Written evidence submitted by Tom Brooks
EXECUTIVE SUMMARY
1. This memorandum of evidence has been assembled
following discussions on the Organ Donation LCO at two meetings
of Labour Party members in North Wales. In each discussion it
was clear that a wide variety of views exist, many conflicting
with one another. Although many of the points below originate
from various individuals involved in those discussions, the responsibility
for selecting which opinions to express in this evidence statement
is mine and mine alone.
2. I have selected evidence which describe the
many concerns expressed by persons involved in the discussion
which challenge the wisdom and possibly the legality of the LCO
approach as drafted. Other persons participating in the discussions
considered that the need to obtain more organs for donation was
such that the Welsh Assembly Government should be given free rein
to take whatever action it wished to procure organs. This point
of view is not supported by me.
3. It is noted that the consultation conducted
by the Welsh Assembly Government in 2009 drew a similar wide range
of opinions from the public. In the consultation report, Options
For Changes To The Organ Donation System In Wales[30]
the Minister For Health And Social Services noted that "the
public debate and views offered in this consultation about an
opt-out system are complex and highly emotive". However,
in proceeding with this LCO few of the complex and highly emotive
opinions raised have been taken on board and no restrictions to
address these appear to have been included in the LCO.
4. This memorandum of evidence addresses principally
the 12 questions posed by the Committee and adheres to the structure
requested by the Committee.
5. This evidence statement asserts that:
- Most people wish to increase the number of organs
available for donation, but many do not believe that presumed
consent will maximise the number of organs donated.
- The LCO is very much a "conscience issue";
"presumed consent" is viewed as having a compulsion
element and introducing "compulsion" into as sensitive
a topic as organ donation is likely to generate persistent adverse
publicity.
- The WAG publicity focuses on the presumed consent
approach being implemented under a "soft opt-out system".
The press reflected "soft opt-out" as being that the
deceased's relatives would have the final decision. The Minister
For Health And Social Services in her response to the consultation
dropped the phrase "soft opt-out" and appears to be
proceeding on the basis of an omission by the deceased to opt-out
being treated as equal to a legally binding election made by a
voluntary donor under the Human Tissue Acts.
- A register based upon presumed consent must be
populated with personal data. This raises many Data Protection
Act issues. A view has been promoted that the NHS register, which
relates people with their GP, is the Welsh Assembly Government's
preferred source.
- The presumed consent proposal is seen generally
as people registered with a Welsh GP being used as guinea pigs.
This is considered good by some and unacceptable by others.
6. This evidence statement asserts in relation
to the joint organ donor service which currently covers both England
and Wales that:
- The provision of an organ donor service is through
a joint special health authority between England and Wales. It
is for the lawyers to decide if as such it falls outside of the
Welsh Assembly's competence. Certainly operating different organ
donation consent systems for two co-joint parts of one United
Kingdom is difficult to justify.
- Some 30% of the population of England and Wales
currently have given consent for their organs to be donated and
those persons are already included on the English-Welsh joint
donor register. If presumed consent is introduced in Wales the
percentage of the joint population on the register will rise to
only 34% of the combined population of England and Wales, less
than that if there is a reaction by the public against presumed
consent. Hence the number of organs that may be made available
to England and Wales, if presumed consent is applied in Wales,
will increase by only a small amount if at all.
- If a presumed consent scheme is introduced for
persons in Wales then 90% of the people on the joint England-Wales
Organ Donor register will be confirmed as having given formal
voluntary consent while 10% of the people on the Organ Donor register
will have been presumed to have given their consent but will not
actually have done so. It will be for lawyers to determine whether
the Human Tissue Acts should apply to "presumed" consent
entries on the Organ Donor Register or not.
7. This evidence statement asserts in relation
to Organ Donor Register that:
- Primary legislation wider than just for Wales
may be required to provide a degree of patient confidentiality
sufficient to avoid frequent referrals by patients to the UK and
European Courts alleging breaches of European "Data Protection"
directives and increasing amounts of patient litigation in relation
to patient record accuracy and integrity.
