Memorandum by the British Medical Association
EXECUTIVE SUMMARY
The BMA has been concerned for many years about
the shortage of organs available for donation and has been actively
working with other organisations to find ways to address the problem.
We welcome any initiatives that are likely to improve organ donation
rates in the UK, and in particular, seeing what lessons we can
learn from other countries within Europe.
The BMA believes that the most effective way
of addressing this issue is a shift to presumed consent, combined
with continued organisational change and financial investment.
Over the last seven years we have seen increasing support for
presumed consent and we believe that it is time to move to this
option, following public debate.
The BMA supports increased communication and
sharing of examples of good practice within Europe but is concerned
that any European approach to the problem should bring clear benefits
to the UK and not simply add an additional layer of bureaucracy
which could, in fact, hinder progress.
SHORTAGE OF
ORGANS AVAILABLE
FOR TRANSPLANTATION
1. Surveys show that around 90% of the UK
population are willing to donate organs after their death,[1]
yet only 23% have signed up to the NHS Organ Donor Register.[2]
For those whose wishes are not known, a nominated individual or
family member is asked to give consent on their behalf but the
Potential Donor Audit,[3]
co-ordinated by UK Transplant, shows that the relative refusal
rate currently sits at around 40%. This means that many organs
that could be used for donation are lost because individuals never
got around to making their views known—either by signing
up to the ODR or discussing their wishes with their relatives.
This is the fundamental problem that needs to be addressed and,
we believe, where attention needs to be focussed.
Public campaigns
2. There is an important role for public
campaigns and the BMA has supported and initiated many campaigns
to improve awareness of organ donation generally and specifically
to encourage people to make their wishes about donation known.
We have co-ordinated public campaigns and run campaigns within
our own membership. One of the most successful campaigns run by
UK Transplant was the "vote for life" scheme where people
could register on the ODR at the same time as completing their
electoral registration forms. Between 1999 and 2004, this campaign
was taken up by a number of councils resulting in responses from
more than 719,000 people. This campaign was stopped however when
the Electoral Commission issued a Circular informing electoral
registration staff that the scheme risked contravening regulation
94(3) of the Representation of the People (England and Wales)
Regulations, since the material had no connection with electoral
issues. Similar advice was provided in Scotland. The BMA recommends
amending the relevant statutory instruments so that this very
successful campaign can continue.
The role of relatives
3. The BMA welcomes the changes introduced
in the Human Tissue Act 2004 and the Human Tissue (Scotland) Act
2006 clarifying that where an individual has given prior consent
to donation, there is no legal right of veto by the relatives.
The Human Tissue Authority's code of practice and, we understand,
training of transplant co-ordinators, now focuses on the importance
of strongly encouraging relatives to respect the wishes of the
deceased person. The legislation is, however, permissive and does
not require donation to proceed, so there are exceptional cases
where donation would not proceed despite consent having been obtained
from the potential donor. The BMA believes, from a practical perspective,
that this is correct since insisting on donation against the very
strong and sustained views of the relatives risks causing more,
and lasting, damage to the organ donor programme. The duty of
care owed by health professionals to recently bereaved relatives
also requires a flexible and humane approach in exceptional cases
where donation is likely to cause additional severe distress.
The more individuals are encouraged to discuss their wishes with
their relatives, however, the less likely such disagreements are
to occur.
Presumed consent
4. Whilst supporting all of these attempts
to increase the number of donors available, the BMA strongly believes
that the change that is likely to have the most impact on donor
numbers is a shift to a system of presumed consent with safeguards.
The Chief Medical Officer for England has also recently supported
a shift to presumed consent in order to address "the current
supply and demand crisis"[4]
and we are delighted that the Government has asked the Organ Donation
Task Force to investigate this option. This is the way such a
scheme would work:
— in advance of the change there
would be extensive and high profile publicity advising people
of how to opt out if they do not wish to be donors;
— mechanisms must be in place
to ensure all sections of the public are informed and can register
an objection easily and quickly;
— after the system has come into
effect, when a person dies in a situation that makes donation
a possibility, the opt-out register must be checked;
— if the individual had not opted
out, the relatives would be informed of this and asked if they
are aware of any objection to donation by the individual that
had not been registered;
— if the relatives are not aware
of any objection, they would be informed that the intention would
be to proceed with donation; and
— donation would proceed unless
it became evident that to do so would cause severe distress to
those close to the deceased patient.
