Memorandum by the Scottish Council on
Human Bioethics
The Scottish Council on Human Bioethics (SCHB)
is an independent, non-partisan, non-religious registered Scottish
charity comprising doctors, lawyers, psychologists, ethicists
and other professionals from disciplines associated with medical
ethics.
The SCHB subscribes to the principles set out
in the United Nations Universal Declaration of Human Rights which
was adopted and proclaimed by the UN General Assembly by resolution
217A (III) on 10 December 1948.The SCHB is grateful to the UK
House of Lords for this opportunity to respond to the consultation
entitled Inquiry into the EU Commission's Communication on
organ donation and transplantation: Policy actions at the EU level.
It welcomes the Committee's intent to promote public consultation,
understanding and discussion on transplantation.
In addressing the consultation, the SCHB has
formulated the following responses, which can be made publicly
available by the Committee.
CONSULTATION RESPONSE
ON BEHALF
OF THE
SCOTTISH COUNCIL
ON HUMAN
BIOETHICS
Scottish Legislative Perspective
1. In Scotland, the Human Tissue (Scotland)
Act 2006 has created a hybrid system between the explicit consent
(opt-in) and presumed consent (opt-out) systems for the removal
of organs from a deceased person for transplantation.
In other words, the proposed system in Scotland
is of:
(i) informed consent (opt-in) for those who
register their wish to donate a number of organs before death
on the NHS Organ Donor Registry or by carrying an organ donor
card (though their nearest relatives may greatly add to this number
of body parts being donated after death, without the informed
consent of the deceased person, in conformity with Section 7 of
the Act), and
(ii) "soft" presumed consent (opt-out),
similar to the Spanish system, when no prior wishes of the deceased
person are known. Indeed, the general thrust of the opt-out system
in Spain enables nearest relatives to agree to the presumed consent
from a deceased person to the removal of organs when they have
no "actual knowledge that the adult was unwilling for
any part of the adult's body... to be used for transplantation"
(using the words of the Scottish Act in Section 7).
2. However, in contrast to all other systems
of "soft" presumed consent in Europe in which nearest
relatives usually tend to make the final decision, the Scottish
Act does not enable persons, who wish to do so, to register their
opposition to the removal of all or certain specific body parts
after death. Indeed, the UK does not have a national register
opposing general or specific organ donation.
In other words, a problem arises if a person
does not know or trust, his or her relatives, characterised in
Section 50 of the Act (and who may be just friends), concerning
the decision to use his or her body parts after death. Indeed
this person cannot stop his or her potentially unknown or unreliable
relatives indicating that they have no "actual knowledge
that the adult was unwilling for any part of the adult's body...
to be used for transplantation" after death in the present
UK context (using the words of the Scottish Act in Section 7).
The absence of fail-safe mechanisms to allow
people to record their wishes, be they positive or negative, in
the Act is a cause of concern for the SCHB.[5]
3. The SCHB is even aware of a case where
just a landlord of a deceased person was asked to authorise the
removal or organs for transplantation.
4. Moreover, in the context of what is believed,
by many, to be a gradual disintegration of family and social structures
in Scotland it is very questionable whether the nearest relatives
mentioned in Section 50 of the Human Tissue (Scotland) Act
2006 are even aware of the wishes of the deceased person.
5. Unfortunately, the present situation
in Scotland has very serious ethical consequences and could lead
to the undermining of the principle of informed consent in transplantation.
As a result, it may undermine public confidence in the transplantation
system and thereby reduce the number of organs available for transplantation.
6. The SCHB is already aware of a number
of single persons who are considering taking their names off the
NHS Organ Donor Register. This is because they do not have any
appropriate close relatives, as characterised in Section 50 of
the Act, on which they can really rely to implement their wishes
after death.
Organ donor and transplant system
7. The SCHB has not taken a position on
whether or not an "opting in" or "opting out"
scheme would be preferable in possible future Scottish legislation.
However, the SCHB considers it crucial that organs or tissue should
only be removed from a deceased person if this person has given
his or her prior informed consent to the procedure. In other words,
if a system is put into place in which there is any uncertainty
about the expressed wishes of the deceased person and body parts
are removed, then the procedure can only be considered as unethical.
8. The possibility for the next of kin to
authorise the retrieval of organs when an individual has left
no wishes should not be possible in an "opting in" ie
informed consent system. If body parts are removed without any
explicit prior informed consent of the deceased person, then the
procedure would be unethical. In the case of an "opting out"
system, the next-of-kin could be able to authorise the removal
of body parts. But this would only be ethical if the next-of-kin
was absolutely certain that the deceased person was aware of the
"opting out" system and had not objected to the procedure.
9. The SCHB agrees that in relation to adults
and mature children, the carrying of an organ donor card, or the
registering of their names on the NHS Organ Donor Register should
be sufficient indication of the individuals' wishes. Verbally
expressed wishes should be witnessed by two persons who are assured
that the person has the capacity to make such a decision.
