Memorandum by the Royal College of Physicians
The Royal College of Physicians (RCP) plays
a leading role in the delivery of high quality patient care by
setting standards of medical practice and promoting clinical excellence.
We provide physicians in the United Kingdom and overseas with
education, training and support throughout their careers. As an
independent body representing over 20,000 Fellows and Members
worldwide, we advise and work with government, the public, patients
and other professions to improve health and healthcare.
The RCP has a number of specialties with an
interest in this issue, and our evidence has involved some of
their views. We are pleased that the inquiry is addressing the
key issues which are limiting the desired increase in organ donation.
The following responses are based on opinion among a number of
key specialties with an interest in this issue, including nephrology,
lung transplant physicians, and a wider discussion at our Committee
on Ethical Issues in Medicine (CEIM). Although there are many
generic issues pertinent to organ transplantation, organ specific
issues can be very different depending on which organ is discussed,
and there are still a number of key ethical issues that the committee
should consider.
PARTICULAR ISSUES
RAISED IN
THE COMMISSION'S
COMMUNICATION
EU-wide shortage of organs available for transplantation
It is acknowledged that there is a shortage
of organs available for all forms of solid organ transplant and
that this problem is both European and world-wide. In kidney transplantation,
for example, this shortage can only be realistically met in by
the continuing expansion of living kidney donation. It is also
clear that, with regards to organ donation rates per million population
(pmp), there is wide variability across Europe. This reflects
differences in organisation of organ donor services between different
countries and also represents different legislative arrangements
in different member States. Some States use a presumed consent
law, while others require next of kin consent even when an individual
expressed a wish to be an organ donor before their death. In Spain,
organ donation is managed in a very pro-active manner with dedicated
donor co-ordinators in each major hospital and financial rewards
to hospitals which identify donors. This approach means Spain
has the highest pmp donor rate in the world. We believe that "best
practice" from across Europe should be identified. This process
should provide an opportunity for harmonisation of legislative
approaches to consent for organ donation across the EU.
As well as a need to increase the number of
donors, it is clear that there needs to be improved utilisation
of existing donors. In lung transplantation the percentage of
potential donor lungs actually used in transplantation varies
widely between member states, from as low as 16% to 40%. There
are a number of reasons for this observation. The lung is particularly
susceptible to damage after death and caution on behalf of the
transplanting surgeon to prevent early graft dysfunction means
many donor organs are declined as unusable. Additionally, infrastructural
problems at both a national and regional centre level, prevent
maximal utilisation of available donors.
Organisation of organ donor and transplantation
systems
In the United Kingdom the co-ordination of organ
donation and allocation of organs to transplanting centres is
performed by UK Transplant, an NHS body. Different systems operate
for different organs, changing how waiting list patients are managed.
For example, in kidney transplantation there is a national waiting
list whereas for lung transplantation each centre manages their
waiting list independently. Further consideration needs to be
given to the benefits of national versus centre-controlled waiting
lists as there are advantages and disadvantages to both approaches.
There is some support for an expansion of the Eurotransplant system
for donor organ distribution beyond the limited part of Northern
Europe that it currently covers, and improve liaison, such as
organ sharing with other parts of the EU.
In the United States the adoption of a lung
allocation score to help prioritise patients on the lung transplant
waiting list has led to a dramatic reduction in waiting list mortality
and has meant the patients in most need have received the organs
as they become available. It has also however meant slight worsening
in early outcomes as more sick patients are now receiving transplants
than previously. The merits of such a system should be investigated
certainly at a national level and perhaps on a European Union
wide basis.
The ability to perform lung transplants, even
when organs are available, is not infrequently limited by infrastructural
problems. If transplantation is to succeed as a recognised treatment,
services need to be backed up by appropriate resources to allow
simultaneous transplants to occur, sufficient transport by air
to be available for moving organs between centres and by the development
of an organised and highly skilled organ retrieval service. These
issues could be addressed on an EU wide level with minimum standards
set for member states.
Raising public awareness of organ donation
It is the experience of our colleagues in renal
medicine that sustaining interest with the public is very challenging.
There should be an increase in resources available to obtain expert
opinion and advice from PR and communications experts about this.
It is also broadly recognised that a huge amount
of effort has gone into raising public awareness of organ donation
through national organ donor registers in the UK, donor cards
and maximising publicity on television, radio and in printed material.
