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Law, ethics and medicine

The potential impact of an opt-out system for organ


donation in the UK
Romelie Rieu

Oxford University, Green ABSTRACT published in late 2008, concluded that policy
Templeton College, UK The recent report of the UK governments Organ changes should not happen at the present time.
Donation Taskforce is in favour of continuing with the In this article I outline the current and proposed
Correspondence to
Ms Romelie Rieu, Oxford current organ donation system rather than changing to systems and appraise the second Taskforce report,
University, Green Templeton an opt-out system where people are assumed to be examining its ethical position and its assessment of
College, Woodstock Road, willing to donate. How did it reach this decision and is it empirical data under three headings: assessment of
Oxford OX2 6HG, UK; correct? public opinion, analysis of faith and belief groups,
romelie.rieu@gtc.ox.ac.uk
and the impact of opt-out systems. I shall conclude
Received 17 June 2009 that both the ethical position and the assessment
Revised 21 March 2010 of data are inadequate and the conclusion is wrong.
INTRODUCTION
Accepted 31 March 2010
The government needs to increase organ donation
in the UK to meet the increasing demand for CURRENT AND PROPOSED SYSTEMS
organs. Scientic breakthroughs in transplant The current system
technology and the introduction of immunosup- Since the Human Tissue Act 2004 (which was
pressive drugs have revolutionised the potential enforced in 2006), the UK employs an opt-in
benet of organ transplantation. Furthermore, the system. Theoretically, it requires those wishing to
demand for these sophisticated surgical procedures donate organs after death to join the ODR and/or
has increased signicantly as the population ages, carry an organ donor card, or to otherwise clearly
the incidence of predisposing diseases rises and the express their wishes. In this way wishes regarding
care of co-existing diseases improves. The number organ donation are made clear in life and can be
of patients on the waiting list for organs currently respected in death. In reality this rarely happens.
exceeds 9000, and has increased by 40% since 2001. Thus families are often relied upon in the difcult
Moreover, this gure is likely to radically underes- time around the death to decide whether organ
timate the number who would benet from donation should take place. Indeed, over 80% of
transplantation, given that the shortage of organs current donations are agreed to by the family
i
dissuades doctors from recommending patients for without a background of ofcial registration.
transplants and as patients who become too ill to Meanwhile, the high family refusal rate in the UK,
i
undergo surgery are taken off the list. Meanwhile, averaging 40% and approximately 45% in situa-
the number of heart-beating cadaveric donors, the tions where the potential donor has not registered
most common source of deceased donation in the on the ODR, is the major factor limiting the
UK, has fallen by 13% since 2004; these are indi- number of potential donors who go on to donate.2
viduals who have suffered a catastrophic injury and Furthermore, a minority (10%) of families refuse
are ventilated before death. The number of people despite the deceased having registered a wish to
on the Organ Donor Register (ODR) has doubled donate on the ODR. While the familys power to
from 8 to 16 million between 2001 and 2009.i Thus refuse permission for organ donation has no legal
there is a widening gap between the number of basis, in practice their wishes are often given
organs available and the number of patients precedence over the autonomy of the donor.
awaiting organs for transplantation, with the Despite the NHS declaring a doubling of the ODR
inevitable tragic consequences. between 2001e2009, currently only 28% of the
Perhaps the most poignant reminder that the population are registered and any rise has not
current system of organ donation is failing us is the translated into increases in organ donation; indeed,
number of those dying prematurely on the waiting the number of heart-beating donors has fallen since
list: now at approximately 1000 every year.1 3 2004.
One way to increase organ donation might be to
change the system of donation. At the request of Proposed: an opt-out system for organ donation
the government, the Organ Donation Taskforce The possibility of introducing an opt-out system of
(referred to here as the Taskforce) carried out two organ donation has received strong support from
studies. The rst focused on optimising the infra- the Prime Minister, the British Medical Associa-
structure and public awareness of organ donation,1 tion,3 the Chief medical Ofcer and, according to
and the second on the potential impact of an various polls, a signicant majority of the public.
opt-out system of donation.2 This second report, An opt-out system is one where adults are
considered to be willing to donate unless they opt
i out by joining a national register, shifting the
This information was made available by personal request to the
UK-transplant statistical office as data from the National Donor
default position to presumed willingness to donate.
Database. For the latest published data please visit http://www. There are two types of opt-out. In hard systems
uktransplant.org.uk, or ring them on 0117 975 7575 and ask. the familys wishes are not considered when

