Written evidence submitted by the Kidney
Wales Foundation
TIME TO SAVE LIVES—A SOFT OPT OUT SYSTEM
SUMMARY OF
EVIDENCE
- In the UK more than 10,000 people are currently
waiting for a transplant.[61]
- Across the UK three people die every day waiting
for a transplant, in Wales someone dies every 11 days on the transplant
waiting list.
- The number of people in the UK needing an organ
rises year on year,[62]
yet the number of organs donated remains amongst the lowest in
Europe.
- In May 2010 the British Medical Journal published
an analysis[63]
which showed that on even a conservative estimate an extra 2,880
extra donors would have given organs under an opt out system.
- This was supported by other studies[64]
which confirm that a move to presumed consent increases the organ
donation rate by up to 30%. Legal advice obtained by Kidney Wales
Foundation may be summarised as follows:
- (a) The proposed draft National Assembly
for Wales (Legislative Competence) Health and Health Services)
Order 2011 (LCO) is within the legislative competence envisaged
by the Government of Wales 2006 Act;
- (b) Although there are restrictions on the
nature of any substantive measure which could follow the LCO,
they are not of such a nature as to preclude the introduction
of an opt out system in relation to organ transplantation;
- (c) It would be possible for a measure introducing
such an opt out to be drafted in such a way as to make it compatible
both with the European Convention on Human Rights, and with European
Community law.
- Different systems of presumed consent for organ
donation have already been introduced in Spain, Belgium, Sweden,
Denmark, Finland, France, Italy and Norway saving thousands of
lives each year.
- Kidney Wales strongly agrees with the introduction
of legislation to introduce a system of "soft" Opt Out,[65]
in which the people would be presumed to be organ donors after
death unless:
- they have opted out;
- they cannot be identified;
- their place of residence cannot be identified;
- the wishes of the deceased can be proven to be
contrary after relatives have been contacted; and
- immediate relatives object.
- Under a "soft" opt out system there
is no compulsion. No one donates organs unless they want to do
so.
- It is widely recognised that a successful switch
to an opt out system must be accompanied by an increase and transplant
infrastructure. This is already happening in Wales, with the development
of a new Transplant Unit and the appointment of a national network
of Clinical Leads on Organ Donation and donation co-ordinators.
We do not see the practicality of a different
system operating in Wales with respect to organ donation to that
operating in other parts of the United Kingdom as a legal issue,
as much as a political one, unless it were suggested that concerns
over practicality were of such weight as to make legislation impossible
to operate in a non-arbitrary manner so as to be compatible with
human rights principles. We are not aware of any such suggestion
having been made. According to our legal advice "It would,
at first sight, seem surprising if this were the case in circumstances
where, notwithstanding the free movement provisions of European
Community law, some European Union countries operate opt-out systems
and some do not".
1. THE UNITED
KINGDOM CONTEXT
1.1 There is currently an insufficient supply
of donor organs to meet the demand for organ transplantations
in the United Kingdom and worldwide. The UK active transplant
waiting list is increasing, and the ageing population and
increasing incidence of type 2 diabetes are likely to exacerbate
the shortage of available organs.
1.2 In 2006 the UK Organ Donation Taskforce[66]
was established to identify barriers to donation and examine ways
in which organ donations could be increased within the current
legal framework. Its report entitled "Organs for Transplants"
which was published in January 2008, said that "the current
co-ordination system in the UK has developed in an ad hoc and
unsystematic way over many years". It also found that current
organ retrieval arrangements are "not sustainable in many
areas of the country and are not able to support the required
increase in donor numbers".
1.3 The Taskforce's main recommendation was to
establish a UK-wide Organ Donation organisation to identify and
allocate organs on a UK basis. It also called for a doubling of
the number of transplant coordinators; the creation of an organ
donation "champion" in each hospital trust, and improvements
in the processes of identifying potential donors and the monitoring
of donation activity in all hospitals.
1.4 Consideration of a change in the law to a
system of presumed consent was outside the scope of this inquiry.
However, the Taskforce conducted a separate special inquiry[67]
later in 2008 into the possibility of opt out in the UK. It concluded
that it should not be introduced in the UK at the present time.
1.5 While Kidney Wales welcomes much needed improvements
to the transplant infrastructure across the UK, it believes that
a significant gap will remain between the number of donor organs
needed and the number of organs available for transplant unless
opt-out legislation is also introduced.
1.6 Adabie and Gay suggest in their 2005 study
that an increase of the magnitude they expect from presumed consent
(25-30%) "could potentially close the gap between the
demand and the supply of organs in the UK".