- The LCO gives no indication as to where liability
rests if the organs are removed from a deceased person who has
withdrawn consent if the deceased is a resident in Wales for the
purposes of any Measure arising from this LCO; or are removed
from a deceased person who has never given consent if the deceased
is a resident in England for the purposes of any Act arising from
this LCO. It should be clear what liability rests with the Secretary
of State for Health in Westminster, as the person primarily responsible
for the Blood and Transplant Special Health Authority, The Minister
For Health And Social Services in the National Assembly for Wales,
who is the "Authority for Wales" or with any NHS employees
involved in the improper removal of organs.
- Where the deceased did not die on NHS premises,
it is unclear whether the LCO would extend powers to a health
board or ambulance trust in Wales to remove the body from the
place of death to an NHS premises for the purpose of tissue removal.
8. This evidence statement asserts in relation
to ethical and philosophical principles relating to the proposed
LCO and of its effectiveness or otherwise, that there is a profound
concern abut how some critical values which underpin our society
have been overlooked:
- The proposal to introduce "presumed"
consent, as set out by the Welsh Assembly Government Health Minister,
threatens to blow apart a fundamental compact between individual
citizen and State.
- Presumed consent is by definition not a choice
that can be made by an individual, freely and without duress.
This is because the ownership of organs would be deemed already
to be with the State, and the opt-out mechanism is effectively
a request from the individual for a return of ownership of their
bodily integrity. That is, an opt-out from the State's presumed
entitlement to own the organs.
- With the current opt-in, each citizen has a choice,
namely either to agree to donate or to withhold donation: With
opt-out, there is a loss of freedom and autonomy. With the proposed
presumed consent there is, by definition, no choice, as the organs
are deemed already to be owned by the state. Hence the overall
impact is a loss of personal liberty and autonomy of the citizen.
It follows therefore the human rights of Wales-domiciled, UK residents
would be profoundly and irredeemably compromised when compared
to residents within the rest of the UK.
- The current opt-in system respects the citizen's
right to decide to act benevolently by pledging their organs following
death for possible use by an anonymous donor.
- The danger is that this proposed Measure attacks
the profound matter of individual autonomy and seeks to remove
from each person resident in Wales their inalienable right to
decide on bodily integrity.
- It could also exacerbate the fragile area of
trust in our society. In this case, our society would shift sharply
towards a "low trust" society rather than in the direction
of the desired "high trust" alternative.
Evidence Statement
1. Is the LCO request in the spirit and scope
of the devolution settlement?
9. The provision of an organ donor service is
through a joint special health authority shared between England
and Wales; It is for the lawyers to decide if as such it falls
outside of the scope of the Welsh Assembly's competence. Certainly
an arrangement to have a single joint special health authority
operating very different systems for two co-joint parts of the
United Kingdom is difficult to justify and will be seen by many
as being outside the spirit of the devolution settlement.
10. The proposal is to retain the current system
for the allocation and the use of "collected" organs,
according to a joint clinical assessment of need. However, the
donation of organs is planned to be only with specific formal
agreement of the deceased for patients who are registered with
a GP in England, but presumed to be available for extraction from
any deceased person registered with a GP in Wales, irrespective
of the family's wishes or the wishes of the deceased as they may
have been expressed to family members or to third parties.
11. The presumed consent proposal is seen generally
as people living in Wales who are affected being used as guinea
pigs. This is considered good by some and unacceptable by others.
It is for lawyers to decide if the treatment of Welsh persons
as "guinea pigs" in this manner conforms with the spirit
and scope of the devolution settlement or not.
12. Some proponents of the presumed consent scheme
have indicated that a policy could apply that "organs collected
in Wales should be offered first to potential recipients in Wales"
and that this policy could substantially reduce the waiting list
for organs by people registered with GPs in Wales. This LCO would
not appear to permit such a policy.