534 J Med Ethics 2010;36:534e538. doi:10.1136/jme.2009.031757


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Law, ethics and medicine

deciding whether or not to donate. In soft policies, as proposed, The default position
families can volunteer dissent for any reason, retaining their Various opinion polls have reported that approximately 70e90%
veto, but in an environment of anticipated donation. Numerous of the public feel positively about donating their organs.3 Why is
European countries have successfully implemented opt-out this not reected in the default position? Under the current opt-in
systems to increase donation rates (gure 1). system the default position of presumed unwillingness to donate
has arguably limited both the numbers of donors and the
autonomy of potential donors (gure 2, table 1). Under an opt-out
ETHICAL PRINCIPLES RELEVANT TO THE TASKFORCE system the public, including families of the recently deceased,
CONCLUSIONS would be primed to donate unless the deceased had opted out.
The family veto This would support the overall aim to facilitate potential donors
Family input is viewed as a safeguard. If the deceased has not who do not oppose organ donation to donate and, in doing so, save
registered an ofcial position on organ donation but the family lives. This is echoed by support for a change in policy. The most
know his/her views, these can then be acted on. Paradoxically, recent government opinion poll in 2007 showed 64% of the public
this means families can dispute the deceaseds wishes. While the support a change to an opt-out system.5
families have no rights afforded by the law, in practice it is
often their wishes that are respected. In principle, the familys Balancing possible outcomes: loss of autonomy, gain of life
wishes are sought in both systems. However, one might predict The report emphasises the potential loss of personal choice with
that under an opt-out system fewer families would override the an opt-out system but seems not to explore the similar loss in
deceaseds wishes. In Belgium, which has an opt-out system, the the current opt-in system. This emphasis suggests that the
family refusal rate is 13%, compared with 40% in the UK.4 Taskforce think it is worse for an individual who does not want
to donate their organs to then donate, than for an individual
who was happy to donate not to. Is one type of loss of
autonomy better than the other? In the latter position, an
individuals organs are not donated despite their wish for this,
resulting in the death or suffering of someone on the waiting
list. In the former position, an individuals organs are used
against their will, beneting someone on the list.

CURRENT SYSTEM
100 people

OPT IN = 28ppl Dont OPT IN = 72ppl


(28% on ODR) (72% not on ODR)
Wish Yes: 28 Wish Yes: 52
Wish No: 0 Wish No: 20

Family Veto 10% Family Agree 90% Family Refusal Family Agree
Dont Donate: 2.8 Donate: 25.2 (45%) = 32.4 (55%) = 39.6
Wish Yes: 23.4 Wish Yes: 28.6
Wish No: 9 Wish No: 11

PROPOSED SYSTEM
100 people

OPT OUT = 14ppl Dont OPT OUT = 86ppl


Wish Yes: 0 Wish Yes: 80
Wish No : 14 Wish No : 6

Family Veto 0% Family Agree 100% Family Refusal Family Agree


Donate: 0 Don
Dontt Donate: 14 unknown unknown
(20%) = 17.2 (80%) = 68.8
Wished Yes : 16 Wished Yes : 64
Wished No : 1.2 Wished No : 4.8

Figure 2 A mathematical model to predict autonomy in the two organ


donation systems. The model predicts the number of donors in each
system; by comparing these numbers to the percentage we would
expect to want, or not want, to donate, we can predict autonomy.
Numbers used in the model include: 28% of the public are on the ODR;
80% of individuals would like to donate (a conservative estimate from
the figure of 86% in the Taskforces opinion poll below); Number opting
out in the proposed system is 14% (the proportion opposing organ
donation in the Taskforce report)dthe comparable number in other
countries can be very small: 2% in Belgium; family refusal in an opt-out
system was predicted as 0% when individuals had registered, and 20% if
Figure 1 Consent systems and donation rates, 2002. Reprinted with not registered (20% is a conservative estimate given lower rates in
permission from Journal of Health Economics9 and New Scientist10. similar situation in foreign counties, and the fact that we would expect it
Copyright New Scientist. to decrease from the current family refusal rate of 40%).

