Written evidence submitted by Mrs Pauline
Gately
SUMMARY
The Welsh Assembly's application for a Legislative
Competence Order (LCO) to permit the establishment of a system
of presumed consent to organ donation should be opposed because:
- It fails to respect the right of the individual
to personal autonomy and in particular, to determine, within existing
limits, the treatment of his mortal remains.
- Recent Inquiries by the UK Organ Donation Taskforce
and a Committee of the Welsh Assembly concluded that there is
no clear evidence that such a move would result in an increased
rate of organ donation and that other moves might be more effective
and more likely to command public support.
- It compounds an existing wrong, increasingly
evident and acknowledged, that vital organs are harvested prior
to death and fails to take account of the danger that this practice
may be extended to cover serious, but not fatal, disabilities.
1: THE MOVE
TO PRESUMED
CONSENT IS
OBJECTIONABLE IN
PRINCIPLE
1.1 In line with the importance rightly placed
on patient autonomy in medical practice and the necessity for
adequate information to facilitate this it is argued that it is
wrong in principle to harvest organs without clear and explicit
evidence that this would be consonant with the deceased's expressed
wishes and that these were adequately informed.
1.2 Under a system of presumed consent the level
of evidence required of the deceased's consent is inevitably and
clearly lower than that required under the existing "opt
in" system. This is true in principle and is also, realistically,
highly likely to be true in practice regardless of efforts, however
strenuous and sincere, to ensure that those who would not wish
their organs to be harvested are fully informed as to the implications
of the presumed consent system and of the procedures for opting
out.
1.3 It is recognised, in principle, that a failure
to harvest usable organs contrary to the deceased's informed wishes
is also an undesirable outcome and that efforts should be made
to avoid this. However this proposal shifts the balance from a
presumption against harvesting to a presumption for. This unduly
compromises the rights of the individual over the treatment of
his remains. These rights must trump the interests of potential
organ recipients, however compelling their need.
1.4 It is also wrong in principle because it
is predicated on the assumption of a right by the state to interfere
with the remains of the deceased person. While it is acknowledged
that the state already has certain rights, necessary for societal
protection, with regard to the examination and disposal of human
remains, the harvesting of vital organs has to date been subject
to the will of the deceased and not been the prerogative of the
state. It must be questionable whether, in the light of the Alder
Hey experience, the public would actually support such a change.
1.5 No degree of commitment to education and
consultation can mitigate the profound ethical change implied
by this measure in moving from harvesting only on clear evidence
of (informed) consent to harvesting in the absence of clear evidence
of opposition.
2. THERE IS
A LACK
OF EVIDENCE
THAT IT
IS EFFECTIVE
IN PRACTICE
2.1 This was the conclusion of the UK Organ Donation
Taskforce (the Taskforce) following their 2008 Inquiry on this
matter1 and also of the 2008 Welsh Assembly investigation.2
2.2 It is surprising, in view of the conclusions
of both these reports that the Welsh Assembly are seeking a LCO
at this time. This is justified by reference to the majority view
in submissions to their inquiry in favour of presumed consent.3
However, it is suggested that policy is best developed by focus
on the validity of the arguments offered in the light of supporting
evidence rather than on the basis of a "head count"
of self-selected responses.4
3. A MOVE TO
PRESUMED CONSENT
WOULD COMPOUND
AN EXISTING
WRONG
3.1 The Taskforce addressed a number of concerns
raised by the public with regard to current practice. Among these
was the issue of whether the donor was truly dead at the time
the vital organs were removed. This concern was dismissed as "absolutely
false" and countered by asserting that: "exactly
the same tests are used to establish death in those who donate
as in those whose organs cannot be donated."5
3.2 The writer understands that the normal criteria
for clinical death are the irreversible cessation of respiration
and heartbeat. For the purpose of harvesting vital organs, particularly
the heart, awaiting clinical death may render the heart unusable
and the criterion therefore used in the UK for harvesting organs
is the death of the brain stem. This may herald imminent clinical
death in the absence of medical intervention but this is not the
same as death, as traditionally understood. Indeed, it is acknowledged
that the adoption of brain death as an alternative criterion was
driven, in part at least, by the imperative to harvest vital organs
prior to clinical death.
3.3 Further, the death of the brain stem alone
is not widely accepted elsewhere. In most countries the death
of the whole brain, not just the brain stem, is required and the
harvesting of organs on the weaker criterion of the death of the
brain stem alone is illegal. Even on this, more stringent, criterion
developing observations and experience have raised doubts as to
its true validity as a criterion for death.6
3.4 Those who acknowledge this difficulty do
not all agree on its consequences. For some, organ retrieval on
this basis should stop. For others, however, the continued retrieval
of vital organs from those perceived not to be dead encourages
a widening of the criteria to encompass other non-dead donors.
