Written evidence submitted by the British
Heart Foundation
SUMMARY
- There is a shortage of donor organs for transplant
across the UK.
- We believe that a soft opt out system should
underpin organ transplantation in Wales, and support the Legislative
Competence Order (LCO) to grant the National Assembly for Wales
the power to introduce this.
- This move would help to increase the number of
donor organs available for transplant.
- We believe that the wording of the LCO is appropriate
within the context of the Government of Wales Act 2006, and that
there are safeguards to ensure there will be no conflict with
the European Convention on Human Rights.
1. Background
1.1 The British Heart Foundation (BHF) is the
nation's heart charity. We're fighting to eradicate premature
death from heart and circulatory disease, the UK's biggest killer,
and provide support and voice for heart patients around the UK.
1.2 The BHF supports measures to improve the
UK's rate of organ donation. These measures include consistent
national promotion coupled with a strong infrastructure of organ
retrieval and professional training. Whilst such measures will
go a long way to improving donor organ availability, we believe
that a soft opt out system where close relatives retain the power
of veto should underpin organ transplantation in Wales, and more
broadly the UK as a whole.
1.3 We welcome the opportunity to contribute
to the pre-legislative scrutiny of this LCO, which aims to grant
the power to the National Assembly for Wales for establishing
a soft opt out system for organ donation within Wales. Heart transplants
offer the best chance of long term survival for those patients
with severe heart failure, and we support the Welsh Assembly Government's
attempts to legislate for such a change.
2. Is the LCO request in the spirit and scope
of the devolution settlement?
2.1 The National Assembly for Wales has been
leading the UK in considering the benefits that a change to the
organ donation system could bring, and following several consultations
on the issue has asked for the power to change the system in Wales.
They have recognised that there is a shortage of donor organs,
and that this is having a detrimental effect on health and wellbeing
within Wales for those critically ill patients in desperate need
of a transplant.
2.2 We believe that there is strong precedent
for introducing this LCO and that the request falls within the
spirit and scope of the devolution settlement. This is an Order
that aims to introduce an innovative and progressive change within
health policy in Wales, and therefore we consider this an appropriate
area within which the National Assembly for Wales should be able
to legislate.
3. Is the use of the LCO mechanism in accordance
with the Government of Wales Act 2006?
3.1 As highlighted by the Secretary of State
for Wales in the foreword to the pre-legislative scrutiny for
the proposed Order, LCOs are specifically designed to extend the
scope of the powers granted to the National Assembly for Wales
within Part 3 of the Government of Wales Act 2006.
3.2 The aim of the LCO is to amend Schedule 5
of the Government of Wales Act 2006, enabling the National Assembly
for Wales to legislate in the proposed Matter 9.3, which covers
the storage, use and removal of parts of the human body for the
purposes of cadaveric organ and tissue donation. Providing the
Assembly with this power would enable them to amend the organ
donation system within Wales, and to increase the numbers of donor
organs as a result. This would bring health benefits to Wales,
and we believe the text as worded in the Order is appropriate
to be added to Field 9 of Part 1 of Schedule 5 to the 2006 Act,
as this clearly relates to health and health services within Wales.
4. Does the Order relate to Field 9, Part
1 of Schedule 5 and Subject 9, Schedule 7 of the Government of
Wales Act 2006?
4.1 We strongly believe that the Order does relate
to Field 9, Part 1 of Schedule 5 of the Government of Wales Act
2006, and that the issue of organ transplantation appropriately
falls within the area of health and health services. The Order
will empower the National Assembly for Wales to be able to introduce
a soft opt out system of organ donation for those people living
and dying in Wales. This is a health measure in response to a
clear health problem, whereby there is a shortage of organs for
donation.
4.2 With regards to Subject 9, Schedule 7 of
the Government of Wales Act 2006, which concerns areas highlighted
as exceptions to the fields of competence where the Assembly cannot
legislate, we see no complications with existing exceptions. The
only mention of transplantation within Subject 9, Schedule 7 of
the Act relates to the issue of xenotransplantation, the transplantation
of organs from one species to another. The issue within the Order
concerns the transplantation of organs from one human to another,
which is not listed as an exception in the Act. Furthermore, the
very absence of human transplantation being listed as an exception,
and the fact that xenotransplantation is, suggests that the UK
Parliament did not wish to exclude all forms of transplantation
from the National Assembly's legislative competence.
5. To what extent is there a demand for legislation
on the matter(s) in question?
5.1 We believe there is strong demand for legislation
to improve organ donation within Wales. There is a shortage of
donor organs for transplantations across all four nations of the
UK. These are desperately needed for patients with end-stage failure
of organs, including the heart. For critically ill heart failure
patients, transplants offer the best chance of long-term survival.
In February 2011, the BHF launched a new programme of research
called Mending Broken Hearts, which is specifically aimed at developing
regenerative medicine treatments to enable the heart to repair
its own damage. It will still be some time before treatments such
as these are developed, and so heart transplants will remain a
crucial life-saving treatment for many patients with severe heart
failure. Between April 2009 and March 2010, 120 heart transplant
operations were carried out in the UK.[26]
35 of this total were for patients below the age of 16. 126 people
were on the active waiting list for a new heart in March 2010—24
died in the previous 12 months before a transplant could be arranged.
