Commission staff working document accompanying the Proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation and the Communication from the Commission : action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States - Summary of the impact assessment {COM(2008) 818 final} {COM(2008) 819 final} {SEC(2008) 2956}
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 
SEC(2008) 2957 

COMMISSION STAFF WORKING DOCUMENT 

accompanying the 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

and the 

COMMUNICATION FROM THE COMMISSION 

Action plan on Organ Donation and Transplantation (2009-2015): Strengthened 
Cooperation between Member States 

Summary of the Impact Assessment 

{COM(2008) 818 final} 
{COM(2008) 819 final} 
{SEC(2008) 2956} 

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SUMMARY OF THE IMPACT ASSESSMENT1 IMPROVING ORGAN DONATION 
AND TRANSPLANTATION IN THE EUROPEAN UNION 

1. PROBLEM DEFINITION 

Due  to  rapid  advances  in  transplantation  medicine,  the  use  of  human  organs  for 
transplantation has steadily increased during the past decades. Organ donation has a very high 
potential of saving lives and increasing the quality of life for patients. This potential can only 
be  realised,  however,  when  a  sufficient  number  of  organs  is  available  for  transplantation, 
when there are adequate quality and safety measures in place to reduce the risks of diseases 
being transmitted, and when processes are organised efficiently and are accessible to all those 
who are in need.  

1.1. Organ availability 

Currently,  demand  for  organs  exceeds  their  availability  in  all  Member  States  and  demand 
increases faster than organ donation rates in most Member States. While there is an increasing 
demand  for  organs,  the  availability  of  organs  varies  widely  between  the  Member  States, 
ranging from 33.8 deceased donors per million of population in Spain to 1 deceased donor per 
million population in Romania. Only Spain and few others Member States have succeeded in 
increasing  significantly  the  number  of  donors.  It  has  been  proven  that  these  increases  are 
linked to the introduction of organisational practices. 

Living donation rates also differ substantially between Member States, and it seems that not 
all countries realise their potential for living donation.  

The  importance  of  organisational aspects  of  organ  procurement  and  the  large  differences  in 
practices  and  performances  across  Member  States  show  a  clear  benefit  of  exchanging  best 
practices between the Member States of the European Union.  

1.2. Quality and Safety in organ transplantation 

Organ  transplantation  is  a  potentially  life  saving  treatment,  which  nevertheless  involves 
substantial  risks  to  the  patients.  These  risks  emanate  from  the  quality  and  matching 
characteristics of the organ as well as the medical treatment received. 

The use of organs in therapy poses a risk of infectious diseases being transmitted to the organ 
recipient.  Transplantation  can  also  lead  to  the  transmission  of  different  types  of  cancers.  In 
addition,  the  quality  and  safety  of  organs  can  be  at  risk  due  to  organ  damage  during  the 
procurement  process.  To  reduce  these  risks,  most  transplantation  systems  apply  quality  and 
safety  procedures  throughout  the  complex  donation  process.  Currently  quality  and  safety 
standards differ widely across Member States.  

1.3. Enhancing the efficiency and accessibility of transplantation systems  

The exchange of organs between Member States is already common practice between them. 
There are however large differences between the number of organs exchanged across borders 
between  Member  States  which  set  up  bodies  and  rules  for  the  international  exchange  of 
organs such as Eurotransplant and Scandiatransplant and the other Member States.  

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On the basis of SEC(2005) 791 of 15 June 2005 (Impact Assessment Guidelines). 

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The differences in exchange rates indicate that the full potential of exchanging organs has not 
yet  been  reached.  This  is  problematic  as  the  cross  border  exchange  of  organs  has  clear 
benefits.  Given  the  need  of  matching  between  donor  and  recipient,  a  large  donor  pool  is 
important  to  cover  the  needs  of  all  patients  on  the  waiting  lists.  If  there  is  no  exchange  of 
organs between Member States, then recipients that need an infrequent match will have very 
low chances of receiving an organ, while at the same time donors are not considered because 
there is not a compatible recipient in the waiting lists. This is particularly true for difficult to 
treat  patients  (paediatric,  urgent  or  hyper-sensitised  patients  that  require  very  specific 
matching) and small Member States. The mobility of potential organ donors and recipients is 
the  second  major  challenge  for  the  current  quality  and  safety  frameworks,  after  organ 
shortage.  Evidence  shows  that  more  and  more  people  might  become  organ  donors  while 
residing in another Member State. To ensure that organs available for therapy are not wasted, 
it is important that there are no legal barriers to the use of these organs and that the families of 
these donors have trust in the donation system so that they do not refuse donation. 