Brain Stem Death
10. The SCHB is of the view that specific
provisions should exist which enable the physician removing the
organs for transplantation to be satisfied that brain stem death
tests have been performed adequately and duly recorded in an appropriate
manner.
Required Request
11. The possibility of enabling "required
requests", in which staff in intensive care environments
must always approach the family about organ donation when
medical treatment has stopped and death has been confirmed by
brain stem tests, should be supported. It may then encourage more
positive attitudes within the NHS by taking away the feeling that
complying with a request for organ donation should be done as
a favour to the transplant unit.
Paired Donation
12. Since live kidney donation could be
increased by paired donation, the SCHB notes that this procedure
should be considered for any new legislation. Two potential pairs,
hampered by blood group incompatibility, would then be able to
exchange kidneys between pairs (for example, donor A, who is incompatible
with recipient A, gives to recipient B, and donor B gives to recipient
A).
Altruistic Donation
13. The possibility of "altruistic"
donation, whereby a member of the public expresses a wish to donate
a body part, such as a kidney, to the national pool of potential
recipients should also be taken into account, provided the donor
is not subjected to any serious harm to himself or herself and
after (1) providing extensive counseling to the potential donor
and (2) obtaining informed consent.
Deceased Person's wishes should be respected
14. The SCHB supports the principle that
the deceased person's wishes should be respected as long as they
reflect an "informed decision", whether these have been
expressed verbally or in writing (for example, using donor cards
or a registration on the NHS Organ Donor Register).[6]
This principle implies that when the deceased's wishes are clear,
the nearest relatives should not have a right of veto.
15. However, the SCHB is concerned that
persons are sometimes not adequately informed of what is involved
when they consider donating their bodies or their parts after
death for purposes such as transplantation, medical research and
education or training. For example, the SCHB is aware that many
individuals do not realise that this may include the dissection
of a naked body in front of large number of undergraduate medical
students. Thus the Council would like to see better information
being available to the Scottish general public in order to enable
the important principle of "informed consent" to exist.
16. Studies show that around 90% of the
UK population would be willing to donate organs after their death,
yet only 11.3 million out of a UK population of 59.2 million are
registered on the NHS Organ Donor Register (as at May 2004).[7]
In this regard, questions can be asked relating to the reasons
for this discrepancy. Moreover, should this discrepancy be respected
as reflecting a difference between good intentions and actual
decision making? This is a difficult question since the principle
of informed consent does not relate to intentions but decisions.
17. Even the Policy Memorandum of the draft
Human Tissue (Scotland) Bill—when it was being discussed—accepted
that nearest relatives were "changing their mind" with
respect to what they believed were the wishes of the deceased
person when these have not been communicated. Indeed, in paragraph
10 it stated that: "For reasons which are not entirely
clear, but which may be related to the effect of issues surrounding
retention of organs at post-mortem examination, in... Scotland,
the relatives' refusal rate where the deceased's wishes are not
known has risen from just over 30% in the early 1990s to around
49% now."[8]
18. The SCHB agrees that if there are no
next-of-kin, organ and tissue retrieval should only take place
on the basis that the deceased person carried a donor card or
had registered his or her decision on the NHS Organ Donor Register.
No removal of body parts should take place when
the wishes of the deceased person are unknown
19. Any decision that may go against the
real wishes of the deceased person would enable a very unethical
situation to exist.[9]
The removal or organs from a deceased person would only be acceptable
if the nearest relative was absolutely certain that the deceased
person was aware of the authorisation system, had not objected
to the procedure and had very recently shared his or her wishes
with his or her nearest relative. Any legislation which resulted
in even only one decision being made by a nearest relative which
did not reflect the real wishes of a deceased person could be
considered as enabling unethical practices to exist.
20. The SCHB is extremely concerned about
the potential for serious mistakes resulting from the possibility
of a "nearest relative" authorising the removal of body
parts from a deceased person who has not left any specific expression
of wishes.[10]
This is because there is no certainty that the decisions of a
"nearest relative" is a true reflection of the wishes
of the person at the time of his or her death.
21. To go beyond the express and specific
wishes of a person by letting others make important decisions
on what they "assume" or "presume" are the
wishes of this person is what specifically lead to the scandal
at Alder Hey Children's Hospital in Liverpool. At this hospital,
body parts of children were retained after post-mortem examination
when healthcare professionals "presumed" that this would
be acceptable to parents without consultation.
22. The SCHB also agrees that it would be
extremely difficult for absolutely everyone in Scotland to be
aware of the system in place. Promises that advertising and publicity
campaigns will be undertaken to promote the message that people
should not simply carry a donor card or put their name on the
Register, but also let their nearest relatives know of their wishes,[11]
will never be sufficient. Talking about death can still be considered
taboo in many sections of Scottish society and members of the
general public are entitled to not have to address this topic.
23. As with the present voting procedure
at elections, people are entitled and have the right, in Scotland,
not to make a specific decision. Thus, it would be unacceptable
for electoral officers, after an election, to ask the nearest
relatives of those who did not vote (either directly or using
a proxy) to "presume" the wishes of those who did not
vote and thereby cast a vote for them.
