Proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation {COM(2008) 819 final} {SEC(2008)2956} {SEC(2008)2957}
Date: 2008-12-08
Institutions: European Commission
Subjects: EU Member State, medicine, organ transplantation, product quality, product safety, public health

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.12.2008 
COM(2008) 818 final 

2008/0238 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on standards of quality and safety of human organs intended for transplantation 

{COM(2008) 819 final} 
{SEC(2008)2956} 
{SEC(2008)2957} 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

INTRODUCTION 

1. 

2. 

3. 

4. 

Organ  transplantation  is  the  therapeutic  use  of  human  organs  involving  the 
substitution  of  a  non-functional  organ  by  an  organ  from  a  donor.  Organ 
transplantation  is  now  the  most  cost-effective  treatment  for  end-stage  renal  failure, 
and  for  end-stage  failure  of  organs  such  the  liver,  lung  and  heart,  it  is  the  only 
available treatment.  

The use of organs in therapy poses a risk of transmission of diseases to the recipient; 
infectious  or  cancerous  diseases  could  be  transmitted.  While  most  Member  States 
have  adopted legislation on  the ethical aspects of organ transplantation,  many have 
yet  to  agree  on  rules  covering  quality  and  safety.  In  2003,  the  Commission  carried 
out a survey of legal requirements relating to organ transplantation in the EU which 
showed discrepancies in quality and safety requirements between Member States1.  

The exchange of organs between Member States in an effort to achieve better quality 
in  the  allocation  process  is  already  common  practice.  There  are,  however,  large 
differences  between  the  number  of  organs  exchanged  across  borders  between 
Member  States  that  have  set  up  bodies  and  laid  down  rules  for  the  international 
exchange  of  organs  such  as  Eurotransplant  and  Scandiatransplant  and  the  other 
Member States.  

The  shortage  of  organs  is  a  major  factor  affecting  transplantation  programmes. 
Nearly 56.000 patients are now on waiting lists2. Mortality rates while waiting for a 
heart,  liver  or  lung  transplant  usually  range  from  15  to  30%.  Donation  rates  and 
availability  of  organs  varies  considerably  across  Europe  with  achievable  good 
practice delivering far greater benefits in some Member States than in others.  

5.      One of the potential consequences of the scarcity of organs is the trafficking of human 
organs by organised criminal groups. Trafficking in human organs can be linked with 
trafficking  in  human  beings  for  the  purpose  of  the  removal  of  organs  which 
constitutes  a  serious  violation  of  fundamental  rights  and,  in  particular,  of  human 
dignity  and  physical  integrity.  It  is  recognised  that  the  best  way  of  fighting  organ 
trafficking  is  increasing  the  number  of  available  organs  and  securing  their  quality 
and safety. This Directive, although having as its first objective the safety and quality 
of  organs,  will  indirectly  contribute  to  combating  organ  trafficking  through  the 
establishment  of  competent  authorities,  the  authorisation  of  transplantation  centres, 
the establishment of conditions of procurement and systems of traceability.  

6. 

Since 1999, Article 152 of the EC Treaty, as introduced by the Treaty of Amsterdam, 
has  enabled  the  European  Parliament  and  the  Council  to  adopt  health  measures 
setting  high  standards  of  quality  and  safety  of  organs  and  substances  of  human 
origin, blood and blood derivatives. The Community has already adopted directives, 
on quality and safety standards for blood in 2003 and for Tissues and Cells in 2004.  

1 
2 Council of Europe (2007). 

http://ec.europa.eu/health/ph_threats/human_substance/documents/organ_survey.pdf 

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7. 

8. 

9. 

10. 

11. 

There  are  important  differences  between  organ  transplantation  and  the  use  of  other 
human  substances  such  as  blood,  tissues  and  cells.  Given  the  current  shortage  of 
organs, two factors have to be balanced: the need for organs' transplantation that is 
usually a matter of life and death with the need to ensure high standards of quality 
and safety.  

The  Venice  Conference  on  Safety  and  Quality 
in  Organ  Donation  and 
Transplantation in the European Union was held on 17-18 September 2003 under the 
Italian presidency. The conclusions of the expert conference organised by the Italian 
government during its Presidency of the EU Council listed the shortage of organs as 
the  main  priority  in  this  area  and  stressed  the  importance  of  addressing  the  quality 
and  safety  aspects  given  the  current  situation  regarding  the  supply  and  demand  for 
organs. 

When adopting the Tissues and cells Directive on 31 March 2004, the Commission 
committed itself to conducting a thorough scientific review of the situation regarding 
organ transplantation. On 31 May 2007, the Commission adopted a Communication 
on organ donation and transplantation3 based on that analysis. This Communication 
proposes  what  activities 
the  field  of  organ 
the  EU  should  undertake 
transplantation.  The  Communication  concludes  that  a  flexible  European  legal 
framework establishing quality and safety standards would be the right Community 
response to meeting the mandate provided in Article 152 (4) (a) of the Treaty. 

in 

On  6  December  2007,  the  Council  adopted  conclusions  on  organ  donation  and 
transplantation. The Council recognises the importance of having high standards with 
respect to the quality and safety of organs for transplantation, so as to ensure a high 
level of protection for patients throughout Europe and called on the Commission to 
consult  the  Member  States,  and  continue  its  examination  of  the  need  for  an  EU 
framework on quality and safety for human organs.  

The European Parliament resolution adopted on 22 April 2008 recognised that it is 
vitally  important  to  improve  the  quality  and  safety  of  organ  donation  and 
transplantation to reduce transplant risks. Hence, the resolution looks forward to the 
Commission’s proposal for a directive stipulating requirements to ensure the quality 
and safety of organ donation across the EU. 

SCOPE AND OBJECTIVES  

12. 

13. 

3 

This proposal for a Directive covers human organs, that are used for transplantation, 
during  all  the  phases  of  the  process  –  donation,  procurement,  testing,  preservation, 
transport and use – and aims to ensure their quality and safety and hence a high level 
of health protection.  

The  proposal  excludes  blood  and  blood  components,  human  tissues  and  cells  and 
organs or tissues and cells of animal origin. Blood and blood products are currently 
covered  by  Directives  2002/98/EC,  2004/33/EC,  2005/61/EC  and  2005/62/EC, 

Communication  from  the  Commission  to  the  European  Parliament  and  the  Council  -  Organ  donation 
and transplantation: Policy actions at EU level, Brussels - COM(2007) 275, 30.5.2007. 

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14. 

15. 

whereas  Human  Tissues  and  Cells  are  regulated  by  Directive  2004/23/EC, 
2006/17/EC and 2006/86/EC. 

This  Directive  does  not  intend  to  cover  research  using  human  organs,  for  purposes 
other  than  transplantation.  However,  organs  that  are  transplanted  into  the  human 
body in clinical trials should comply with the quality and safety standards laid down 
in this Directive. 

This  proposal  aims  to  ensure  that  human  organs  used  for  transplantation  in  the  EU 
comply with the same quality and safety requirements. In this way, the Directive will 
facilitate their exchange between Member States.  

THE ADDED VALUE OF THE DIRECTIVE  

Ensuring quality and safety for patients at EU level  

16. 

17. 

18. 

19. 

There  are  significant  risks  to  using  organs  in  therapy,  but  these  can  be  effectively 
offset  through  the  application  of  quality  and  safety  procedures.  A  well-regulated 
donation and transplantation system is essential if organs are to be delivered on time, 
with accurate information and without any unnecessary risk of transmitting disease to 
the recipient.  

