Communication from the Commission to the European Parliament and the Council organ donation and Transplantation: policy actions at EU level {SEC(2007) 704} {SEC(2007) 705}
Date: 2007-05-30
Institutions: European Commission
Subjects: EU Member State, EU programme, cooperation policy, health policy, organ transplantation, public awareness campaign

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.5.2007 
COM(2007) 275 final 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT AND THE COUNCIL 

ORGAN DONATION AND TRANSPLANTATION: POLICY ACTIONS AT EU 
LEVEL 

{SEC(2007) 704} 
{SEC(2007) 705} 

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1. 

INTRODUCTION 

Over  the  past  50  years  organ  transplantation  has  become  established  worldwide,  bringing 
immense benefits to hundreds of thousands of patients.  

Organ donation  and  transplantation are sensitive and complex issues, with important ethical 
dimension, which require the full participation of the societies for their development. Several 
aspects  are  dealt  with  differently  in  different  Member  States  depending  on  cultural,  legal, 
administrative and organisational issues.  

The use of human organs for transplantation has steadily increased during the past 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.  

The excellent results of transplants, in terms of life years gained and improvement in quality 
of life, have multiplied the indications of these therapies. Transplant procedures continue to 
develop and in the future may offer practical treatment for other unmet medical needs. 

The use of organs in therapy however poses a risk of transmission of diseases. Every year, a 
number of organs are exchanged between EU Member States. Cross-border exchanges mean 
that  the  transplantation  process  is  carried  out  by  hospitals  or  professionals  falling  under 
different jurisdictions.  

On  the  other  hand,  the  shortage  of  organs  is  a  major  factor  affecting  transplantation 
programmes. Nearly 40 000 patients are now on waiting lists in Europe. Mortality rates while 
waiting  for  a  heart,  liver  or  lung  transplant  usually  range  from  15  to  30%.  There  are  large 
differences  in  the  deceased  and  living  organ  donor  rate  within  the  EU.  These  differences 
cannot be easily explained. Even among EU countries with well-developed services, there are 
considerable differences in organ donation and transplantation activity and it seems that some 
organisational models are performing better than others. 

One of the potential consequences of the scarcity of organs is the trafficking of human organs 
carried out by organised criminal groups, who track down and remove organs in developing 
countries and hand them on to recipients within the European Union.  

This Commission Communication on organ donation and transplantation intends to respond to 
these challenges based on the mandate in Article 152(4)(a) of the Treaty, which enables the 
European  Parliament  and  Council  to  adopt  harmonised  health  measures  on  the  basis  of  the 
codecision  procedure  pursuant  to  Article  251  EC,  by  setting  high  standards  of  quality  and 
safety of human organs. It sets out the actions the Commission is planning to take to respond 
to the main policy challenges in relation to organ donation and transplantation: ensure quality 
and safety of organs, increase organ availability and fight organ trafficking.  

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2. 

ORGAN DONATION AND TRANSPLANTATION: CURRENT CHALLENGES 

2.1. 

Transplant risks 

The  use  of  organs  in  therapy  poses  a  risk  of  diseases  being  transmitted  to  the  recipient. 
Transmission of HIV, hepatitis B and C, bacteria, fungi and parasites through transplantation 
has been described in scientific literature, as has transmission of different types of cancers.  

The  transmission  of  disease  by  a  deceased  donor  organ  can  result  not  only  in  loss  of  the 
allograft  but  also  in  the  death  of  the  immune  suppressed  recipient.  Despite  the  shortage  of 
deceased organ donors, every organ must be evaluated thoroughly.  

Every year, a number of organs are exchanged between EU Member States. The number of 
organs  interchanged  represents  a  small  proportion  of  the  total  number  of  organs  used  for 
transplantation  in  the  EU,  with  the  exception  of  those  areas  covered  by  international 
agreements (Eurotransplant), where the interchange of organs accounts for up to 20% of total 
organ  transplants.  In  addition,  every  year  a  number  of  EU  citizens  undertake  organ 
transplantation  in  a  Member  State  other  than  their  country  of  origin.  It  seems  that  the 
phenomenon  of patients from one  country  trying to get a transplant in another  country with 
higher  donation  rates  than  in  their  own  is  increasing.  However,  the  legal  quality  and  safety 
requirements differ amongst Member States1. Ensuring a high level of protection of patients 
throughout Europe is therefore a priority. 