24. The only instances where authorisation
from a nearest relative may be considered when the wishes of a
deceased person are not known are when the person is a child or
a person who did not have the capacity to consent to such a procedure
while still alive. This would then reflect the provisions in the
European Convention on Human Rights and Biomedicine whereby
Article 6 (Protection of persons not able to consent) states that:
2. "Where, according to law, a minor
does not have the capacity to consent to an intervention, the
intervention may only be carried out with the authorisation of
his or her representative or an authority or a person or body
provided for by law.
The opinion of the minor shall be taken into
consideration as an increasingly determining factor in proportion
to his or her age and degree of maturity.
3. Where, according to law, an adult does
not have the capacity to consent to an intervention because of
a mental disability, a disease or for similar reasons, the intervention
may only be carried out with the authorisation of his or her representative
or an authority or a person or body provided for by law. The individual
concerned shall as far as possible take part in the authorisation
procedure."
25. If there are no nearest relatives and
no expression of wishes by the deceased, there should be no role
for the "person lawfully in possession of the body"
to make a decision on organ retrieval since he or she cannot reflect
the wished of the deceased person. Therefore, in these circumstances,
no organ retrieval should take place.
Organ Trafficking
26. The SCHB is of the view that the Scottish
government should ensure that it respects the following international
legislation.
UNITED NATIONS
(1) Protocol to Prevent, Suppress and Punish Trafficking
in Persons, Especially Women and Children, supplementing the United
Nations Convention against Transnational Organized Crime. This
Protocol entered into force on 25 December 2003.
(2) Optional Protocol to the Convention
on the Rights of the Child on the sale of children, child prostitution
and child pornography. This Protocol entered into force on 18
January 2002.
In order to combat organ trafficking the SCHB
supports extra-territorial provisions making it an offence for
habitual residents in Scotland going abroad to undertake transplantation
procedures which are prohibited in Scotland. Precedent has already
been established in this regard with Article 4 of the UN Optional
Protocol to the Convention on the Rights of the Child on the sale
of children, child prostitution and child pornography.
COUNCIL OF
EUROPE
(3) Convention on Human Rights and Biomedicine CETS No
164. Entered into force on 1 December 1999.[12]
(4) Additional Protocol to the Convention
on Human Rights and Biomedicine concerning Transplantation of
Organs and Tissues of Human Origin CETS No 186. Entered into force
on 1 May 2006.
(5) Convention on Action against Trafficking
in Human Beings (CETS No 197). Adopted on 16 May 2005 but has
not yet entered into force.
As with the Hague Convention on the International
Protection of Adults (with Incapacity),[13]
the SCHB would like to see the United Kingdom ratify, as soon
as possible, the above Council of Europe legal instruments on
behalf of Scotland.
EUROPEAN UNION
(6) Directive 2004/23/EC of the European Parliament and
of the Council of 31 March 2004 on setting standards of quality
and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells.
(7) Draft European Parliament Legislative
Resolution on the Initiative of the Hellenic Republic with a view
to adopting a Council Framework Decision concerning the prevention
and control of trafficking in human organs and tissues (7247/2003—C5-0166/2003—2003/0812(CNS)).
5 October 2007
5 Organ Donation and Transplantation-SPICe Briefing-1
June 2000: http://www.scottish.parliament.uk/business/research/pdf_res_notes/rn00-40.pdf
Organ Donation-Experiences Internationally-SPICe Briefing-16 une
2005: http://www.scottish.parliament.
uk/business/research/briefings-05/SB05-82.pdf. Back
6
Policy Memorandum, Human Tissue (Scotland) Bill, paragraph 10,
http://www.scottish.parliament.uk/business/bills/pdfs/b42s2-introd-pm.pdf Back
7
Human tissue and organs-shortages, http://www.bma.org.uk/ap.nsf/Content/Humantissueorgansshortages Back
8
Policy Memorandum, Human Tissue (Scotland) Bill, paragraph 10,
http://www.scottish.parliament.uk/business/bills/pdfs/b42s2-introd-pm.pdf Back
9
In the Additional Protocol to the European Convention on Human
Rights and Biomedicine concerning Transplantation of Organs and
Tissues of Human Origin it is indicated that: "It is the
expressed views of the potential donor which are paramount in
deciding whether organs or tissue may be retrieved." Back
10
Policy Memorandum, Human Tissue (Scotland) Bill, paragraph 12,
http://www.scottish.parliament.uk/business/bills/pdfs/b42s2-introd-pm.pdf Back
11
Policy Memorandum, Human Tissue (Scotland) Bill, paragraph 13.,
http://www.scottish.parliament.uk/business/bills/pdfs/b42s2-introd-pm.pdf Back
12
Legally binding if ratified by a country-The United Kingdom has
not signed and not ratified this Convention. Back
13
Legally binding if ratified by a country-Adopted on 13 January
2000 but has not yet entered into force.The United Kingdom has
ratified the Convention on 5 November 2003 (but for Scotland only). Back
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