This  Directive  sets  out  the  basic  quality  and  safety  requirements  needed  in  every 
transplant  system.  A  sound  infrastructure  and  responsible  institutions  for  organ 
procurement  and  transplantation  have  been  identified  as  the  main  features  of  a 
successful  transplantation  system.  The  proposed  Directive  provides  for  the  creation 
or  designation  of  a  competent  national  authority  in  each  Member  State.  These 
Competent authorities will ensure compliance with the requirements of the Directive. 
The Directive also establishes a system for the authorisation of programmes of organ 
procurement and transplantation based on common quality and safety criteria4. This 
system would provide a complete list of authorised centres throughout the European 
Union, accessible to the public and professionals alike. 

Procurement, evaluation and selection of the donor are the first and decisive steps in 
the transplantation chain. The proposed Directive will establish common quality and 
safety  standards  for  the  processes  of  evaluating  donors  and  human  organs,  thus 
ensuring the health of recipients. 

Of  equal  importance  is  to  ensure  the  quality  of  the  processes  performed  by  the 
various organisations in the field. To improve these processes, the Directive proposes 
the introduction of national quality programmes to ensure continuous monitoring of 
performance and improvement and learning. Specific standards for the procurement 
and  transport  of  human  organs  and  training  of  professionals  will  be  part  of  the 
national quality programmes.  

20. 

Establishment  of  a  system  to  ensure  that  all  organs  can  be  traced  from  donation  to 
reception and vice versa is a key factor to ensure safety but also in order to prevent 

4 

Council of Europe Recommendation Rec(2004)19 of the Committee of Ministers to Member States on 
criteria for the authorisation of organ transplantation facilities.  

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remuneration,  trade  and  trafficking  in  organs.  The  proposed  Directive  will  ensure 
that  Member  States  put  in  place  organ  traceability  systems.  The  Commission  will 
adopt  procedures  for  guaranteeing  full  traceability  of  organs  exchanged  between 
Member  States.  Traceability  does  not  mean  that  the  organ  receiver  will  learn  the 
names and further details of the donor, or vice versa. Traceability therefore aims at 
safeguarding  the  health  of  donors  and  recipients  and  serves  no  other  purpose  than 
guaranteeing the quality and safety of the organs. The anonymity of both the donor 
and  the  recipient  remains  a  cornerstone  for  their  protection.  But  the  relevant 
competent  authorities  should  keep  the  necessary  documentation  and  records,  e.g. 
where the organ originated from, who supplied it and under which circumstances. 

21. 

22. 

As organ donors are often also tissue and cell donors, it is additionally important that 
information about adverse events and infections can be quickly traced to a donation 
and  immediately  relayed  to  the  tissue  vigilance  system  provided  for  by  the  Tissue 
and Cell Directive 2004/23/EC. Currently such a system does not exist. 

In addition, the proposal includes measures to capture serious adverse events related 
to  the  procurement,  testing  and  transport  of  organs,  as  well  as  any  serious  adverse 
reactions  observed  during  or  after  transplantation  which  may  be  connected  to  the 
procurement,  testing  and  transport  of  the  organ  in  the  European  Union.  The 
Commission  will  adopt  procedures  for  ensuring  interoperability  between  the 
reporting systems on adverse events and reactions. 

Ensuring the protection of donors  

23. 

24. 

25. 

26. 

The use of human organs should be under conditions protecting the rights and health 
of  donors.  As  a  matter  of  principle,  organ  transplantation  programmes  should  be 
based on the principle of voluntary and unpaid donation, altruism of the donor and 
solidarity  between  donor  and  recipient  while  ensuring  anonymity  of  the  deceased 
donor,  the  living  donor  (when  relevant)  and  the  recipient(s)  and  the  protection  of 
personal  data.  They  should  comply  with  the  Charter  of  Fundamental  Rights  of  the 
European  Union,  and  take  the  principles  of  the  Convention  of  Human  Rights  and 
Biomedicine of the Council of Europe fully into account. 

Consent  for  procurement  is  as  a  general  rule  regulated  by  Member  States  in  very 
different  ways;  ranging  from  presumed  consent  systems  to  systems  where  the 
consent of relatives is required. The Commission believes that this is a very sensitive 
field and that it raises a number of ethical concerns that falls within the competence 
of the Member States and should not be dealt with in this Directive.  

The  use  of  living  donors  is  an  increasing  alternative  given  the  failure  to  meet  the 
growing  need  for  organs  with  cadaver  donation.  The  increase  in  living  organ 
donation  can  be  attributed  to  multiple  factors,  including  pressure  created  by  the 
shortage  of  deceased  donors,  surgical  advances,  and  strong  evidence  of  favourable 
transplant outcome and low donor risk. 

The  proposed  Directive  contains  a  number  of  measures  to  protect  living  donors. 
These  include  correct  evaluation  of  the  health  of  the  donor  and  comprehensive 
information about the risks prior to donation, the introduction of registers for living 
donors to follow up their health and measures to ensure the altruistic and voluntary 
donation of organs by living donors.  

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Facilitating cooperation between Member States and cross-border exchanges 

27. 

28. 

29. 

30. 

31. 

The current proposal seeks to ensure a high level of quality and safety throughout the 
‘organ transplantation chain’ in all Member States, bearing in mind the freedom of 
movement of citizens and the need to enhance the cross-border exchange of organs 
within  the  European  Union.  The  establishment  of  quality  and  safety  standards  will 
help  to  reassure  the  public  that  human  organs  derived  from  donation  in  another 
Member State carry nonetheless the same guarantees as those in their own country. 

The  cross-border  exchange  of  organs  has  clear  benefits.  Given  that  donor  and 
recipient have to be matched, a large donor pool is important to cover the needs of all 
the patients on the waiting lists. If there is no exchange of organs between Member 
States, recipients in need of a rare match will have very low prospects of finding an 
organ,  while  at  the  same  time  donors  will  not  be  considered  because  there  are  no 
compatible recipients on the waiting lists. This holds particularly true for difficult to 
treat patients (paediatric, urgent or hypersensitised patients that require very specific 
matching) and small Member States.  

The Directive will put in place the quality and safety conditions needed to facilitate 
cross-border exchanges. It will standardise the collection of the relevant information 
on the characteristics of the organ needed to make a proper risk assessment. It will 
also establish a mechanism for transmission of the information. Transplant teams in 
all  Member  States  will  be  reassured  that  they  will  receive  the  appropriate  and 
complete information required regardless of the country of origin of the organ. This 
will  minimise  the  risks  to  the  recipient  and  optimise  the  allocation  of  the  organs 
across the EU level. 

In  addition  the  Directive  will  provide  for  the  necessary  mechanisms  to  be  put  in 
place  for  cross-border  exchanges  of  organs  to  ensure  traceability  of  the  organ  and 
pre-empt serious adverse reporting. 

The establishment of competent authorities in all Member States and the organisation 
of regular meetings between them will help to promote European cooperation in this 
field  as  shown  in  the  cases  of  blood  and  tissues  and  cells.  Coordination  between 
these  authorities  would  make  for  a  more  efficient  allocation  of  organs  (especially 
helpful for smaller Member States and for urgent and difficult–to-treat patients). As 
more  people  move  across  borders  information  will  need  to  move  with  them  to 
optimise donation  and transplantation  while maintaining citizens’ confidence  in  the 
system in the country they are visiting. 

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2008/0238 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on standards of quality and safety of human organs intended for transplantation 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
152 (4) (a) thereof, 

Having regard to the proposal from the Commission5, 

Having regard to the opinion of the European Economic and Social Committee6, 

Having regard to the opinion of the Committee of the Regions7, 

After consulting the European Data Protection Supervisor8,  

Acting in accordance with the procedure laid down in Article 251 of the Treaty9, 

Whereas: 

(1) 

(2) 

(3) 

Over  the  past  50  years  organ  transplantation  has  become  an  established  worldwide 
practice, bringing immense benefits to hundreds of thousands of patients. The use of 
human  organs  for  transplantation  has  steadily  increased  during  the  last  two  decades. 
Organ  transplantation  is  now  the  most  cost-effective  treatment  for  end-stage  renal 
failure, while for end-stage failure of organs such as the liver, lung and heart it is the 
only available treatment. 

