Memorandum by the British Transplantation
Society
OVERVIEW
1. The British Transplantation Society (BTS)
is pleased that the Commission is showing this interest in organ
transplantation. We believe this is entirely appropriate because
transplantation has a very high level of success in improving
the life expectancy and quality of life of many EU citizens but
the extent to which citizens can benefit is at present limited
to a significant degree by problems that can reasonably be addressed
by organisational change. In many cases, this change will be most
appropriately implemented at governmental level and there is benefit
to be gained from the cooperation between different governments
and governmental bodies throughout the EU. In other areas, governments
have potentially useful contributions to make in supporting research
into the factors affecting organ donation (and organ failure and
replacement, in general) and implementing strategies for improving
public awareness, with a view to increasing donation. This too
is an area in which the EU can have an impact. Research work in
this area undertaken across the EU may have greater impact at
lower cost than the aggregate of smaller, nationally based research.
ORGAN QUALITY
AND SAFETY
2. The Commission document rightly places
great emphasis on minimising the risks of the transmission of
infection and cancer by transplantation. They are correct that
increasing organ sharing will increase such risks. However, the
BTS feels that the risks are small and the procedures that would
have to be put in place to minimise these risks will require relatively
little effort. Inappropriately onerous restrictions could result
in more deaths on the waiting list than might occur following
the transplantation of higher risk organs.
3. The BTS heartily endorses the framework
for quality and safety of organ donation and transplantation and
the measures outlined in section 3.1. However, we are concerned
that the burden of ensuring the quality and safety of organ donation
and procurement will be great. It includes many factors discussed
in both the Commission's Communication (COM(2077)275 Final) and
the Impact Assessment (SEC(2007)704), such as the transmission
of infection and malignancy. However, there are other areas of
quality and safety that have not been emphasised, such as the
quality of the retrieval process: Were organs damaged at retrieval?
Was the retrieval undertaken in a way that will maximise the utility
of all organs to be used? We believe this should be coupled with
stratagems to increase the number of organs being donated as this
is likely to be most effective and efficient in using resources.
We will return to a proposed mechanism below.
4. An additional factor in improving quality
is maintaining a high level of experience by ensuring a level
of activity in a transplant unit such that the unit and each practitioner
has sufficient ongoing experience to maintain their skills. The
number of centres in different EU countries varies. We suggest
the EU use this opportunity to maintain quality by considering
minimum activity levels.
5. It would similarly be valuable to consider
the quality of the training experiences available throughout Europe.
A training standard in transplantation surgery has very recently
been established and this could be considered for other professions.
6. Finally, safety assurance of professional
performance requires some consideration of manpower provision
and service delivery.
ORGAN TRAFFICKING
7. The BTS shares the concern of the Commission
about organ trafficking. It has the potential for corruption and
has safety implications. We agree that EU countries are rarely
the destination of the transplant tourist. Hence, we think there
is limited scope for its prevention by the EU. The best response
to transplant tourism is to improve the supply of organs within
the high quality, regulated health care systems of Europe so that
the incentive to travel abroad is greatly reduced. We believe
that the enthusiasm for participating in transplant tourism will
fall if the waiting time for organs is significantly reduced and
the prospect of being transplanted feels realistic. We believe
this is not currently the case which is why patients are prepared
to take risks.
ORGAN SHORTAGE
Research potential
8. The biggest problem amenable to intervention
at governmental level is the shortage of organs. We agree that
there are many different reasons for this. We believe that within
any member country there may be more different reasons than exist
between countries. This underscores the value of an EU-wide approach
to considering this problem. Factors such as ethnicity, country
of origin, religion, level of education and socio-economic class
have all been shown to affect attitudes to donation. The BTS believes
there is value in undertaking research across national boundaries
to determine common themes in attitudes to organ donation to inform
public policy responses. We believe this is particularly important
in the area of public awareness of organ donation and transplantation.
Indeed, we believe there is an underemphasised level beyond "awareness",
namely public "perception" and inclination to support
organ donation. Research has shown a disturbingly high level of
mistrust of the medical establishment which has an effect on inclination
to consent to donation. In addition, understanding of cultural
and religious values is important in designing approaches to increasing
organ donation. This need for research is underscored by the Commission's
own concession (in the Impact Assessment accompanying the COM(2007)275
final, SEC(2007)704), that the differences in donation rates are
"not easy to understand".
European Donor Card
9. The BTS has concerns about the wisdom
of a European Donor Card. We believe that maximum acceptability
will be achieved by aligning donation with something with which
the public most closely identifies. It may be that national or
supranational identity may not be the most appropriate medium
of identification in this context. For example, in the US, the
Orthodox Jewish community has developed their own card, which
deals explicitly with some of the concerns of their own community.
This may represent a more effective model. Having said that, a
mark of EU support may add to the value of cards that are primarily
more locally affiliated.
10. This touches explicitly again on the
issues of the impact of faith, ethnic backgrounds, country of
origin, and socio-economic backgrounds as areas for further research.
The BTS feels that these are all crucial factors impinging on
attitudes to donation which probably are more important than nationality.
Hence, they must be the subject of close attention in attempts
to develop donation.
The Organisation of Donation
11. Whereas the number of centres performing
recipient transplant operations will be relatively small, and
thus relatively simple to police, if there is to be a real increase
in the number of organs for donation, every acute hospital in
every country has to be involved as a source of donors.