1.7 In May 2010 the British Medical Journal published
a study estimating that an additional 2,880 organ donors would
have been available in the last 10 years if an opt out system
had been in place. The paper's authors, Bird and Harris, also
questioned the legitimacy of the UK wide enquiry into presumed
consent.
"There are only two options for me. Either
I will receive a transplant or I will die. Opt out organ donation
will mean that more people donate their organs—and we know
that most people want to". Elliw,
34. Waiting for a kidney and pancreas
4.7 There have been some moves in Westminster
to introduce a system of opt out organ donation; most recently
with Jeremy Browne MP's Private Members Bill. Debate in Westminster
has not yet progressed as far as in Wales.
4.8 Public attitudes towards opt out organ donation
through surveys carried out in the UK and elsewhere show strong
public support for a change in the system. The most recent survey
carried out by YouGov[68]
in December 2009 showed that people in Wales back a soft opt out
system two to one. This corresponds with UK wide levels which
showed a near identical level of support in 2007.
2. LEADING THE
WAY
2.1 The Case for a change in the law
2.1.1 10,000 people in Wales[69]
have renal disease with the number effected rising dramatically.
In Wales the number of people needing a Kidney transplant has
risen by 51.7% in the last six years. This trend is similar to
that across the UK which has seen the number needing kidney transplants
rise by 44.6% in the same timeframe.[70]
"Living on dialysis is hell. It's not a life—you're
existing, not living. I was lucky enough to get a second kidney
after the first one failed when I was 12. The best thing is that
I'm now a completely 'normal' person for the first time in my
life. When it comes to donating an organ, the main question I'd
ask people is: 'Why not?' If you can't think of a valid reason,
why not? It's a gift of life, it can give someone a life back—I'm
proof of that." Hanna, 22. Kidney
Transplant recipient
2.1.2 As of April 2010 7,951 people were waiting
for a transplant in the UK[71]
Of those 6,867 need a kidney, 349 need a new liver; and 120 need
a new heart. In Wales nearly 500 patients are currently waiting
for an organ transplant. It is better to transplant a kidney prior
to a patient being put on dialysis. Therefore these numbers offered
by NHS BT are wide of the real problem facing patients.
"Having personally witnessed the anguish
and grief in the patients unable to obtain a transplant, I firmly
believe that we can no longer stand by and see organs being wasted
which could potentially save lives, without a broad informed public
debate about the way forward. Wales has a unique opportunity to
lead the way for patients with end organ failure within the UK."
Dr Richard Moore—Consultant Nephrologist and Clinical Director
of Renal Services and Transplantation at the University Hospital
of Wales, Cardiff.
2.1.3 Organ Donor Register promotion creates
awareness but does not solve the problem, increasing the number
of people on the Organ Donor Register alone is not enough. With
leading academics in agreement "the current policy [opt
in], however reinforced, will not substantially increase the number
of organs available" (Bird and Harris).
2.2 Organ Donation across Europe
2.2.1 Opt out organ donation is not a novel concept.
It has already been introduced in Spain, Belgium, Sweden, Denmark,
Finland, France, Italy and Norway.
2.2.2 Spain runs a "soft" opt-out system,
where even if the person has not themselves opted out of donation
while alive, the views of relatives are sought and they can refuse
consent. Other countries, such as Austria, run a far stricter
system where the views of relatives are not taken into account
at all. In both these examples, the use of presumed consent coupled
with improved transplant infrastructure, has boosted the availability
of organs for transplant.
2.2.3 Belgium introduced its "soft"
opt-out system in 1986 and increased the number of transplant
co-ordinators at the same time. Just 2% of the population has
opted out of organ donation—and the national rate of organ
donation rose by 55% within five years.
2.2.4 The latest figures show that in Belgium
there were 291 deceased organ donors in 2007 compared to only
51 in Wales—Belgium has one of the highest rates of donors
per million people in the world.[72]
2.2.5 The evidence of a link between systems
of presumed consent and increased organ donation is compelling.
In 2003 a study "Presumed Consent" and other predictors
of cadaveric organ donation in Europe,[73]
demonstrated that presumed consent was one of four variables which
emerged as a significant predictor of cadaveric organ donation
rates. In countries where Presumed Consent was a policy, there
were a substantial number of additional organs available.
