  that  restrictions  are  included  in  a  governmental  decision 
and Portugal specified that they are set by the ART national competent authority. It should be 
noted  that  although  Ireland  does  not  provide  any  restriction,  no  ART  clinics  are  currently 
authorised for non-partner oocyte donation. 

Fig. 17. Type of restrictions for non-partner oocyte donation as defined by the reporting 
Member States and EEA countries place (2014 data) 

In  terms  of  specific  restrictions,  oocyte  donation  is  prohibited  in  one  Member  State 
(Germany)  and  non-partner  oocyte  donation  is  not  allowed  in  six  Member  States  and  one 
EEA  country  (Figure  17).  Regarding  this  issue,  Lithuania  stressed  that  partner  donation  of 
gametes is allowed only between married partners. Eleven Member States (BG, EE, ES, FI, 

20 

 
 
 
 
 
FR, HU, LV, NL, PT, SI, SK) and Norway reported having criteria to be fulfilled by oocyte 
donors (e.g. minimum and maximum age for oocyte donation, number of children born before 
donation,  maximum  offspring  born  from  an  individual  oocyte  donor)  (Table  III). 
Additionally,  in  Sweden,  only  university  hospitals  are  allowed  to  use  oocytes  from  non-
partner donors.  

Furthermore,  six  Member  States  (BG,  FI,  HU,  PT,  SI,  UK)  confirmed  having  a  national 
registry or database for non-partner oocyte donors. In addition, Croatia specified that such a 
national registry is currently under development.  

Member State 

Oocyte donor’ age limits 
(years) 

Minimum number 
of children born 
before donation 

Maximum of 
children born from 
a donor 

Bulgaria 

Croatia 

Estonia  

France 

Hungary  

Latvia 

Netherlands 

Portugal 

Slovakia 

Slovenia 

Spain 

18-34 for unrelated non-
partner donation;  
18-38 for relatives of 
women requiring oocyte 
donation 
 Legal age 

<35 

20-37 

< 35 

18-35 

25-40  

18-35 

21-34 

adult 

>18 

1 

1 

 1/0* 

1 

0 

1 

5 

2 

 6 

10 

4 

3 

maximum 3 
donations 

2 

Table III. Criteria to be fulfilled by oocyte donors as reported by the responding Member 
States (2014 data) 

*France  indicated  that  before  2011,  the  law  on  bioethics  stipulated  that  only  women  having  a  child  before 
donation  were  allowed  to  donate  oocytes.  In  2011  the  law  on  bioethics  has  been  changed  and  even  women 
without a child can now donate their oocytes.The same regulation applies to sperm donors.  

Regarding the organisation of national registries of oocyte donors, the answers provided show 
a variety of approaches with the databases serving different purposes: 

o  In Bulgaria, a registry has been in place since 2011. The following data are collected: 
the  number  of  the  donors,  the  tissue  establishment  where  the  donation  took  place, 
unique ID number, number of own children, the unique identification number of the 
cells and the donor, the number of ART procedures, children born or pregnancies by 
ART.  The  aim  is  to  not  exceed  the  number  of  permitted  live-born  children  by  ART 
and to ensure traceability from the donor to the recipient; 

  Finland  indicated  that  the  National  Supervisory  Authority  for  Welfare  and  Health  is 

responsible of their registry; 

  Hungary  specified  that  according  to  a  Government  decree,  the  National  Institute  for 
Quality and Organizational Development in  Healthcare and Medicines (NIQODHM) 
maintains the Database for Reproductive Technologies. Healthcare providers provide 

21 

 
 
  
  
  
  
  
  
  
  
 

 

 

data for the NIQODHM and among other data, information on oocyte donors are also 
collected; 

In Portugal, the registry has the purpose of registering encrypted identification data of 
donors and to process a national donation code for each donation; 

In Slovenia, the registry includes personal and medical data, dates of donation, storage 
and use, follow–up results and birth date. Data are stored for 50 years; 

In  the  United  Kingdom,  the  HFEA  has  a  record  of  all  births  as  a  result  of  assisted 
conception  treatments  from  licensed  UK  fertility  clinics  since  1  August  1991.  The 
information includes details of everyone who has donated sperm, eggs or embryos that 
were  used  at  licensed  UK  fertility  clinics.  Donor  information  is  shared  with  parents 
and patients in order to allow parents to be open with their children about their donor-
conceived origins from an early age. 

