Brussels, 30 May 2007
Q&A on organ donation and
transplantation in the EU
What power does the European Commission have to take action in the field
of human organs?
Since 1999, the EU has had the mandate, under Article 152 of the Treaty, to
legislate on quality and safety standards for human tissues and cells, human
organs, and blood used in medical treatment. EU Directives have already been
adopted on blood (IP/02/1919
and on tissues and cells (IP/04/288
A similar Directive on the quality and safety of organs could be envisaged in
the future, depending on the outcome of the consultations and assessments
currently being carried out by the Commission.
What is the current situation regarding donation and transplantation in
The number of organ donations and transplantations has grown steadily across
the EU and thousands of lives are saved every year through this medical
procedure. However, there are also many problems in this sector. The level of
organ donation does not come close to meeting the demand, and nearly 10 people
die every day in Europe while waiting for an organ. There are wide variations
between Member States in organ donation rates, ranging from 34.6 donations per
million people in Spain to 0.5 per million in Romania. The exchange of organs
between Member States is not common practice 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. When it comes to
quality and safety requirements for organ donation and transplantation, there
are large differences among Member States, while the organisational approach to
transplantation varies from country to country, leading to uneven standards
across the EU.
Why are there such disparities?
It is difficult to attribute the differences between Member States in organ
donation and transplantation rates to one single factor, but several reasons
have been identified.
Organisation: Firstly, organ donation and transplantation is an extremely
complex procedure that requires a well-developed organizational structure. Each
Member State has its own particular methods of organising and carrying out
transplants, often based on type of health systems and available resources.
Training opportunities and the number of qualified doctors to carry out the
transplantations also varies from one country to another. Some of the newer
Member States face greater health problems than the rest of the EU, but have
fewer resources to address them, particularly when it comes to highly
complicated operations such as transplantations.
Approach: Some Member States have dedicated more resources than others to
proactively seeking potential donors (both live and dead).
Attitude: Different societies have different attitudes towards organ
donation, often based on cultural and social factors. Family refusals to
donation also vary widely within Europe, ranging from 6% in Portugal to 42% in
the UK. The level of public awareness of organ donation and the ethical issues
surrounding it, variations in the legal procedures for donor consent, and
different practices on organ registration and allocation, can influence public
perceptions of donation and transplantation and the willingness to donate
What is already being done by the EU?
The European Commission has already undertaken a number of initiatives in
various policy areas.
- The Health and Consumer Protection Directorate General is currently working
towards two new projects to develop a European Training Program on Organ
Donation and to contribute to create a consensus on European common standards
regarding legal, ethical, protection and registration practices in relation to
organ living donors in order to guarantee these donors health and safety.
- The Information Society Directorate General is supporting the creation of a
European registry on organs, cells and tissues through the EUROCET project.
- In the area of research, a number of projects are being carried out. For
example, there is a project to develop a list of national and regional research
programmes on organ transplantation in order to maximise the research already
being carried out and avoid duplication. A separate European research project is
focusing on ways to increase the potential of organ donation, such as promoting
cooperation and sharing information and best practices among certain European
countries. Another project is focussed on reprogramming the immune system to
tolerate transplanted organs.
What could the benefits of EU-level
In 2004, the Council of Europe issued a recommendation for minimum common
standards on organ donation across the EU, given the rise in patient mobility
and the potential for further organ exchange. The authorisation of donation and
procurement standards, establishments and programmes and the maintenance of
donor records were among the areas singled out for a more coordinated approach.
There are large differences among Member States when it comes to quality and
safety requirements for organ donation and transplantation, as well as diverse
organisational approaches that yield varying results. More cooperation in this
field, including the exchange of good practice, could help to raise the overall
standard of donation and transplantation across the EU. Collaboration on organ
donation and transplantation could be of particular benefit to some of the newer
Member States whose health systems have fewer resources and are, therefore,
under more pressure when it comes to transplantation.
In addition, harmonised quality and safety standards could help to encourage
greater exchange of organs between Member States and would provide assurances to
patients donating or receiving organs outside of their own Member State.
Where should EU action focus on?
Four fields have been identified as the main areas of action in organ
donation and transplantation:
- Improving quality and safety: The Commission will define a precise
and balanced scope of the EU legal framework on quality and safety for human
organs. 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
- 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 organ donor
detection and procurement. Other areas where cooperation is important include
the promotion of training of professionals based on best experience, exploring
the promotion of donations from living donors and evaluating the use of expanded
donors, 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. 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”).
- Fighting organ trafficking: The Commission will closely monitor any
developments in the organ trafficking field.
What are the next
steps after the Communication?
As next steps the Commission proposes the following:
- 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.
- 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 Directive on quality and safety of organ donation and transplantation.
The Community has already adopted Parliament and Council Directives on
quality and safety standards for blood and for tissues and cells. A European
Directive setting standards of quality and safety for organs will address
similar topics; however, the risk-benefit ratio is a fundamental approach to
organ transplantation. Because of organ shortage and life threatening diseases
that can be treated with 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 future legal instrument will
include the principles needed to establish a basic quality and safety framework,
- establishment of an oversight authority
- A common set of quality and safety standards for the authorization of
establishments and programs of organ donation and procurement, and also for
effective preservation and transportation of organs
- Ensure traceability and reporting of serious adverse events and
- 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
Taking into account the opinion of the European
Parliament and of the Council on the Communication, the Commission will draw up
an action plan and a Directive on quality and safety at the end of 2008 or