Due to the shortage of organs and the slim chances of receiving
an organ in time, many patients are not even placed on the waiting
list for a transplant—the Organ Donation Taskforce has estimated
that the actual number in need of a transplant is around double
the total on the active waiting list.[27]
5.2 Coupled with the clear shortage of donor
organs, the current opt-in system for organ donation does not
adequately capture the high levels of public support for organ
donation. This remains very high at around 90% in the UK, but
the number of people signed up to the Organ Donor Register (ODR)
is just 28%. This highlights a need for further measures aimed
at improving the number of organ donors. Part of this process
involves increasing the promotion of organ donation nationally,
while improving the infrastructure of organ retrieval and professional
training. We support the recommendations from the Organ Donation
Taskforce 2008 review of donation in the UK that aim to address
many of these issues. However, we believe that a change to a soft
opt out system for organ donation is also essential to make a
substantial difference to the availability of donor organs.
5.3 There are international examples where countries
have experienced higher donor rates under opt out systems, such
as Spain. An American study also analysed the impact of opt out
legislation on donor rates by evaluating datasets over a 10-year
period, concluding that this legislation has a positive and sizeable
effect on organ donation rates.[28]
We believe that the UK should adopt such a change, and we are
supportive of the Welsh Assembly Government's attempts to introduce
this change to organ donation in Wales. Safeguards would be in
place to ensure families remain consulted, and such a move would
prompt greater family discussion within Wales around organ donation.
5.4 There has been a significant amount of public
engagement around the idea of an opt out system for organ donation
for Wales. Pre-legislative scrutiny has been in existence for
over two years, with the National Assembly considering this issue
in October 2008 and consulting on it in May 2009. We have engaged
with the Assembly throughout this period, submitting oral evidence
to a hearing on the issue conducted by the Assembly's Health,
Wellbeing and Local Government Committee. Any move to a soft opt
out system would require further engagement with the Welsh public
before it could come into effect, and the dialogue with the public
over the past two years provides an excellent foundation to build
this on. In the event that the Order is successfully passed, we
will participate in any further public engagement on the issue.
5.5 Such a change has substantial support within
the National Assembly for Wales, in addition to support from a
number of organisations including the BHF, the British Medical
Association and Royal College of Nursing, in addition to the Chief
Medical Officers across the UK.
6. Are there any cross-border issues relating
to the LCO? (eg financial or policy issues)
6.1 A change to the organ donation system within
Wales to an opt out system would mean that separate systems for
organ donation would operate in Wales compared to the other nations
in the UK. Any move to an opt out system specific to Wales would
have to be carefully crafted to ensure that it functions effectively
as part of the overall UK system.
7. Are the purpose and scope of the LCO clearly
defined, including the terms and definitions used?
7.1 We believe the purpose and scope of the LCO
has been clearly defined.
8. Does the LCO have the potential to increase
the regulatory burden on the private or public sector?
8.1 We do not believe that this LCO would increase
the regulatory burden on the private or public sector.
9. 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?
9.1 Under a successful opt out system for organ
donation in Wales, a form of Opt Out Register would need to be
established by the Welsh Assembly Government.
10. 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?
10.1 We believe the use of an LCO is the most
appropriate means under the current system for conferring competence
on the Assembly.
11. Has full use been made of any existing
powers to issue statutory guidance and/or secondary legislation
in relation to this Matter?
11.1 The Order seeks to confer competence on
the Assembly for the area of organ donation within Wales. The
Assembly has been until now unable to legislate in relation to
this Matter.
12. Does the LCO have the potential to cause
confusion regarding legal jurisdiction and the individuals to
whom any Measure would apply to?
12.1 As Assembly Measures can only have effect
in Wales, the Order only applies to those people who live and
die within Wales. The National Assembly will need to develop mechanisms
to ensure that it is clear to which individuals an opt out system
in Wales will apply.
13. What are the implications of Article 8
and Article 9 of the European Convention on Human Rights on any
such Measure?
13.1 The Organ Donation Taskforce assessed the
legal implications of any potential move to a soft opt out system
in the UK in their 2009 report. Their Legal Working Group specifically
looked at potential conflicts with the European Convention on
Human Rights (ECHR), and concluded that a system "based on
the presumption of consent or authorisation that allowed adequate
provisions for a person to opt out would be compatible with the
ECHR".[29]
The Group suggested measures that should be included to aid compliance
with the ECHR. This included ensuring relatives were still consulted
and providing consideration for some particular groups, such as
children and those that may lack the mental capacity to make a
decision on whether to opt out. The Welsh Assembly Government
has made it clear that these safeguards would be included under
a soft opt out system for organ donation in Wales, and we believe
that the Order reflects this.
February 2011
26 NHS Blood and Transplant (2010) Transplant Activity
in the UK 2009-10 Back
27
Organ Donation Taskforce (2008) Organs for Transplant: the Supplement
Report Back
28
Abadie, A and Gay, S (2006): The Impact of presumed consent legislation
on cadaveric organ donation: A cross-country study. In: Journal
of Health Economics, 25 (4), 599-620 Back
29 Organ
Donation Taskforce, The potential impact of an opt out system
for organ donation in the UK (2009), Annex C (Legal Working Group
Report) Back
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