2.2.6 These findings were supported by a study
published in the British Medical Journal in January 2009 investigating
the impact of presumed consent for organ donation and once again
found an increase in donation rates following the introduction
of a system of presumed consent.[74]
This analysis is further supported by the findings of Abadie and
Gay of Harvard and Chicago Universities, which examined 22 countries
who had introduced presumed consent systems over a 10 year period,
and found that presumed consent had a positive and sizeable effect
on organ donation rates of some 25%-35% higher on average in these
countries.
3. MOVING AHEAD
TO A
SYSTEM OF
SOFT OPT-OUT
AND THE
LAW
3.1 Kidney Wales proposed that the law on consent
for organ donation be changed to encompass a "soft"
system of Presumed Consent. This system proposes that for purposes
of disease treatment Welsh residents are presumed to be organ
donors on death unless:
- They have opted out.
- They cannot be identified.
- The person's place of residence cannot be identified.
- The wishes of the deceased can be proven to be
contrary after relatives have been contacted.
- Immediate relatives object.
3.2 There is now considerable cross party support
for moves to a system of soft opt out across the UK
3.3 In July 2008 the Assembly's Health, Wellbeing
and Local Government Committee published its report following
an inquiry into presumed consent. (12) The Committee issued its
report to the Minister advising against a move to opt out organ
donation at this time. However, a number of senior AM's on the
Committee supported a dissenting report that the time had come
to move to an opt out system.
3.4 In December 2009, Health Minister Edwina
Hart announced that she would pursue legislative means to introduce
a "soft" opt-out system for presumed consent on organ
donation in Wales. Her announcement followed a series of public
debates and consultation throughout 2009 which revealed support
for a change in the law to a system of soft opt out. In July 2010
the First Minister for Wales announced proposals for the legislative
programme with confirmation of seeking an LCO on opt out.
3.5 The BMA in Wales has welcomed moving to a
system of "soft" presumed consent, claiming a change
in the law would "at a single stroke, save lives whilst still
giving the individual the right to have a choice".
"Let's show that we still care deeply about
the health of our nation and that we are willing to lead with
bold initiatives whilst other countries dither and waver."
Richard Lewis BMA Welsh Secretary
3.6 At present the UK has one of the lowest rates
of organ donation in Europe at just 13 donors per million of population.
Spain has the highest organ donation rate in Europe at 35 donors
per million of population (pmp).
3.7 On 10 January 2011 the draft National Assembly
for Wales (Legislative Competence) Health and Health Services)
Order 2011 ("the LCO") was laid before the Welsh Assembly
in order to facilitate the passage of legislation which would
introduce an "opt out" system for organ donation
for those living and dying in Wales.
3.8 On 12 January 2011 the Assembly Minister
for Health and Social Services explained the background to the
LCO to the Assembly. She indicated that the United Kingdom Government
had yet to provide confirmation that the LCO would be accepted
as being within the legislative competence conferred by Schedule
5 to the Government of Wales Act 2006 ("the 2006 Act"),
and she described a number of concerns which had been identified
in this regard.
3.9 The concerns identified by the Minister are
inter-related and, to some extent, raise issues of policy. The
Kidney Wales Foundation is interested in these matters as a major
charity engaged in issues relating to organ donation. It is keen
to ensure that a system of opt out is in place in the United Kingdom
as a whole and, in the first instance in Wales and to that end
it wishes to ensure that the legality of such a system is fully
examined at each stage. Accordingly, we asked Timothy Otty
QC to provide us with a written advice on the issues of law
which the concerns referred to by the Minister touch upon.
3.10 Mr Otty's views may be summarised as follows
and are detailed in the Appendix to this evidence:
- The proposed LCO is within the legislative competence
envisaged by the 2006 Act;
- Although there are restrictions on the nature
of any substantive measure which could follow the LCO, they are
not of such a nature as to preclude the introduction of an opt
out system in relation to organ transplantation;
- It would be possible for a measure introducing
such an opt out to be drafted in such a way as to make it compatible
both with the European Convention on Human Rights, and with European
Community law.
3.11 We do not see the practicality of a different
system operating in Wales with respect to organ donation to that
operating in other parts of the United Kingdom as a legal issue,
as much as a political one, unless it were suggested that concerns
over practicality were of such weight as to make legislation impossible
to operate in a non-arbitrary manner so as to be compatible with
human rights principles. We are not aware of any such suggestion
having been made. According to our legal advice "It would,
at first sight, seem surprising if this were the case in circumstances
where, notwithstanding the free movement provisions of European
Community law, some European Union countries operate opt-out systems
and some do not".