2. SUBSIDIARITY  

Article 152 of the EC Treaty provides a clear legal basis for the initiatives proposed An EU 
measure in the area of organ transplantation and donation can be reconciled with the principle 
of subsidiarity on the following grounds: 

1)  The  European  Community  has  a  clear  opportunity  and  obligation  to  implement  binding 
measures laying down high standards of quality and safety for the use of blood, organs, and 
substances of human origin. 

2) European Community action is likely to contribute to public value by providing a platform 
for  implementation  and  mutual  learning  which  combines  standardisation  of  reporting  with 
diversity of service. 

3. THE POLICY OBJECTIVES 

Ultimately, the strategic goal is to achieve a high standard of human health protection. In the 
area of organ donation and transplantation, this goal can be broken down into three objectives 
to tackle current and future shortcomings and to guide European policy: 1) increasing organ 
availability; 2) enhancing the efficiency and accessibility of transplantation systems: and, 3) 
improving quality and safety.  

4. THE POLICY OPTIONS 

Option 1: Continuing Status quo  

Under this option, the European Commission would continue with its current activities in the 
field  of  organ  donation  and  transplantation,  which  involves  predominantly  sponsoring 
research and pilot programmes in this field and participating in international cooperation such 
as in the Council of Europe.  

Option 2: Action plan  

This  option  proposes  a  non-regulatory  approach  establishing  a  European  Action  Plan  on 
Organ  Donation  and  Transplantation  for  the  period  2009-2015  which  sets  out  a  cooperative 
approach between Member State based on a set of priority actions. This approach is based on 

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the identification and development of common objectives, agreed quantitative and qualitative 
indicators and benchmarks, regular reporting and identification of best practices. 

Option 3: Action plan + “flexible directive” 

Option  three  combines  the  Action  Plan  already  described  with  a  “flexible”  Directive.  The 
regulatory approach of this directive will be very much a framework approach, ensuring that 
national  legislation  is  put  in  place  to  deal  with  key  aspects  of  organ  donation  and 
transplantation but without prescribing detailed policy measures.  

The  Directive  will  ensure  that  the  quality  and  safety  structures  are  in  place.  These  will 
facilitate  the  conditions  for  cross  border  exchanges  and  ensure  a  basic  level  of  quality  and 
safety for patients. 

Option 4: Action plan + “stringent directive” 

Option 4 will combine the Action Plan described under Option 2 with a stringent Directive. 
This  stringent  Directive  will  be  modelled  after  the  Tissue  and  Cells  Directive  and  will 
therefore contain detailed regulation about the quality and safety systems Member States have 
to  put  in  place,  leaving  little  national  discretion  in  transposing  the  Directive.  As  mentioned 
above, Option 4 provides for a stricter regulatory approach. This option will include a more 
complex  accreditation  process  for  procurement  sites,  including  regular  inspections  which 
entail the need to put in place a specific inspection structure. It requires also a detailed quality 
system  in  place  in  every  donation  site.  The  Directive  will  lay  down  exclusion  criteria  for 
donors following the same approach followed in the Blood and Tissues and Cells Directives.  

5. ASSESSMENT OF IMPACTS: COMPARING THE OPTIONS 

5.1. Health Impacts 

The  key  health  impacts  emanate  from  an  increase  in  donation  rates  (increase  on  health 
expectancy  and  quality  of  life  for  the  patients  in  need)  and  reduced  risks  to  patients.  The 
policy options are likely to increase donation rates in Europe. In addition, the policy options 
are likely to increase cross border exchange of organs, which result in clear health benefits for 
paediatric, highly sensitised and urgent patients. 

