Scottish Council on Human Bioethics

15 Morningside Road, Edinburgh EH10 4DP, Tel: 0131 447 6394 or 0774 298 4459

11 December 2005

Human Tissue (Scotland) Bill

Proposed Amendments by the Scottish Council on Human Bioethics to the Human Tissue (Scotland) Bill at Stage 2 of the parliamentary process.

For a list of all proposed amendments see here.

Overview of concerns:

(1) Discrimination against vulnerable groups for live donations

The SCHB is concerned that the Bill would discriminate against two very vulnerable groups for live donations, namely children who are under 16 and adults with incapacity (see page 2).

The Bill would allow nearest relatives to authorise the removal of non-regenerative tissue from living adults who do not have the capacity to consent. This is of concern since it may result in pressures being applied on these adults or even their exploitation if nearest relatives may benefit from their organs. On the other hand, and quite rightly, children would be protected from this possibility. It is the opinion of the SCHB that both groups of persons are just as vulnerable and should be protected in the same manner.

See here for proposed amendment and discussion.

(2) The Scottish public should be aware of the transplantation system in place

The SCHB is concerned that the bill does not indicate that the promotion of information and awareness about donation for transplantation of parts of a human body should be undertaken on a regular basis in order to continually inform new generations of the system in place.

See here for proposed amendment and discussion.

(3) The Bill makes possible both opt-in and opt-out systems of consent to take place for transplantation

The SCHB is concerned that the Bill is a hybrid between explicit consent (opt-in) and presumed consent (opt-out) and that the general public in Scotland is not aware of this proposed mixture of systems in the Bill.

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)).

The SCHB is concerned that the assurances made by the Deputy Minister for Health and Community Care (Lewis Macdonald) in his presentation before the Scottish Parliament on the 30th of November 2005 that "The lesson of Alder Hey is that we should not presume consent and that we should encourage authorisation" (Col 21237 of the Official Report) may not be fulfilled.

See here for proposed amendment and discussion

Discrimination between vulnerable groups for live donations

Arguments:

The SCHB is concerned that the Bill would discriminate between two very vulnerable groups for live donations namely children under 16 and adults with incapacity.

At present the Bill would prohibit non-regenerative tissue from being removed from a living child but does not prohibit this possibility for adults with incapacity. However, it is the opinion of the SCHB that both groups of individuals are just as vulnerable and should be protected in the same way.

Though the present Bill may be in conformity to the legislation in England and Wales as regards adults with incapacity, it would contradict the legislation of most other European countries and more specifically the 32 Council of Europe member states who have signed the European Convention on Human Rights and Biomedicine [1]. In addition, the SCHB is of the opinion that it is not because the UK has not signed this Convention, that Scotland should not feel a responsibility to respect the ethical principles found in this important legal instrument.

And in Chapter VI (Organ and tissue removal from living donors for transplantation purposes) of this European Convention on Human Rights and Biomedicine it is stated that:

Article 20 – Protection of persons not able to consent to organ removal

No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 5.

Exceptionally and under the protective conditions prescribed by law, the removal of regenerative tissue from a person who does not have the capacity to consent may be authorised provided the following conditions are met:

there is no compatible donor available who has the capacity to consent;

the recipient is a brother or sister of the donor;

the donation must have the potential to be life-saving for the recipient;

the authorisation provided for under paragraphs 2 and 3 of Article 6 has been given specifically and in writing, in accordance with the law and with the approval of the competent body;

the potential donor concerned does not object.

Proposed Amendments:

To address these concerns, the following amendments are proposed to the Human Tissue (Scotland) Bill (in bold):

Section 15 - Restrictions on transplants involving live donor

(1) Subject to subsections (3) and (5), a person commits an offence—

(a) if—

(i) the person removes an organ, part of an organ, or any tissue which is not regenerative tissue, from the body of a living child or an adult with incapacity intending that it be used for transplantation; and

(ii) when the person removes the organ, part or tissue, the person knows, or might reasonably be expected to know, that the other person from whose body the person removes it is a living child; or

(2) Subject to subsections (3) and (5), a person commits an offence—

(a) if—

(i) the person uses for transplantation an organ, part of an organ or any tissue which is not regenerative tissue, which has come from the body of a living child or an adult with incapacity; and

The SCHB is also of the opinion that the Human Tissue (Scotland) Bill should ensure that it complies to the following Council of Europe legislation:

Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin [2].

The Scottish public should be aware of the transplantation system in place

Arguments:

Proposed Amendment:

In order for (1) the Scottish general public to become aware of the transplantation system in place and (2) to encourage donation, the following amendment is proposed (in bold).

Section 1 - Duties of the Scottish Ministers as respects transplantation, donation of body parts etc.