4. TRANSPLANT
CAPACITY
4.1 Existing infrastructure
4.1.1 At present there is one transplant unit
in Wales, occupying a half of one ward, based at the University
Hospital of Wales. Many patients in North Wales receive their
transplants in England which is also where all paediatric transplantation
takes place.
4.1.2 The Transplant Directorate of the University
Hospital of Wales (UHW) in Cardiff is currently the only Transplant
organisation within Wales and is responsible for kidney and pancreas
transplantation in South, West and Mid Wales. It is also responsible
for zonal retrieval of pancreata all around Wales and is the zonal
retrieval team for non heart beating kidneys for all of South
and West Wales.
4.1.3 The Directorate has performed more than
2,100 transplants over 30 years. There has been a significant
increase of kidney and pancreas transplants in the last year with
113 transplants being performed, an increase of 22% compared to
the previous year. (13)
4.1.4 Kidney transplants for patients in North
Wales are carried out mainly in Liverpool in the Royal Liverpool
Hospital. Transplants for Welsh patients are also carried out
in Bristol and elsewhere, particularly for hearts and lungs.
4.2 Increasing Resources
4.2.1 It is widely recognised that there must
be a substantial increase in resources and infrastructure to allow
more transplants to take place in Wales.
4.2.2 Major steps have been taken in years to
deal with these underlying problems of transplant capacity. Kidney
Wales welcomed the major announcement from Health Minister Edwina
Hart AM in December 2007 that Wales is to have a new state-of-the-art
Transplant Unit, which will almost double the number of transplants
carried out every year. This Unit is now open and is a world class
facility.
4.2.3 Another important aspect of transplant
capacity is the number of co-ordinators available and the networks
underpinning organ retrieval. This matter has been addressed comprehensively
and honestly in the recent report of the Organ Donor Taskforce
for the UK and the Wales Organ Donation Implementation Group.
More Co-ordinators have been appointed. Wales already complies
with the recommendation to commemorate donor families by dedicating
a stone in Cathay's Park in Cardiff in October 2007. Wales was
the first to do so.
5. CHANGE AND
AWARENESS
5.1 Widespread public engagement
5.1.1 Increasing awareness about soft opt out
is key to winning the support of the public for a change in the
law. It is also crucial if soft opt out is to be a success because
under the system, if someone has failed to opt out but would not
wish to donate, family members will be still be able to say no.
5.1.2 The most commonly reported reason for declining
organ donation at present, according to co-ordination teams in
Wales, is because the family member felt the need to protect the
body of the deceased. Other factors include circumstances at time
of death; the need for more time to come to terms with the death
of their relative, or that they did not have enough information
about what organ donation meant.
5.1.3 Even with a "soft" system of
Opt Out, discussions with family members are crucial and need
to be conducted properly and professionally.
5.1.4 Better information and support for families
is vital if more are to give consent. Improved awareness will
be just as important in a system of soft-opt out. Implicit in
that, is that health professionals who discuss these issues with
families also receive appropriate support and training.
5.2 Wales going alone and leading the UK
5.2.1 Legislation to introduce a system of "soft"
Opt Out on presumed consent is currently being pursued by the
Welsh Assembly Government. Kidney Wales Foundation, the British
Medical association and the British Heart Foundation agree with
these proposals. Kidney Wales has led the campaign in Wales and
in the UK.
5.2.2 The legal basis on whether the Assembly
can bring forward an LCO (Legislative Competence Order) on Presumed
Consent has been established.
5.2.3 Having settled the matter of whether it
would be legal for Wales to move forward on its own with regard
to Opt Out, it has been debated whether Wales should do
so alone. Kidney Wales would encourage the UK as a whole to change
the law on organ donation, but believes that Wales has the will
and capacity to take the lead. A position supported by the Welsh
Assembly Government's Health and Wellbeing Committee when considering
the issue. "we looked at the current legal position and whether
there was any fundamental reason why Wales could not seek the
power to introduce presumed consent in Wales, if there is the
will to do so. We concluded that there was not" (Health and
Wellbeing Committee July 2008).Our QC Advice and the Opinion contained
in the attached Appendix confirms this.
5.2.4 Whether Wales goes alone or in partnership
with the UK to introduce a system of opt out, national boundaries
will play no part in the availability of organs. Organs, from
wherever they are donated in the UK, will continue to be distributed
throughout the UK on the basis of clinical need. Wales receives
organs from all parts of the UK and indeed countries such as Spain.
