Memorandum by Professor David Price
PRESUMED VERSUS
EXPLICIT CONSENT
AND THE
ROLE OF
RELATIVES
1. This submission contrasts the different
types of consent "model" employed across Europe for
the procurement of organs for transplantation, which in turn has
implications for the role of relatives. Despite low procurement
rates, some jurisdictions remain extremely sceptical regarding
the notion of presumed consent. However, one needs to contrast
the two systems as they actually work in practice in order to
fairly represent them. In many societies, not only is the public
ambivalent about presumed consent but so are professionals and
healthcare staff. This is frequently a function of simplistic
caricatures which require rectification following proper and full
debate, or the central actors in the process will inevitably themselves
undermine the scheme in any event.
2. In one sense, explicit consent is indeed
the "ideal". If one seeks informed first person agreement
to organ donation, explicit consent from the preposthumous person,
either by the person adding his name to the relevant organ donor
register or signing an organ donor card, is the best unambiguous
evidence that a person wanted and had decided to donate. It must
be conceded that it is inevitable in various instances of presumed
consent, even with a full and proper education process for the
public in general, that organs will be taken and used for transplantation
from some persons who did not want this to happen or at least
had not decided that this should happen. Those at the margins
of society are one cohort likely to be within this group, due
to being outside relevant official and educational loops, and
another would be those individuals who, due to some form of mental
incapacity, are unable to reach a decision ie choose, whether
to become an organ donor or not. Support for the explicit consent
model seems to be principally premised on the notion that any
such unwilling removal and use renders such a (presumed) system
unethical and unacceptable. Yet even under current explicit consent
systems such supposedly unethical removal will consistently occur
also, in particular where relevant relatives are unaware of individuals'
wishes or act upon their own views.
3. Explicit consent is only "ideal"
however where the wishes of the majority of now deceased persons
have been reliably and directly recorded, or at a minimum have
been conveyed to relatives with decision-making power at the time
of death. In the United Kingdom only 24% of the population (14.6
million) have placed their names on the NHS Organ Donor Register
(at 5.10.07) yet we know from opinion polls and other sources
that this is considerably less than the percentage of individuals
who are in fact inclined to donate. Partly it seems for this reason,
the absence of such an explicit decision to consent to
donate by the preposthumous person is not seen as a reason to
conclusively decline organ removal for transplantation even though
many such individuals clearly did not wish to become organ donors
or had made no decision. In an explicit consent system, if we
were to insist upon "first person" (preposthumous) consent
in all cases the volume of transplants would slump to even lower
levels.
4. Where the wishes of most individuals
are not directly known, which is the position in all Member
States, the issue is how we handle such uncertainty. In explicit
regimes, relatives generally fill the void to one degree or other.
Relatives are a valuable and important conduit for conveying the
wishes of the now deceased person. In many situations though such
a task is no more than guesswork. This is because even where the
deceased had not prior to death nominated a relative or other
person as a representative to make such a decision, relatives—"qualifying
relatives" as they are labelled under the Human Tissue Act
2004—are permitted to decide whether to agree to organ donation
or not. Yet, the available evidence suggests that no more than
50% of relatives in the United Kingdom know their deceased's wishes
at their death. Indeed, the European Commission's Eurobarometer
Survey revealed that across the Member States as a whole only
41% of individuals had even raised the subject with their relatives
(43% in the UK).
5. In such an existing state of uncertainty,
there are two profound objections to explicit consent. Firstly,
it is not clear to all why, despite the knowledge that many people
who have failed to explicitly consent to donate are nonetheless
agreeable to becoming organ donors, it is considered better to
allow such individuals to die "intact" with usable organs
(as is the inherent impact of an explicit consent system) than
taking organs from some apathetic, undecided or indifferent (and
a very few objecting) individuals under a presumed consent system?