3.5 For example, writing in the prestigious New
England Journal of Medicine Drs. Truog and Miller review relevant
research and acknowledge that "The uncomfortable conclusion
to be drawn from this literature is that although it may be perfectly
ethical to remove vital organs for transplantation from patients
who satisfy the diagnostic criteria of brain death, the reason
it is ethical cannot be that we are convinced they are really
dead." They go on to argue that, this being the case,
we should abandon the "dead donor rule" and permit potential
donors to sanction the removal of their vital organs should they
succumb to specified, seriously disabling conditions.7
3.6 While ethically highly contentious, this
does, at least, have the virtue of transparency. Others, however,
argue that death itself should be re-defined to encompass some
not previously regarded as dead. An editorial in the influential
science journal Nature, for example, argued that the criteria
for death should be widened.8 To support this proposal
they observe that "In practice, unfortunately, physicians
know that when they declare that someone on life support is dead,
they are usually obeying the spirit, but not the letter, of this
law. And many are feeling increasingly uncomfortable about it".
3.7 They conclude that: "concerns about
the legal details of declaring death in someone who will never
again be the person he or she was should be weighed against the
value of giving a full and healthy life to someone who will die
without a transplant." They thus imply that death should
be redefined to encompass those with a permanent loss of significant
prior mental faculties (however that may be defined or determined)
apparently regardless of physical prognosis.
3.8 It is suggested that neither potential donors,
nor potential recipients, nor the general public nor policy-makers
should or would regard such matters as "legal details".
4. COMMENTS ON
ASPECTS OF
THE PROPOSED
ORDER
4.1 In the light of these considerations brief
comments are offered on aspects 4, 5, 7 and 12 as listed in your
call for evidence.
4.2 (4): To what extent is there a demand
for legislation on the matter(s) in question?
The Welsh Assembly claims this "meets the
wishes of the Welsh people".9 However, the
Committee is invited to consider the evidence for this and the
extent to which those polled were informed of the issues of concern.
4.3 (5): Are there any cross-border issues
relating to the LCO? (eg financial or policy issues)
If the Welsh Assembly were to move to presumed consent
this would have clear political implications for the rest of the
UK. This was acknowledged in the minority report within the Welsh
Assembly Inquiry which sought an LCO in part on these grounds.10
This would, in turn have financial implications, as discussed
in the Taskforce report.
4.4 (7): Does the LCO have the potential to
increase the regulatory burden on the private or public sector?
The increased regulatory burden was a factor in the
Taskforce recommendations.11 In particular there is
a danger that a sincere effort to facilitate adequate information
and encourage active family discussion and decision-making in
order to avoid a false interpretation of a failure to opt out
could prove an unjustifiable use of limited (healthcare) resources.
4.5 (12): What are the implications of Article
8 and Article 9 of the European Convention on Human Rights on
any such Measure?
Article 2 of the ECHR is also offered for the Committee's
consideration for the reasons given.
The objection in principle to the harvesting of organs
without explicit consent may be seen as offending against the
right to respect for both private and family life under Article
8.
With regard to Article 9, the harvesting of organs
prior to clinical death, particularly if extended in line with
the proposals referenced above, may run contrary to the beliefs
of the donor where consent is presumed and family members are
unaware of this or otherwise unwilling to veto or where there
are no family members to consult. It also has clear implications
for healthcare workers. A widening of the definition of death
and/or overt abandonment of the dead donor rule would further
aggravate this—and particularly so where clear evidence
of informed consent is absent.
5. CONCLUSION
The Committee is urged to advise against this LCO
on the grounds that it is contrary to the public interest for
the reasons given.
February 2011
REFERENCES
1 See Taskforce
Report, for example §§ 1.5, 1.9, 1.13 and 1.14.
2 See Welsh Assembly
Report § 10.1.
3 Written statement
by the Welsh Assembly Government: Organ and Tissue Donation Legislative
Competence Order 17 November 2010.
http://www.assemblywales.org/bus-home/bus-guide-docs-pub/bus-business-documents/bus-business-documents-written-min-state.htm?act=dis&id=205572&ds=12/2010
4 See, for example,
the UK Government Code of Practice on Consultation §6.1.
http://www.berr.gov.uk/files/file47158.pdf
5 See Taskforce
Report § 12.7.
6 See Truog, R
D and Miller F G, 2008 "The Dead Donor Rule and Organ Transplantation"
New England Journal of Medicine Vol. 359:674-675.
http://www.nejm.org/doi/full/10.1056/NEJMp0804474
7 As 6.
8 "Delimiting
death". Nature Vol 461 1 October 2009.
http://www.nature.com/nature/journal/v461/n7264/full/461570a.html
9 See Health Minister's
comments at: "Wales will seek further powers to increase
organ donation"
http://wales.gov.uk/newsroom/healthandsocialcare/2010/100713organ/?lang=en
10 See Welsh Assembly
Report § 10.6.
11 See Taskforce
Report § 1.11.
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