5.3 European Convention on Human Rights
5.3.1 On 17 November 2008 an "Organ Donation
Taskforce" established by the previous Government of
the United Kingdom published an independent report entitled "The
Potential Impact of An Opt Out System for Organ Donation in the
UK". Annex C to that report contained a careful analysis
of the potential Convention issues arising in respect of any opt
out system adopted focusing, in particular, on the concept of
presumed consent. The analysis was prepared by the Legal Working
Group to the Taskforce.
5.3.2 The Working Group correctly identified
the core Convention provisions falling for consideration as being
Articles 8 (right to respect for private life) and 9 (freedom
of religion). It focused on the principles that would need to
underpin any opt out system rather than any detailed proposals.
It summarised its views in the following way: "a system
that was based on a presumption of consent or authorisation that
allowed adequate provisions for a person to opt out would be compatible
with the ECHR. Such a system would need to allow a person to indicate
their wishes (such as on a register) during their lifetime and
also to allow for evidence from family members about the person's
wishes and beliefs after their death. Particular consideration
would be needed for some groups of people, in particular children,
people who lack the mental capacity to make a decision to opt
out and those whose identity was unknown at the time of their
death".
5.3.3 For present purposes the Working Group's
most important conclusion was that there was no necessary incompatibility
problem with an opt out system such as to make any assertion of
legislative competence illegitimate. Our legal advice agrees with
this view and we believe it is further justified by the following
considerations:
- (a) Opt out systems operate in a substantial
number of European Union and Council of Europe countries and they
have never, so far as I am aware, led to any challenge before
the European Court of Human Rights;[75]
- (b) The Additional Protocol to the Council
of Europe's European Convention on Human Rights and Biomedicine
concerning Transplantation of Organs and Tissues of Human Origin
(ETS No. 186)[76]
provides at least some insight into the core standards which the
European Court might expect to be respected in this field. It
includes the following key provisions, none of which preclude
the existence of an opt out system:
Signatory
States must have a clear legally recognised system specifying
the conditions under which removal of organs or tissues is authorised
(Article 17);
- The only absolute bar to organ and tissue removal
concerning a deceased person is presented if that person had objected
to it (Article 17);
- The human body must be treated with respect and
all reasonable measures must be taken to preserve the appearance
of the donor corpse (Article 18);
- Signatory States are obliged to take "all
appropriate measures to promote the donation of organs and tissues"
(Article 19);
- The Convention requires adequate measures for
the protection of the confidentiality of any donor (Article 23).
5.3.4 There is no indication in the approach
of the European Commission of the European Community to the issue
of transplantation that it considers that such a system would
be incompatible with fundamental rights. This is of at least some
significance, even having regard to limitations on European Union
competence in this area.
6. CONCLUSION
The time has come for a change in our attitudes to
organ donation in the United Kingdom. Despite decades of campaigning
only 29% of people have joined the organ donor register in the
UK—yet study after study shows that most people would wish
to donate their organs.
International experience shows that the most effective
way to increase the number of organs donated is to move to an
opt out system of organ donation. A position supported by most
clinicians and the public. This change must be accompanied by
improving the infrastructure needed to deliver more transplants.
The reality is that people in the UK are dying, at
a rate of three per day. This switch will save lives. Wales has
moved first, now we have thrown down the gauntlet to the rest
of the UK to follow suit.
February 2011
APPENDIX
RE: PROPOSED LEGISLATIVE COMPETENCE ORDER
AN OPINION FOR THE KIDNEY WALES FOUNDATION
FROM TIMOTHY OTTY QC
BLACKSTONE CHAMBERS
INTRODUCTION
1. On 10 January 2011 the draft National Assembly
for Wales (Legislative Competence) Health and Health Services)
Order 2011 ("the LCO") was laid before the Welsh Assembly
in order to facilitate the passage of legislation which would
introduce an "opt out" system for organ donation
for those living and dying in Wales.
2. On 12 January 2011 the Minister for Health
and Social Services explained the background to the LCO to the
Assembly. She indicated that the United Kingdom Government had
yet to provide confirmation that the LCO would be accepted as
being within the legislative competence conferred by Schedule
5 to the Government of Wales Act 2006 ("the 2006 Act"),
and she described a number of concerns which had been identified
in this regard.
3. The concerns identified by the Minister are
inter-related and, to some extent, raise issues of policy. The
Kidney Wales Foundation is interested in these matters as a major
charity engaged in issues relating to organ donation. It is keen
to ensure that a system of opt out is in place in the United Kingdom
as a whole and, in the first instance in Wales and to that end
it wishes to ensure that the legality of such a system is fully
examined at each stage. I have been asked to provide it with a
written advice on the issues of law which the concerns referred
to by the Minister touch upon.