Risks however are associated with the use of organs in transplantation. The extensive 
therapeutic  use  of  human  organs  for  transplantation  demands  that  their  quality  and 
safety  should  be  such  as  to  minimise  any  risks  associated  with  the  transmission  of 
diseases.  

In addition the availability of organs of human origin used for therapeutic purposes is 
dependent  on  Community  citizens  being  prepared  to  donate  them.  In  order  to 
safeguard  public  health  and  to  prevent  the  transmission  of  diseases  by  these  organs, 
precautionary measures should be taken during their procurement, transport and use.  

5 
6 
7 
8 
9 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Every year organs are exchanged between Member States. The exchange of organs is 
an  important  way  of  expanding  the  pool  of  organs  available  and  ensuring  a  better 
match  between  donor  and  recipient  and  therefore  improving  the  quality  of  the 
transplant. This is particularly important for the optimum treatment of specific patients 
such  as  patients  requiring  urgent  treatments,  hypersensitised  patients  or  paediatric 
patients.  Available  organs  should  be  able  to  cross  borders  without  unnecessary 
problems and delays. 

However, the transplantation process is carried out by hospitals or professionals falling 
under different jurisdictions and there are significant differences in quality and safety 
requirements between Member States.  

There  is  therefore  a  need  for  common  quality  and  safety  standards  for  the 
procurement, transport and use of human organs at Community level. These standards 
would facilitate exchanges of organs to the benefit of thousands of European patients 
in  need  of  this  type  of  therapy  each  year.  Community  legislation  should  ensure  that 
human organs comply with acceptable standards of quality and safety. Therefore such 
standards  will  help  to  reassure  the  public  that  human  organs  procured  in  another 
Member State nonetheless carry the same basic quality and safety guarantees as those 
obtained in their own country. 

In order to reduce the risks and maximise the benefits of the transplantation process. 
Member  States  need  to  operate  an  effective  national  quality  programme.  This 
programme  should  be  implemented  and  maintained  throughout  the  entire  chain  from 
donation  to  transplantation  or  disposal,  and  should  cover  the  personnel  and 
organisation,  premises,  equipment,  materials,  documentation  and  record-keeping 
involved.  The  national  quality  programme  should  include  auditing  where  necessary. 
Member  States  should  be  able  to  delegate,  through  written  agreements,  the 
responsibility for parts of this programme to European organ exchange organisations. 

The  conditions  of  procurement  should  be  supervised  by  the  Competent  Authorities 
through  the  authorisation  of  identified  procurement  organisations.  The  authorisation 
should  assume  that  proper  organisation,  qualified  staff  and  adequate  facilities  and 
material are in place.  

The risk-benefit ratio is a fundamental approach to organ transplantation. Owing to the 
shortage  of  organs  and  the  inherent  life  threatening  nature  of  organ  transplants,  the 
overall benefits of organ transplantation are high and more risks are accepted than with 
blood or most tissues and cell-based treatments. The clinician plays an important role 
in  this  context  by  deciding  whether  or  not  organs  are  suitable  for  transplantation; 
therefore this Directive stipulates the information required to make this assessment.  

(10)  Pre-transplant  evaluation  of  potential  donors 

is  an  essential  part  of  organ 
transplantation.  This  evaluation  must  provide  enough  information  for  the  transplant 
centre to undertake a proper risk-benefit analysis. The risks and characteristics of the 
organ  must  be  identified  and  documented  to  allow  allocation  to  a  suitable  recipient. 
Information  should  be  collected  for  complete  characterisation  of  the  organ  and  the 
donor. 

(11)  Effective  rules  for  the  transportation  of  organs  should  be  provided  which  minimises 
times  and  prevents  organ  damage.  While  maintaining  medical 

ischemic 

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confidentiality,  the  organ  container  should  be  clearly  labelled  and  contain  the 
necessary documentation.  

(12)  The transplant  system must  ensure traceability of organs from donation  to reception. 
The  system  must  have  the  capacity  to  raise  the  alert  if  there  is  any  unexpected 
complication.  A  system  should  therefore  be  put  in  place  to  detect  and  investigate 
serious  adverse  events  or  reactions,  for  the  protection  of  vital  interest  of  the 
individuals concerned.  

(13)  An organ donor is also very often a tissue donor. Quality and safety requirements for 
organs  should  complement  and  be  linked  with  the  existing  Community  system  for 
tissues and cells laid down in 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  cells10.  An  unexpected  adverse  reaction  in  an  organ  donor  or 
recipient  should  be  traced  by  the  competent  authority  and  reported  in  the  tissue 
vigilance system as provided for in that Directive.  

(14)  Personnel  directly  involved  in  the  donation,  procurement,  testing,  preservation, 
transport and transplantation of human organs should be suitable qualified and trained. 

(15)  As  a  general  principle,  exchange  of  organs  from/to  third  countries  should  be 
supervised  by  the  Competent  Authority.  Authorisation  should  be  granted  only  if 
standards  equivalent  to  those  provided  for  in  this  Directive  are  met.  However,  the 
important  role  played  by  existing  European  organ  exchange  organisations  in  the 
exchange  of  organs  between  the  Member  States  and  third  countries  participating  in 
such organisations should be taken into account. (16) 
should 
respect the fundamental  rights and  observe the principles recognised  in particular by 
the Charter of Fundamental Rights of the European Union11. In line with that charter 
and  to  take  account  of,  as  appropriate  the  Convention  on  human  rights  and 
biomedicine12, organ transplantation programmes should be founded on the principles 
of voluntary and unpaid donation, altruism of the donor and solidarity between donor 
and recipient while ensuring anonymity of the deceased donor and the recipient(s). 

This  Directive 

(17)  Article 8 of Directive 95/46/EC of the European Parliament and of the Council of 24 
October  1995  on  the  protection  of  individuals  with  regard  to  the  processing  of 
personal  data  and  on  the  free  movement  of  such  data13  prohibits  in  principle  the 
processing of data concerning health. Limited exemptions to this prohibition principle 
are  laid  down.  Directive  95/46/EC  also  requires  the  controller  to  implement 
appropriate  technical  and  organisational  measures  to  protect  personal  data  against 
accidental  or  unlawful  destruction  or  accidental  loss,  alteration,  unauthorised 
disclosure or access and against all other unlawful forms of processing.  

10 

11 
12 

13 

Directive 2004/23/EC of the European Parliament and of the Council setting high standards of quality 
and safety for the donation, procurement, testing, processing, preservation, storage and distribution of 
human tissues and cells (OJ L 102, 7.4.2004, p. 48). 
OJ C 364 18.12.2000 , p. 1. 
Convention  for  the  protection  of  Human  Rights  and  dignity  of  the  human  being  with  regard  to  the 
application of biology and medicine: Convention on Human Rights and Biomedicine of the Council Of 
Europe. 
OJ L 281, 23.11.1995, p. 31. 