2. Is the use of the LCO mechanism in accordance
with the Government of Wales Act 2006?
13. This is a mainly a question for lawyers to
address, but in one respect, that of the European Data Protection
legislation and the UK Data Protection Acts, serious questions
need to be answered.
14. A register based upon presumed consent must
be populated with personal data. This raises many Data Protection
Act issues. A view has been promoted that the NHS register, which
relates people with their GP, is the Welsh Assembly Government's
preferred source.
15. Primary legislation wider than just for Wales
may be required to provide a degree of patient confidentiality
sufficient to avoid frequent referrals by patients to the UK and
European Courts alleging breaches of European "Data Protection"
directives and increasing amounts of patient litigation in relation
to patient record accuracy and integrity
16. The Data Protection Act 1998 gives effect
in UK law to EC Directive 95/46/EC, and introduces eight data
protection principles that set out standards for information handling.
The term "health record" is defined by Section 68 of
the Act, and means any record which:
- consists of information relating to the physical
or mental health or condition of an individual, and
- has been made by or on behalf of a health professional
in connection with the care of that individual.
The term "health professional" is also
defined by the Act. It is for lawyers to decide whether records
on the Organ Donor Register are now, or would remain if the proposed
Measure is approved, "health records" within the definition
of the Data Protection Act. It is for lawyers to decide whether
use of GP records, or patient registration records maintained
by GP practices, could be used to create and maintain a tissue
donor register without breeching EC Directive 95/46/EC and its
subsequent amendments.
17. There has long been tension in the NHS regarding
whether the practices for ensuring patient confidentiality are
complied with in a sufficiently disciplined manner to conform
with the Act and often a lack of clarity about who would be accountable
for any breaches. On 18 October 2001, Nigel Crisp wrote in his
management letter,
"There has been widespread concern about the
need to comply with legal requirements and professional guidelines,
notably the need in certain circumstances to obtain patient consent
prior to disclosure and use of patient identifiable data. Whilst
it is clear that current NHS practice does not always meet required
standards, the NHS is dependent on information collected from
and about patients and the Department of Health policy is to encourage
and support the necessary improvements without disruption to important
NHS and related work. The General Medical Council, the Information
Commissioner, and many others, are working with the Department
to ensure that reasonable and managed progress is made but it
is clearly in no-one's interests for any aspect of health service
provision to be impaired. The Department of Health will shortly
publish a strategy document that will set out ….new powers
provided under section 60 of the Health and Social Care Act 2001
that can be used to support key uses of patient information where
there are particular concerns".
18. The Health and Social Care Act 2001 requires
that resulting regulations under section 60 of the Act are to
be laid under affirmative process. Despite Lord Crisp's letter,
it is understood that few such regulations have been laid and
that there is no such intent yet expressed to invoke a section
60 regulation in support of this LCO. It is contended that none
of the sources of data suggested for use in creating the presumed
consent section of the Organ Donor Register was collected for
that purpose and hence any use of such data would be in conflict
with the Data Protection Act.
19. In May 2002, the then Information Commissioner,
Elizabeth France, published "USE AND DISCLOSURE OF HEALTH
DATA—Guidance on the Application of the Data Protection
Act 1998". This 43 page document remains the principal source
of guidance to NHS staff. It is a document that addresses practical
issues related to the confidentiality of patient data in a detailed
clear manner. It is difficult to see how the proposed presumed
consent element of the Organ Donor Register can be made to comply
with the guidance in Mrs France's document.
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?
20. This is a question for lawyers to address.
4. To what extent is there a demand for legislation
on the matter(s) in question?
21. Most people wish to increase the number of
organs available for donation, but many do not believe that "presumed
consent" will maximise the number of organs donated. "Experts"
interpret differently the evidence from other countries, both
in relation to "presumed consent" and the other actions
intended to increase the availability of organs for transplant.