4. My views may be summarised as follows:
- (a) The proposed LCO is within the legislative
competence envisaged by the 2006 Act;
- (b) Although there are restrictions on the
nature of any substantive measure which could follow the LCO,
they are not of such a nature as to preclude the introduction
of an opt out system in relation to organ transplantation;
- (c) It would be possible for a measure introducing
such an opt out to be drafted in such a way as to make it compatible
both with the European Convention on Human Rights, and with European
Community law.
For present purposes it is, I understand, the first
of these issues which is of greatest significance.
WHETHER THE
LCO RELATED TO
FIELD 9, PART
1 OF SCHEDULE
5 TO THE
2006 ACT
5. Section 95(1)(a) of the 2006 Act empowers
Her Majesty by Order in Council to "amend Part 1 of Schedule
5 to add a matter which relates to one or more of the fields listed
in that Part". It is this power which requires consideration
for the purposes of assessing the proposed LCO.
6. Part 1 of Schedule 5 includes within its fields
"Field 9: health and health services". I consider
that this leads to the conclusion that the proposed LCO would
be clearly within the legislative competence envisaged by the
2006 Act. This is because the matter which would be added by the
LCO does relate to "health and health services",
and so satisfies s. 95(1)(a). I have reached this view for the
following reasons:
- (a) As a matter of straightforward language
transplantation is within the natural and ordinary meaning of
the term "health services";
- (b) Section 108(4)(a) and Schedule 7 to the
2006 Act are consistent with such a view. Schedule 7 (when in
force) will exclude from the Assembly's legislative competence
"xenotransplantation" (ie the transplantation
of organs from one species to another eg pigs to humans). Importantly
for present purposes these measures achieve their goal by excluding
xenotransplantation from a broad category of "Health and
health services" to which legislative competence would
otherwise extend. Two conclusions supporting the interpretation
of "health services" explained above flow from this:
first if the legislature had wished to include all forms of transplantation
from the Assembly's legislative competence it could have done
so here; secondly at least this form of transplantation is treated
as falling within the description "health services"
so as to require exclusion;
(c) This
view is also consistent with the terminology adopted in other
legislation relating to "health care" and indicates
a close symmetry between the terms. Two domestic examples can
be provided. Section 24(8) of the National Health Service Act
2006 defines "health care" as meaning "(a)
services provided to individuals for or in connection with the
prevention, diagnosis or treatment of illness, and (b) the promotion
and protection of public health". Section 59(6) of the
Safeguarding Vulnerable Groups Act 2006 s. 59(6) defines "health
care" as including "treatment, therapy or palliative
care of any description". European Community law (see
further below) also treats organ transplantation expressly as
a means of "treatment" in the terminology used
in Directive 2010/45/EU of the European Parliament and of the
Council on standards of quality and safety of human organs intended
for transplantation (see eg recital (1)).
RESTRICTIONS ON
THE MEASURES
CAPABLE OF
BEING MADE
UNDER THE
LCO
7. This issue will be regulated by s. 94 of the
2006 Act. This provision places the following potentially material
restrictions on any Assembly Measure which could be introduced
even after the proposed LCO:
- (a) It must not be such that it would apply
otherwise than in relation to Wales, nor modify functions exercisable
otherwise than in relation to Wales (s. 94(4)(b));
- (b) It must not be incompatible with either
the rights protected by the European Convention on Human Rights,
or with European Community law (s. 94(6)(c)).
Similar restrictions would apply were the Assembly
Act provisions of the 2006 Act to come into force (see ss. 108(4)(b)
& 108(6)(c)).
Geographical restriction
8. The first of these restrictions will require
careful drafting in any substantive measure, but I note from paragraphs
32 to 36 of the Memorandum from the Minister for Health and Social
Services that two key objectives are to be at the heart of any
proposals: first that people be properly informed and given a
genuine opportunity to opt out of the proposed scheme; and secondly
that criteria will be drawn so as to focus application of the
scheme on those who live and die in Wales. I also understand that
criteria which may be used include reference to the electoral
register and the GP Register, and that there will be a minimum
prior residence period of 6 months before deemed consent could
arise. It is my view that these proposals illustrate that appropriate
focus is being given to ensuring that the restrictions imposed
by s. 94(4)(b) of the 2006 Act. The adequacy of the precise wording
utilised in any draft legislation will of course require detailed
scrutiny once it is available.[77]
Practicality of a different system operating in
Wales with respect to organ donation to that operating in other
parts of the United Kingdom
9. Although this concern was referred to by the
Minister I do not see that this is a legal issue, as much as a
political one, unless it were suggested that concerns over practicality
were of such weight as to make legislation impossible to operate
in a non-arbitrary manner so as to be compatible with human rights
principles. I am not aware of any such suggestion having been
made. It would, at first sight, seem surprising if this were the
case in circumstances where, notwithstanding the free movement
provisions of European Community law, some European Union countries
operate opt-out systems and some do not.