2.2.2.2. Special provisions for non-partner sperm donation 

In  regard  to  non-partner  sperm  donation,  the  majority  of  the  responding  countries  reported 
having some restrictions, whereas seven Member States declared having no such restrictions 
(Figure  18).  Although  Ireland  does  not  provide  any  restrictions,  it  should  be  noted  that  no 
ART clinics are authorised for non-partner sperm donation. 

Fig. 18. Member States and EEA countries’ approaches towards non-partner sperm donation 
(2014 data) 

An overview of the legal status and type of restrictions defined by the Member States for non-
partner  sperm  donation  is  presented  in  Figure  18  and  19.  Most  of  the  responding  countries 
reported that restrictions related to non-partner sperm donation are laid down in their national 
legislation.  Six  Member  States  declared  that  such  restrictions  are  included  in  guidelines 
developed  by  professional  associations  and  in  two  Member  States  they  are  covered  by  the 
guidelines  issued  by  the  national  competent  authorities.  Liechtenstein  reported  that  such 
restrictions are taken by governmental decision and Portugal indicated that they are included 
in a relevant regulation issued by the national competent authority. 

22 

 
 
 
 
 
Fig. 19. Legal status of the restrictions put in place for non-partner sperm donation by the 
reporting Member States and EEA countries (2014 data) 

Regarding  the  type  of  restrictions,  they  range  from  number  of  donations  and  number  of 
children  born  from  the  same  donor  to  complete  prohibition  of  non-partner  sperm  donation 
(Figure  20,  Table  IV).  Liechtenstein  confirmed  having  no  establishments  using  donated 
sperm. Additionally, Lithuania specified allowing ART procedures in which donated sperm is 
used only between married partners.  

Fig. 20. Type of restrictions for non-partner sperm donation as defined by the reporting 
Member States and EEA countries place (2014 data) 

23 

 
 
 
 
 
 
Member State 

Sperm donor’ 
age limits 
(years) 

Number of 
inseminations/ 
pregnancies 

Maximum of children 
born from a donor 

Number of 
beneficiaries 

Austria 

Belgium 

Bulgaria 

Croatia 

Denmark 

Estonia  

France 

Germany 

Hungary  

Latvia 

Netherlands 

Norway 

Portugal 

Slovakia 

Slovenia 

Spain 

Sweden 

18-40 

Max 20 
inseminations 

5 

Max. 3 partnerships. 
Donation restricted to 
one clinic. 
Max. 6 women 

Max. 10 
pregnancies 

25 

>18 

<40 

<45 

<35 

18-45 

20-45 

18-45 

<35 

>18 

Adult age 

3 in 3 different families 
Max 12 children for 
recipients living in 
Denmark except when 
families already have 
children born with sperm 
from the same donor 
6 

Max 10 children 

4 
3 (except multiple 
pregnancies) 

Max 2 children per 4 
families or one child per 6 
families 
8 

Max.2 children born in 2 
different families 

Max. children born in 6 
families   

Table IV. Criteria for sperm donation as reported by the responding Member States (2014 
data) 

Five  Member  States  (BG,  FI,  PT,  SI,  UK)  and  Norway  reported  having  a  national 
registry/database  for  non-partner  sperm  donors.  While  Hungary  reported  having  a  national 
registry or database for oocytes donors, there is no similar registry for sperm donors. On the 
other  hand,  Norway  has  a  national  registry  for  sperm  donors,  but  not  for  oocyte  donors. 
Croatia and Latvia indicated that such national registries are currently under development. 