However, it is noted that despite the NHS Blood and Transplant
Authority's duties including:
- "encouraging people to donate organs, and
tissues;
- optimising the safety and supply of blood organs
and tissues;
- helping to raise the quality, effectiveness and
clinical outcomes of transplant services;
- commissioning and conducting research and development";
and providing expert advice to both the Department
of Health and the Welsh Assembly Government, it does not appear
that the NHS Blood and Transplant Authority has made a recommendation
to both Authorities on the introduction of a system of presumed
consent. It is important for the Welsh Affairs Select Committee
to obtain clear expert advice from the NHS Blood and Transplant
Authority on the topic and if the advice given for Wales is different
to that given for England to understand why. If Parliament is
to give permission for a presumed consent system to be introduced
in Wales while the NHS Blood and Transplant Authority is not recommending
that a presumed consent organ donor system be introduced in England,
the public will wish to understand the justification.
22. The LCO is very much a "conscience issue".
Presumed consent is viewed as having a powerful compulsion element
and introducing "compulsion" into as sensitive a topic
as organ donation is likely to generate persistent adverse publicity.
Such compulsion undermines the nurturing of trust in a society
like the UK, where the citizen is encouraged to participate voluntarily
without their autonomy being compromised. Pro-active and creative
awareness-raising is conducive to encouraging benevolence and
trust among the people. The present opt-in system encourages citizen
empowerment, while the introduction of opt-out as proposed in
the LCO would be retrogressive and disempowering for Welsh domiciled
residents of the UK.
23. The WAG publicity focuses on the presumed
consent approach being implemented under a "soft opt-out
system". The press reflected "soft opt-out" as
being that the deceased's relatives would have the final decision.
The Minister For Health And Social Services in her response to
the consultation dropped the phrase "soft opt-out" and
appears to be proceeding on the basis of an omission by the deceased
to opt-out being treated as a legally binding election made by
a voluntary donor under the Human Tissue Acts. The NHS Blood and
Transplant Authority[31]
stresses that if relatives object "They will be encouraged
to accept the dead person's wishes but it will be made clear that
they do not have the legal right to veto or overrule those wishes".
It is for lawyers to decide if relatives are still without a "legal
right to veto or overrule those wishes" in a presumed consent
system.
5. Are there any cross-border issues relating
to the LCO? (eg financial or policy issues)?
24. There are severe cross border issues if the
same special health authority seeks to run two conflicting organ
donation systems for citizens of the same United Kingdom dependent
upon some interpretation of presumed domicile at the time of death.
25. If a person who is included under the register
as a presumed consent person while domiciled in Wales moves from
Wales to England, are they automatically removed from the register?
The Data Protection Act lays a duty on the Data Controller to
keep information up to date. Will the LCO give powers to the Welsh
Assembly to enter a person with a "presumed consent tag"
on the Register "for life or until that person formally requests
removal" or would the LCO give powers only for the person
to be entered on the Register while domiciled in Wales?
26. In normal circumstances, a patient can only
be registered with a GP in either England or Wales. Hence if the
NHS Register is used as the basis for populating a presumed consent
Organ Donor Register presume domicile is clear. There are exceptions
where a person lives in an address in one country but works in
the other. Registration with GPs in both England and Wales then
becomes possible. If the electoral register is used, the same
person can be included in a register in both England and Wales.
In both of these examples the issue of which takes precedence
for inclusion or exclusion on the Organ Donor Register arises
and such a decision may be consisted as not in accordance with
the Government of Wales Act.
27. Some 30% of the population of England and
Wales currently have given consent for their organs to be donated
and those persons are already included on the English-Welsh joint
donor register. If presumed consent is introduced in Wales the
percentage of the joint population on the register will rise to
only 34% of the combined population of England and Wales, less
than that if there is a reaction by the public against presumed
consent. Hence the number of organs that may be made available
to England and Wales, if presumed consent is applied in Wales,
will increase by only a small amount if at all.