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(18)  Living donor should undertake an adequate evaluation to determine their suitability for 
donation in order to minimise the risk of transmission of diseases to the recipient. In 
addition  living  donors  of  organs  face  risks  linked  both  to  testing  to  ascertain  their 
suitability as a donor and to the procedure to obtain the organ. Complications may be 
medical,  surgical,  social,  financial  or  psychological.  The  level  of  risk  very  much 
depends  on  the  type  of  organ  to  be  donated.  Therefore,  living  donations  needs  to  be 
performed  in  a  manner  that  minimizes  the  physical,  psychological  and  social  risk  to 
the individual donor and the recipient and does not jeopardise the public's trust in the 
healthcare community. The potential living donor must be able to take an independent 
decision  on  the  basis  of  all  the  relevant  information14  and  should  be  informed  in 
advance as to the purpose and nature of the donation, the consequences and risks, as 
established  in  the  additional  protocol  to  the  Convention  on  Human  Rights  and 
Biomedicine,  on  Transplantation  of  Organs  and  Tissues  of  Human  Origin  of  the 
Council  of  Europe.  This  will  contribute  to  assess  the  exclusion  of  persons  whose 
donation  could  present  a  health  risk  to  others,  such  as  the  possibility  of  transmitting 
diseases, or a serious risk to themselves. 

(19)  The  competent  authorities  of  the  Member  States  should  have  a  key  role  to  play  in 
ensuring  the  quality  and  safety  of  organs  during  the  entire  chain  from  donation  to 
transplantation.  As  emphasised  by  the  Recommendation  of  the  Committee  of 
Ministers  to  Member  States  on  the  background,  functions  and  responsibilities  of  a 
National Transplant Organisation (NTO) of the Council of Europe15, it is preferable to 
have a single body which is officially recognised and non-profit making with overall 
responsibility  for  donation,  allocation,  traceability  and  accountability.  However, 
depending  especially  on  the  repartition  of  competences  within  the  Member  States,  a 
combination of local, regional, national and/or international bodies may work together 
to co-ordinate donation, allocation and/or transplantation, provided that the framework 
in place ensures accountability, co-operation and efficiency.  

(20)  The Member States should lay down rules on penalties applicable to infringements of 
the provisions of this Directive and ensure that these penalties are implemented. Those 
penalties must be effective, proportionate and dissuasive.  

(21)  The  measures  needed  to  implement  this  Directive  should  be  adopted  in  accordance 
with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for 
the exercise of implementing powers conferred on the Commission16. 

(22) 

In particular, power should  be conferred on  the  Commission to lay  down, where the 
organs concerned are to be exchanged between Member States, the procedures for the 
transmission to transplantation centres of the information on the characteristics of the 
organs,  the  procedures  needed  to  ensure  the  traceability  of  the  organs,  including 
labelling requirements, and the procedures for the reporting of serious adverse events 
or  reactions.  Since  these  measures  are  of  general  scope  and  are  designed  to  amend 
non-essential elements of this Directive, or to supplement this Directive with new non-

14 

15 
16 

Consensus Statement of the Amsterdam Forum on the care of living kidney donor and the Vancouver 
Forum, on the care of the non kidney living donor. 
Rec(2006)15.  
OJ  L  184,  17.7.1999,  p.  23,  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 

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10 

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essential elements, they must be adopted in accordance with the regulatory procedure 
with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

(23)  Since the objectives of this Directive, namely laying down quality and safety standards 
for human organs intended for transplantation, cannot be sufficiently achieved by the 
Member  States  and  can  therefore,  by  reason  of  the  scale  of  the  action,  be  better 
achieved  at  Community  level,  the  Community  may  adopt  measures,  in  accordance 
with  the  principle  of  subsidiarity  as  set  out in Article  5 of the Treaty. In accordance 
with the principle of proportionality, as set out in that Article, this Directive does not 
go beyond what is necessary in order to achieve those objectives. 

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER I 

SUBJECT MATTER, SCOPE AND DEFINITIONS 

Article 1 
Subject Matter 

This  Directive  lays  down  rules  to  ensure  high  standards  of  quality  and  safety  for  organs  of 
human origin intended for transplantation to the human body, in order to ensure a high level 
of human health protection. 

Article 2 
Scope 

1. 

2. 

This  Directive  applies  to  the  donation,  procurement,  testing,  characterisation, 
preservation,  transport  and  transplantation  of  organs  of  human  origin  intended  for 
transplantation. 

However,  where  such  organs  are  used  for  research  purposes,  this  Directive  only 
applies where they are intended for transplantation into the human body.  

Article 3 
Definitions 

For the purposes of this Directive, the following definitions apply: 

(a) 

(b) 

‘authorisation‘  means  authorisation,  accreditation,  designation  or  licensing, 
depending of the concepts used in each Member State; 

´disposal'  means  the  final  placement  of  an  organ  when  it  is  not  used  for 
transplantation; 

(c) 

‘donor’ means every human source of organs, whether living or deceased ; 

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11 

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(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

‘donation’ means donating human organs for transplantation; 

‘donor characterisation’ means the collection of the relevant information on the 
characteristics  of  the  donor  needed  to  undertake  a  proper  risk  assessment  in 
order to minimise the risks for the recipient and to optimise organ allocation; 

‘European  organ  exchange  organisation‘  means  a  non-profit  organisation, 
whether public or private, dedicated especially to cross-border organ exchange; 
the  countries  members  of  such  an  organisation  are  in  their  majority  Member 
States of the Community;  

‘organ’  means  a  differentiated  and  vital  part  of  the  human  body,  formed  by 
different  tissues,  that  maintains  its  structure,  vascularisation,  and  capacity  to 
develop physiological functions with an important level of autonomy; 

‘organ characterisation’ means the collection of the relevant information on the 
characteristics  of  the  organ  needed  to  undertake  a  proper  risk  assessment  in 
order to minimise the risks for the recipient and to optimise organ allocation; 

‘procurement’ means a process by which the donated organs become available; 

"procurement organisation" means a health care establishment, a team or a unit 
of a hospital or another body which is authorised by the competent authority to 
undertakes procurement of human organs; 

‘preservation’  means  the  use  of  chemical  agents,  alterations  in  environmental 
conditions or other means during processing to prevent or retard biological or 
physical  deterioration  of  human  organs  from  the  procurement  until  the 
transplantation; 

(l) 

‘recipient’: means a person who receives a transplant of an organ; 

(m) 

(n) 

(o) 

(p) 

‘serious adverse event’ means any unexpected occurrence associated with any 
stage  of  the  chain  from  donation  to  transplantation  that  might  lead  to  the 
transmission of a communicable disease, to death or life-threatening, disabling, 
or  incapacitating  conditions  for  patients  or  which  results  in,  or  prolongs, 
hospitalisation or morbidity; 

‘serious  adverse  reaction’  means  an  unintended  response,  including  a 
communicable  disease,  in  the  donor  or  in  the  recipient  associated  with  any 
stage of the chain from donation to transplantation that is fatal, life-threatening, 
disabling,  incapacitating,  or  which  results  in,  or  prolongs,  hospitalisation  or 
morbidity; 

‘standard operating procedures’ means written instructions describing the steps 
in  a  specific  process,  including  the  materials  and  methods  to  be  used  and  the 
expected end product; 

‘transplantation’ means the process of restoring certain functions of the human 
body by transferring equivalent organs to a recipient.; 

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(q) 

(r) 

‘transplantation centre’ means a health care establishment, a team or a unit of a 
hospital  or  any  other  body  which  is  authorised  by  the  competent  authority  to 
undertake transplantation of human organs; 

‘traceability’ means the ability for a competent authority to locate and identify 
the organ at each stage in the chain from donation to transplantation or disposal, 
which under specified circumstances in this Directive is authorised to : 

– 

– 

– 

identify the donor and the procurement organisation 

identify the recipient(s) at the transplantation centre(s) 

locate  and  identify  all  relevant  non-personal  information  relating  to 
products and materials coming into contact with that organ;  

CHAPTER II 

THE QUALITY AND SAFETY OF ORGANS 

Article 4 
National quality programmes  

1. 

2. 