With  regard  to  the  purpose  of  the  registry  for  non-partner  sperm  donors,  Bulgaria  indicated 
that  the  national  registry  allows  verification  of  compliance  with  the  provisions  on  the 
maximum number of children conceived through ART procedures and to ensure appropriate 
traceability.  The  Bulgarian  registry  contains  data  such  as  the  number  of  donors,  tissue 
establishments  where  donations  take  place,  personal  data,  number  of  own  children,  donor 
code,  codes  of  the  donated  samples,  number  of  inseminations,  pregnancies  and  live-born 
children. Portugal specified that their national registry ensures the central allocation of donor 
and  donation  numbers.  The  registry  in  Norway  serves  the  same  purpose  as  in  Portugal.  In 
Slovenia, the registry includes donor medical and personal data as well as testing results. The 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
United Kingdom stated that HFEA has been keeping track of results of assisted reproduction 
since  1991  and  includes  information  on  donors  whose  cells  were  used  in  national  clinics. 
People conceived as a result of a donation have a legal entitlement to apply to the HFEA for 
information  about  their  origins,  including  details  the  donor  provided  at  the  clinic.  Patients 
seeking  treatment  with  donor  gametes  and  parents  of  donor-conceived  children  will  also  be 
able to  access  anonymous donor  information.  Donor information  is  shared with  parents and 
patients  in  order  to  help  people  be  open  with  their  children  about  their  donor-conceived 
origins from an early age. 

Countries who declared not having a national registry of sperm donors explained that either 
non-partner  donation  of  sperm  is  not  allowed  (IE,  IT,  LT,  MT)  or  there  is  no  legal 
requirement  to  develop  such  a  registry  (AT,  DE,  HU,  PL).  Croatia,  Latvia  and  Slovakia 
indicated  that  a  national  registry  is  under  development.  Nine  Member  States  (BE,  CY,  DK, 
EE,  FR,  HU,  NL,  RO,  SE)  and  Norway  reported  that  registries  are  maintained  by  the 
operators (e.g. mostly private ART clinics). 

2.2.3. Practices vis-à-vis relatives of deceased donors of tissues and cells 

Concerning  practices  vis-à-vis  relatives  of  deceased  donors  of  tissues  and  cells,  only  three 
Members States (Bulgaria, Romania and Spain) reported giving some form of compensation. 
A  summary  of  the  practices  accepted  in  these  three  countries  is  presented  in  Figure  21. 
Compared  with  the  previous  Commission  survey,  one  Member  State  has  stopped  paying 
donors, namely Slovenia, who stressed that tissue donation from deceased donors is provided 
without any financial or material compensation. 

Fig. 21. Practices vis-à-vis deceased donors (2014 data) 

All  the  practices  outlined  above  are  considered  by  the  Member  States  concerned  as 
compensation  provided  to  the  family  or  relatives  of  deceased  donors.  The  decision  on  the 
form  and  value  of  the  compensation  is  taken  at  different  levels.  Romania  specified  that  the 
form of compensation for deceased donors is laid down in the law, but its value is established 

25 

 
 
 
 
by  the  National  Transplant  Agency  (average  value  EUR  600),  whereas  in  Bulgaria  the 
decisions  are  taken  by operators (i.e.  tissues  establishments;  average  value  EUR  300  with  a 
maximum  of  EUR  750).  Spain  clarified  that  compensations  are  decided  at  regional/hospital 
level and only in exceptional cases, when there is no insurance covering the funeral expenses 
and  the  family  has  no  resources  to  afford  them,  the  regional  authorities  (Comunidades 
Autónomas) may allow the full coverage for the costs of the funeral/burial/cremation or other 
forms  of  compensation.  No  further  information  was  provided  on  the  value  of  the 
compensation. 