EUROPEAN CONVENTION
ON HUMAN
RIGHTS AND
EUROPEAN COMMUNITY
LAW
European Convention on Human Rights
10. On 17 November 2008 an "Organ Donation
Taskforce" established by the previous Government of
the United Kingdom published an independent report entitled "The
Potential Impact of An Opt Out System for Organ Donation in the
UK". Annex C to that report contained a careful analysis
of the potential Convention issues arising in respect of any opt
out system adopted focusing, in particular, on the concept of
presumed consent. The analysis was prepared by the Legal Working
Group to the Taskforce.
11. The Working Group correctly identified the
core Convention provisions falling for consideration as being
Articles 8 (right to respect for private life) and 9 (freedom
of religion). It focused on the principles that would need to
underpin any opt out system rather than any detailed proposals.
It summarised its views in the following way: "a system
that was based on a presumption of consent or authorisation that
allowed adequate provisions for a person to opt out would be compatible
with the ECHR. Such a system would need to allow a person to indicate
their wishes (such as on a register) during their lifetime and
also to allow for evidence from family members about the person's
wishes and beliefs after their death. Particular consideration
would be needed for some groups of people, in particular children,
people who lack the mental capacity to make a decision to opt
out and those whose identity was unknown at the time of their
death."
12. For present purposes the Working Group's
most important conclusion was that there was no necessary incompatibility
problem with an opt out system such as to make any assertion of
legislative competence illegitimate. I agree with this view and
believe it is further justified by the following considerations:
- (c) Opt out systems operate in a substantial
number of European Union and Council of Europe countries and they
have never, so far as I am aware, led to any challenge before
the European Court of Human Rights;[78]
- (d) The Additional Protocol to the Council
of Europe's European Convention on Human Rights and Biomedicine
concerning Transplantation of Organs and Tissues of Human Origin
(ETS No. 186)[79]
provides at least some insight into the core standards which the
European Court might expect to be respected in this field. It
includes the following key provisions, none of which preclude
the existence of an opt out system:
- Signatory States must have a clear legally recognised
system specifying the conditions under which removal of organs
or tissues is authorised (Article 17);
- The only absolute bar to organ and tissue removal
concerning a deceased person is presented if that person had objected
to it (Article 17);
- The human body must be treated with respect and
all reasonable measures must be taken to preserve the appearance
of the donor corpse (Article 18);
- Signatory States are obliged to take "all
appropriate measures to promote the donation of organs and tissues"
(Article 19);
- The Convention requires adequate measures for
the protection of the confidentiality of any donor (Article 23).
- (e) There is no indication in the approach
of the European Commission of the European Community to the issue
of transplantation that it considers that such a system would
be incompatible with fundamental rights. This is of at least some
significance, even having regard to limitations on European Union
competence in this area, (see further below).
13. In view of the care of the analysis set out,
and to avoid unnecessary repetition, a copy of the Working Group's
report dated 11 April 2008 and published as Annex C to the Taskforce
report should be considered.
European Community Law
14. A helpful summary of recent developments
in European Union governance over organ donation and transplantation,
focusing on the Commission's action plan and the (then proposed)
Organs Directive (subsequently Directive 2010/45/EU 7 July 2010)
is set out in the article "Adding Value? EU Governance
of Organ Donation and Transplantation" Ann Maree Farell,
EJHL 17 (2010) 51-79. This article makes the following important
points each of which support my view that an opt out system would
be compatible with European Community law:
- (a) The Commission and the Directive allow
for flexibility on the part of Member States in relation to the
meeting of obligations with respect to eg donor consent (see paragraph
4.3 & Directive Article 14);
- (b) As Farell explains "in relation
to regulatory requirements covering consent to organ donation,
the EU's competence to act on this issue is circumscribed by Article
168(7) TFEU which states that national provisions regarding the
donation or medical use of organs shall not be affected by the
adoption of minimum harmonisation measures under Article 168(4)(a)
TFEU" (p. 73);
- (c) The Commission has expressly acknowledged
that there is a "degree of variation as between Member
States in relation to the consent regimes that have been adopted
in relation to deceased organ donation, reflecting the national
specificities of historical, socio cultural protection and political
flexibility" (p. 73 citing Commission Impact Assessment
accompanying Communication 30.5.02007 SEC (207) 704 at 24-27).