The existence of a presumption of donation respects the preposthumous
wish of individuals to donate in a higher percentage of
instances. This "neglected wish" in explicit consent
contexts is no less a wrong to deceased persons, although rarely
recognised or appreciated. The interests of those who will die
or suffer compromised quality of life due to the absence of a
transplant might also be seen to weigh in the balance in determining
which scheme is to be preferred. Secondly, as stated, even
under explicit consent regimes some organs will also be used for
transplantation where the deceased was unwilling to donate or
at least was undecided, apathetic or indifferent, where such wishes
remain hidden or ignored. Moreover, to compound matters, there
is often (although not invariably) no mechanism for recording
objections apart from informing relatives to ensure that
organs are not used where the deceased was unwilling. Yet,
presumed consent regimes invariably have just such a register.
6. Thus, "error", viewed in terms
of the deceased's actual wishes, is a concomitant ingredient in
every system, not just presumed consent systems, and as
shown above, in explicit systems there are two alternative
potential sources of error, not just one. In a presumed consent
system, where relatives views are solicited at all (ie in weak
as opposed to strong regimes) relatives only add objections, as
the silence of the deceased is itself an authorisation for donation.
In an explicit consent system relatives can make decisions either
to donate or not to donate, on any basis. Of course, the
premise underpinning these contentions is that the wishes of the
deceased are the central ethical and legal concern, not the personal
views of relatives themselves (other than parents of deceased
children insufficiently mature to formulate their own views).
Thus, some would deny that any "error" occurs where
the relatives agree to donate, whatever the deceased thought about
the matter. However, the stance adopted here is that taken recently
by most politicians, regulatory agencies and healthcare professionals
in the United Kingdom and in Europe as a whole. The Human Tissue
Act 2004 treats the wishes of the deceased as the principal factor,
reinforced in the Human Tissue Authority Code of Practice, as
does the Human Tissue (Scotland) Act 2006. Indeed even most relatives
generally state that giving effect to the wishes of the deceased
is their main function or role.
7. We know that most individuals in most
States are inclined to donate, yet the UK Donor Audit, 2005-06
revealed rates of relative refusal of organs in the United Kingdom
are hovering around 40%, 50% in some areas, leading ultimately
to low rates of transplantation (Eurobarometer Report showed rates
ranging within Europe from 6% to 42%). Thus, in societies where
the evidence suggests that most individuals are willing to donate
organs for transplant on their deaths, and where individuals'
wishes are generally not directly known, rates of "error"
are seemingly much greater in explicit systems. Public opinion
polls reveal that in the preponderance of Member States the majority
of the populace are in agreement with donating their organs
for transplantation after death. Whilst the Eurobarometer Report
showed 56% of Europeans willing to donate (of course not all others
were unwilling, many were undecided), there were wide jurisdictional
variations. 63% of UK citizens were willing to donate, as well
as 69% in three other explicit consent jurisdictions, Denmark,
Germany and The Netherlands. Presumed consent regimes apparently
better reflect most individuals' true wishes as to the use of
their organs in jurisdictions such as these.
8. We are therefore typically dealing with
policies to handle doubt. The options are to either attempt to
drastically eliminate such doubt, which in an explicit consent
regime would in theory lead to many more organs being made available,
or to otherwise handle such doubt in the most appropriate way.
The first strategy would presumably have to be based around some
system of mandated choice, which has not so far found favour either
on account of the supposed coerciveness of forcing people to make
a choice and/or the potential negative backlash towards organ
donation of such a policy. Otherwise it seems we would typically
need to invest extremely substantial additional resources
into initiatives to increase organ registration and the adoption
of donor cards, including further, productive opportunities for
decisions to be made and recorded, probably following direct discussions
with clinicians, etc, to make substantial inroads. To properly
handle continued situations of substantial doubt it would seem
appropriate though to start instead with a presumption which reflects
the views of the majority; as far as we can tell.
9. There are various misperceptions
surrounding presumed consent. Firstly, that it is simply the taking
of organs by the state and, secondly, that organs will be taken
despite the deceased's objections. The first perception stems
from a view of consent as always explicitly given despite the
fact that our agreement is often reflected in our lack of objection,
such as to the use of personal data for research or to medical
students being present at in-patient examinations. If one opts
out the state is not entitled to touch one's organs to such ends.