2.3. Tissue and cell donation and anonymity 

All  reporting  countries  apart  from  Ireland  and  Liechtenstein  have  legislative  provisions 
regarding anonymity/non-anonymity of donors of non-reproductive tissues and cells. Twenty-
four Member States (BE, BG, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IT, LT, LV, 
NL, PL, PT, RO, SE, SI, SK, UK) and Norway indicated that donation should be anonymous. 
Non-anonymous  donation  of  non-reproductive  tissues  and  cells  is  required  in  only  three 
Member States (Austria, Luxembourg, and Netherlands).  

For donors of reproductive tissues and cells, 24 countries indicated having in place provisions 
regarding anonymity/non-anonymity. Sixteen Member States (BE, BG, CY, CZ, DK, EE, ES, 
FI,  FR,  HU,  LV,  PT,  RO,  SE,  SI,  SK)  and  Norway  reported  that  donation  must  be 
anonymous,  whereas  seven  Member  States  (AT,  DE,  HR,  LU,  MT,  NL,  UK)  indicated that 
their  legislation  requires  donations  to  be  non-anonymous.  Four  Member  States  (IE,  IT,  LT, 
PL) and Liechtenstein have no requirements concerning this issue. 

Sweden  indicated that,  even  though  donation  of reproductive  cells  is  anonymous,  in  special 
circumstances  the  donor's  identity  should  be  made  available  to  children  conceived  with 
donated gametes, when they reach adulthood. Additionally, two Member States (Belgium and 
Denmark) specified allowing both anonymous and non-anonymous donation of reproductive 
tissues  and  cells.  In  this  regard,  Denmark  specified  that  non-anonymous  donation  refers  to 
sperm donors with an extended profile (“known donors”) or donors whose identity is known 
by the recipient or to “open donors”; the latter refers to situations when the child conceived 
with the donor has the possibility to contact and meet the donor when he/she turns 18.  

An  overview  of  the  requirements  on  donor  anonymity/non-anonymity  for  both  reproductive 
and non-reproductive tissues and cells is presented in Figure 22. 

26 

 
 
 
 
Fig. 22. Donor anonymity for donation of non-reproductive and reproductive tissues and cells 
as reported by the EU and EEA countries (2014 data) 

Two  Member  States  (Latvia  and  Lithuania)  notified  changes  to  the  national  legislative 
provisions  on  donor  anonymity  since  the  previous  reporting  exercise.  Latvia  reported 
introducing  an  obligation  for  tissue  establishments,  procurement  organisations  and  sites  for 
human application to ensure anonymity of the tissue and cell donor, as well as protection and 
confidentiality of donor personal and genetic data. Lithuania indicated that the national law on 
transplantation  of  human  tissues,  cells  and  organs,  was  amended  in  2013  by  adding  a 
provision  requiring  that  human  tissue,  cell,  organ  donation  and  transplantation  is  voluntary 
and  unpaid  in  accordance  with  the  principles  of  anonymity,  confidentiality  and  respect  for 
human  dignity.  Additionally,  Ireland  specified  that  donor  identification  issues  will  be 
addressed in the national provisions and guidelines on VUD currently in preparation. 

2.4. Promotion and advertising 

Twenty Member States (BE, BG, CY, DE, EL, ES, FR, HR, IE, IT, LT, LU, LV, MT, NL, 
PL,  RO,  SE,  SI,  UK)  and  Norway  confirmed  having  taken  measures  to  promote  VUD  of 
tissues and cells. A summary of the measures reported is shown in Figure 23. Compared to 
the second Commission report on the application of the VUD principle, three Member States 
(Croatia, Luxembourg, Romania) and Norway reported starting to promote VUD. 