Member States shall ensure that a national quality programme is established to cover 
all stages of the chain from donation to transplantation or disposal, in order to ensure 
compliance with the rules laid down in this Directive.  

The national quality programmes shall provide for the adoption and implementation 
of:  

(a) standard operating procedures for the verification of donor identity; 

(b) standard operating procedures for the verification of the details of donor or donor 
family consent or authorisation in accordance with national rules; 

(c) standard operating procedures for the verification of the completion of the organ 
and donor characterisation in accordance with Article 7 and with the model set out in 
the Annex;  

(d) procedures for the procurement, preservation packaging and labelling of organs, 
in accordance with Article 5, 6 and 8 ; 

(e) rules for the transportation of human organs in accordance with Article 8. 

3. 

The national quality programmes shall  

(a) lay down rules to ensure the traceability of organs at all stages of the chain from 
donation to transplantation or disposal, in accordance with Article 10, including 

EN 

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– 

– 

– 

the  standard  operating  procedures  under  which  the  traceability  of 
organs is ensured at national level,  

the data necessary to ensure traceability and how the legal requirements 
on the protection of personal data and confidentiality are complied with, 

the  responsibilities  of  procurement  organisations  and  transplantation 
centres with regard to traceability.  

(b) establish the standard operating procedures for: 

– 

– 

– 

the  accurate,  rapid  and  verifiable  reporting  of  serious  adverse  events 
and reactions in accordance with Article 11(1), 

the recall of organs as referred in Article 11(2), 

the  responsibilities  of  procurement  organisations  and  transplantation 
centres in the process of reporting. 

(c) establish the qualifications required by the personnel involved at all stages of the 
chain  from  donation  to  transplantation  or  disposal,  and  develop  specific  training 
programmes for personnel in accordance with recognised international standards.  

Article 5 
Procurement organisations  

Member  States  shall  ensure  that  the  procurement  takes  place  in  procurement 
organisations that comply with the rules laid down in this Directive. 

The  organisational 
organisations shall include:  

structure  and  operational  procedures  of  procurement 

(a) an organisational chart which clearly defines job descriptions, accountability and 
reporting relationships; 

(b) standard operating procedures as specified in national quality programmes . 

Member States shall, upon the request of the Commission or another Member State, 
the  authorisation  of 
information  on 
provide 
procurement organisations. 

the  national  requirements  for 

Article 6 
Organ procurement  

Member  States  shall  ensure  that  medical  activities  in  procurement  organisations, 
such  as  donor  selection,  are  performed  under  the  advice  and  the  supervision  of  a 
medical doctor as defined in Directive 2005/36/EC. 

Member  States  shall  ensure  that  procurement  takes  place  in  dedicated  facilities, 
which are designed, constructed, maintained and operated so as to comply with the 
requirements  laid  down  in  this  Directive  and  which  allow  minimising  bacterial  or 

1. 

2. 

3. 

1. 

2. 

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14 

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other  contamination  of  procured  human  organs  in  accordance  with  best  medical 
practices.  

Those facilities shall comply with normal standard for operating theatres, including: 

(a) Restricted access; 

(b)  personnel  that  are  appropriately  dressed  for  sterile  operations,  wearing  sterile 
gloves, hats and facemasks.  

Member States shall ensure that procurement material and equipment are managed in 
accordance  with  relevant  national  and  international  regulation,  standards  and 
guidelines  covering  the  sterilisation  of  medicines  and  medical  devices.  Qualified, 
sterile instruments and procurement devices shall be used for procurement. 

Article 7 
Organ and donor characterisation  

Member  States  shall  ensure  that  all  procured  organs  and  donors  thereof  are 
characterised  before  transplantation  through  the  collection  of  the  information  and 
data  listed  in  the  organ  characterisation  form  in  the  Annex.  The  tests  required  for 
organ characterisation shall be carried out by a qualified laboratory. 

Member  States  shall  ensure  that  organisations,  bodies  and  qualified  laboratories 
involved  in  organ  and  donor  characterisation  have  appropriate  standard  operating 
procedures 
information  on  organ  and  donor 
to  ensure 
characterisation reaches the transplantation centre in time.  

in  place 

that 

the 

3. 

1. 

2. 

Article 8 
Transport of organs 

1. 

Member States shall ensure that the following requirements are met: 

(a)  the  organisations,  bodies  or  companies  involved  in  the  transportation  of  organs 
have appropriate standard operating procedures in place to ensure the integrity of the 
organ during transport and that transport time is minimised.  

(b)the  shipping  containers  used  for  transporting  organs  are  labelled  with  the 
following information: 

– 

– 

– 

identification of the procurement organisation, including its address and 
telephone number; 

identification  of  the  transplantation  centre  of  destination,  including 
address and telephone number; 

a  statement  that  the  package  contains  a  human  organ  and  marked 
HANDLE WITH CARE; 

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15 

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– 

– 

recommended  transport  conditions,  including  instructions  for  keeping 
the container at a certain temperature and in a certain position  

safety instructions and method of cooling (when applicable). 

However  point  (b)  shall  not  apply  where  the  transportation  is  carried  out  within  the  same 
establishment 

Article 9 
Transplantation centres  

1. 

2. 

Member States shall ensure that transplantation takes place in transplantation centres 
that comply with the rules laid down in this Directive. 

The  Competent  authority  shall 
the  accreditation,  designation, 
indicate 
authorisation  or  licence  which  activities  the  transplantation  centre  concerned  may 
undertake. 

in 

3. 

Transplantation centres shall verify before proceeding to transplantation that:  

a)  the  organ  and  donor  characterisation  is  completed  in  accordance  with  the  model 
set  out  in  the  Annex  and  that  records  are  kept  of  the  information  contained  in  that 
form ;  

b)  the  indicated  storage  temperature  and  other  conditions  of  transport  of  shipped 
human organs have been maintained. 

4. 

1. 

2. 

Member States shall, upon the request of the Commission or another Member State , 
provide 
the  authorisation  of 
transplantation centres. 

the  national  requirements  for 

information  on 

Article 10 
Traceability 

Member States shall ensure that all organs procured and allocated on their territory 
can be traced from the donor to the recipient and vice versa in order to safeguard the 
health of donors and recipients. 

Member States shall ensure the implementation of a donor identification system that 
can identify each donation and each of the organs associated with it. Member States 
shall  ensure  that  this  donor  identification  system  are  designed  and  selected  in 
accordance  with  the  aim  of  collecting,  processing  or  using  no  personal  data  or  as 
little personal data as possible. In particular, use is to be made of the possibilities for 
pseudonymisation or rendering individuals anonymous. 

3. 

Member States shall ensure that: 

a) 

The Competent authority or other bodies involved in the chain from donation 
to transplantation or disposal keep the data needed to ensure traceability at all 

EN 

16 

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stages of the chain from donation to transplantation or disposal in accordance 
with the national quality programmes.  

b)  Data  required  for  full  traceability  is  kept  for  a  minimum  of  30  years  after 

donation. Such data storage may be stored in electronic form. 

Article 11 
Reporting systems for serious adverse events and reactions 

1. 

2. 

3. 

Member  States  shall  ensure  that  there  is  a  reporting  system  in  place  to  report, 
investigate,  register  and  transmit  relevant  and  necessary  information  concerning 
serious  adverse  events  and  reactions  that  may  influence  the  quality  and  safety  of 
human organs and which may be attributed to the procurement, testing, and transport 
of  organs,  as  well  as  any  serious  adverse  reaction  observed  during  or  after 
transplantation which may be connected to those activities. 

Member States shall ensure that a procedure is in place to enable the rapid recall of 
any organ which may be related to a serious adverse event or reaction as specified in 
the national quality programme. 