28. If a presumed consent scheme is introduced
for persons in Wales then 90% of the people on the joint England-Wales
Organ Donor register will be confirmed as having given formal
voluntary consent while 10% of the people on the Organ Donor register
will have been presumed to have given their consent but will not
actually have done so. It will be for lawyers to determine whether
the Human Tissue Acts should apply to "presumed" consent
entries on the Organ Donor Register or not.
29. The LCO gives no indication as to where liability
rests if the organs are removed from a deceased person who has
withdrawn consent if the deceased is a resident in Wales for the
purposes of any Measure arising from this LCO, or are removed
from a deceased person who has never given consent if the deceased
is a resident in England for the purposes of any Act arising from
this LCO. It should be clear what liability rests with the Secretary
of State for Health in Westminster, as the person primarily responsible
for the Blood and Transplant Special Health Authority, The Minister
for Health and Social Services in the National Assembly for Wales,
who is the "Authority for Wales" or with any NHS employees
involved in the improper removal of organs.
30. Where the deceased did not die on NHS premises,
it is unclear whether the LCO would extend powers to a health
board or ambulance trust in Wales to remove the body from the
place of death to an NHS premises for the purpose of tissue removal.
It is understood that no such powers exist in England.
6. Are the purpose and scope of the LCO clearly
defined, including the terms and definitions used?
31. It is noted that the consultation conducted
by the Welsh Assembly Government in 2009 drew a wide range of
opinions from the public. In the consultation report, Options
For Changes To The Organ Donation System In Wales[32]
the Minister For Health And Social Services noted that "the
public debate and views offered in this consultation about an
opt-out system are complex and highly emotive". However,
in proceeding with this LCO few of the complex and highly emotive
opinions raised have been taken on board and no restrictions to
address these appear to have been included in the LCO.
32. A key question that has not been answered
is whether medical staff accessing the Organ Donor Register will
be able to determine whether a deceased person is a "presumed
consent" deceased or someone who had made a specific request
to be included on the Organ Donor Register. Fundamentally the
Welsh Assembly Government Minister for Health and Social Services
has not addressed the key issue of the transfer of ownership of
a person's organs from the person to the State, if presumed consent
was introduced in Wales. The moment "presumed consent"
became law in Wales, the State would be presumed to own each person's
organs, and so an application would have to be made by the person
requesting a return of the ownership of their organs to that person.
7. Does the LCO have the potential to increase
the regulatory burden on the private or public sector?
33. The NHS Organ Donor Register is a national,
confidential list of people who are willing to become donors after
their death. It can be quickly accessed to see whether an individual
has registered a willingness to be an organ donor or not and if
so for what organs.
34. Where a relative wishes to pre-empt the taking
of an organ on the basis of presumed consent, the use of a solicitor
to raise potential matters with the Coroner would be an effective
mechanism under the proposed LCO. It would add to the public administration
burden.
35. It any legislation under the LCO were to
introduce a right for a family member to veto any action in relation
to presumed consent to remove organs, details of next of kin and
powers of attorney etc would need to be included in the Organ
Donor Register, making some significant changes
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?
36. It is hard to see how the NHS Blood and Transplant
Authority could serve both England and Wales with two such very
different schemes as indicated. Currently, only one appointment
to the Board of the NHS Blood and Transplant Authority is made
on behalf of the Welsh Assembly Government. If the "guinea
pig" "presumed consent" scheme is introduced, there
will be a major conflict of focus and priorities. The NHS Blood
and Transplant Authority's management will need to focus much
attention on the new system in Wales as it seeks to grapple with
the issues that "presumed consent" will raise. On the
other hand at least 93% of the NHS Blood and Transplant Authority's
activities will relate to England.
37. If efficient and effective management of
the NHS Blood and Transplant activities in England and Wales is
to be maintained, an arrangement similar to that in Scotland would
need to be introduced and a separate Welsh NHS Blood and Transplant
Authority established.
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?
38. If presumed consent is the recommended advice
by the NHS Blood and Transplant Authority to both the English
and Welsh Authorities to whom it reports, then Westminster legislation
applicable to both parts of the United Kingdom would be the appropriate
way to proceed.