It is the opinion of the lung transplant community that this approach
has now been exhausted and that to have a significant impact on
the number of organ donors, a change to legislation to introduce
presumed consent is needed. The fact that an individual can carry
a donor card and yet still not be able to act as an organ donor
due to refusal of the next of kin would seem to fundamentally
undermine the value of pushing further with the donor card scheme.
However, our Committee for Ethical Issues in
Medicine (CEIM) raise issues around the UK Chief Medical Officer's
proposal to change the law to an "opt out" system. The
committee noted that the language used was misleading. So called
"presumed consent" is not consent at all: it consists
of the non-consensual removal of organs and tissues. Similarly,
such organs are not "donated": they are removed (or,
rather less delicately, harvested). It is felt that the use of
the terms "presumed consent" and "donation"
should not be used in this context.
Use of organ donor cards, including the idea of
a European organ donor card
The introduction of a European organ donor card
is likely to require significant resource effort and yet unless
there is a change in the law in the legal status of prior consent
this is likely to yield little reward by producing more donor
organs. (Please also note response above).
However, a significant body of our ethics committee
did not believe that increased participation in the current donor
card scheme represented an approach that had been exhausted. There
had been no use of income tax forms or electoral registration
forms, for example. The success in increasing donor card registrations
from the Boots Advantage Card scheme suggested that similar approaches
through banks or other commercial bodies might also be considered.
Some CEIM members were supportive of an opt-out
scheme. However there was considerable doubt that a so called
"soft opt-out" scheme, such as that supported by the
British Medical Association, would improve the present donor rates—and
could even make them significantly worse. Our understanding is
that many practitioners approaching a bereaved family already
introduce discussion of organ retrieval by inquiring if the family
members are aware of objection, rather than of positive wishes
to donate. The BMA proposal has little to offer beyond that and
the public debate needed to achieve it could easily backfire with
reduced donations. (The similarity to the opt-out arrangements
for removal of organs post mortem in the Bristol and Alder Hey
events was noted). Some members felt that if an opt out scheme
is to be introduced, this would need to be the `tougher' version
which we understand to be in use in Austria, but there are other
ethical issues relating to this kind of system.
There was a strong view in the CEIM that the
provisions of the Human Tissue Act, which prevents a veto by the
family where the potential donor has registered his/her wishes
in the donor card scheme, should be supported in practice, without
the possibility of being over-ruled as in the Human Tissue Authority
Code of Practice 2, para 40. This states "It should be made
clear that they do not have the legal right to veto or overrule
those wishes... There may nevertheless be cases in which donation
is inappropriate and each case should be considered individually."
The committee felt the latter sentence would be best withdrawn.
Use of volunteer living donors
In kidney transplantation, use of living donors
is in many cases by far the best therapeutic approach.
It is the opinion of the UK lung transplant
centres that this approach to donor organs for lung transplantation
should be considered second choice to use of cadaveric or non-heart
beating donor lungs. There is no survival advantage to patients
undergoing lung transplantation using lungs from living donors.
There are however, in addition, significant morbidity risks to
the two living donors. This service should be available in UK
centres, but perhaps to focus expertise it should only be offered
in one or two centres nationally.
Ensuring the quality and safety of cross-border
organ donation within the EU
Clearly the effective communication of donor
details is essential in order to allow effective decision making
on the suitability of a donor organ for transplantation. A minimum
data set should be agreed when donor details are communicated
and also a timely transfer of information between centres is essential.
There are a number of laboratory based assessments which are an
essential part of organ transplantation, including tissue typing,
viral serology etc which must be robust and accurate if organs
are to be safely used between member states of EU. Any member
taking part in organ sharing would need to guarantee the standard
of these.
Modern e-communication and rapid movements of
organs should be explored to maximise opportunities for cross-border
organ donation in Europe.
There is a need to explore the reasons for regional
differences within the UK. It seems likely that EU member states
may also demonstrate such differences. Such reasons may be capable
of change.
Ethical issues relating to organ donation and
transplantation
(i) Lung
There are a number of key ethical issues which
face the lung transplant field at present. First is the issue
of re-transplantation. Outcomes for re-transplantation of patients
who have previously undergone lung transplantation can be as good
as first transplants when patients are very highly selected. However,
there is an ethical issue associated with giving individuals a
second opportunity when those who are still waiting their first
transplant may die on the waiting list. At present each centre
assesses individuals for re-transplantation on their merits, but,
as the number of lung transplant recipients increases, the demand
for re-transplantation is also likely to increase. If there is
not a significant increase in the supply of donor lungs then ethical
issues about restricting access to re-transplantation may arise.
