Scottish Council on Human Bioethics
15 Morningside Road, Edinburgh EH10 4DP, Tel: 0131 447 6394 or 0774 298 4459
19 January 2006
Human Tissue (Scotland) Bill
Proposed Amendments by the Scottish Council on Human Bioethics to the Human Tissue (Scotland) Bill at Stage 3 of the parliamentary process.
Overview of concerns:
The Bill makes possible an opt-out (presumed consent) system to take place for transplantation but does not enable persons to register their opposition to the removal of body parts after death
This is because the Bill is a hybrid between explicit consent (opt-in) and presumed consent (opt-out).
Indeed, the proposed system in Scotland is of:
- informed consent (opt-in) for those who register their wish to donate a number of organs before death (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 Bill), and
- '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 Bill in Section 7, paragraph (4)).
This is reflected in the Scottish Executive Press Release of the 30th of November 2005 which indicated that a Consultant Surgeon and Clinical Director at Edinburgh Royal Infirmary Transplant Unit, John Forsyth said [1]:
"These changes will make the legislation similar to the way in which Spanish law is put into effect. I can only hope that we too will see a positive effect on the organ donor rate in Scotland."
However, in contrast to all other systems of ‘soft’ presumed consent in Europe, the Scottish Bill does not enable a person to register their opposition to the removal of body parts after death. This, unfortunately, has very serious ethical consequences and could lead to an undermining of the principle of informed consent in transplantation.
For a review of different transplantation systems in Europe see: http://www.scottish.parliament.uk/business/research/briefings-05/SB05-82_000.pdf
List of Proposed Amendments (in bold Italics):
6. Authorisation: adult
(1) An adult may authorise or oppose the removal and use of a part of the adult’s body after the adult's death for one or more of the purposes referred to in section 3(1).
(2) Authorisation or opposition by virtue of subsection (1)—
(a) must be—
(i) in writing; or
(ii) expressed verbally;
(b) subject to subsections (3) and (4), may be withdrawn in writing.
(3) If the adult is blind or unable to write, withdrawal of authorisation or opposition by virtue of subsection (2)(b) may be signed by another adult (a “signatory”) on the adult’s behalf and if it is so signed it must be witnessed by one witness.
(4) Withdrawal of authorisation or opposition which is signed by a signatory on behalf of an adult by virtue of subsection (3) must contain a statement signed by both the signatory and the witness in the presence of the adult and of each other that the adult, in the presence of them both, expressed the intention to withdraw the authorisation or opposition and requested the signatory to sign the withdrawal on behalf of the adult.
(5) Nothing in subsection (3) prevents an adult who is blind from withdrawing, in accordance with subsection (2)(b), any authorisation or opposition by virtue of subsection (1).
(6) In subsection (2)(a)(i), "writing" includes, in relation to the requirement there for authorisation or opposition to be in writing, representation of a character in visible form.
Replace in subsequent text "authorisation" by "authorisation or opposition".
Discussion:
The Bill enables a ‘soft’ presumed consent (opt-out) system to exist similar to the one found in Spain. However, the person wanting to generally oppose donation or donate only certain body parts after death may not know or trust a nearest relatives, characterised in Section 45 of the Bill, who will be asked to authorise his or her wishes.
- The SCHB continues to share the concerns of Dr. Nanette Milne MSP, expressed on the 30th of November 2005 in the Scottish Parliament at stage 1 (Col 21241), whereby the Bill does not allow any provisions for people who either object to donation in general or to some of their specific organs. The absence of fail-safe mechanisms to allow people to record their wishes, be they positive or negative, is a cause for concern that the Bill should consider.
- In other words, a problem arises if a person does not know or trust his or her relatives, characterised in Section 45 of the Bill, 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 making the decision to use his or her body parts after death in the present UK context. This is because the UK does not have a national register opposing organ donation.
- The SCHB thus remains very concerned about the present drafting of Section 6 in the Human Tissue (Scotland) Bill. It is convinced that it would undermine confidence in the transplantation system and thereby reduce the number of organs available for transplantation.
- The SCHB is already aware of a number of single persons who are considering taking their names off the NHS Organ Donor Register and obtaining legal advice if the provisions proposed in Section 6 are not amended by the Scottish Parliament. This is because they do not have any appropriate close relatives, as characterised in Section 45 of the Bill, on which they can really rely to implement their wishes after death.
- Furthermore, even the Policy Memorandum of the Bill accepts that nearest relatives are ‘changing their mind’ with respect to what they believe are the wishes of the deceased person when these have not been communicated. Indeed, in paragraph 10 it states 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." [2]
- Finally, in the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin [3] 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."
- Thus, 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 45 of the Bill are aware of the real wishes of the deceased person or even knew him or her when he or she was still alive.
- Unfortunately, the proposed bill seems to have been drafted at the expense of one of the most important ethical principles in medicine, namely the principle of ‘informed consent’. Indeed, 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.
- Any decision that may go against the real wishes of the deceased person would enable a very unethical situation to exist. Even if the proposed bill resulted in only one decision being made by a nearest relative which did not reflect the real wishes of a deceased person, then the Bill could be considered as enabling unethical practices to exist.