5. The main reasons underpinning the BMA's
support for this change are:
— the vast majority of people
are willing to donate their organs for transplantation purposes,
but less than a quarter of the population are on the NHS Organ
Donor Register;
— given that the majority of people
would be willing to donate, presuming consent rather than presuming
objection is more likely to achieve the aim of respecting the
wishes of the deceased person;
— unlike the current system, there
would be a clear mechanism for protecting the wishes of those
who do not want to become a donor;
— while relatives would still
be consulted, they would be relieved of the burden of making the
decision in the absence of any indication of the deceased person's
wishes;
— a shift to presumed consent
would prompt more discussion within families about organ donation;
and
— with such a shift, organ donation
becomes the default position—this represents a more positive
view of organ donation, which is to be encouraged.
6. Despite the difficulties of obtaining
meaningful data about the success of presumed consent in other
countries, there is growing evidence that presumed consent has
a positive effect on donation rates. In 2006, a detailed regression
analysis was published[5]
comparing 22 countries over 10 years taking account of determinants
that might affect donation rates including gross domestic product
per capita, health expenditure, religious beliefs, legislative
system, and number of deaths from road traffic accidents and cerebrovascular
diseases. It concluded that "When other determinants of donation
rates are accounted for, presumed consent countries have roughly
25-30% higher donation rates than informed consent countries."
Another study, published in 2003[6]
concluded that presumed consent was one of four variables considered
that was a significant predictor of cadaveric organ donation rates.
The authors stated that evidence from their study clearly suggest
that the practice of presumed consent legislation has a "significant
effect" on the number of cadaveric donors per million population.
7. The BMA agrees with those who say that
it is crucial that there is public support for a change to presumed
consent but we firmly believe that there is growing support for
such a shift. There have been a number of public opinion surveys
on this topic over the last five years, which show up to 60% support
for such a change.[7]
This is 60% before there has been any concerted effort to educate
and inform the public about the way such a system would work and
to facilitate an informed public debate on the matter. The BMA
does not believe it is acceptable to use lack of public support
as a reason to reject presumed consent without at least making
a clear effort to determine what the public's opinion is on this
matter. We believe that now is the time for an informed public
debate about moving to this option.
European organ donor card
8. We have been able to find very little
information in the European Commission's reports about the benefits
of a European organ donor card, or how such a card would work.
Donor cards can be helpful in promoting debate within families
but they are less effective than the ODR in terms of advising
health care staff of the donor's wishes at the time of an illness
or accident.
9. It is not clear whether the intention
of a European organ donor card is that organs would be routinely
shared throughout Europe, rather than throughout the UK as at
present, but this seems unlikely because of the short period of
time available between retrieval and transplantation of the organ.
We would also be concerned that routine sharing across Europe
may make people less, rather than more, inclined to sign up for
donation. If this is not the intention of such a card, it is unclear
why the European Commission is considering putting in place a
system to facilitate the transmission of "full donor records"
within Europe which, in itself, raises issues about confidentiality.
10. The idea may be that if an individual
is in another European country and is taken ill or has an accident
whilst carrying a European donor card, that card would be sufficient
evidence of consent to permit donation in that country. This would
require harmonisation of the legal framework throughout Europe
which is likely to be difficult. In the UK most people sign up
to the ODR rather than carrying a card. Although some people may
wish to carry a European card, in addition to being on the register,
the numbers may be small and it is questionable how much of an
impact such a scheme would have on the donation rates in specific
countries.
11. We have concerns about the idea of a
European organ donor card, but we do not feel that sufficient
information has been provided to make an informed judgement on
this issue. We would need to see good evidence of benefit arising
from such an initiative before we could support it.
EXTENDING DONORS
12. The BMA strongly supports the increased
use of living organ donors and non-heartbeating donors with the
safeguards that are currently in place in the UK. We are pleased
that the new system for approval of living organ donation in the
UK appears to be working well[8]
and that, with the implementation of the new legislation new safeguards
have been put in place to ensure that potential donors are not
subject to coercion.
13. We also support the use of "expanded
donors" (increased donor age, donors with a history of malignancy,
congenital or inherited disorders etc) subject to a careful assessment
of the benefits and risks in each individual case.
ORGANISATION OF
ORGAN TRANSPLANTATION
SYSTEMS
14. It is clear from those countries that
have successfully increased their donation rates, most notably
Spain, that this has been achieved through financial investment
in the donation service, including the recruitment of additional
staff. In Spain, for example, over a decade the number of transplant
coordinator teams increased from 25 to 139.[9]
If the UK is serious about improving donation rates, financial
investment in the service is an important factor.