CONCLUSION
15. My overall views on the basis of the information
currently available are set out at paragraph 4 above. I would
be happy to assist further once more detailed information becomes
available.
61 http://www.uktransplant.org.uk/ukt/statistics/latest_statistics/monthly.jsp Back
62
http://www.uktransplant.org.uk/ukt/statistics/transplant_activity_report/current_activity_reports/ukt/2008_09/transplant_activity_uk_2008-09.pdf Back
63
S Bird and J Harris Time to move to presumed consent for organ
donation. British Medical Journal, BMJ 2010;340:c2188 Back
64
Abadie A, Gay S. The impact of presumed consent legislation
on cadaveric organ donation: a cross-country study. Journal
of Health Economics 2006;25 :599-620 Back
65
Opt out throughout this evidence refers to a system of soft opt
out organ donation Back
66
UK Organ Donation Taskforce report entitled Organs for Transplant,
published January 2008 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_082120.pdf Back
67
UK Organ Donation Taskforce inquiry into presumed consent, report
published November 2008 titled "The potential impact of
an opt out system for organ donation in the UK" http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_090303.pdf Back
68
http://shakespeare.yougov.com/2010/01/05/71-of-welsh-would-donate-their-organs-to-help-others/ Back
69
National Service Framework for Renal Disease launched by Welsh
Assembly Government in 2007. http://www.wales.nhs.uk/sites3/home.cfm?orgid=434 Back
70
Figures from NHSBT, available on request. Back
71
http://www.uktransplant.org.uk/ukt/statistics/latest_statistics/latest_statistics.jsp Back
72
http://www.europeantransplantcoordinators.org/uploads/pdfs/Irodat/02_Irodat%202008.pdf Back
73
Gimbel R W, Strosberg M A, Lehrman S E, Gefenas E, Taft F. Presumed
consent and other predictors of cadaveric organ donation in Europe.
Progress in Transplantation 2003;13(1):17-23 Back
74
http://www.bmj.com/cgi/content/long/338/jan14_2/a3162 Back
75
Spain, Austria and Belgium are the most prominent examples but
they are not alone: see eg S Gevers, A Janssen and R Friele "Consent
Systems for Post Mortem Organ Donation in Europe" European
Journal of Health Law 11 (2004) 176-177; New York Times 23 April
2010; Impact of presumed consent for organ donation on donation
rates: a systematic review BMJ 2009 338: a3162; The Impact of
Presumed Consent Legislation on Cadaveric Organ Donation: A Cross
Country Study (December 2005)-Alberto Abadie & Sebastian Gat. Back
76
Although the United Kingdom has not signed or ratified this Convention
it has been ratified by 12 member States of the Council of Europe.
The Convention has only been referred to in the case law of the
European Court of Human Rights in an unrelated context (see eg
SH & Others v Austria Application No. 57813/00 1 April
2010 relating to the availability of fertility treatments). Back
77
For the purposes of this advice I have assumed that it is to the
issue of "geographical restriction" that the Minister
was referring when she spoke of the "need to ensure that
there is no ambiguity with regard to jurisdiction" (see
paragraph 2 above). Back
78
Spain, Austria and Belgium are the most prominent examples but
they are not alone: see eg S Gevers, A Janssen and R Friele "Consent
Systems for Post Mortem Organ Donation in Europe" European
Journal of Health Law 11 (2004) 176-177; New York Times 23 April
2010; Impact of presumed consent for organ donation on donation
rates: a systematic review BMJ 2009 338: a3162; The Impact
of Presumed Consent Legislation on Cadaveric Organ Donation: A
Cross Country Study (December 2005)-Alberto Abadie & Sebastian
Gat. Back
79
Although the United Kingdom has not signed or ratified this Convention
it has been ratified by 12 member States of the Council of Europe.
The Convention has only been referred to in the case law of the
European Court of Human Rights in an unrelated context (see eg
SH & Others v Austria Application No. 57813/00 1 April
2010 relating to the availability of fertility treatments). Back
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