J Med Ethics 2010;36:534e538. doi:10.1136/jme.2009.031757 535


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Law, ethics and medicine

Table 1 A table to show the results of the mathematical model shown sessions 50% denitely and 36% possibly wanted to donate (a
above (figure 2). It shows the number of potential donors, and the total of 86%), while after the deliberative sessions 61% denitely
percentage of people who achieve or loose autonomy. To achieve and 26% possibly wanted to donate (a total of 87%). Thus the
autonomy the individual would have wanted to donate and done so, or overall percentage of people who thought positively, or nega-
not wanted and not done so. A loss of autonomy is counted when an tively, towards organ donation did not change signicantly after
individual who did not want to donate does, or when an individual who
increasing awareness via the sessions. This suggests that future
does want to donate doesnt.
awareness campaigns will have little effect on the number of
Current system Proposed system
people willing to donate.
Total donors 64.8 68.8 The key nding is that that the majority of the public support
Achieve autonomy 62.8 79.2 organ donation and are willing to donate their organs. This
Loss of autonomy 37.2 20.8 conclusion is supported by previous opinion polls. This high-
lights the ethical question of whether the organ donation policy
Furthermore, some individuals who oppose organ donation should reect public opinion.
will become donors under either system, ie, currently some
families allow donation when the deceased would not have Interpretation of support for change in policy
wanted it, and in an opt-out system an individual may not Subsequently the same 350 members of the public were asked To
register despite not wanting to donate. Using data in the report, what extent would you support the law of organ donation in the
we can produce a mathematical model to predict the extent of UK changing from an opt-in to an opt-out system? Figure 3 is
autonomy under the two systems, (gure 2, table 1). This taken directly from the Taskforce report.2 It clearly shows that
suggests that an opt-out system will greatly increase autonomy. after the events (other deliberative sessions) 72% of the public
If we consider the Taskforces position that it is worse to donate either supported or strongly supported a change in policy.
when you do not want to, our model suggests that an individual The members of the Taskforce misinterpret these results by
is more than twice as likely to lose autonomy by donating in an stating that, The evidence shows that most people would accept
opt-in system than in an opt-out system (11% cf. 4.8%). There is a move to an opt-out system on the basis that they assume this
presently no way of ensuring ones organs are not donated. For would lead to an increase in organ donation rates. A more honest
those who oppose donation, an opt-out system would provide statement would comment not merely on acceptance, but
a register in which to record their wishes, which may otherwise support by the majority for an opt-out policy. That the public
be unknown. If coupled with our assumption that fewer fami- believes a new system would increase donation, and hence
lies will override such wishes, levels of autonomy will be higher would allow it to save lives, should be better appreciated by the
(79.2% cf. 62.8%). Taskforce.
Instead the Taskforce seemingly overvalue the smaller
The relationship between the patient and state/doctors percentage that oppose the change in the law; However, there is
The Taskforce highlighted concerns that an opt-out policy a sizeable minority who are strongly opposed to a system of
would threaten individual rights; that is, there will be a conict opt-out, and even those who support it in theory have reser-
of interest between care of the dying and those waiting for vations around about certain issues. Why, having previously
organs, and that the state will gain unwarranted control and described the 14% of the public who do not want to donate as
exploit donors. However, these concerns apply to all systems, a small minority, do they now describe the 12% who oppose the
and the best solution is to have enough donors. change in law as a sizeable minority? It would be more
reasonable to emphasise the 43% who strongly support a policy
The gift element change, or the overall 72% who would support it.
A major argument put forward is that the concept that organ
donation as a gift will be lost by moving away from an opt-in ANALYSIS OF FAITH AND BELIEF GROUPS
system. However, the primary object is not to make people feel The taskforce aimed to analyse prevailing attitudes to organ
good about giving organs but to prolong lives; and anyway, donation and consent in the many and varied cultural and faith
changing to an opt-out system would increase the possibility for groups within the UK.6 There are two aspects of this: to learn
people to donate and hence feel good about it. about the ofcial position of faith groups on organ donation,
and of the prevailing attitudes of individuals within different
ASSESSMENT OF PUBLIC OPINION
The Taskforce concluded that the evidence from the eight
reviews they commissioned into public attitudes to opt-out
systems was limited and incomplete. Similarly, discussions
with key stakeholders revealed practical concerns on the Before the events 9% 11% 15% 40% 25%

potential change in donor numbers but little on public opinion,


except support for an opt-out system alongside efforts to
increase awareness of organ donation. This was echoed in letters
from individual members of the public, charities and other
organisations. The taskforce largely drew its conclusions on After the events 5% 12% 11% 29% 43%
public opinion from the surveys discussed below.