Fig. 23. Measures taken at national level to promote VUD of tissues and cells (2014 data) 

The  most  commonly  used  measure  is  the  launching  of  information  campaigns  organised  by 
public or private actors either at national or local level. The second most commonly used tool 
is organising donor days/donor weeks, an initiative reported by six Member States (BG, CY, 
HR,  MT,  NL,  RO).  In  addition,  several  countries  reported  having  routine  promotional 
initiatives (Germany - telephone line; Netherlands – website; Sweden - appointed persons at 
local levels; Lithuania - lectures about VUD in secondary schools, medical faculties and other 
institutions).  Spain  specified  that  its  national  donation  system  does  not  allow  promotional 
campaigns for individual patients and that no specific measures to promote VUD were taken 
in the ART sector. 

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  the  guidelines  or  legislative  provisions  laid  down  at 

27 

 
 
 
national level. Twenty-six  Member States (AT, BE, BG,  CY, CZ, DE, EE, EL, ES, FI, FR, 
HR,  HU,  IT,  LT,  LU,  LV,  MT,  NL,  PL,  PT,  RO,  SE,  SI,  SK,  UK)  reported  having  such 
restrictions,  of  which  seven  (EL,  ES,  LT,  LV,  PL,  SE,  SK)  noted  that  their  current  binding 
provisions concerning restrictions or prohibitions of advertising changed since the publication 
of the second VUD survey.  

Specific  provisions  providing  for  restrictions  or  prohibitions  of  advertising  the  need  for,  or 
availability of particular tissue and cells with a view to offering or seeking financial gain or 
comparable advantages are in place for: 

  Haematopoietic stem cells - in 14 Member States (AT, BE, CZ, DE, EL, ES, FR, HR, 

HU, LU, NL, PL, SI, SK); 

  Gametes  and  embryos  –  in  15  Member  States  (AT,  BE,  BG,  CZ,  DE,  DK,  ES,  FR, 

HR, HU, LU, NL, PT, SK, UK). 

Penalties for infringements of the legislative provisions related to  Article 12(2) in Directive 
2004/23/EC have  been defined in  22 countries (AT, BE, BG, CZ, DE,  EE, EL, ES, FI,  FR, 
HR, HU, LT, LU, MT, NL, PL, PT, RO, SI, UK and LI). An outline of the type of penalties 
included in the Member States' legislation is shown in Figure 24. However, no Member State 
has imposed such penalties.  

Fig. 24. Penalties for infringements of the legislative provisions related to Article 12.2. in the 
Directive 2004/23/EC (2014 data) 

More  than  half  of  the  responding  countries  indicated  using  only  one  type  of  penalty,  as 
following:  fines  (BG,  CZ,  EE,  LT,  PT,  SI),  imprisonment  (Belgium,  Croatia,  Romania), 
licence  suspension  or  revocation  (Hungary,  Spain).  Eight  countries  use  a  combination  of 
penalties. Fines  and imprisonment were reported by four Member States (DE, FR, PL, UK) 
and  Liechtenstein,  and  fines  and  licence  suspension/revocation  were  described  by  three 
Member  States  (Austria,  Finland,  Spain).  The  duration  of  imprisonment  ranges  from  six 
months (Liechtenstein), up to one year (Netherlands, United Kingdom) or five years (France, 
Germany)  and  even  longer,  between  one  and  ten  years  (Poland).  Malta  did  not  provide  any 
information on the type of penalties established at national level. 

Seven Member States (BE, CY, DE, EL, FR, NL, SI) reported having legal requirements for 
tissue establishments/commercial operators when advertising tissues and cells via the internet. 
Advertising with the purpose of obtaining a financial gain or any other material gain is illegal 
in  Cyprus,  Germany,  Netherlands  and  Slovenia.  In  France,  tissue  establishments  and 

28 

 
 
 
commercial operators do not have the right to take any type of advertising initiative, whereas 
in  Belgium  advertisements  are  only  allowed  as  part  of  public  awareness  campaigns.  In 
Greece,  issuing  a  brochure  or  any  other  form  of  advertisement  for  donation  requires  prior 
approval by the competent authority.  