15. Spain also has a system of presumed
consent, although in practice relatives are still consulted before
donation proceeds. As discussed above, the BMA believes that presumed
consent would significantly increase donation rates in the UK
and would provide a more positive ethos around donation, which
would eventually be seen as the norm rather than the exception.
EU DIRECTIVE ON
THE SAFETY
AND QUALITY
OF ORGANS
16. Whilst safety is an important issue,
we believe that the main problem that needs to be addressed in
the UK is the shortage of donors. The EU Tissues and Cells Directive
has created considerable additional work, with the need for inspections
every two years by a "competent authority" and we are
concerned that money would be diverted away from transplantation
and patient care towards meeting regulatory requirements for inspections
and additional bureaucracy, without any clear benefits. There
are existing procedures in place to ensure the safety and quality
of organs and this does not appear to be a major problem in the
UK.
17. Unless clear benefits to the UK can
be demonstrated from a European Directive on organs, we would
have serious concerns about this option.
ILLEGAL ORGAN
TRAFFICKING
18. The BMA supports moves to stop illegal
organ trafficking and the UK has enacted legislation with this
aim. Other countries that have not taken this action may wish
to adopt a similar approach. It is not clear how a European approach
to this problem would work but the BMA would be willing to consider
any proposals aimed at reducing this practice.
ETHICAL ISSUES
RELATING TO
TRANSPLANTATION
19. The current opt-in system of organ donation
is usually presented as requiring explicit consent from the donor
but in reality this is not the case. While some people have given
explicit consent to donation, before their death, the majority
have not. In these cases it is the wishes of the relatives that
prevail, usually based on their "best guess" of what
the deceased person would have wanted. At a time of recent bereavement
and in the absence of any prior discussion with the deceased,
many relatives, understandably, opt for the default position—which
is not to donate and this leads to the high relative refusal rate.
20. Although the current opt-in scheme is
often justified as respecting the autonomy of the individual,
this is highly questionable. In fact, given that we know the majority
of people are willing to donate, a system that presumes consent
is more likely to respect the wishes and autonomy of the donor,
than the current system which presumes objection.
21. Whilst the autonomy and interests of
the donor are important, the needs and interests of those who
are waiting for a transplant are often overlooked. Many of these
people will die because of the organ shortage. An appropriate
balance needs to be sought between the interests of the donors
and those of the potential recipients. It is interesting, for
example, that the Human Tissue (Scotland) Act 2006 gives priority
to transplantation over other uses of the body after death. So,
if an individual had given prior consent to the donation of his
or her body for research but the relatives were willing to donate
the body for transplantation, the relatives' consent for donation
would override the individuals' own wishes. The rationale for
this approach was that transplantation can save lives.
AN EU APPROACH
22. The BMA supports improved co-operation
and communication within Europe, particularly in order to identify
methods that have been effective in increasing donor numbers in
other countries and exchanging examples of good practice. We are
concerned, however, that any measures should help and not hinder
the current situation in the UK. There is a risk that European
activity, such as an EU Directive, may simply add another layer
of bureaucracy to existing practice in the UK without bringing
added benefit or addressing the main problem, which is the shortage
of donors.
8 October 2007
1 UK Transplant. Survey shows huge support for organ
donation. Press release, 23 March 2003. Back
2
UK Transplant. Transplants saves lives. www.uktransplant.org.uk Back
3
UK Transplant. Potential donor audit, 36 months summary report
1 April 2003-31 March 2006. Back
4
Chief Medical Officer. 2006 Annual Report of the Chief Medical
Officer: On the state of public health, 2007. London: Department
of Health. Back
5
Abadie A, Gay S. The impact of presumed consent legislation on
cadaveric organ donation: a cross-country study. J Health Econ
2006;25 : 599-620. Back
6
Gimbel RW, Strosberg MA, Lehrman SE, Gefenas E, Taft F. Presumed
consent and other predictors of cadaveric organ donation in Europe.
Progress in Transplantation 2003;13(1):17-23. Back
7
In May 2005, a representative sample of 2,067 people over 16 years
of age was interviewed on behalf of the BBC and 6/10 respondents
supported a shift to presumed consent. Back
8
Human Tissue Authority. Delivering better regulation. Human
Tissue Authority, Annual Report and Accounts 2006-07, July 2007
London: The Stationery Office. Back
9
Miranda B, Fernández Lucas M, de Felipe C, Naya M, González-Posada
JM, Matesanz R. Organ donation in Spain. Nephrol Dial Transplant
1999;14 (suppl 3): 15-21. Back
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