shortage of organ donors remains the main challenge that EU Member States face
with regard to organ transplantation of humans organs by organized criminal
between the demand for organs and the current supply is a growing problem in Europe. More than 60.000 patients are now on waiting lists in Europe. About 10 people
waiting for an organ donation die everyday in Europe waiting for a transplant.
Mortality rates while waiting for a heart, liver or lung transplant usually
range from 15 to 30%. Despite the burgeoning demand for transplanted organ, the
number of available cadaveric organs has remained essentially static over the
Even in cases
where there have been sustained increases in the number of donors, it is very
difficult to reduce the number of patients and time spent on waiting lists.
Demand for transplants is increasing faster than organ donor rates.
different reasons for the shortage of donors. There are also large differences
between Member States’ successes in increasing their donor pool. Donor rates
vary widely in different European countries (see Figure 11.10). 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 each country.
One of the
adverse consequences of the scarcity of organs for transplant is trafficking of
human organs by organized criminal groups.
trafficking is not a new problem worldwide. In the 1980s, experts began to
notice what was to become known as “transplant tourism” when prosperous people
began travelling to poor countries 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 legal political and ethical concern.
States have put in place different initiatives focusing on the organisation of
donation systems and current practices that have been shown to increase organ
establishment of an efficient system for identifying people 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 healthcare 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 due to multiple factors, including pressure created by the shortage of
deceased donors, surgical advances, strong evidence of favourable transplant
outcome and low donor risk.
The extent to
which living donors volunteer for donation also varies widely within Europe.
circumstances an additional option is to consider other potential donors
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.
and opinion also has an important role to play in increasing 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
Europeans declared themselves ready to donate their organs to an organ donation
service after their death. Answers to the question differ widely between
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 the society’s
perception of the benefit of donation.
cost-effective means of increasing public willingness to donate seems to be
improving the knowledge of health professionals and the media about
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.
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 family. 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 citizens 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.
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.
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
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, with some
organisational models seem to be performing better than others.
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
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 particularly difficult to
address. This leads to huge differences between Member States in terms of
accessibility to transplants and length of waiting lists.
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
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. The 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 cooperation.
Quality and safety of organ donation and
Transmission of HIV/AIDS,
hepatitis B and C, bacteria, fungi and parasites through transplantation, as
well as of for different types of cancers has been described in scientific
literature. The transmission of disease by a deceased donor organ can result
not only in the 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.
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.
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.
of donor records and quality systems have been identified as key steps towards
quality and safety. Standard procedures for procurement and requirements for
organ preservation and transport must be in place.
transportation of organs must be guaranteed in order to minimise ischemic times
and avoid organ damage. While maintaining medical confidentiality, the organ
container must be clearly labelled and must contain the necessary
system must ensure traceability from donor to recipient(s). The system must
have an alert capacity for any unexpected complication ane be able 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 cells. 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 already 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.
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.