Legal requirements or guidelines concerning posting donation offers (e.g. donation of sperm 
or oocytes) by individuals in newspapers, social media or other means are in place in seven 
countries (BE, DE, EL, FR, HR, PL, SI). In Belgium and France, national legislation prohibits 
any  form  of  advertising  on  procurement  or  activities  related  to  human  body  material.  In 
Croatia, Germany, Greece and Poland, posting such advertisements is illegal and punishable 
with imprisonment. 

In  addition,  France  and  Slovenia  indicated  that  in  their  countries  promotion  activities  for 
tissue  and  cell  donation  were  entrusted  only  to  the  national  competent  authorities.  Malta, 
Greece and Poland underlined that promotion and advertisement activities are supervised and 
require prior approval from the national competent authorities.  

2.5. Donation-related practices in the healthcare system 

This section of the survey aims to establish which are the main suppliers of tissues and cells 
across the EU, whether Member States provide or do not provide incentives to donors and/or 
healthcare professionals involved in recruiting donors or procuring tissues and cells, and if a 
sufficiency policy for human tissues and cells has been defined at national level.  

An overview of the main suppliers of replacement tissues (e.g. skeletal tissue, ocular tissues, 
skin, cardiovascular tissue) is presented in Figure 25.  

Fig. 25. Main suppliers of replacement tissues in the EU and EEA countries (2014 data) 

The  survey  shows  that,  for  replacement  tissues,  public  tissue  establishments  prevail.  Five 
Member States (DE, IE, LU, SI, SK) and Norway indicated having a dual system of private 
and public suppliers. Three Member States, namely Cyprus, Malta and United Kingdom rely 
entirely  on  brokers  in  order  to  ensure  the  national  supply  of  replacement  tissues.  Three 
Member  States  (France,  Greece  and  Ireland)  and  Norway  indicated  that  third  country 

29 

 
 
 
suppliers are also important for ensuring an adequate national supply. It has to be noted that 
seven countries did not perform such an analysis. 

As shown in Figure 25, with regard to the main registries of haematopoietic stem cell donors 
(Figure  26),  19  Member  States  and  Norway  reported  having  national  registries.  However, 
only  two  Member  States  (Croatia  and  Finland)  and  Norway  rely  entirely  on  them.  Most 
Member  States  recruit  donors  from  both  national  and  WMDA  registries,  with  four  Member 
States  using  all  available  registries  (AT,  FR,  IE,  LT).  Estonia  uses  only  WMDA  accredited 
registries. 

Fig. 26. Main suppliers of haematopoietic stem cells in the EU and EEA countries (2014 
data) 

Replies  concerning  the  main  suppliers  of  gametes  and  embryos  from  non-partner  donations 
are summarised in Figure 27.  

Fig. 27. Main suppliers of gametes and embryos in the EU and EEA countries (2014 data) 

The  survey  shows  that  the  ART  sector  is  dominated  by  private  establishments  with  15 
Member States indicating they are the main suppliers. Public ART establishments are the only 

30 

 
 
 
 
 
suppliers in three Member States (Belgium, France, Sweden). In contrast, four Member States 
(BG, LV, NL, SK) reported that only the private ART establishments provide gametes in their 
countries.  Three  Member  States  (EE,  IE,  UK)  and  Norway  indicated  that  establishments  in 
third countries are among their main suppliers for this type of cells. Similar to the sector of 
non-reproductive  tissues  and  cells,  most  of  the respondents  indicated that  reproductive  cells 
are supplied by both private and public ART establishments in their countries, but also from 
other  EU  Member  States.  No  such  analysis  was  performed  at  national  level  in  ten  of  the 
responding countries.  