It is the duty of the Scottish Ministers to—

(a) promote, support and develop programmes of transplantation;

(b) promote information and awareness about the donation for transplantation of parts of a human body on a regular basis;

Discussion:

This amendment would address the concerns expressed by Dr. Nanette Milne MSP in her presentation before the Scottish Parliament on the 30th of November 2005 in which she indicated (under Col 21242) that:

"It is extremely important that the public be made aware of any new systems that are put in place. There will have to be an adequate public awareness programme, coupled with professional training for those who are involved in the system. Such public awareness raising will have to be done on an on-going basis, even though that will be costly, with repeated campaigns over time to ensure that successive organisations understand the systems that are in place for organ donation and post-mortem examination. Such things can be forgotten as time passes."

The Bill makes possible opt-in and opt-out systems of consent to take place for transplantation

Arguments:

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 confirmed 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:

"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."

For a review of different transplantation systems in Europe see: http://www.bbc.co.uk/health/donation/factfilesod_index.shtml.

Proposed Amendment:

In order to enable a true system of informed consent to exist in Scotland and not enable nearest relatives to presume the consent of the deceased person to:

donate body parts when no prior wishes of this deceased person are known, or

donate body parts in addition to the specific list of body parts for donation which was left by the deceased person,

the following amendment is proposed in (bold):

Section 7 - Authorisation by adult’s nearest relative

(1) If there is in force immediately before an adult’s death no authorisation by the adult by virtue of section 6(1) of removal and use of any part of the adult’s body for transplantation, the nearest relative of the deceased adult may~~, subject to subsection (4), authorise the removal and use of any part for one or more of the purposes referred to in 5 section 3(1)~~ authorise the removal and use of any part for one or more of the purposes referred to in section 3(1) if the relative has actual knowledge that the adult was willing to donate a particular part of the adult’s body to be used for the purposes referred to in section 3(1).

In addition delete in Section 7, paragraphs (2),(3),(4),(5),(6). Delete also in Section 48, paragraph (2), indent (c).

If these amendments are accepted, there would be no need for any register of persons opposing the donation of organs or certain specific organs since only those body parts, specifically mentioned by the person before death would be removed. This would be undertaken either by registering their wishes (electronically or in written form) or by letting their nearest relatives know of their wishes.

Discussion:

Deceased Person’s wishes should be respected

The SCHB very much welcomes the provisions in the draft Bill which support 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) [3]. This principle implies that when the deceased’s wishes are clear the nearest relatives should not have a right of veto.
However, the SCHB is extremely concerned about the potential for mistakes resulting from Section 7 of the proposed bill if a ‘nearest relative’ is able to authorise the removal of body parts from a deceased person who has not left any specific expression of wishes [4]. 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.
The SCHB remains very concerned about the present drafting of Section 7 in the Human Tissue (Scotland) Bill. It is convinced that it would undermine confidence in the transplantation system. The SCHB is indeed aware of a number of single persons who are already considering taking their names off the NHS Organ Donor Register and obtaining legal advice if the provisions proposed in Section 7 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.
Unfortunately, the proposed bill seems to have been drafted with the aim of increasing the supply of organs for transplantation, or of human material for education, training, research or audit 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.
In the Policy Memorandum of the Human Tissue (Scotland) Bill, it is indicated in paragraph 22 that:

"the public’s reaction to the revelations about organ retention at post-mortem examination shows that, for many people, presumed consent does not represent a valid form of consent. They feel it deprives them of a sense of control over what happens to their bodies, or the bodies of their loved ones, after death." [5]

Accordingly, it is the opinion of the SCHB that the draft Human Tissue (Scotland) Bill may enable the same unacceptable mistakes to be made as in Alder Hey Children’s Hospital which would undermine public confidence in the organ transplantation system.

The removal of body parts when the wishes of the deceased person are unknown may be an unethical intervention

Any decision that may go against the real wishes of the deceased person would enable a very unethical situation to exist. It 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. 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.
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 [6], 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.
Accordingly, the SCHB believes that for the draft bill to support ethical practice and public confidence it is imperative to exclude the possibility for nearest relatives to authorise the removal of body parts from a deceased person when his or her wishes are completely unknown. In other words, Section 7 of the proposed Bill should be substantially amended.
The only instances where authorisation from a nearest relative may be considered are when the person who has died 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."

Nearest relatives may not know the wishes of the deceased person

The manner in which a nearest relative makes a decision concerning a relative who has died without leaving any prior wishes may be extremely problematic. For example, relatives may only have discussed transplantation with the deceased person a number of years before the death took place and may not, in any way, represent a true reflection of the wishes of the person at the time of his or her death.
In addition, a problem arises if a person does not trust his or her relatives 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 which does not have a national register opposing organ donation.
Furthermore, even the Policy Memorandum of the draft 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." [7]

Finally, in the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin [8] 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 draft bill are aware of the wishes of the deceased person or even knew him or her when he or she was still alive.

The procedure may be challenged at the European Court of Human Rights

The SCHB was surprised to note in paragraph 28 of the Policy Memorandum that [9]:

"The Executive is satisfied that the provisions of the Bill are compatible with the European Convention on Human Rights."