The second major issues relates to pushing the
boundaries of donor lung acceptability. Very few donor lungs now
fulfil the ideal selection criteria for use in lung transplantation.
Many centres extend the acceptability of donor organs by using,
for example, lungs from older donors, donors with a smoking history,
donors where there may be signs of mild infection etc. It is imperative
that more research is done to try and determine some objective
measures of predicting outcome from different organ donors. It
is also imperative that more research is done on trying to optimise
potential donor organs to transform them from unsuitable to useable
organs. Such research should be seen as a priority and integral
to the provision of an EU wide transplant service.
(ii) General issues
As well as specific issues raised throughout
this submission relating to points made by our CEIM, there are
further points around ethical issues to organ donation and transplantation
that are relevant here. There was a significant view within the
CEIM that the proposal for mandated choice should be explored
in more detail. Mandated choice means that it would be legally
binding to make a choice whether to donate or not (or even whether
or not to make a decision at the present time). This would have
the advantage over opt out schemes of ensuring that all organ
retrieval was consensual. It could be introduced in addition to
the current donor card scheme and the documentation by which choice
is recorded could be an addendum to either electoral registration
papers or income tax forms or both. Special arrangements would
still be needed for potential heart beating child donors. The
view was expressed that this may be too cumbersome a proposal
to be practical, but proponents argue that it has not been seriously
explored. Ethically it has the benefit of putting consent at the
heart of the process.
Health and social welfare benefits of organ transplantation
We feel that the benefits to health and social
welfare are clear, in terms of reduced mortality as well as quality
of life and health.
There are a significant number of studies now
showing a dramatic improvement in quality of life associated with
lung transplantation, but this improvement does vary between disease
indications and with the age of the patient at time of transplant.
However, many patients having undergone lung transplantation will
return to work and will no longer be seeking welfare benefits.
Medical risks of organ transplantation
In many situations the medical risks are clearly
outweighed by the benefits; but there is a substantial minority
keen for live donor kidney transplant where the risks to both
recipient and donor are substantial. The alternative situation
in renal medicine is for the patient to remain on dialysis.
As experience increases both early and later
outcomes from lung transplantation are also improving. A point
will be reached where the major medical risk limiting quality
of life after lung transplantation will relate to the side affects
of immunosuppression. This can cause significant morbidity to
lung transplant recipients due to the development of hypertension,
significant renal dysfunction, increased risk of malignancy and
neurological toxicity. There is a significant need to develop
newer generation immunosuppressants which have fewer side effects
and to develop new protocols where immunosuppression can be weaned
down to as low as possible in those individuals who have become
tolerant of their organ. This would make sure that only those
patients requiring higher levels of immuno-suppression receive
more aggressive treatment.
The use of more heart beating donors and of
greater use of marginal donors—(e.g. diabetic, older donors
or even hepatitis B & C positive donors in particular cases)—should
also be considered.
Illegal trafficking in organs
All UK lung transplant centres support patients'
rights to a second opinion. If a patient has been declined for
lung transplant by a UK transplant centre, we are very happy to
provide a second opinion at a second centre within the UK. Some
patients however will seek private transplantation in countries
outside the EU. Significant concern remains as to how donor organs
are procured in certain countries. When patients return from these
countries having undergone lung transplantation there is an expectation
that they will be provided with on-going follow up care within
UK lung transplant centres. This causes significant ethical dilemmas
as clearly there is a duty of care to the individual patient yet
there is also a wish not to be seen to condone illegal donor organ
procurement in other countries. The International Society of Heart
and Lung Transplantation recently published a position statement
on this situation. Rigorous steps by the EU to minimise the risk
of illegal trafficking are emerging in Europe, and to make plain
our antithesis to such trafficking.
OTHER
ISSUES OF
RELEVANCE TO
THE COMMISSION
DOCUMENT
Questions which may arise in relation to organ
donation and transplantation from a faith-based point of view
The UK experience in kidney transplantation
suggests that faith-based perspectives are usually not the limiting
factor for the expansion of kidney transplant services, but misunderstanding
of the views of faith leaders among ordinary members of these
faith communities often undermines progress in increasing donation
rates.
12 October 2007
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