2.2. 

Organ shortage 

The severe shortage of organ donors remains the main challenge that EU Member States face 
with regard to organ transplantation. 

Every  day  nearly  ten  patients  die  waiting  for  an  organ  in  European  societies.  Waiting  lists 
have  grown  longer  in  all  EU  countries.  Even  in  cases  where  there  have  been  sustained 
increases in the number of donors, it is very difficult to reduce numbers of patients and time 
spent  on  waiting  lists.  Demand  for  transplants  is  increasing  faster  than  organ  donor  rates. 
However, the increase in the number of available donors will help to reduce the gap between 
supply and demand if not achieving an absolute reduction in the waiting list. 

There  are  different  reasons  for  the  shortage  of  donors2.  There  are  also  large  differences 
between Member States’ successes in increasing their donor pool. Donor rates vary widely in 
different  European  countries:  the  deceased  donor  rate  ranges  from  0.8  donors  to  35.1  per 
million population. These differences cannot be easily explained. They are probably due to a 
complex  mix  of  cultural,  historical  and  social  factors  combined  with  aspects  related  to  the 
characteristics  of  the  health  service  and  the  organisational  aspects  of  the  donation  system 
within a country. 

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http://ec.europa.eu/health/ph_threats/human_substance/documents/organ_survey.pdf. 
Information detailed in the IA attached to the Communication. 

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2.3. 

Organ trafficking 

As already mentioned, the supply of organs is very limited.  

Although  so  far  no  evidence  has  been  given  in  criminal  proceedings,  it  is  possible  that 
international  criminal  organisations  have  identified  the  lucrative  opportunity  created  by  the 
gap between organ supply and demand, putting more pressure on people in extreme poverty to 
resort to selling their organs.  

Organ trafficking is not a new problem worldwide. In the 1980s experts began to notice what 
was  to  become  known  as  “transplant  tourism”  when  prosperous  Asians  began  travelling  to 
India and other parts of Southeast Asia to receive organs from poor donors. Since then other 
routes have opened up.  

While current estimations indicate that organ trafficking remains on a relatively modest scale 
in Europe, the issue is nevertheless of serious political and ethical concern. 

3. 

THE ADDED VALUE OF EU ACTION 

In recent years, the Commission has put considerable effort into supporting the area of organ 
transplantation  under  different  Community  programmes.  A  large  number  of  projects  have 
been funded3; the results of which have generated a considerable amount of information and 
knowledge useful for activating EU policies in this area. It is now time for these ideas to be 
put into effect.  

In  June  2006  the  Commission  launched  an  open  consultation  on  organ  donation  and 
transplantation.  Based  on  the  outcome  of  this  consultation,  the  Commission  now  proposes  
future  initiatives  to  be  taken  at  Community  level  that  have  added  value  in  addressing  the 
challenges ahead.  

Ensuring  the  quality  and  safety  of  human  organs  in  Europe  lies  at  the  core  of  Community 
activities  in  this  field,  as  this  aspect  is  prioritised  in  the  Treaty  establishing  the  European 
Community4. An expert conference organised by the Italian government during its Presidency 
of  the  EU  Council  in  2003,  listed  the  shortage  of  organs  and  organ  trafficking  as  the  main 
priorities in this area and underlined that the quality and safety aspects have to be considered 
fully within the framework of supply and demand for organs. In order to address the identified 
challenges adequately, an integrated approach of three actions is needed.  

3 
4 

A description of the projects is available in the Impact assessment attached to this Communication. 
From  1999  onwards,  Article  152  of  the  Treaty  has  enabled  the  European  Parliament  and  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 of the Parliament 
and the Council on blood, and on tissues and cells. 

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3.1. 

Framework for quality and safety of organ donation and transplantation 

A number of measures can be introduced into every stage of the transplant process in order to 
improve the quality and safety of organs.  

Pre-transplant evaluation of potential donors is an essential part of solid organ transplantation. 
This evaluation must provide enough information to undertake a proper risk-benefit analysis 
by  the  transplant  team.  Risks  and  characteristics  of  the  organ  must  be  identified  and 
documented to allow allocation to a suitable recipient. 

