Memorandum by Kidney Research (UK)
INTRODUCTION
1. Kidney Research (UK) warmly welcomes
the involvement of the European Commission in developing policy
in regard to organ donation and transplantation. For those patients
with kidney failure for whom transplantation is an appropriate
option, it offers on average a doubling of their life expectancy
and a similarly significant rise in the quality of their lives
compared with remaining on dialysis. However, too few patients
have this option because of the lack of organs available for transplantation.
We believe that the involvement of the Commission may indeed provide
opportunities to increase the number of available organs. Given
the interests of Kidney Research (UK), the focus of our comments
will be on the potential for the Commission to support research
into organ donation and transplantation.
2. Shortage of donors.
DECEASED DONOR
TRANSPLANTATION
3. There are many different reasons for
the shortage of organs donated for transplantation. However, the
differences between countries may be less that those between different
groups within any individual country. This means that there are
potentially significantly greater insights to be gained by the
sharing of information. Research needs to undertaken across national
boundaries to address the impact of ethnicity, country of origin,
religion, level of education and socio-economic class on the decision
to offer organs for donation. All these factors have all been
shown to affect attitudes to donation. This need for research
is underscored by the Commission's own statement (in the Impact
Assessment accompanying the COM (2007)275 final, SEC (2007)704),
that the differences in donation rates are "not easy to understand".
4. A greater understanding of how each of
these impacts on the decision to donate has the potential to inform
public policy responses. Kidney Research (UK) believes that such
public policy responses include not just a re-evaluation of the
legislative framework by which transplantation is regulated, but
also the way in which organ donation is treated as a factor in
health education. This is an area in which Kidney Research (UK)
has a significant track record of achievement. In our ABLE ("A
Better Life") programme of research we have studied the impact
of renal disease in the ethnic minority communities in the UK,
including attitudes to organ donation. We have been instrumental
in developing and studying "peer educators" as a route
by which to disseminate rapidly the outcomes of research we have
sponsored with a view to informing the public and altering misperceptions.
5. Recent research and clinical experience
in the UK and abroad has shown that non-heart beating donors (NHBD)
can be an effective additional source of organs for cadaveric
renal transplantation. This requires significant investment in
infrastructure and attention to service organisation. However,
although NHBD is very successful, it remains somewhat less successful
than heart-beating donor transplantation. Kidney Research (UK)
believes that it is important to invest further in more research
in this area to improve organ preservation techniques and to address
the common problem of poor initial function associated with these
grafts.
LIVING DONOR
TRANSPLANTATION
6. Living donor transplantation is very
successful and is associated with very low level risk to the donor.
However, in this field too there is much still to be understood
about the factors that motivate and concern potential donors.
Similarly, the cultural context has a significant bearing on attitudes
to altruistic unrelated organ donation, including "paired"
and "pooled" donations and non-directed donation. These
need to be the subject of further research. As above, we believe
that the pooled knowledge across different countries of the EU
will be useful in informing public policy and practice.
RECIPIENTS WHO
ARE DIFFICULT
TO TRANSPLANT
7. An additional benefit of collaboration
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.
We believe this has the maximum potential applicability to help
potential recipients who are difficult to transplant.
8. Some patients represent a significant
challenge to the transplant team in that they are more likely
to reject an organ because, for example, their donor is blood
group-incompatible or the recipient has been sensitised to HLA
antigens. Other patients are difficult to transplant because of
concurrent co-morbidities, because of sensitivities to immunosuppression
or because of anatomical abnormalities. In many of these cases,
a successful transplant is still in the patient's interest. Hence,
there is great potential for improving these people's transplantability
by undertaking basic and clinical research on how to develop these
programmes for higher risk transplantation. This would be very
appropriately organised at an EU-level since there are laboratories
and clinical services with extensive appropriate experience located
throughout Europe which could and should effectively collaborate
in order to understand better how to serve these particularly
disadvantaged patients.
9. An additional factor derives from the
potential for sharing organs to help patients who are difficult
to transplant. 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.
CONSENT ISSUES
10. UK law has recently changed to move
the focus of consent directly to the donor him or herself. Different
countries have different approaches to consent. The decision as
to which approach should be implemented is often cultural or historical.
However, Kidney Research (UK) believes it would be much better
to base the decision on how to best obtain consent for organ donation
on the basis of evidence. We would encourage the EU to commission
research into the factors that render each form of consenting
acceptable, the ethical implications of each and to disseminate
information of consent between states to maximise citizen comfort
and satisfaction. This would have a potential knock-on effect
for improving organ shortage.
INFRASTRUCTURE
11. Every acute hospital in the EU should
be involved in recruitment of deceased organ donors. Indeed, there
is potential for encouraging registration as potential donors
at the level of primary care. The reality of all health care systems
is that all professionals are subject to a number of competing
pressures. In order to make the encouragement of organ donation
a high priority, ways of incentivising these professionals must
be identified. These will vary between environments as disparate,
say, as intensive care units and general practice. Kidney Research
(UK) believes that there is important health service organisation
research to be undertaken across the EU from which member countries
can learn from each other. We believe that the supporting of this
type of research should be a priority for the EU.
12. There are obvious issues around the
conflict of interest between donor and the recipient in pre-donation
donor care. However, it is well known that the pre-donation phase
has a significant impact on the outcome following transplantation.
Kidney Research (UK) would like to encourage the support of research
into both the organic and the ethical aspects of optimal pre-donation
donor care. Also in this area, the regulatory aspects of undertaking
pre-donation and post-brain stem death research need to be made
less onerous.
CONCLUSION
13. In this brief submission, we have identified
several areas of research which we believe should be considered
in the context of the response to the Communication from the Commission
to the European Parliament and the Council, "Organ Donation
and Transplantation: Policy actions at EU Level" (COM (2007)275
Final). It is clear that this will demand significant extra research
funding. Kidney Research (UK) believes that such an investment
will be well spent. Not only will there be real benefit in terms
of life expectancy and quality of life for the citizens of the
EU; numerous health economic studies have demonstrated that the
cost to the health care provider of maintaining a person with
a transplant is much less that maintaining him on dialysis. Hence,
investment in research that leads to an increase in successful
transplantation will be cost effective for the EU and we would
commend it to the Commission.
1 October 2007
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