EN    EN EN 
EN    EN  COMMISSION OF THE E UROPEAN 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 hum an 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} 
EN    EN SUMMARY OF THE IMPACT ASSESSMENT1 IMPROVING ORGAN DONATION 
AND TRANSPLANTATION IN THE EUROPEAN UNION 
1. PROBLEM DEFINITION  
Due to rapid advances in transplantati on medicine, the use of human organs for 
transplantation has steadily increased during th e past decades. Organ donation has a very high 
potential of saving lives and incr easing the quality of life for pa tients. This potential can only 
be realised, however, when a sufficient number of organs is availabl e for transplantation, 
when there are adequate quality and safety measures in place to reduce the risks of diseases being transmitted, and when processes are organi sed efficiently and are accessible to all those 
who are in need.  
1.1. Organ availability 
Currently, demand for organs exceeds their av ailability in all Member States and demand 
increases faster than organ donatio n 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 fe w others Member States have succeeded in 
increasing significantly the num ber of donors. It has been pr oven that these increases are 
linked to the introduction of  organisational practices. 
Living donation rates also differ substantially be tween 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 Stat es 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 po tentially life saving treatment,  which nevertheless involves 
substantial risks to the patients. These ri sks emanate from the quality and matching 
characteristics of the organ as we ll 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 th e 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, mo st transplantation systems apply quality and 
safety procedures throughout the complex dona tion process. Currently  quality and safety 
standards differ widely across Member States.  
1.3. Enhancing the efficiency and accessi bility of transplantation systems  
The exchange of organs between Member Stat es is already common practice between them. 
There are however large differences between th e number of organs exchanged across borders 
between Member States which set up bodies a nd rules for the international exchange of 
organs such as Eurotransplant and Scandi atransplant and the other Member States.  
                                                
 
1 On the basis of SEC(2005) 791 of 15 J une 2005 (Impact Asse ssment Guidelines).  
EN    EN 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 th e 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, urge nt or hyper-sensitised patients that require ve ry specific 
matching) and small Member States. The mobility of potential organ donors and recipients is 
the second major challenge for the current qua lity and safety frameworks, after organ 
shortage. Evidence shows that more and mo re people might become organ donors while 
residing in another Member State.  To ensure that organs availa ble 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. S UBSIDIARITY  
Article 152 of the EC Treaty provi des a clear legal basis for th e initiatives pr oposed An EU 
measure in the area of organ transplantation a nd donation can be reconcil ed with the principle 
of subsidiarity on the following grounds: 
1) The European Community has a clear oppor tunity 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 co ntribute to public value by providing a platform 
for implementation and mutual learning which combines standardisat ion 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 go al can be broken down in to three objectives 
to tackle current and future shortcomings and to guide European policy: 1) increasing organ 
availability; 2) enhancin g 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 intern ational cooperation such 
as in the Council of Europe.  
Option 2: Action plan  
This option proposes a non-regulatory approa ch establishing a European Action Plan on 
Organ Donation and Transplantation for the period 2009-2015 which sets out a cooperative 
approach between Member State ba sed on a set of priority actions. This approach is based on 
EN    EN the identification and developmen t of common objectives, agreed  quantitative and qualitative 
indicators and benchmarks, regular reporti ng and identification of best practices. 
Option 3: Action plan + “flexible directive” 
Option three combines the Action Plan already described with a “flexi ble” Directive. The 
regulatory approach of this dire ctive will be very much a fr amework approach, ensuring that 
national legislation is put in place to d eal with key aspects of organ donation and 
transplantation but without prescr ibing detailed policy measures.  
The Directive will ensure that the quality and safety structures are in place. These will 
facilitate the conditions for cross border exch anges and ensure a basic level of quality and 
safety for patients. 
Option 4: Action plan + “stringent directive” 
Option 4 will combine the Action Plan describe d under Option 2 with a stringent Directive. 
This stringent Directive will be modelled af ter the Tissue and Cells Directive and will 
therefore contain detailed regulation about the qua lity 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 regulator y 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 inspecti on structure. It requires also a detailed quality 
system in place in every donation site. The Di rective will lay down ex clusion 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 incr ease 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 in crease donation rates in Europe. In addition, the policy options 
are likely to increase cross borde r exchange of organs, which result  in clear health benefits for 
paediatric, highly sensitis ed and urgent patients. 
Option 1 would not change the current unsatisfactory status quo, with diverging quality and 
safety standards across Europe and, an undeve loped 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 leve l of discretion in na tional 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 he alth care for living donors; without however 
including provisions for eventu ally necessary social care. 
Option 3 and 4 supplement Option 2 through lega l standards and will have a more certain 
effect on donation rates to the degree that posit ive 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 year s or 37.000 more QALYs; we coul d assume that the average 
QALYs gained will be superior, reaching 90.0 00 QALYs. In addition, Option 3 and 4 will 
establish common quality and safety standards across the European Union, which will reduce 
EN    EN risks to patients and stimulate cr oss border exchange of organs. Nonetheless, Option 4 in turn 
by ensuring stringent quality and safety standa rds 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 po sitive social impacts for organ recipients and 
donor families. Evidence shows that organ tran splantation 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 estab lishing common quality and safety standards, 
increasing public awareness, a nd improving processes to deal wi th the relatives of deceased 
donors. However, the available evidence on such so cial impacts such as social participation 
and improved standards of livi ng do not allow for an adequate  assessment of the precise 
impacts in order to compare the options. 
Given the social impacts of increasing donati on 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 rate s 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 improve ment of processes to realise thes e 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 cr eate any additional costs or 
economic benefits. Option 2 could generate subs tantial economic benefits  of up to €1.2 billion 
savings in treatment costs and an additional pr oductivity 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 register s, reporting activities an d 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. 
EN    EN 6. IDENTIFYING A PREFERRED OPTION 
In weighing the available evidence, Option 3, wh ich combines an Action Plan with a flexible 
Directive creating a European framework regula tion 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 creat e a robust qual ity 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 reli es on the commitment of Member States to 
voluntarily change organisationa l structures, improve proce sses 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 crea ting 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 th e objective should be to increa se 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 implementati on costs, as even countries with already well 
established donation and transplantation syst ems will need to change some of their 
infrastructures and processes to comply with EU prescriptions. Nevertheless, Option 4 will also have also substantia l economic benefits through sa ved treatment costs and the 
productivity impacts of longer life expectancy. 
There is however a clear need to  ensure that the c onditions of procuremen t 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 ex clusion criteria of donor s). In the contrary, 
Option 3 will introduce a new approach by ensuri ng a complete characterisation of the organ 
without prejudging the suitability of the donor a nd 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 fu lly informed) risk assessment.  
This approach is key to respecting the use of  expanded donors (donors th at 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 donor s". 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 achie ve 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 fl exibility for the Member States, this option 
reduces implementation costs and administrativ e burden, while at the same time safeguarding 
minimum quality and safety standards. Th e introduction of a flexible set of binding 
requirements on quality and safety will not only  cover properly the third objective but will 
EN    EN also trigger and stimulate the objectives under th e Action Plan. It is likely to increase donation 
rates which would result in substa ntial benefits for patients as well as substantial cost savings 
for the national health systems.