The  maintenance  of  donor  records  and  quality  systems  has  been  identified  as  key  steps 
towards quality and safety. Standard procedures for procurement and requirements for organ 
preservation and transport must be in place. 

Effective transportation of organs which minimises ischemic times and avoids organ damage 
must  be  ensured.  While  maintaining  medical  confidentiality,  the  organ  container  must  be 
clearly labelled and must contain the necessary documentation.  

The  transplant  system  must  ensure  traceability  from  donor  to  recipient(s).  The  system  must 
have the capacity to alert of an unexpected complication. A system must be in place to detect 
and investigate serious or unexpected adverse events.  

Many times an organ donor is also a tissue donor. Quality and safety requirements for organs 
shall complement and be linked with the existing community system for tissues and cells5. An 
adverse  reaction  in  an  organ  donor  recipient  should  be  traced  and  reported  on  the  tissue 
vigilance system if needed. 

The  key  role  of  national  competent  authorities  in  ensuring  the  quality  and  safety  of  this 
process  has  been  stressed,  as  well  as  the  importance  of  establishing  systems  for  the 
authorisation of establishments and programmes of organ donation and procurement based on 
common quality and safety criteria. This system would provide a complete list of authorised 
centres throughout Europe, accessible to the public and professionals. 

Binding safety and quality criteria should not have as a consequence a reduction in the actual 
number  of  donors.  It  is  important  to  have  a  clear  understanding  of  the  disease  transmission 
risk  inherent  in  each  case.  Although  a  definition  of  risk  based  upon  the  donor’s  profile  is 
critical  to  rational  decision-making,  each  decision  also  depends  upon  the  recipient’s 
characteristics. In every case there is a balance of risks and benefits to be considered: the risk 
associated with the organ versus the consequences of not getting a transplant. 

5 

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). 

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3.2. 

Cooperation between Member States 

Organ  shortage  is  a  common  dilemma  in  all  European  countries,  and  sharing  of  expertise 
across  the  EU  Member  States  has  already  proved  useful  in  increasing  organ  donor  rates  in 
some countries.  

3.2.1.  Organ availability 

Some  Member  States  have  put  in  place  diverse  initiatives  focusing  on  the  organisation  of 
donation systems and current practices that have been shown to increase organ availability. 

The  establishment  of  an  efficient  system  for  identifying  persons  that  could  become  organ 
donors  upon  their  death,  once  all  mandatory  consent  requirements  in  Member  States  have 
been  met,  has  been  identified  as  a  key  element  in  increasing  the  donation  rate.  It  has  been 
indicated that many donors are lost due to lack of evaluation, lack of referral or because the 
option of donation is not presented to relatives.  

In some Member States, the training and employment of health care professionals responsible 
for identifying persons, that could become organ donors upon their death and organising the 
donation  process  has  increased  efficiency  in  the  procurement  of  organs  and  improved  the 
functioning of transplant systems.  

In order to expand the donor pool it could be important to explore the promotion of altruistic 
donations from living donors, on the basis of appropriate safeguards concerning the protection 
of  the  living  donors  and  the  prevention  of  organ  trafficking.  Living  donation  in  Europe 
represents 17% of kidney transplant activity and 5% of liver transplantation. Although living 
donors  have  always  been  critical  for  transplantation,  the  donations  from  living  donors  has 
dramatically  increased  over  recent  years.  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 extent to which living donors volunteer for donation also varies widely within Europe.  

In  specific  circumstances  an  additional  option  is  to  consider  other  potential  donors 
(“expanded donors”) who are not ideal donor candidates due to positive serology, congenital 
and inherited disorders, history of malignancy or other characteristics such as donor age or a 
history of hypertension and diabetes.  

3.2.2.  Public awareness 

Public awareness and opinion also has an important role to play in increasing organ donation.  

Organ donation and transplantation are medical treatments that require the full participation of 
society  for  their  development.  There  are  many  complex  and  sensitive  ethical  issues  in  this 
area, and it has become clear that several of these aspects are dealt with differently in different 
countries depending on cultural values. 