Option 1 would not change the current unsatisfactory status quo, with diverging quality and 
safety  standards  across  Europe  and,  an  undeveloped  potential  for  cross  border  exchange  of 
organs Option 2 can create substantial health gains though increases in donation rates. These 
gains could range normally from 0-113.000 QALYs gained. Nonetheless these increases are 
uncertain  as  the  option  allows  for  a  high  level  of  discretion  in  national  implementation, 
therefore  an  estimation  of  60,000  QALYs  seems  more  realistic.  Option  2  will  not  have  an 
impact on the quality and safety of organs, but will for instance remove possible disincentives 
to become a living donor by ensuring access to health care for living donors; without however 
including provisions for eventually necessary social care. 

Option  3  and  4  supplement  Option  2  through  legal  standards  and  will  have  a  more  certain 
effect on donation rates to the degree that positive changes will become mandatory. It is likely 
that  these  options  ensure  at  least  a  modest  increase  of  2.600  organs  being  transplanted, 
resulting in 39.000 saved life years or 37.000 more QALYs; we could assume that the average 
QALYs  gained  will  be  superior,  reaching  90.000  QALYs.  In  addition,  Option  3  and  4  will 
establish common quality and safety standards across the European Union, which will reduce 

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risks to patients and stimulate cross border exchange of organs. Nonetheless, Option 4 in turn 
by  ensuring  stringent  quality  and  safety  standards  across  the  European  Union  might  lead  to 
substantial difficulties in implementation for the relevant facilities and therefore might even 
have a negative impact on donation rates for some of them.  

5.2. Social impacts 

Increasing organ transplantation will result in positive social impacts for organ recipients and 
donor  families.  Evidence  shows  that  organ  transplantation  increases  the  possibilities  for 
patients  to  participate  in  social  and  working  life.  In  general,  organ  transplantation  has  a 
positive  effect  on  the  Quality  of  Life  of  organ  recipients.  Thus,  the  different  options  will 
generate  additional  social  benefits,  depending  on  the  additional  transplantations  achieved 
from increased donation rates. 

European  action  can  be  expected  to  contribute  to  increasing  trust  and  confidence  in  organ 
donation  and  transplantation  systems,  by  establishing  common  quality  and  safety  standards, 
increasing public awareness, and improving processes to deal with the relatives of deceased 
donors.  However,  the available evidence  on  such social impacts such as social participation 
and  improved  standards  of  living  do  not  allow  for  an  adequate  assessment  of  the  precise 
impacts in order to compare the options. 

Given  the  social  impacts  of  increasing  donation  rates  and  the  importance  of  having  more 
robust  donation  and  transplantation  processes,  we  would  expect  the  highest  social  benefits 
from option 3 and 4, which increase donation rates with higher certainty and are more likely 
to enforce standards of good processes. 

5.3.  Economic Impacts 

The analysis of the policy options suggest that Options 2 to 4 can lead to substantial economic 
benefits across the European Union, although Member States will have to invest in national 
infrastructures  of  organ  donation  and  the  improvement  of  processes  to  realise  these  gains. 
Nonetheless,  the  available  evidence  does  not  allow  for  the  production  of  detailed  cost 
estimates  for  Member  States.  The  economic  benefits  arise  primarily  from  saved  treatment 
costs as transplanted kidneys replace dialysis treatment. Scenarios developed see a potential 
of saving up to €1.2 billion in treatment cost s, and reaching productivity gains of up to €2.4 
billion.  

Policy Option 1 continues the status quo and is expected not to create any additional costs or 
economic benefits. Option 2 could generate substantial economic benefits of up to €1.2 billion 
savings in treatment costs and an additional productivity impact of €3.6 billion at low costs 
for process and infrastructure improvement. Due to the voluntary nature of the Action Plan, it 
is recognised that the impacts are highly uncertain because the extent of implementation by 
Member States is to a large extent unknown. 