As regards the policy to provide financial incentives to the tissue establishments, recruitment 
organisations  or  professionals  in  procurement  organisations,  only  four  Member  States  (HR, 
LT,  PL,  SE)  reported  giving  some  form  of  financial  incentive.  Croatia  provides  financial 
incentives  to  hospital  administration,  recruitment  organisations  and  tissue  establishments, 
whereas  Lithuania  and  Portugal  indicated  motivating  only  hospital  administrations  and 
Sweden  providing  inducements  only  to  tissue  establishments.  The  existing  incentives  are 
provided  especially  for  the  donation  and  procurement  of  tissues  and  cells  (Lithuania  and 
Portugal),  for  organising  donor  drivers  (Croatia  and  Sweden)  and  for  organising  awareness 
campaigns  (Croatia  and  Sweden).  Both  Croatia  and  Sweden  reported  that  resources  for 
providing financial incentives were allocated by the national government (i.e. in Sweden ten 
million  euros  have  been  allocated  over  a  period  of  10  years  for  the  implementation  of  the 
tissue and cells Directives; in Croatia 0,6 million euros are allocated for such activities).  

The  types  of  tissues  and  cells  for  which  the  four  Member  States  grant  such  incentives  are 
shown in Figure 28.  

Fig. 28. Tissues and cells for which incentives to professionals are provided by the Member 
States (2014 data) 
Only Portugal1 notified a change in its national practices since the previous survey, specifying 
that  incentives  provided  to  healthcare  professionals  for  the  procurement  of  tissues  and  cells 
have  been  increased  in  order  to  stimulate  procurement  activities.  Additionally,  Bulgaria 
declared foreseeing a change of its national policy in this area. Croatia indicated that besides 
financial incentives, educational support to professionals in the tissue banking sector is also 
provided.  Lithuania  provides  tissue  establishments  with  information  on  the  tissues 
transplanted, acknowledging their contribution to the transplantation therapies, thus ensuring 
the motivation of the personnel working in this sector. 

1 Despacho no. 1886/2014 

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All Member States reported that stimulating donations by remunerating the donors of tissues 
and  cells  is  not  allowed.  Estonia,  which  is  the  only  Member  State  not  prohibiting 
remuneration  of  gamete  donors,  specified  that  the  sum  offered  is  not  considered  to  be  an 
incentive, but there are no national requirements on the amount of the remuneration, its value 
being decided solely by the operators. 

2.6. National sufficiency and shortages of tissues and cells  

The current survey proposed definitions for sufficiency, self-sufficiency and shortage, terms 
which  are  not  defined  in  Directive  2004/23/EC.  The  abovementioned  definitions  do  not 
constitute  an  interpretation  of  the  EU  Tissues  and  Cells  Directives,  and  were  proposed  in 
order to facilitate a consistent interpretation of these concepts for the purpose of this survey. 
National self-sufficiency was defined as fulfilling the needs of human tissue and cell products 
for  medical application (e.g. transplantation, ART procedures)  of the resident  population by 
accessing resources from within the country’s population. National sufficiency was defined as 
fulfilling  the  needs  of  human  tissue  and  cell  products  for  medical  application  (e.g. 
transplantation,  ART  procedures)  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 human tissue and cell products for medical application, which 
requires creation of waiting lists or makes a certain therapy temporary unavailable at national 
level.  

In relation to the supply-demand balance, 18 Member States (AT, BE, BG, EE, EL, ES, HR, 
IE,  IT,  LT,  LV,  MT,  PL,  PT,  SE,  SI,  SK,  UK)  and  Norway  reported  experiencing  regular 
shortages of tissues and cells on a national level (Figure 29). Shortages were reported mostly 
for  bone  marrow  and  haematopoietic  stem  cells  (11  countries),  corneas  (11  countries)  and 
musculoskeletal tissues (9 countries).  

Fig. 29. Type of tissues and cells for which shortages were reported (2014 data) 

Other tissues and cells subject to shortages include skin (Croatia, Malta), heart values (Malta) 
and trachea (Austria). 

The main reasons for shortages are summarised in Figure 30. It should be emphasised that the 
main cause for shortages is the lack of donors, followed by insufficient procurement capacity 
at  national  level  and  other  reasons.  Among  these  additional  reasons,  practical  difficulties  in 
finding  a  compatible  match  for  patients  in  need  of  an  HSC  transplantation  and  insufficient 

32 

 
 
 
cooperation  between  healthcare  professionals  were  mentioned.  An  insufficient  processing 
capacity  was  reported  by  three  Member  States.  Malta  indicated  that  there  are  no  tissue 
establishments.  