In  2006,  56%  of  Europeans6  declared  themselves  ready  to  donate  their  organs  to  an  organ 
donation service after their death. Answers to the question differ widely between countries. 

6 

Eurobarometer survey 2006. 

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Family refusals to donate organs of their deceased relatives fluctuate in Europe from 6% to 
42%.  Again,  these  differences  are  not  easy  to  understand.  They  could  be  explained  by  the 
wide  variability  of  procedures  in  the  law  of  donor  consent,  for  living  and  deceased  donors, 
different organisational practices, and also other important cultural, economic or social factors 
that influence society’s perception of the benefit of donation. 

The  most  cost-effective  means  of  increasing  public  willingness  to  donate  seems  to  be 
improving the knowledge of health professionals and the media about transplantation issues. 
Because  both  positive  and  negative  messages  can  affect  the  public’s  willingness  to  donate, 
there  is  a  need  for  a  professional  attitude  towards  donation  and  support  from  experts  in  the 
field of communication. 

Continued education should form an essential element of any communication strategy. People 
should be encouraged to speak about organ donation and to communicate their wishes to their 
relatives. Only 41% of European citizens have discussed organ donation within the family6. 
There is an important positive correlation between having discussed it within the family and 
willingness to donate organs. 

The creation of a European organ donor card which indicates the willingness of the holder to 
donate  organs  or  not,  will  contribute  to  increasing  public  awareness.  81%  of  European 
citizens6 support the use an organ donor card to make it easier to identify people willing to 
donate organs after their death. In spite of this only 12% of Europeans currently have an organ 
donation card. 

3.2.3.  Organisational aspects  

Comparison  between  countries  shows  that  final  national  donation  rates  do  not  always 
correlate  with  the  percentage  of  people  who  have  previously  declared  themselves  ready  to 
donate  in  these  countries.  This  clearly  indicates  the  importance  of  having  an  efficient 
transplant  system  in  place  ensuring  that  the  organs  of  people  willing  to  donate  become 
available. 

A prerequisite for any action in this area is the establishment of adequate transplant systems at 
national level. This system needs an appropriate legal framework, a good technical approach 
and organisational support. The role of competent authorities is crucial in the organisational 
system.  These  authorities  must  ensure  compliance  with  basic  standards  and  organise  the 
donation and transplantation activities.  

The different organisation systems in Europe are the result of their origin and history. Even 
among EU countries with well-developed services, there are considerable differences in organ 
donation and transplantation activity and some organisational models seem to be performing 
better than others. 

Organ  transplants  are  subject  to  time  pressure.  The  process  from  procurement  to 
transplantation should be completed in a few hours (in order to preserve organ viability). In 
addition, for organs to be transplanted the donor has to match with the recipient. This makes 
the organisational structure a key element of organ donation/transplantation systems.  

As part of this organisation, an effective allocation system is essential. This system has to take 
into account the short time that organs can be maintained and the need to ensure that the organ 
is assigned to the most suitable recipient, according to predefined criteria. 

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The new Member States face greater health problems than the rest of the Union but have less 
economic means to address them. Their health systems are therefore under particular pressure, 
notably  when  it  comes  to  the  process  from  organ  donation  to  transplantation,  whose 
complexity may make it especially difficult to address. This leads to huge differences between 
Member  States  in  terms  of  accessibility  to  transplants  and  length  of  waiting  lists. 
Collaboration at EU level can bring particular benefits to those systems. 

It has been accepted that the larger the pool of donors the better the match. Urgent patients 
and difficult recipients (children, highly sensitised patients, etc.) cannot be treated efficiently 
within the scope of a small organisation; this is of particular concern for small Member States. 
At  the  same  time,  on  the  donation  side,  involvement  of  the  local  actors  (hospital  transplant 
teams and transplant coordinators) in the decision-making process has helped to motivate the 
professionals concerned and produced more efficient results.  

A  flexible  system  combining  a  decentralised  network  formed  by  local  organisations  mainly 
focused  on  organ  procurement,  and  the  promotion  of  donation  with  large  organisations 
focused  on  promoting  organ  sharing  and  cooperation,  seems  to  be  the  most  effective 
organisational approach. 