Indeed, it is the opinion of the SCHB that Section 7 of the draft Human Tissue (Scotland) Bill relating to the power of relatives to authorise the use of body parts of a deceased person who has not left any wishes may be open to a legal challenge at the European Court of Human Rights under the European Convention of Human Rights and specifically under:

- Article 8 (Right to respect for private and family life)
- Article 9 (Freedom of thought, conscience and religion)
- Article 10 (Freedom of expression)

This is all the more a possibility since the European Convention on Human Rights and Biomedicine can be used by the European Court to seek guidance [10] and this instrument indicates in Article 5 (General rule) [11] that:

"- An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.

This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks."
Thus, if a deceased person was not aware of (1) the system of consent/authorisation in place and (2) the possible destiny of his or her body parts (transplantation, research, etc.), and the use of the body parts did go ahead without the individual having given his or her informed consent, there may be grounds for taking the case to the European Court of Human Rights. This is because the European Convention on Human Rights and Biomedicine requires informed consent to take place before any intervention is envisaged. And in this case an intervention would also include a procedure after death under the spirit of the law.
With respect to the presumed consent system in Spain, though the general public is probably more aware of the system than in France, it would be interesting to know what percentage of the population is really aware of the legislation. Has the Scottish Executive examined surveys concerning this? Accordingly, if relatives authorise the removal of organs from a deceased person who has not communicated his or her wishes and this person did not know about the system in place in Spain or in France, then there is no informed consent and there is scope for other relatives or even human rights organisations to bring a case against the governments of these countries to the European Court of Human Rights.

List of Proposed Amendments (in bold):

(1) Discrimination against vulnerable groups for live donations

Section 15 - Restrictions on transplants involving live donor

(1) Subject to subsections (3) and (5), a person commits an offence—

(a) if—

the person removes an organ, part of an organ, or any tissue which is not regenerative tissue, from the body of a living child or an adult with incapacity intending that it be used for transplantation; and
when the person removes the organ, part or tissue, the person knows, or might reasonably be expected to know, that the other person from whose body the person removes it is a living child; or

(2) Subject to subsections (3) and (5), a person commits an offence—

(a) if—

the person uses for transplantation an organ, part of an organ or any tissue which is not regenerative tissue, which has come from the body of a living child or an adult with incapacity; and

The SCHB is also of the opinion that the Human Tissue (Scotland) Bill should ensure that it complies with the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin [12].

(2) The Scottish public should be aware of the transplantation system in place

Section 1 - Duties of the Scottish Ministers as respects transplantation, donation of body parts etc.

It is the duty of the Scottish Ministers to—

(a) promote, support and develop programmes of transplantation;

(b) promote information and awareness about the donation for transplantation of parts of a human body on a regular basis;

(3) The Bill makes possible both opt-in and opt-out systems of consent to take place for transplantation

Section 7 - Authorisation by adult’s nearest relative

(1) If there is in force immediately before an adult’s death no authorisation by the adult by virtue of section 6(1) of removal and use of any part of the adult’s body for transplantation, the nearest relative of the deceased adult may~~, subject to subsection (4), authorise the removal and use of any part for one or more of the purposes referred to in 5 section 3(1).~~ authorise the removal and use of any part for one or more of the purposes referred to in section 3(1) if the relative has actual knowledge that the adult was willing to donate a particular part of the adult’s body to be used for the purposes referred to in section 3(1).

In addition delete in Section 7, paragraphs (2),(3),(4),(5),(6). Delete also in Section 48, paragraph (2), indent (c).

1 Convention on Human Rights and Biomedicine, http://conventions.coe.int/Treaty/en/Treaties/Word/164.doc - Entered into force on 1 December 1999 - Legally binding if ratified by a country - The United Kingdom has not signed nor ratified this Convention

2 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, http://conventions.coe.int/Treaty/en/Treaties/Word/186.doc - Adopted on 24 January 2002 but has not yet entered into force - Legally binding if ratified by a country - The United Kingdom has not signed nor ratified this additional Protocol

3 Policy Memorandum, Human Tissue (Scotland) Bill, paragraph 10., http://www.scottish.parliament.uk/business/bills/pdfs/b42s2-introd-pm.pdf

4 ibid

5 ibid

6 ibid

7 ibid

8 Explanatory Report: Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin paragraph 102. http://conventions.coe.int/Treaty/en/Reports/Html/186.htm

9 Policy Memorandum, Human Tissue (Scotland) Bill, paragraph 28., http://www.scottish.parliament.uk/business/bills/pdfs/b42s2-introd-pm.pdf

10 Even if the UK has not ratified this instrument the Court can still use the provisions found in this Biomedical Convention as guidance on ethical matters.

11 Convention on Human Rights and Biomedicine, http://conventions.coe.int/Treaty/en/Treaties/Word/164.doc

12 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, http://conventions.coe.int/Treaty/en/Treaties/Word/186.doc - Adopted on 24 January 2002 but has not yet entered into force - Legally binding if ratified by a country - The United Kingdom has not signed nor ratified this additional Protocol