Written evidence submitted by the Human
Tissue Authority (HTA)
- The Human Tissue Authority (HTA) welcomes the
opportunity to make this submission to the Welsh Affairs Committee
(WAC).
- We have addressed those matters which are linked
to the Human Tissue Act 2004 and within our remit. We have clearly
indicated which of the questions posed by the WAC we have responded
to.
- Issues not addressed in the questions, but which
we believe are significant and would aid the pre-legislative scrutiny
process, are detailed in the Additional Considerations section
at the end of this document.
- The key points to note are:
- No compelling evidence has been presented to
demonstrate the move to an opt-out system in Wales will increase
the number of organs available for transplantation.
- There is a risk of public uncertainty as to whether
or not an individual is affected by the opt-out system.
- There is a risk that the "wrong" sort
of consent is taken, which could lead to surgeons committing an
offence under the Human Tissue Act.
Question 4—To what extent is there a demand
for legislation on the matter(s) in question?
1. There is little, if any, convincing data provided
which suggests that there is demand for legislation on an opt-out
organ donation scheme from the Welsh population. There is however,
a growing demand for organs with people dying each day waiting
for a transplant. Efforts to increase organ donation should be
encouraged, but such a significant change to the consent process
should only be considered in the light of compelling evidence.
2. The memorandum quotes statistics from a number
of research projects, indicating that the majority of people support
organ donation. A commonly quoted statistic is that over 90% of
people support organ donation, while only 28%[51]
have signed the Organ Donor Register (ODR).
3. It is of value to look a little further at
the statistical evidence available. A recent HTA survey, conducted
on our behalf by Ipsos MORI, found that 62% of people surveyed
were either fairly likely, very likely, or certain to donate their
tissue or organs for use in transplantation after their death.
25% of people were either fairly unlikely, very unlikely of certain
not to.[52]
With at least a quarter of those surveyed expressing an unwillingness
to donate (a further 6% did not know how they felt on this issue)
a move to presuming consent would appear premature.
4. It should be noted that the responses to the
Ipsos MORI survey were given with the current opt-in system in
operation. Many of the concerns that people express when the issue
of an opt-out system is discussed were unlikely to be at the front
of their minds when responding.
5. Spain is often cited as an example of a country
which has both an opt-out system and high rates of deceased donation.
The opt-out system was introduced in 1979, however the significant
increase in donation rates took place during the 1990s. The director
of the national transplant organisation in Spain was clear that
the increase was not linked to the introduction of the opt-out
scheme, but was likely to be linked to the implementation of a
comprehensive national procurement system.[53]
A number of the recommendations of the Organ Donation Taskforce
were based on the successful system which operates in Spain.
6. Not all countries which have an opt-out system
in place have high rates of donation. Greece is an example of
a European country where citizens are presumed to consent to organ
donation, but the rates of deceased donation are low at 8.9 people
per million, compared to 14.7 people per million in the UK.[54]
7. The results of the Welsh Assembly Government's
public debate on organ donation, held between October 2008 and
January 2009, point towards the most popular organ donation system
being that of mandated choice with support from 27% of respondents,
with an opt-out scheme garnering 22% support. This is a clear
indication that there is a desire of respondents to be able to
make a positive choice, and for there to be compulsion to make
a decision either way. Without substantive evidence that an opt-out
scheme will increase the number of organs available in Wales,
and having consulted on this issue, the case does not seem to
be made to introduce anything except the most popular alternative
to the status quo, which is mandated choice.
8. Only 316 people expressed a preference for
an alternative organ donation scheme, so the 22% who support the
introduction of an opt-out scheme represents just 69 people. This
small sample size means that there can be less certainty as to
the proportion of the entire Welsh population who would support
the proposal.
9. The memorandum which accompanies the proposed
LCO explains that the aim of the National Assembly for Wales is
to increase the number of organs available for transplantation.
No clear evidence is presented that the implementation of an opt-out
scheme in Wales would do this.
10. There is undoubtedly, however, a need for
more organs to be made available. Across the UK three people a
day die waiting for an organ;[55]
this data only includes those who were on a waiting list at the
time they died, and not those who under current listing criteria
are not deemed suitable. The opt-out scheme proposed has not been
found to conclusively increase the number of available organs,
without such evidence a move away from the implementation and
delivery of the recommendations of the Organ Donation Taskforce
and the work of the Programme Delivery Board would seem premature.
There are significant risks in moving from one system which is
yielding results to another which is unproven and which will incur
significant costs during implementation.
11. The Ipsos MORI research also showed that
those surveyed were more likely to donate when they knew regulation
was in place. 52% of those surveyed stated they would be more
confident to donate an organ or organs if they knew the system
was regulated. This evidence suggests that ensuring the public
are aware of the regulatory framework brings confidence in donation
and is an important consideration when seeking to raise donation
rates. It is likely to be more difficult to communicate the regulatory
framework when consent is no longer a positive act, but rather
indicated by silence.