Member  States  shall  ensure  the  interconnection  between  the  reporting  system 
referred  to  in  paragraph  1  of  this  Article  and  the  reporting  system  established  in 
accordance with Article 11 of Directive 2004/23/EC. 

Article 12 
Personnel 

Member States shall ensure that personnel directly involved in the chain from donation to the 
transplantation or disposal of organs are qualified to perform their tasks and are provided with 
the relevant training, as specified in the national quality programmes. 

CHAPTER III 

DONOR AND RECIPIENT PROTECTION 

Article 13 
Principles governing organ donation 

1. 

2. 

3. 

Member States shall ensure that donations of human organs from deceased and living 
donors are voluntary and unpaid. 

Member  States  shall  prohibit  advertising  the  need  for  or,  availability  of,  human 
organs  where  such  advertising  has  a  view  to  offering  or  seeking  financial  gain  or 
comparable advantage. 

Member States shall ensure that the procurement of organs is carried out on a non-
profit basis. 

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Article 14 
Consent and authorisation requirements prior to procurement 

Procurement  shall  only  be  carried  out  only  after  compliance  with  all  mandatory  consent  or 
authorisation requirements in force in the Member State concerned.  

Article 15 
Protection of the living donor  

1. 

2. 

3. 

Member  States  shall  take  all  necessary  measures  to  ensure  that  potential  living 
donors are provided with all the information necessary, as to the purpose and nature 
of  the  donation,  the  consequences  and  risks,  and  on  alternative  therapies  for  the 
potential  recipient  to  enable  them  to  make an informed decision.  . The information 
shall be supplied in advance of the donation. 

Member States shall ensure that living donors are selected on the basis of their health 
and  medical  history,  including  a  psychological  evaluation  if  deemed  necessary,  by 
qualified and trained professionals. Such assessments may provide for the exclusion 
of  persons  whose  donation  could  present  a  health  risk  to  others,  such  as  the 
possibility of transmitting diseases, or a serious risk to themselves.  

Member States shall ensure that the competent authority keeps a register of the living 
donors  after  the  donation,  in  line  with  provisions  on  the  protection  of  the  personal 
data  and  statistical  confidentiality,  and  collects  information  on  their  follow  up  and, 
and specifically, on complications related to their donation that might appear in the 
short, mid and long term. 

Article 16 
Protection of personal data, confidentiality and security of processing. 

Member States shall ensure that the fundamental right to protection of personal data is fully 
and  effectively  protected  in  all  organ  transplantation  activities,  in  conformity  with 
Community provisions on the protection of personal data, such as Directive 95/46/EC, and in 
particular Articles 8 (3), 16, 17 and 28 (2) of that Directive. 

Article 17 
Anonymisation of donors and recipients 

Member States shall take all necessary measures to ensure that all personal data of donors and 
recipients processed within the scope of this Directive are rendered anonymous so that neither 
donors nor recipients remain identifiable. 

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CHAPTER IV 

OBLIGATIONS OF THE COMPETENT AUTHORITIES AND 
EXCHANGES OF INFORMATION 

Article 18 
Designation and tasks of competent authorities 

Member  States  shall  designate  the  competent  authority,  or  authorities  (hereafter  competent 
authority), responsible for implementing the requirements of this Directive.  

The competent authorities shall, in particular, take the following measures: 

(a) 

(b) 

(c) 

put in place and keep updated a national quality programme in accordance with 
Article 4;  

ensure  that  procurement  organisations  and  transplantations  centres  are 
controlled  and  audited  on  a  regular  basis  to  ascertain  compliance  with  the 
requirements of this Directive;  

grant, suspend, or withdraw, as appropriate, the authorisations of procurement 
organisations  or  transplantation  centres  if  control  measures  demonstrate  that 
such  organisations  or  centres  do  not  comply  with  the  requirements  of  this 
Directive;  

(d)  put  in  place  a  reporting  system  and  a  system  for  the  recall  of  organs  as 

provided for in Article 11(1) and (2); 

(e) 

(f) 

(g) 

(f) 

issue  appropriate  guidance  to  health  care  establishments,  professionals  and 
other parties involved in all stages of the chain from donation to transplantation 
or disposal;  

participate in the Community network referred to in Article 20 and coordinate 
at national level input to the activities of the network; 

supervise  the  exchanges  of  organs  with  other  Member  States  and  with  third 
countries; 

ensure, in cooperation with the supervisory authority established in compliance 
with Article 28 of Directive 95/46/EC, that the fundamental right to protection 
of  personal  data  is  fully  and  effectively  protected  in  all  organ  transplantation 
activities,  in  conformity  with  Community  provisions  on  the  protection  of 
personal data, in particular Directive 95/46/EC. 

Article 19 
Registers and reports concerning procurement organisations and transplantation centres  

1. 

Member States shall ensure that the competent authority: 

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(a) 

record  of 

keeps  a 
the  activities  of  procurement  organisations  and 
transplantation  centres,  including  aggregated  and  anonymised  numbers  of 
living  and  deceased  donors,  and  the  types  and  quantities  of  organs  procured 
and  transplanted,  or  otherwise  disposed  of  in  line  with  provisions  on  the 
protection of personal data and statistical confidentiality;  

(b)  draws up and makes publicly accessible an annual report on those activities; 

(c) 

establishes  and  maintains  a  register  of  procurement  organisations  and 
transplantation centres. 

Member States shall, upon the request of the Commission or another Member State, 
provide information on the register of procurement organisations and transplantation 
centres . 

Article 20 
Exchange of information 

The Commission shall set up a network of the competent authorities with a view to 
the 
exchanging 
implementation of this Directive.  

the  experience  acquired  with 

information  on 

regard 

to 

Where appropriate, experts on organ transplantation, representatives from European 
organ exchange organisations, as well as data protection supervisory authorities and 
other relevant parties may be associated to this network. 

2. 

1. 

2. 

CHAPTER V 
EXCHANGES OF ORGANS WITH THIRD COUNTRIES AND 
EUROPEAN ORGAN EXCHANGE ORGANISATIONS 

Article 21 
Exchange of organs with third countries 

1. 

2. 

Member States shall ensure that all exchanges of organs from or to third countries, 
are authorised by the competent authority.  

Authorisations for exchanges of organs, as referred to in paragraph 1, shall only be 
granted if the organs:  

(a) 

can be traced from the donor to the recipient and vice versa;  

(b)  meet quality and safety requirements equivalent to the ones laid down in this 

Directive. 

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Article 22 
European organ exchange organisations 

Member  States  may  establish  written  agreements  with  European  organ  exchange 
organisations, provided that such organisations ensure compliance with the requirements laid 
down in this Directive, delegating to them: 

(a) 

(b) 

the  performance  of  activities  provided  for  under  the  national  quality 
programmes;  

the granting of authorisation and specific tasks in relation to the exchanges of 
organs to and from Member States and third countries. 

CHAPTER VI 
GENERAL PROVISIONS 

Article 23 
Reports concerning this Directive  

1. 

2. 

Member  States  shall  report  to  the  Commission  before  ………….and  every  three 
years  thereafter  on  the  activities  undertaken  in  relation  to  the  provisions  of  this 
Directive, and on the experience gained in implementing it. 

Before ……. and every three years thereafter, the Commission shall transmit to the 
European  Parliament,  the  Council,  the  European  Economic  and  Social  Committee 
and the Committee of the Regions ,a report on the implementation of this Directive 

Article 24 
Penalties 

Member  States  shall  lay  down  the  rules  on  penalties  applicable  to  infringements  of  the 
national provisions adopted pursuant to this Directive and shall take all measures necessary to 
ensure  that  the  penalties  are  implemented.  The  penalties  provided  for  must  be  effective, 
proportionate and dissuasive. Member States shall notify those provisions to the Commission 
by […] and shall notify it without delay of any subsequent amendments affecting them. 