Assessment of public attitudes towards organ donation and the


influence of education Don't know Strongly Oppose Oppose Support Strongly Support
The Taskforce performed a small survey of 350 members of the
public, asking them before and again after deliberative sessions Figure 3 Evidence for support for a change in the law. Reprinted with
whether they were willing to donate their organs. Before the full permission from the Organ Donation Taskforce.2

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Law, ethics and medicine

groups. The Taskforces methodology for this involved inter- IMPACT OF OPT-OUT SYSTEMS
viewing only 17 religious leaders on the views of their respec- Analysing the potential impact of an opt-out system involved
tive religions. reviewing studies, including an independent systematic review,7
By interviewing leaders one can reasonably analyse the ofcial of organ donation in European countries. The review was set out
position of different faith groups. This revealed that While the in three parts: the rst examined before and after studies, the
majority of faith and belief groups permit organ donation, and second scrutinised between country studies and the last
some even have core beliefs which support it, religion was not involved surveys of public and professional attitudes to opt-out.
described as a key inuence for people opting in. If the majority
of faith and belief groups feel positively towards organ donation, Before and after studies reveal positive correlation
it follows that the most appropriate donation policy would have The Taskforce analysed ve studies on the impact of introducing
a default towards donating organs, that is, opt-out. opt-out systems on organ donation in Austria, Belgium and
If the aim was to assess the majority opinion of individuals Singapore. All revealed positive associations between policy
within the groups, the method was inappropriate. A large change and organ donation. In Austria, where legislation
opinion poll of the individuals whose opinion they wanted changed in 1982, donation rates more than doubled from 4.6 per
would be a valid technique. In effect, the Taskforce have ended million people per year (pmp/yr) to 10.1 pmp/yr in 1985. In
up with an opinion poll of only 17 leaders. Furthermore, as Belgium, the policy change resulted in the number of kidney
leaders of the groups, the background on which they form an retrievals increasing from 18.9pmp/yr to 41.3pmp/yr after 3 yrs,
opinion is different from those of the grass roots level on which and in Singapore, after opt-out was introduced in 1987, donor
they were specically asked to comment. Indeed, some leaders numbers increased from 4.7pmp/yr to 31.3pmp/yr.
sensibly suggested that their views and opinions were not The Taskforce rejected the signicance of the correlation due
necessarily representative of the group they head. to confounding inuences. Changes in legislation are inevitably
A good example of incongruities between opinions of the linked to contextual changes in a country, including awareness
leaders compared to those of individuals following a religion is and educational campaigns, as well as improvements in trans-
presented in the report. A 2007 study in Birmingham reported plantation infrastructure. Effects of this consolidation cannot
that 60% of Muslims, from a wide variety of ethnic back- easily be disentangled from the effects of policy change and
grounds, thought that organ donation was contrary to their hence it remains uncertain which aspects are directly responsible
faith. However, discussion with Muslim leaders revealed only for increasing donors. Nevertheless, given the methodology, the
that organ donation is an individual choice and not specied by optimum positive result towards policy change was reported;
religious guidance. a positive association. Further exploration into the issue of
Moreover, some of the questions provided by the Taskforce in causation, although not done by the Taskforce, is possible.
a discussion aid for the interviewers were misleading. One ques-
tion asked was the faiths position of the current opt in system, Two methods of exploring causation
whereby members of the public need to opt-in, or volunteer, to One method is to minimise the inuence of external
become a donor? It is not clear if the leaders were aware that only confounders such as publicity, road-trafc accidents and culture
20% of donations come from people on the ODR and hence are etc by performing between region studies. A well-cited study of
voluntary gifts. The consequent conclusion that, regarding the this sort compared two Belgium cities, Antwerp and Leuven.8
current system, Its key advantage was considered to be that it The cities had equivalent opt-in systems until a change in policy
allowed for free choice, and ensures that organs have been donated was made in 1986. At this point Leuven introduced an opt-out
under conditions of informed consent, is a reection of the policy, while the main hospital in Antwerp refused to adopt the
misleading question and a lack of understanding. new policy and continued practising opt-in donation. Donation
Another question was, What is your faiths position on the rates rose only in Leuven, where the law was implemented. This
idea of an opt-out or presumed consent system, whereby strongly suggests changing the law and shifting the default
members of the public are assumed to be donors unless they position is instrumental in increasing organ donation.
have formally opted out whilst alive. As commented by the The second method is to see if the increases in organ donation
Taskforce, presumed consent is a misnomer. Consent refers to are sustained after confounding inuences such as increased
a well-informed, balanced, decision by the individual, which by publicity and awareness have ceased. Relevant data available to
denition, can never be presumed. Indeed, even in the current the Taskforce, and mentioned in the report, came from a 2002
opt-in system, it is hard to argue that registration is equivalent study of 22 countries with different consent systems and
to consent; without interviewing someone it is impossible to donation rates shows the four countries with the highest
know if the decision is informed. By referring to opt-out as donation rates have a system of presumed consent including
presumed consent, it suggests that an opt-in system would, Austria, which, even after 20 years, continues to boast an
rather than presuming consent, preserve personal choice by impressive donation rate (gure 1).
leaving it up to the individual. This is reected in the inter- Therefore the confounding factors cited by the Taskforce are
viewees answers: The opt-out system would not allow for arguably insufcient to deem the positive correlation between
personal choice. However, people can effectively register their the opt-out systems and increase in donor number irrelevant.
choice in both systems. In terms of people ultimately getting
what they want our model (gure 2) suggests greater autonomy Between country studies
is achieved in an opt-out system. The systematic review considered four robust between country
The Taskforce, despite concluding that all religions support studies. These compared organ donation rates between (mainly)
organ donation, and that no religious beliefs favour one system European countries with different consent systems. Using
of organ donation over the other, draws strong conclusions from regression models the studies attempted to identify the effect of
the personal opinions of only 17 individuals. Their conclusions policy change separately from other variables. A range of 3e7
are then used as some of the main arguments against a change in variables were chosen, including GDP/health expenditure per
organ donation policy. capita, mortality rates, incidence of road trafc accidents,