Question 5—Are there any cross-border issues
relating to the LCO? (eg financial or policy issues); and
Question 11—Does the LCO have the potential
to cause confusion regarding legal jurisdiction and the individuals
to whom any Measure would apply
12. This LCO introduces both cross-border issues
and potential confusion. We have addressed questions five and
eleven together.
13. The HTA is the statutory regulator responsible
for ensuring that organs and tissue are only removed for transplantation
with consent in England, Wales and Northern Ireland. While we
do not have jurisdiction over this matter in Scotland, it should
be noted that the organ donation system is consistent, with all
four home nations operating an opt-in system.
14. The ODR which is run and maintained by NHS
Blood and Transplant (NHSBT) covers England, Scotland, Wales and
Northern Ireland. Specialist Nurses for Organ Donation (SN-ODs)
currently consult the ODR when they are informed there may be
a suitable donor at their Trust. The information as to whether
the person had signed the ODR or not, and any specific choices
they have made, is shared with their family and friends to give
them an indication of the person's wishes.
15. Under the opt-out system proposed by the
National Assembly for Wales it would be necessary for a separate,
additional register to be kept of those people subject to the
system (those over 18, who live and die in Wales, who are competent).
The introduction and maintenance of such a register would be at
a cost drawn from public funds. SN-ODs would need to consult this
register to establish whether they would be applying the Welsh
system or not. If the potential donor was not on this list then
the SN-OD would be seeking consent under the Human Tissue Act.
16. The Citizen Information Project, commissioned
in 2004, established that the cost of a national population register
would be in the region of £2.4 billion. Although the register
of those affected by the proposal would be smaller, it should
be noted that previous feasibility studies have found such registers
to be costly and difficult to form and maintain.
17. SN-ODs are employed and trained by NHSBT.
It will be necessary to train all SN-ODs on all systems, so that
they are all available to work in Wales and the rest of the UK,
and can explain the differences between the two systems to a family
if required.
18. It is not clear from the information made
available by the National Assembly for Wales how the capacity
of the person before their death would be assessed. The proposal
states that the opt-out system would not apply to those who lacked
capacity prior to their death, rather this group of people would
come under the jurisdiction of the Human Tissue Act. It would
be possible to keep a register of those people ordinarily resident
in Wales who permanently lack capacity, however it would be a
much more difficult task for those whose lack of capacity is temporary.
More information is required to fully assess this aspect of the
scheme, however it is an area where confusion may arise as to
which system of consent is to be applied.
19. Under the Human Tissue Act it is an offence
for a reward to be offered or sought for an organ.[56]
It is unclear if the consent requirements of the Act were to no
longer apply in Wales, whether the scrutiny of the activity of
donation, and the offences associated with it, would still be
the responsibility of the HTA. Any separation of these responsibilities
is likely to cause confusion and increase bureaucracy.
20. There will be the need for a communication
campaign alerting people to the introduction of the new scheme.
This will need to cover both Wales and England, with consideration
given as to whether it should also be extended to Scotland and
Northern Ireland. The primary purpose of this campaign in Wales
will be to alert residents to the changes and provide them with
information on how to opt-out, as well as the benefits of remaining
opted-in. In England it will need to focus on explaining that
those who are not ordinarily resident in Wales will not be affected
by it, meaning that there is no need to opt-out in case you die
in Wales, and do not wish your consent to be presumed.
21. This communication campaign will have two
very different aims and will be of significant cost. In 2008 the
Organ Donation Taskforce identified the cost of a three year,
UK-wide, communications campaign to be £25 million.[57]
While the scale of the campaign under the proposed scheme would
be smaller, it would clearly still cost millions rather than thousands
of pounds.
22. The potential for confusion is considerable,
and special attention will need to be given to communicating with
those living in the English towns and villages which border Wales.
The HTA believes that there will be a relatively high number of
incidences of people seeking to establish whether or not they
are on the list and consideration will need to given to how people
are informed of this, and how requests for information will be
dealt with.
23. There is a risk of the wrong system being
applied. If the opt-out scheme is relied on for a person who in
fact is subject to Human Tissue Act consent, then the surgeon
who removes the organ or organs will have committed an offence.[58]
Surgeons will need to ensure they have suitable professional and
legal indemnity in place in case of mistake. If such an error
was made the HTA would be required to refer the case to the Crown
Prosecution Service (CPS) for consideration.
24. If the primary aim is to increase organ donation
by ensuring families are aware of the potential donor's wishes,
and therefore increasing their likelihood to consent, then this
could be done more economically with increased promotion of the
ODR and full implementation of the recommendations of the Organ
Donation Taskforce. This would also have the benefit of not creating
any cross-border issues.
25. In the absence of an impact assessment it
is not clear how much the National Assembly for Wales expect this
change will cost, however it would certainly require significant
investment. If there was a guarantee that more organs would be
made available, and less people would require dialysis, and those
that do for a shorter period of time, then this may be seen as
a proportionate step. However, in the absence of such evidence
an increase in spend on the proposed scheme does not appear to
be justified.
26. It should also be noted that at present when
consent is sought for organ donation, it is normally also sought
for research. As research would remain a Human Tissue Act issue
in Wales the family would be required to actively consent to this,
potentially introducing confusion at an emotional time.