Thus, whilst presumed consent to donation may be less certain
than an explicit consent it is not "no consent at all",
it is a tacit consent. Moreover, explicit consent is typically
that of relatives not the deceased person.
10. Secondly, as noted above, where doubt
exists organs will always sometimes be taken in some scenarios
where the deceased was not a (preposthumous) willing party, no
matter what colour of scheme is adopted. Whilst objections by
the deceased are always respected in presumed consent systems
with reliable communication mechanisms, the individual concerned
nevertheless has to take actual physical steps to opt out. This
means that only those who have real objections will be
likely to do so ie if one can't even be bothered to go to the
Town Hall or go online to register an opt out, this implies that
the individual is not really anti-donation. Further, as noted
earlier, in most explicit consent systems there is no dependable
mechanism for recording objections to ensure that organs
are not used. Thus, in reality it is less likely in a presumed
consent system that organs will be removed from clearly unwilling
persons.
11. There might seemingly be a risk of a
public backlash to presumed consent, as there was in Brazil towards
the end of the last millennium. But if deceased and relatives
objections are solicited, recorded and acted upon in all cases,
such a likelihood is minimal. Reliable and comprehensive processes
are therefore essential. Thus, the BMA's preference for weak presumed
consent such as exists in Belgium is well founded. Of course,
the introduction of presumed consent would need to be preceded
by an extensive public education campaign and the setting up of
easy to access means of opting out.
12. Relatives would not be excluded from
influencing decisions with presumed consent, but they would not
be the "decisionmakers". They could add knowledge of
known individual objections or indeed that the person concerned
had insufficient capacity to make such a decision (although most
individuals lacking such capacity at death will not have been
permanently incapacitated during life) and veto removal by objecting.
But the decision to donate would be essentially that of the preposthumous
individual ie if he opted out he objected and if he failed to
opt out he tacitly agreed to donation.
13. In the truly ideal system, one
would have reliable knowledge of the wishes of all deceased persons,
whether for or against donation. However, explicit consent
may be an appropriate, may be even the best, system where reliable
knowledge of the majority of deceased persons is accurately
known. Whilst numbers continue to rise steadily, it will be some
very considerable time before the NHS Organ Donor Register has
a sufficient volume of registrants for this to be achieved in
the UK, and a similar situation prevails elsewhere. Nor is it
realistic to expect that in the short term individuals will share
their (probably positive) views with relevant relatives to a very
substantially greater extent than at present (Eurobarometer Survey
suggests that this tendency is in fact generally declining). Thus,
we are in many jurisdictions operating a much less than ideal
system ethically, whilst simultaneously accepting the death and
suffering of many patients.
14. Whether more organs are procured should
be viewed as an important bi-product as opposed to the goal of
any such change. Most importantly it is simply the ethically "right"
interim scheme in situations of major uncertainty. In any event,
on its own presumed consent would not an instant panacea to satisfy
transplants needs, but it would tend to that end. Supported by
other infrastructural, resourcing and educational changes, many
of which require implementation in any event whatever system is
chosen, a steady improvement can be confidently predicted. Whether
an incidental effect or not, many existing regimes are dramatically
failing to meet the needs of sick transplantable patients.
15. Whatever system is adopted an appropriate
infrastructure is necessary to record the wishes of individuals.
In view of their accessibility and reliability, registers are
the preferred mechanism to this end. Donor cards are at best a
supplementary strategy, as evidence shows that they do not generally
achieve a wide range of coverage in addition to which they are
often not available at or around the moment of death. Registers
should in all cases be able to record (1) evidence of consent
to donate (2) evidence of an objection to donation, and (3) where
permitted by the jurisdiction concerned, allow for evidence of
any individual nominated to make the relevant decision at the
point of death.
16. This is not a communitarian proposal
or approach per se; it is compatible with liberalism which can
nonetheless be supportive of the value of community. Only where
the evidence suggests that consent to donation runs counter to
the views of the majority of the population is it necessary to
underpin such a policy by a communitarian rationale.
5 October 2007
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