The  Council  of  Europe’s  Agreement  No  26  on  the  exchange  of  therapeutic  substances  of 
human  origin  in  1958  became  the  starting  point  for  cross-border  activities  in  this  field.  Tne 
work  of  the  Council  of  Europe,  Eurotransplant,  Scandiatransplant,  European  Transplant 
Network  or  the  regular  meetings  of  the  European  organ  exchange  organisations  are  good 
examples of the need of European cooperation7. 

3.3. 

Fighting organ trafficking 

Article 3 of the EU Charter of Fundamental Rights states that everyone has the right to respect 
for  his/her  physical  integrity.  Moreover,  the  Charter  contains  the  prohibition  of  making  the 
human body and its  parts  as  a  source of financial gain, and  the prohibition of trafficking in 
human beings. As part of the general phenomenon of trafficking in human beings, trafficking 
for  the  purpose  of  the  removal  of  organs  constitutes  a  serious  violation  of  the  freedom  and 
physical integrity of its victims.  

The Council of Europe8 and the World Health Organisation9 have repeatedly called for action 
to counter organ trafficking. The ban on trafficking in human organs and tissues is already in 
force  via  international  legal  instruments,  such  as  the  Oviedo  Treaty  on  Human  Rights  and 
Biomedicine  and  its  Additional  Protocol  on  the  Transplantation  of  Organs  and  Tissues  of 
Human Origin. Furthermore, the Protocol on the Prevention, Suppression and Punishment of 
Trafficking  in  Human  Beings,  which  complements  the  UN  Treaty  against  International 
Organised  Crime,  requires  the  contracting  parties  to  criminalise  this  form  of  human 
trafficking and adopt proportionate and dissuasive penalties.  

The Commission is consistently referring to these important International instruments and it 
will closely monitor any developments in the organ trafficking field both inside the EU and 
worldwide.  

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9 

Detailed information could be found in the IA attached to this Communication. 
Recommendation Rec (2004) 7 of the Committee of Ministers. 
WHO resolution WHA 42.5 condemning the purchase and sale of organs of human origin. 

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4. 

CONCLUSIONS AND FOLLOW-UP ACTIONS 

Work under the different Community programmes will continue in the forthcoming years. It 
is  important  that  the  results  of  these  projects  have  continuity  and  are  endorsed  at  political 
level; the results need to be made accessible to all players. 

The  following  have  been  identified  as  the  main  areas  of  action  in  organ  donation  and 
transplantation: 

•  Improving quality and safety 

The Commission will define the precise, balanced scope of the EU legal framework on quality 
and  safety  for  human  organs  taking  into  account  the  dialogue  it  has  had  so  far  with  the 
Member States on the issues. This framework needs to be backed up by cooperation between 
Member  States  leading  to  the  compilation  of  sufficient  information  that  will  assist  in 
determining the acceptable levels of risk in the use of expanded donors and by the promotion 
of good medical practices and evaluation of post-transplant results (“organovigilance”). 

•  Increasing organ availability 

The  Commission  will  promote  cooperation  between  Member  States  in  order  to  share 
experience and best practices with a view to establishing efficient systems for identified those 
citizens that could become organ donors upon their death. 

Other  areas  where  cooperation  is  important  are  the  promotion  of  training  of  professionals 
based  on  best  experience,  exploring  the  promotion  of  donations  from  living  donors  and 
evaluate the use of organs from "expanded" donors (donors that from a medical point of view 
can  only  be  considered  for  specific  recipients  under  specific  circumstances),  taking  into 
account the quality and safety aspects.  

It will also be important to pool efforts and expertise in order to increase public awareness. In 
this context the creation of a European organ donor card or its incorporation into the existing 
European insurance health card is to be considered. 

•  Making transplantation systems more efficient and accessible 

Like other healthcare access issues, this question has to be seen in relation to other initiatives 
at Community level in this area.  

Initiatives will be focused on  identifying the most efficient  systems, sharing  experience  and 
promoting  best  practices  in  accordance  with  local  characteristics.  Those  Member  States 
whose transplant systems are not yet sufficiently  developed can be supported and guided in 
their efforts to improve patient care. 