27. There are also occasions when consent is
sought to procure tissue for use in human application. This activity
is governed by the Human Tissue (Quality and Safety for Human
Application) Regulations 2007 and requires Human Tissue Act consent
to be in place prior to the procurement.
Question 6—Are the purpose and scope of
the LCO clearly defined, including the terms and definitions used?
28. Broadly the purpose and scope of the LCO
are clearly defined. The HTA has only one area of concern which
is addressed below.
29. The proposed LCO seeks to make consent or
any other authorisation a matter for the Welsh Assembly
Government. There is no definition of any other authorisation
given in either the Order itself or the memorandum which accompanies
it. We assume that this is to allow the introduction of the opt-out
system detailed, however it is important that the precise intention
of this form of words is shared as a matter of priority, to ensure
that pre-legislative scrutiny is as robust as possible.
30. We note that a Report of the National Assembly
for Wales Legislation Committee No. 1 recommends that the term
"or other authorisation" is "deleted or replaced
by another form of words that more clearly describes the powers
that the Welsh Government is seeking to acquire".[59]
The HTA welcomes this recommendation and awaits the outcome with
interest.
Question 7—Does the LCO have the potential
to increase the regulatory burden on the private or public sector?
31. The LCO has the potential to increase the
regulatory burden to the public sector, and has limited potential
to reduce it.
32. There is no existing requirement that a register
of potential donors is kept. While the ODR is both a record of
people's wishes and a tool for the promotion of organ donation,
it is not a statutory requirement.
33. It will be necessary under the proposed system
to maintain a register of people ordinarily resident in Wales,
and record whether they have opted-out. This will need to be a
dynamic and robust register which takes the recommendations of
the Review of the Organ Donor Register conducted by Sir Gordon
Duff[60]
and implements them from the outset. This will impose an additional
regulatory burden on the public sector.
34. The National Assembly for Wales has the benefit
of the recommendations and guidance contained in Sir Gordon's
report and should seek to apply them where applicable.
35. A standardised form is used in all hospitals
in the UK to record the consent of the donor or their family and
friends to donation, and in some cases research. It is unclear
whether the National Assembly for Wales intends to continue the
use of this form, or another one similar to it, or whether this
requirement would be removed. In the case of removal this would
reduce the regulatory burden. It would still be necessary however,
to take details of the donor's medical and social history to ensure
the quality and safety of the organ/s and/or tissue. This is currently
standard practice and a requirement of the EU Organ Donation Directive
which will be operational in the UK by August 2012. Therefore
the removal of the need for a consent form to be filled in may
not of itself significantly reduce the regulatory burden.
36. As noted in paragraph 17, NHSBT will require
their SN-ODs to be trained on both the Welsh system and that which
applies in the rest of the UK, increasing the regulatory burden
on a public sector organisation.
ADDITIONAL CONSIDERATIONS
37. No mention is made in the memorandum of the
effect of an individual's decision to opt-out during life. Would
their family members still be approached to establish whether
they will consent to organ donation (under the Human Tissue Act)
or will the decision to be opt-out be taken as a definite and
enduring "no"? It is important that this is made clear
as a matter of priority to allow full consultation of the practical
implications of this LCO.
38. When an individual signs the ODR they are
able to choose whether they wish to donate all of their organs,
or to select a specific organ or organs. It is not clear whether
the proposed system will allow for this level of flexibility,
eg could you opt-out for certain organs, but remain opted-in for
others?
39. There is no information given on whether
those affected by the proposed system will still be able to sign
the ODR to express their wishes positively, and whether this will
be checked as a matter of course as it is at the moment. There
may be occasions where the two records are conflicting with the
ODR showing a wish to donate, while the Welsh register shows a
decision to opt-out. More information is needed in the relative
status of the two registers.
40. As noted above it would be the surgeon who
would commit an offence if the absence of opting-out is relied
on, when Human Tissue Act consent should have been. In light of
this it will be necessary to communicate with this group specifically
if the proposed system were to be introduced, and there would
be value in engaging with this group to fully explore practical
issues prior to implementation.
41. The Human Tissue Act will need to be amended
to introduce the proposed measure in Wales and a suitable legislative
vehicle for this will have to be identified.
February 2011
51 http://www.organdonation.nhs.uk/ukt/default.jsp
- 22 February 2011 Back
52
http://www.hta.gov.uk/_db/_documents/HTA_General_Public__report_FINAL_221010.doc
Back
53
http://www.organdonation.nhs.uk/ukt/newsroom/statements_and_stances/statements/opt_in_or_out.jsp
Back
54
2008 statistics-Committee of Experts on the Organisational Aspects
if Co-operation in Organ Transplantation Back
55
http://www.organdonation.nhs.uk/ukt/default.jsp-22 February 2011 Back
56
s.32(1) Back
57
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_090310.pdf Back
58
s.5(1) Back
59
http://www.assemblywales.org/cr-ld8395-e.pdf Back
60
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_120579.pdf Back
| 