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Law, ethics and medicine

transplant capacity, religion and education. Three studies polls supports the contrary conclusion that organ donations
demonstrate a signicant association between presumed would increase with an opt-out system.
consent and increased organ donation rate (at the 5% level); the The Taskforce continue by saying that policy change would
last was not signicant but nevertheless reported a positive distract from essential improvements to systems, infrastruc-
association. ture and urgently needed increases in public awareness and
The Taskforce agree that these four studies have no major understanding. These refer to improvements they themselves
aws and applaud their methodology. Having then acknowl- recommended in a previous report.1 Without taking away from
edged that .overall the evidence suggests that presumed the importance of infrastructure, public attitude towards organ
consent law is associated with increased organ donation. they donation is critical. Hence, an opt-out system of organ donation,
eventually refute the conclusions on the grounds of statistical in which the default position reects the majority opinion,
short-comings. In the three sentences devoted to this section in should be adopted. Furthermore, given the current failure of the
the nal report there is no mention that any positive correlation ODR and the lack of effect of deliberative sessions on changing
was found, and the last sentence, centrally placed, and in bold public opinion, simply promoting the current system would be
italics, reads: The evidence identied and appraised is not robust futile.
enough to provide clear guidance for policy. I believe both the ethical position and assessment of evidence
by the Taskforce is wrong, and the debate into the impact of an
Spain, an example opt-out system in the UK should be reopened.
The taskforce over-values the importance of this example, which
is of little statistical weight, and makes inferences from Acknowledgements Thanks to the Journal of Health Economics, the New Scientist
contentious data. Strong emphasis is given to the personal and the Organ Donation Taskforce for their co-operation and the use of their figures.
opinion of Dr Rafael Matesanz, president of the Spanish Thanks also to the statistics department at UK Transplant for their help.
National Transplant organisation, who questioned the impor- Competing interests None.
tance of an opt-out policy for increasing donation rates when
Provenance and peer review Not commissioned; externally peer reviewed.
compared to infrastructure changes he implemented.
Spain has had an opt-out policy since 1979, and has the
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538 J Med Ethics 2010;36:534e538. doi:10.1136/jme.2009.031757


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The potential impact of an opt-out system for


organ donation in the UK
Romelie Rieu

J Med Ethics 2010 36: 534-538


doi: 10.1136/jme.2009.031757

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