Fig. 30. Main reasons for shortages of tissues and cells in the Member States and EEA 
countries (2014 data) 

Ten Member States (EL, ES, FR, HR, IT, LT, MT, NL, PT, SI) and Norway indicated having 
policies in place to promote self-sufficiency for tissues and cells. It should be highlighted that 
Member States have various understandings of self-sufficiency and/or sufficiency.  

Four Member States (FR, LT, MT, NL) have defined the concept in relation to the extent that 
national  supply  meets  national  demand.  The  same  criterion  is  used  by  Spain  for  non-
reproductive tissues and cells, but it doesn’t apply for bone marrow and PBSC donors, who 
also  need  to  be  recruited  from  international  registries.  Finally,  Slovenia  referred  to  waiting 
lists, reporting that self-sufficiency and/or sufficiency requires that there are no long waiting 
lists  and  no  long  waiting  time  on  lists.  Other  countries  referred  to  their  national  policies  or 
estimations  of  national  needs.  In  this  regard,  Croatia  and  Poland  mentioned  national 
programmes which include promotion of donation, but also development of registries, support 
for upgrading tissue establishment facilities and promotion of the use of new types of tissue 
and  cell  grafts.  Italy  stated  that  national  needs  of  human  tissues  and  cells  are  based  on  the 
number of tissue/cell transplantation procedures performed and reported the previous year.  

Since  2009,  four  of  the  above-mentioned  Member  States  (Greece,  Lithuania,  Malta  and 
Poland) have changed their policy on self-sufficiency and/or sufficiency. Since 2011, Poland 
has been promoting bone marrow donations by creating bone marrow donor centres, building 
a  national  registry  of  unrelated  donors  of  bone  marrow  and  cord  blood,  and  finally  by 
developing  new  tissue  and  cell  processing  and  transplantation  techniques.  Malta  indicated 
having plans to set up the first tissue establishment in the country. Greece indicated that the 
new law adopted in 2011 places special emphasis on public information in order to increase 
organ, tissue and cell donation. 

33 

 
 
 
 
Fig. 31. Measures for ensuring an adequate supply of human tissues and cells in EU 
and EEA countries (2014 data) 

In cases where self-sufficiency is not a feasible aim, due to the need to ensure compatibility 
between  donor  and  recipient  (e.g.  bone  marrow,  peripheral  blood  stem  cells),  most  of  the 
responding  countries  indicated  organising  various  activities  from  awareness  campaigns  to 
bilateral  agreements  and  cooperation  with  recruitment  organisations.  An  outline  of  these 
measures is shown in Figure 31.  

Seventeen Member States (AT, BE, BG, CY, CZ, DE, DK, EE, FI, HU, IE, LU, LV, PL, RO, 
SE, SK) as well as Liechtenstein and Norway declared having no policy for promoting self-
sufficiency/sufficiency for tissues and cells.  

Five  Member  States  (ES,  FR,  HR,  NL,  SI)  indicated  having  no  intention  to  change  their 
current policy on sufficiency, whereas one Member State, namely Italy, stated that initiatives 
for defining self-sufficiency for haematopoietic stem cells are ongoing. Five Member States 
(CY,  CZ,  FI,  RO,  SE)  reported  that  there  is  no  need  to  address  this  issue  at  national  level 
because  they  don’t  experience  major  shortages.  Bulgaria  and  Slovakia  indicated  that  such 
policies are in preparation, whereas Austria, Estonia and Ireland specified that no change of 
policy is foreseen because the self-sufficiency concept has not been defined at national level. 
France indicated that in the field of ART, their objective is to reach self-sufficiency for non-
partner oocyte donation.  

34