Written evidence submitted by NHS Blood
and Transplant
SUMMARY
NHS Blood and Transplant is the UK Organ Donor Organisation
and accountable for the delivery of the organ donation service.
We have no comments to make on the policy of presumed consent
as set out in the LCO. We do wish to highlight the following issues
for consideration:
- Potential for public confusion of different consent
systems and two registers recording different details about organ
donation.
- The impact on flourishing partnerships which
enable people easily to register to be organ donors.
- The importance of avoiding ambiguity for the
clinical staff involved in identifying potential organ donors.
- The potential for confusion over the different
legislative arrangements which would apply and the risk that an
offence might unwittingly be committed.
- The costs of implementing a new system and the
burden of maintaining the current system being shared by three
rather than four health departments.
We have responded to the Committee's specific questions
on aspects of the proposed Order as follows:
1. Is the LCO request in the spirit and scope
of the devolution settlement?
1.1 Not within NHS Blood and Transplant's remit.
2. Is the use of the LCO mechanism in accordance
with the Government of Wales Act 2006?
2.1 Not within NHS Blood and Transplant's remit.
3. Does the Order relate to Field 9, Part
1 of Schedule 5 and Subject 9, Schedule 7 of the Government of
Wales Act 2006?
3.1 Not within NHS Blood and Transplant's remit.
4. To what extent is there a demand for legislation
on the matter(s) in question?
4.1 The Inquiry into Presumed Consent for Organ
Donation published by the Health, Well-Being and Local Government
Committee for the National Assembly examined public support for
legislation. It did not examine whether there is support for a
change in the model of consent amongst clinicians who deal with
families at this most distressing of times. It is important that
doctors and nurses working in Intensive Care and Emergency Medicine
support the consent model if they are actively to identify and
refer donors to the specialist nursing service. Without such support
there is the potential for the legislative change to act as a
disincentive to organ donation with the risk that clinicians may
not identify potential donors rather than deal with a process
with which they are unfamiliar.
5. Are there any cross-border issues relating
to the LCO? (eg financial or policy issues)
5.1 The cross border issues are as follows:
- (i) We understand the intention is to develop
an Opt out Register for Wales whilst maintaining the UK Opt in
Register. This has the potential for confusion in the minds of
the public. It raises the possibility that an individual might
register on the UK Opt in Register, change their mind about organ
donation and register on the Wales Opt Out register. Should such
a person die whilst somewhere else in the UK, their earlier wish
to be a donor would still be on record and there would be no mechanism
for a clinician in the rest of the UK to check the Welsh register.
This is particularly relevant for the citizens of North Wales,
many of whom receive their hospital treatment across the border
in England. Similarly, it is not clear whether a clinician caring
for a dying patient in Wales would be able to check the UK register
if the patient were not Welsh. Any requirement to check two registers
presents the potential for considerable operational confusion
and the potential to commit an offence if the organ were taken
without proper consent.
- (ii) Currently 43% of people joining the
UK Organ Donor Register do so by ticking the relevant box on a
form when applying for a driving licence from the DVLA. A further
31% join via their GP registration, the Boots Advantage card and
other partnership arrangements. There is no facility to amend
these forms to allow a different choice for over 18's living in
Wales. The partnership arrangement with the DVLA is currently
the focus of a Cabinet Office initiative to increase registration
through prompted choice. The DVLA have told us that it would cost
about £2 million to withdraw and reissue all their driving
licence forms. If NHSBT were unable to continue the current partnership
arrangements, there would be considerable risks to the continued
viability of the UK Organ Donor system with a potential loss of
up to 75% of registrations.
- (iii) Campaigns to increase registration
on the UK Organ Donor Register (Opt-in) and to explain a Welsh
Opt out Register may be very confusing for the public. It is not
possible to confine media campaigns within national boundaries,
particularly with the growing prominence of the internet as a
source of information.
- (iv) The public may not understand why the
Welsh Opt out Register only applies to over 18s while the UK Opt-in
Register can be joined at any age. Currently parents can register
their children and children may register themselves (although
under the age of 12 a welcome letter is sent to the child's parents/guardian
to let them know the child has registered. Between the ages of
12 and 16, the child is advised to let their parents/guardian
know of their wishes.).
6. Are the purpose and scope of the LCO clearly
defined, including the terms and definitions used?
6.1 It is essential that there is no ambiguity
about who will be covered by the LCO and who is entitled to register
on a Welsh Opt out Register. Any system which creates confusion
about entitlement could lead to unauthorised organ donation: this
could be highly distressing and damaging for all involved; damaging
to the overall aim of securing the broadest support for organ
donation; and, potentially, result in an illegal act, see para
6.6 below.