12. In our comments above on organ quality
and safety, we stated that we were concerned that the burden of
ensuring the quality and safety of organ donation and procurement
would be great. Similarly, we believe that increasing the number
of organs donated will also require the commitment of a large
number of professionals at many different centres. We believe
that systems should be developed in parallel to develop local
processes that both ensure the generation of large numbers of
donors and the maintenance of the high quality and safety of those
donated organs.
13. Donor care needs to be considered from
an early stage. Recipients will be dependent on clinical and laboratory
evaluations undertaken by a large number of professionals. The
task of assuring uniformity and quality is thus huge. The BTS
believes that it will be possible to design detailed guidelines,
but ensuring their implementation is a responsibility that will
have to be devolved. Experience from countries such as Spain has
suggested that if responsibility is devolved to an individual
of high enough seniority and influence within his institution
and if there is a financial benefit (or at least no financial
disincentive) to donate, then this local delegation of authority
is likely to be most effective. We also believe that central to
the effectiveness of this process is the completion of the audit
loop, also undertaken at a high level, to reward institutions
that have generated high numbers of donors and demonstrated high
levels of quality and safety in those organs.
14. For these reasons we agree with the
proposal that a flexible system of decentralisation for procurement
and centralisation for promotion of donation and organ distribution
is desirable. We would add, however, that a centralised quality
assurance for procurement with significant incentives and disincentives
for failure needs to be part of that system. This might mean that
the promotion of organ donation and evaluation of the effectiveness
of such activities by local health care bodies would be included
in the criteria by which a trust is evaluated. Money might follow
success and external assessment of processes be triggered by failure.
15. The BTS agrees with the sentiment that
a major issue to be tackled is the loss of donors due to lack
of evaluation, referral or discussion with relatives. We believe
that this will be greatly assisted by the process described above,
of setting in place a high level of audit and incentivisation
of hospitals to maximise the number of donors being generated
locally.
16. It is currently unclear which interventions
are appropriate before death to maintain organ health. The law
needs to be clarified in this area for the benefit of both the
public and critical care staff. In addition, pre-donation and
post-brain stem death research need to be made easier to undertake.
17. One area of significant disparity within
the EU is in the provision of intensive care facilities for potential
donors and the approach to donor care. There is significant potential
for a general improvement in practice following the sharing of
experience between states.
18. Finally, all levels within the donor
pathway need to be considered. The Commission's Communication
gives very little attention to the intensive care community. The
training and practice of these professionals and the provision
of adequate facilities in this sector needs to be incorporated
into any consideration of the organisation of an organ donation
service.
Consent
19. UK law has only recently changed to
move the focus of consent directly to the donor himself. However,
operationally, the family retains an important role. At a practical
level, they may be the only source of information about the deceased's
preparedness to consent to donation. In addition, it is very difficult
to use historical evidence of consent to ignore the implacable
opposition of the deceased's relatives. In practice, they could
say the deceased underwent a last minute change of heart on consent.
We believe this is likely to be true whether the consent is actual
or presumed.
Donation after Cardiac Death
20. The BTS feels that the Commission has
given insufficient emphasis to the development of donation after
cardiac death. This is discussed in some detail in the Impact
Assessment, but not in the Commission's Communication. This is
a labour intensive approach which would be culturally unacceptable
in certain parts of the EU. However, it could make a significant
impact on the issue of organ shortage and, we believe, should
be given more prominence. Data suggest that it is still potentially
cost-effective and we would encourage the Sub-Committee to press
for more detailed consideration of this approach as an additional
string to the bow of increasing organ donation.
Living Donors
21. In view of the proven beneficial outcomes
of live donor programmes and the very low level of donor risk,
the BTS strongly supports their expansion throughout the EU. In
particular, altruistic unrelated organ donation, including "paired"
and "pooled" donations, non-directed donation, and the
development of programmes for higher risk transplantation, such
as blood group-incompatible transplantation and the transplantation
of HLA-sensitised patients, should be encouraged. This is likely
to require additional funding. The BTS has developed Guidelines
in some of these areas of practice which have been widely recognised
as useful aids in practice.
22. All member states should develop appropriate
protocols to eliminate the possibility of undue inducement or
coercion and ensure informed donor consent. However, given the
continued, and growing, overall organ shortage, the urgent need
to expand cadaver donation remains unchanged.
Recipients who are difficult to transplant
23. An additional benefit of sharing between
EU countries which is discussed in the Impact Assessment, but
is insufficiently emphasised in the Commission's Communication,
is the potential value of organ sharing between EU countries for
potential recipients who are difficult to transplant, for example
because of HLA sensitisation. Even in a country as large as the
UK, UK Transplant has found it difficult to develop the practice
of paired donation. This would be greatly improved if the pool
of potential participants could be expanded.
ROLE OF
THE EU
24. The BTS agrees that EU-led cooperation
is essential in preventing organ trafficking and could be helpful
in facilitating the exchange of expertise on safety, organisation
and expanding the donor pool. We also feel that a centrally defined
minimum standard for assessment would be useful. We are not convinced
that there is yet a role for a Europe-wide unified single organ
sharing scheme.
25. An additional important role for the
EU will be in raising public awareness of organ donation.
October 2007
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