Article 25 
Implementing measures  

1. 

Detailed  rules  for  the  following  measures  shall  be  adopted  in  accordance  with  the 
procedure referred to in Article 26(3): 

(a) 

rules  for  the  updating  and  transmission  of  information  on  human  organs 
characterisation as detailed in the Annex;  

(b)  procedures  for  ensuring  the  full  traceability  of  organs,  including  labelling 

requirements;  

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(c) 

procedures for ensuring the reporting of serious adverse events and reactions.  

2. 

Detailed rules for the uniform implementation of this Directive, and in particular for 
the following measures, shall be adopted in accordance with the procedure referred 
to in Article 26(2): 

(a) 

(b) 

the  interconnection  between  the  reporting  systems  on  adverse  events  and 
reactions referred to in Article 11 (3); 

the establishment and functioning of the network of the competent authorities 
referred to in Article 20. 

Article 26 
Committee 

1. 

2. 

3. 

1. 

The  Commission  shall  be  assisted  by  the  Committee  on  organ  transplantation, 
hereinafter referred to as 'the Committee.' 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8  thereof.  The 
period  laid  down  to  in  Article  5(6)  of  Decision  1999/468/EC  shall  be  set  at  three 
months.  

Where  reference  is  made  to  this  paragraph,  Article  5a  (1)  to  (4)  and  Article  7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof.  

Article 27 
Transposition 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  by  [...]at  the  latest.  They  shall 
forthwith  communicate  to  the  Commission  the  text  of  those  provisions  and  a 
correlation table between those provisions and this Directive. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

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CHAPTER VII 
FINAL PROVISIONS 

Article 28 
Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 29 
Addresses 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX  

ORGAN AND DONOR CHARACTERISATION 

For  the  purpose  of  Article  7  the  following  information  shall  be  gathered  by  the 
procurement  organisation  or  procurement  team  on  the  characteristics  of  the  organ 
and  of  the  donor,  following  testing  where  necessary  and  processed  in  line  with  the 
legal requirements on the protection of personal data and confidentiality: 

CATEGORY 

SUB-CATEGORY 

ITEM 

ACRONYM

GENERAL DATA 

Donor identification  

DONOR DATA 

ICU ADMISSION 

hospital 

local coordinator/contact person 

donor type* 

date of birth 

age 

gender 

weight 

height 

chest perimeter (if required) 

abdomen perimeter (if required) 

ABO group 

HLA (if required) 

Cause of death 

Date of death 

Date  and  time  of  ICU  (intensive 
care units) 

Date and time of intubation 

DONOR MEDICAL HISTORY 

neoplasia 

(general description) 

EN 

relevant  nephro-, 
Indicate  all 
pneumo-, 
cardio-, 
hepato- 
pancreato- and neuropathology as 
well 
previous 
relevant 
operations,  traumata  or  parasitic 
diseases  

as 

diabetes 

24 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hypertension 

alcohol 

smoking 

drugs 

PHYSICAL 
DATA 

/ 

CLINICAL 

Blood pressure 

LABORATORY 

Hypotension (duration) 

Body temperature 

Diuresis (last 24 hours) 

Diuresis last hour 

Cardiorespiratory  reanimation  (if 
relevant) (duration) 

Heart rate 

Date time values 

HEMATOLOGY 

Prothrombine 

White blood cell count 

platelettes 

haemoglobin 

Haematocrit 

BIOCHEMISTRY  Na+  

K+  

PT 

WBC 

Hb 

PCV 

Alk. Phos. (liver) 

AP 

Glucose 

Bilirubine Tot_Dir (liver) 

Amylase or Lipase(Pancreas) 

Glut oxalacetic trans(GOT). 

Glut pyruvic trans (GPT). 

AST 

ALT 

glutamil 

trans(GGT). 

GGT 

Gamma 
(liver) 

Creatinine 

25 

   EN 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Troponine (Heart) 

Urea (For Kidney transplantation)  BUN 

LDH 

TOTAL 
recommended) 

Protein 

(highly 

Albumin (highly recommended) 

culture 

blood 
recommended  at 
procurement) 

(highly 
time  of 

the 

culture 

urine 
recommended  at 
procurement) 

(highly 
time  of 

the 

tracheal 
recommended  at 
procurement) 

secretions 
the 

(highly 
time  of 

MICROBIOLOGY 

information 
(This 
could  be  available 
after 
transplantation) 

SEROLOGY 

HIV 1-2 

HBsAg 

AntiHbc (highly recommended) 

HCV 

Anti CMV IgG (recommended)  

Anti CMV IgM (recommended)  

Syphilis  

HTLV  I  II  (for  donors  living  in,  or 
originating  from  high  incidence 
areas, or with risk factors of been 
exposed to the virus)  

URINE 

Glucose (yes/no) 

Protein (yes/no) 

echography 

(if 

Abdominal 
required)  

Chest X Ray  

ECG  

Cardiac ECHO (heart) 

DIAGNOSTICS 

EN 

26 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BLOOD 
VENTILATION 

GAS 

AND 

FiO2 % 

PEEP 

PaO2 (with indicated FiO2) 

PaCO2 (with indicated FiO2) 

PH 

HCO3 

Sat O2 

FiO2 1,0 / PEEP 5 (lung) 

PaO2 (lung) with FiO2 1,0 / PEEP 
5 (lung) 

PaCO2  (lung)  with  FiO2  1,0  / 
PEEP 5 (lung) 

THERAPY 

(general description) 

Antibiotics  

Diuretics 

support 

Inotropic 
Noradrenaline, 
Dopamine…) 

(Adrenaline, 
Dobutamine, 

Blood transfusion 

Other medication 

EN 

27 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS HAVING A 
BUDGETARY IMPACT EXCLUSIVELY LIMITED TO THE REVENUE SIDE 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Directive  setting  standards  of  quality  and  safety  of  human  organs 
intended for transplantation.  

2. 

ABM / ABB FRAMEWORK 

Public health 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B.A lines)) including headings: 

XX0101: for the payment of the officials 

XX010211: for the payment of the committee costs 

3.2. 

Duration of the action and of the financial impact: 

From 2009, duration not defined  

This  budget  intends  to  cover  the  costs  of  the  future  Regulatory  Committee 
(comitology) and Network (Competent Authorities meeting) on organ donation and 
transplantation that will be set up according to the provisions of the Directive after 
the adoption of that Directive by the Parliament and the Council: 

2 FTE administrator valued at € 122,000 each  (according to the specific Guidelines), 
to support the transposition and comitology processes. 

Costs of the plenary session (first CA meeting), with one participant from each 
of the 27 Member States. 3 meetings scheduled per year (first 2 years after adoption), 
valued at € 20,000 each; this number will dimini sh from 3 meetings per/year to 2 and 
then  to  1  per/year.  Actual  costs  of  the  meetings  and  frequency  of  those  meetings 
might need revision, depending on the final shape of the directive, after adoption by 
council  and  parliament,  and  the  necessary  comitology  structures.  Moreover  3 
comitology metings per year should be calculated at a cost of € 20,000 each. 

3.3. 

Budgetary characteristics:  

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

EN 

28 

   EN 

 
 
XX 0101 

Comp 

XX 
010211 

Non com 

Non-
diff17 

Non-
diff18 

NO 

NO 

NO 

NO 

NO 

NO 

5 

5 

4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

Expenditure type 

Section 
no. 

2011 

2012 

2013  Total 
2009-
2013 

2014 
and 
later 

2009 

2010 

EUR million (to 3 decimal places) 

Operational expenditure19 

Commitment Appropriations 
(CA) 

8.1. 