39. Since introducing presumed consent in England
does not appear to be the current recommendation of the expert
body (NHS Blood and Transplant Authority) responsible for giving
such advice, it may be argued that allowing the National Assembly
for Wales to reject the NHS Blood and Transplant Authority's presumed
guidance is outwith the spirit and scope of the devolution settlement.
10. Has full use been made of any existing
powers to issue statutory guidance and/or secondary legislation
in relation to this Matter?
40. This is a question for lawyers to address.
11. Does the LCO have the potential to cause
confusion regarding legal jurisdiction and the individuals to
whom any Measure would apply to?
41. The extent of the impact on United Kingdom
subjects whose domicile moves between England and Wales is not
clarified by the LCO. If a person who is registered when domiciled
in Wales as a presumed consent donor moves to England, are they
taken off of the register, especially since the Data protection
Act requires data to be kept up to date and the move to England
will invalidate any "presumed consent tag" applied while
they were resident in Wales. A series of related questions apply
to students from either Wales or England who study in the other.
42. When registering as an organ donor under
the current system, the prospective donor may choose between "A"
"any of my organs and tissue" or "B" "only
those I have ticked of my kidneys heart liver corneas lungs and
pancreas". Where prospective donors have registered for one
or more selected organs only, will a "presumed consent"
regime in Wales change their selection to "any of my organs".
If not, why not and if so how will the "compulsory"
change be handled? Will any person who decides to opt out from
the presumed consent register be able to register under category
"B"?
12. What are the implications of Article 8
and Article 9 of the European Convention on Human Rights on any
such Measure? Concurrent to the work of the Welsh Affairs Select
Committee, a detailed legal examination of the proposed Order
will be conducted by the Constitution Committee, House of Lords?
43. Article 8, European Convention on Human Rights:
"Everyone has the right to respect for his private
and family life, his home and his correspondence."
44. This LCO would result in a direct challenge
on the human rights of a person domiciled in Wales in so far as
their inalienable right, to choose whether or not to relinquish
rights to their bodily organs to the State would be removed if
the proposed "Presumed Consent" Measure became law.
Those domiciled in the rest of the UK, however, would still be
protected by Article 8, paragraph 1.
45. Also Article 8, European Convention on Human
Rights:
"There shall be no interference by a public
authority with the exercise of this right (respect for private
and family life) except such as is in accordance with the law
and is necessary in a democratic society in the interests of national
security, public safety or the economic well-being of the country,
for the prevention of disorder or crime, for the protection of
health or morals, or for the protection of the rights and freedoms
of others."
46. The danger is that this proposed Measure
attacks the profound matter of individual autonomy and seeks to
remove from each person resident in Wales their inalienable right
to decide on bodily integrity. It could also exacerbate the fragile
area of trust in our society. In this case, our society would
shift sharply towards a "low trust" society rather than
in the direction of the desired "high trust" alternative.
In my opinion, this proposed Measure would amount to "interference
by a public authority".
47. Article 9, European Convention on Human Rights:
"Everyone has the right to freedom of thought,
conscience and religion; this right includes freedom to change
his religion or belief, and freedom, either alone or in community
with others and in public or private, to manifest his religion
or belief, in worship, teaching, practice and observance."
48. Many people hold the view that each person
has an inalienable right to their body, and should have the autonomy,
free from compulsion and coercion, to decide whether or not to
donate their organs and that this view is a cornerstone of our
liberal democratic values and guarantor of our freedom.
49. This proposed measure would undermine this
right to freedom, namely the choice of the autonomous individual
whether to donate their organs or not, and at a stroke would profoundly
and irredeemably change the relationship between State and individual,
which should be a foundation stone of our liberty.
February 2011
30 Welsh Assembly Government September 2009 Back
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Organ and Tissue Donation, Your Questions Answered. Back
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Welsh Assembly Government September 2009 Back
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