Policy  Option  3  combines  the  Action  plan  with  a  flexible  Directive.  Option  3  will  lead  to 
substantial costs to implement national registers, reporting activities and a national vigilance 
system.  However,  due  to  the  mandatory  character  of  the  option,  we  see  cost  savings  and 
productivity to occur under less uncertainty, at a range between €132 million and €1.2 billion 
for cost savings, and €460 million and €2.4 billion 
for productivity impacts. Finally, Option 4 
is  expected  to  bring  the  same  economic  benefits  as  Option  3,  however  at  higher 
implementation costs, as Member States have less freedom to use existing systems and devise 
tailor-made national solutions. 

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6. IDENTIFYING A PREFERRED OPTION 

In weighing the available evidence, Option 3, which combines an Action Plan with a flexible 
Directive creating a European framework regulation for quality and safety, will help achieve 
the objectives at the best cost benefit ratio. 

The least costly option, Option 2, will not be sufficient to create a robust quality and safety 
framework  and  will  thus  not  help  achieve  the  third  objective.  In  addition,  the  potential 
positive  health  and  economic  impacts  are  more  uncertain  than  for  the  other  three  options. 
Even more so than Option 3 and 4, Option 2 relies on the commitment of Member States to 
voluntarily  change  organisational  structures,  improve  processes  and  invest  into  organ 
donation and transplantation.  

Option  4  in  turn  will  ensure  the  most  stringent  quality  and  safety  standards  across  Europe, 
which  comes  however  at  the  risk  of  creating  unnecessary  administrative  burden.  These 
requirements while fully justified in the tissues and cells field, could when it comes to organs 
disincentive  donation  activity  in  small  and  medium  hospitals  by  creating  unnecessary 
administrative burden, whereas the objective should be to increase the involvement of these 
actors in the donation process 

A strict regulatory approach might lead to substantial difficulties in implementation and might 
even have a negative impact on donation rates for some facilities. In addition, Option 4 can be 
expected to have the highest overall implementation costs, as even countries with already well 
established  donation  and  transplantation  systems  will  need  to  change  some  of  their 
infrastructures  and  processes  to  comply  with  EU  prescriptions.  Nevertheless,  Option  4  will 
also  have  also  substantial  economic  benefits  through  saved  treatment  costs  and  the 
productivity impacts of longer life expectancy. 

There is however a clear need to ensure that the conditions of procurement comply with basic 
quality and safety standards and to designate those procurement sites entitled to carrying out 
these  activities.  Option  3  will  achieve  these  objectives  tailoring  the  quality  and  safety 
requirements to this particular field.  

In  addition  Option  4  would  also  include,  as  in  the  Tissues  and  Cells  legal  framework, 
suitability  criteria  for  the  donor  (including  exclusion  criteria  of  donors).  In  the  contrary, 
Option 3 will introduce a new approach by ensuring a complete characterisation of the organ 
without prejudging the suitability of the donor and therefore respecting the clinical decision 
that has to take into account the condition of the recipient. This will allow the transplant team 
to undertake the appropriate (and fully informed) risk assessment.  

This approach is key to respecting the use of expanded donors (donors that are not in theory 
ideal)  for  specific  recipients  in  waiting  list  (e.g.  very  aged  donors  can  be  used  to  aged 
recipients in particular circumstances). In the contrary Option 4 could restrict the potential of 
increasing  organ  donation  by  diminishing  the  use  of  "expanded  donors".  Option  3  provides 
enough  flexibility  to  the  transplant  team  to  undertake  the  appropriate  risk  assessment  and 
balance it with the potential benefit. 

Overall,  Option  3  will  be  best  suited  to  achieve  the  objectives  of  increasing  donation  rates, 
making  transplant  systems  more  accessible  and  efficient  and  ensuring  quality  and  safety 
standards.  By  allowing  a  certain  degree  of  flexibility  for  the  Member  States,  this  option 
reduces implementation costs and administrative burden, while at the same time safeguarding 
minimum  quality  and  safety  standards.  The  introduction  of  a  flexible  set  of  binding 
requirements  on  quality  and  safety  will  not  only  cover  properly  the  third  objective  but  will 

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also trigger and stimulate the objectives under the Action Plan. It is likely to increase donation 
rates which would result in substantial benefits for patients as well as substantial cost savings 
for the national health systems. 

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