Payment 
(PA) 

Appropriations 

a 

b 

Administrative expenditure within reference amount20 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

Payment Appropriations 

a+c 

b+c 

Administrative expenditure not included in reference amount21 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
included 
reference 
in 
amount (NDA) 

costs, 

8.2.5. 

d 

0.244  0.244 

0.244 

0.244 

0.244 

8.2.6. 

e 

0.120  0.120 

0.100 

 0.100  0.080 

1.220 

0.244 

0.420 

0.080 

17 
18 
19 
20 
21 

Non-differentiated appropriations hereafter referred to as NDA. 
Non-differentiated appropriations hereafter referred to as NDA. 
Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

29 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
                                                 
Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

TOTAL  PA  including  cost 
of Human Resources 

a+c
+d+
e 

b+c
+d+
e 

0.364  0.364 

0.344 

0.344 

0.324 

1.640 

0.364  0.364 

0.344 

0.344 

0.324 

1.640 

0.324 

0.324 

Co-financing details: not applicable 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 

EUR million (to 3 decimal places) 

Year  

2010 

2011 

2012 

2013 

2009 

2014 
and 
later 

Total 
2009-
2013 

Co-financing body 

…………………… 

TOTAL  CA  including  co-
financing 

f 

a+c
+d+
e+f 

4.1.2.  Compatibility with Financial Programming 

(cid:58) 

(cid:133) 

(cid:133) 

Proposal is compatible with existing financial programming. 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective. 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement22 (i.e. flexibility instrument or revision of the financial perspective). 

4.1.3.  Financial impact on Revenue 

(cid:58) 

(cid:133) 

Proposal has no financial implications on revenue 

Proposal has financial impact – the effect on revenue is as follows: 

22 

See points 19 and 24 of the Interinstitutional agreement. 

EN 

30 

   EN 

 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Budget line 

Revenue 

EUR million (to one decimal place) 

Prior to
action 
[Year n-
1] 

[Year 
2009] 

Situation following action 

[+1] 

[+2] 

[+3] 

[+4] 

[+5]23 

a) Revenue in absolute terms 

b) Change in revenue 

 ∆ 

4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

Year  

2010 

2011 

2012 

2013 

2009 

2014 
and 
later 

Total  number  of  human 
resources 

2 

2 

2 

2 

2 

2 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

Not applicable. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

Not applicable. 

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

Not applicable. 

5.4.  Method of Implementation (indicative) 

(cid:133)  Centralised Management 

(cid:58) 

(cid:133) 

directly by the Commission 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

23 

Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years. 

EN 

31 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:133) 

(cid:133) 

(cid:133) 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 

national public-sector bodies/bodies with public-service mission 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

Regular  reporting  of  the  working  groups  will  be  ensured  and  disseminated  to  the 
member States and Commission services. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

Not applicable. 

6.2.2.  Measures taken  following  an intermediate/ex-post evaluation (lessons learned from 

similar experiences in the past) 

Not applicable. 

6.2.3.  Terms and frequency of future evaluation 

An evaluation of the running of the working group will be done after 5 years. 

7. 

ANTI-FRAUD MEASURES  

Not applicable. 

EN 

32 

   EN 

 
8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

Type of output 

Av. 
cost 

Year 2009 

Year 2010 

Year 2011 

Year 2012 

Year 2013 

Year 2014 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

of 

(Headings 
Objectives, 
and 
actions 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE  No.1 
24……… 

Action 1:  

- - Output 

N° meetings 

- Output 2 

Action 
2………………. 

- Output 1 

Sub-total 
Objective 1 

OPERATIONAL 
OBJECTIVE  No.2 
1……… 

Action 
1………………. 

24 

As described under Section 5.3. 

EN 

33 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
- Output 1 

Sub-total 
Objective 2 

OPERATIONAL 
OBJECTIVE  No.n 
1 

Sub-total 
Objective n 

TOTAL COST 

EN 

34 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year 2009  Year 2010  Year 2011  Year 2012  Year 2013  Year 2014 

A*/AD 

2 

2 

2 

2 

2 

2 

B*, 
C*/AST 

Officials or 
temporary 
staff25 (XX 01 
01) 

Staff  financed26  by  art. 
XX 01 02 

Other  staff27  financed by 
art. XX 01 04/05 

TOTAL 

2 

2 

2 

2 

2 

2 

8.2.2.  Description of tasks deriving from the action 

2  FTE  administrators  valued  at  €  122,000  each  (according  to  the  specific 
Guidelines),  to  support  the  transposition  and  comitology  processes.  Running  of 
Regulatory  Committee  and  Network  (CA  meetings)  established  in  accordance  with 
Article 26 and 20 respectively of this Directive and its potential working groups that 
will work on the implementation of the Directive.  

8.2.3. 

Sources of human resources (statutory) 

(cid:58) 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts currently allocated to the management of the programme to be replaced 
or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

Posts required for year n although not foreseen in the APS/PDB exercise of the 
year in question 

25 
26 
27 

Cost of which is NOT covered by the reference amount. 
Cost of which is NOT covered by the reference amount. 
Cost of which is included within the reference amount. 

EN 

35 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

EUR million (to 3 decimal places) 

Budget line 

(number and heading) 

Year 
2009 

Year 
2010 

Year 
2011 

Year 
2012 

Year 
2013 

Total 
2009-
2013 

2014 
and 
later 

Technical 

and 
1 
assistance (including related staff costs) 

administrative 

Executive agencies28 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

Total  Technical  and  administrative 
assistance 

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

EUR million (to 3 decimal places) 

Type of human resources 

Year 
2009 

Year 
2010 

Year 
2011 

Year 
2012 

Year 
2013 

Year 
2014 

and later 

0.244 

0.244 

0.244 

0.244 

0.244 

0.244 

Officials  and  temporary  staff 
(XX 01 01) 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

(specify budget line) 

cost 

Total 
of  Human 
Resources  and  associated 
costs 
in  reference 
amount) 

(NOT 

0.244 

0.244 

0.244 

0.244 

0.244 

0.244 

28 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

36 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Calculation– Officials and Temporary agents 

Rate of €122,000/ staff used to quantify the  costs, as suggested in BUDG guidelines 

Calculation– Staff financed under art. XX 01 02 

[…] 

8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

Year 
2009 

Year 
2010 

Year 
2011 

Year 
2012 

Year 
2013 

Total 
2009-
2013 

2014 
and 
later 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees29  

0.120 

0.120  0.100  0.100  0.080 

0.080 

0.420 

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2 

Total 

Other  Management 

Expenditure (XX 01 02 11) 

0.120 

0.120  0.100  0.100  0.080 

0.080 

0.420 

3  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

0.120 

0.120  0.100  0.100  0.080 

0.080 

0.420 

29 

Specify the type of committee and the group to which it belongs. 

EN 

37 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Calculation - Other administrative expenditure not included in reference amount 

Running  of  Regulatory  Committee  and  Network  (CA  meetings)  established  in 
accordance  with  Article  23  and  19  respectively  of  this  Directive  and  its  potential 
working groups that will work on the implementation of the Directive 

Costs of the plenary session (first CA meeting), with one participant from each of the 
27  Member  States.  3  meetings  scheduled  per  year  (first  2  years  after  adoption), 
valued at € 20,000 each; this number will dimini sh from 3 meetings per/year to 2 and 
then  to  1  per/year.  Actual  costs  of  the  meetings  and  frequency  of  those  meetings 
might need revision, depending on the final shape of the directive, after adoption by 
the  Council  and  the  Parliament.  Moreover  3  comitology  meting  per  year  should  be 
calculated at a cost of € 20,000. 

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the 
allocation  granted  to  the  managing  DG  in  the  framework  of  the  annual  allocation 
procedure in the light of budgetary constraints 

EN 

38 

   EN