Other  actions  will  be  geared  to  identifying  needs  at  EU  level  for  the  interchange  of  organs 
between  national  authorities.  Guidelines  for  systems  for  offering  surplus  organs  to  other 
countries  can  be  evaluated,  with  special  reference  to  the  exchange  of  organs  for  urgent 
patients and difficult-to treat patients. 

The  increasing  mobility  of  people  within  the  EU  makes  it  necessary  to  identify  the  main 
problems  regarding  patient mobility. It  will also  be important to  secure  EU-wide agreement 
on all issues concerning transplant medicine for extra-Community patients (“non-residents”). 

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The Commission proposes the following mechanisms of action:  

•  Action plan on strengthened cooperation between Member States 

Analysis of the organ transplantation situation in the EU has revealed large differences in the 
deceased  and  living  organ  donor  rate  within  the  EU  and  also  considerable  differences  in 
transplantation activity. These differences cannot be easily explained and it is clear that some 
models  are  performing  better  than  others.  There  is  scope  for  sharing  expertise  among  EU 
Member States and for cooperation between countries to help maximise organ donation and 
equalise  access  to  transplantation.  The  Community  will  identify  the  best  of  the  best  models 
and  support  its  application  throughout  the  EU  while  respecting  cultural  and  organisational 
diversity. 

Already in the resolution adopted by the Council of Ministers for Health in 199110 concerning 
fundamental health choices, the Council took note that analysis of the Community’s possible 
contribution concerning the availability of organs for transplants was identified as one of the 
topics  which  warranted  joint  consideration,  regular  joint  discussions  and/or  joint  efforts  to 
assist  Member  States  in  framing  their  health  policies.  The  main  European  organ  exchange 
organisations have also recommended identifying the best initiatives for promoting exchange 
of  experience  and  information  between  EU  countries  in  order  to  improve  organisational 
aspects. 

An  action  plan  for  closer  cooperation  between  Member  States,  specifically  tailored  to  this 
concrete  field,  will  provide  the  necessary  policy  mix  to  achieve  a  gradual  approach  to  the 
development  of  an  EU  policy.  This  approach  should  be  based  on  the  identification  and 
development  of  common  objectives  for  which  it  is  agreed  that  a  Community  response  is 
necessary,  agreed  quantitative  and  qualitative  indicators  and  benchmarks,  regular  reporting, 
and identification and sharing of best practices. 

•  EU legal instrument on quality and safety of organ donation and transplantation 

The Community has already adopted Parliament and Council Directives on quality and safety 
standards  for  blood11  and  for  tissues  and  cells12.  A  possible  European  Directive  setting 
standards  of  quality  and  safety  for  organs  could  address  similar  topics;  however  the  risk-
benefit ratio is a fundamental approach for organ transplantation. Owing to the organ shortage 
and  the  life  threatening  indications  of  organ  transplants,  the  benefits  of  an  organ 
transplantation are high and more risks can be accepted than with blood or most tissues and 
cells treatments. In this context the clinical doctor has an important role in the decision on the 
acceptance  of  organs  for  transplantation.  The  Commission  proposal  will  take  into  account 
these specificities of organ donation and transplantation.  

The  conclusion  of  the  impact  assessment  attached  to  this  Communication  is  that,  based  on 
further  cooperation  with  the  Member  States,  an  appropriate  and  flexible  European  legal 
framework could be an adequate community response to meet the mandate provided in Article 
152(4)(a).  

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12 

Resolution of the Council and the Ministers for health (OJ C 304, 23.11.1991, p. 5). 
OJ L 33, 8.2.2003, p. 30. 
OJ L 102, 7.4.2004, p. 48. 

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The  future  legal  instrument  based  on  a  separate  impact  assessment,  could  include  the 
principles needed to establish a basic quality and safety framework, such as: 

–  the  establishment  of  national  oversight  authority  or  authorities  responsible  for 

implementing the requirements of the Directive;  

–  a  common  set  of  quality  and  safety  standards  for  the  authorization  of 
establishments and programs of organ donation and procurement, and also for an 
effective preservation and transportation of organs;  

–  ensure traceability and reporting of serious adverse events and reactions; 

–  establishment of inspection structures and control measures; 

–  ensure a complete characterisation of the organ, in order that the transplant team 

could undertake the appropriate risk assessment. 

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