6.2 The body that administers the register needs
to be able to confirm entitlement to register and have validation
rules which prevent registration by those who are not entitled
to Opt out, ie those who are not a Welsh citizen. Sections 32-35
show that this matter has not yet been resolved, consideration
needs to be given to how the proposed entitlement would be operated
by busy clinicians.
6.3 A further complication is clinical staff
in Intensive Care and Emergency Medicine departments will need
to be able to establish quickly and simply whether any law arising
from the LCO applies to the patient they are treating. In most
cases the patient is likely to be too ill to answer questions
about their residency status.
6.4 Occasionally potential donors present in
Intensive Care and Emergency Departments and have no family that
can be identified. It is not clear whether presumed consent would
apply in such circumstances and donation would proceed providing
the person was not registered to Opt out.
6.5 It will be important to establish from what
point the new arrangements would apply and how potential donors
and their families are to be treated during any transitional period.
Even with extensive advertising campaigns, it takes time to build
up any register and be confident that it records the wishes of
those entitled to register.
6.6 There are concerns about when the new arrangements
will apply and when the Human Tissue Act will apply. For example,
it seems that people who die in Wales but did not live there,
all under 18s and adults who lack capacity will be subject to
the Human Tissue Act's provisions on consent. Organ donation teams
in Welsh hospitals will need to be trained on both systems and
able to identify which group the potential donor belongs to. We
are concerned that the new arrangements would introduce complexity,
and potentially confusion, to a clear statutory system. This could
diminish people's confidence in organ donation and consent more
widely. Most concerning for NHSBT is the risk of the wrong legislation
being applied to a person and an offence inadvertently being committed.
We are concerned about the risks our staff and our organisation
would face in this situation.
6.7 We are unclear about the status of an opt
out registration. Would this be enduring regardless of the time
elapsed since the person opted out or would it be expected that
the family is consulted to establish whether the person had changed
their mind, even if they had not got round to changing their registration.
6.8 It is important that the position with regard
to consent for removal of organs and tissue for research is established.
Currently these are governed by the Human Tissue Act and so the
family would actively have to agree to this. This could be very
confusing at such a difficult time.
7. Does the LCO have the potential to increase
the regulatory burden on the private or public sector?
7.1 Implementation of the LCO will require the
creation of a new Welsh Opt Out Register and a campaign to publicise
the legislation. Although the numbers opting out are likely to
be fairly small (300,000 estimate based on our experience of operating
the ODR), the cost of establishing and maintaining such a register
is considerable. In addition to the costs of establishing the
register, the ongoing maintenance and support and processes and
procedures for registration, amendment and withdrawal need to
be developed and resourced. We have assumed that about 3% of registrants
would amend their record annually.
7.2 Further costs will be incurred in changing
policies and procedures followed by the NHS staff dealing with
potential donors and their families. Staff will need additional
training to know how to deal with donors and their families under
the presumed consent system whilst maintaining their skills to
operate within the current system for anyone who is not covered
by the legislation (eg children, non-Welsh residents being treated
in a Welsh hospital, patients who lack mental capacity).
7.3 NHSBT records consent and transmits information
regarding organ donors using an Electronic Offering System. Any
requirement to change the consent process will also require a
change to this system. This will need to be funded, and, dependent
on the cost of the change, may require Department of Health approval
to allow NHSBT as an arm's length body, to engage our suppliers
to undertake the work.
7.4 Assuming that the Welsh Assembly Government
would no longer contribute to funding the UK Organ Donor Register,
the burden of these costs would fall on England, Scotland and
Northern Ireland. This is particularly pertinent as a recent independent
review of the register has called for complete redevelopment of
the system.
8. Would the proposed LCO necessitate the
formation or abolition of Welsh institutions and structures? If
so, where does the legislative competence to exercise such changes
lie?
8.1 Not within NHS Blood and Transplant's remit.
9. Is the use of an LCO more appropriate than,
for example, the use of framework powers in a Westminster Bill
to confer competence on the Assembly?
9.1 Not within NHS Blood and Transplant's remit.
10. Has full use been made of any existing
powers to issue statutory guidance and/or secondary legislation
in relation to this Matter?
10.1 Not within NHS Blood and Transplant's remit.
11. Does the LCO have the potential to cause
confusion regarding legal jurisdiction and the individuals to
whom any Measure would apply to?
11.1 The LCO does have the potential to cause
confusion: see answers to 5 (cross border issues) above.
11.2 The LCO may also cause confusion amongst
citizens in other UK countries who may not realise that the legislative
change would not apply to them. Any misunderstanding about presumed
consent in other UK counties might lead to fewer people joining
the UK Organ Donor Register and giving consent/authorisation for
organ donation. This would reduce the number of available organs
for allocation in Wales and across the rest of the UK.
12. What are the implications of Article 8
and Article 9 of the European Convention on Human Rights on any
such Measure?
12.1 Not within NHS Blood and Transplant's remit.
February 2011
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