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LEGISLATION RELATING TO ORGAN AND TISSUE DONATION AND TRANSPLANTATION: ANALYSIS OF CONSULTATION RESPONSES

CHAPTER 7: TRANSPLANTATION OF ORGANS AND TISSUE FROM THE LIVING

The consultation raised a number of issues relating to transplantation of organs and tissue from the living. These are taken in turn below.

The consultation stated:

The increasingly severe shortage of cadaveric organs for transplantation has led to a growing emphasis on the donation of organs from the living.

The transplantation of whole organs from living people is dealt with in the Human Organ Transplants Act 1989, and regulations made under that Act. Section 2 of the 1989 Act prohibits organs from being removed from a living person and transplanted into another person unless the donor and recipient are genetically related. If the donor is able to give valid consent and is genetically related, there is no legal requirement for independent scrutiny.

If the potential donor is not genetically related to the recipient, the donation of an organ cannot take place until approval has been obtained from the Unrelated Live Transplant Regulatory Authority (ULTRA). ULTRA is a cross-border public authority in terms of the Scotland Act 1998 (Cross Border Public Authority) (Specification) Order 1998.

The legislation proposed for the rest of the UK is intended to embody 2 changes relating to the current functions of ULTRA. The independent scrutiny which is currently given to unrelated live transplants would be extended to cover all live transplants. It would also cease to exist as a separate body, with its extended functions being absorbed into those of the Inspectorate for Organs and Tissue for Human Use.

Given that this protection will extend in principle to live donations in the rest of the UK, it would be difficult not to follow suit in Scotland. Most live donors in Scotland already receive independent medical review, so placing this on a statutory basis would in part confirm good medical practice.

7.1 ISSUES WHERE DONOR AND RECIPIENT ARE GENETICALLY RELATED

The consultation asked:

SHOULD THE SCRUTINY OF LIVE TRANSPLANTS IN SCOTLAND BE EXTENDED TO COVER CASES WHERE THE DONOR AND RECIPIENT ARE GENETICALLY RELATED?

Of the 47 respondents who provided a clear recommendation all but one (98%) were in favour of extending the scrutiny of live transplants to cover cases where the donor and recipient are genetically related.

The most common reasons cited for this recommendation were that this would be consistent with the rest of the UK (2 Prof Rep, 8 Indiv, 18 Indiv, 19 Educ, 21 Indiv, 36 Indiv, 37 NHS/Med, 40 Educ, 44 Acad, 53 Pub Rep, 62 Indiv); and that such scrutiny would ensure that donations had been made free from pressure and coercion (30 Prof Rep, 37 NHS/Med, 39 NHS/Med, 43 Prof Rep).

Other reasons provided in support of the proposition were that this would contribute to public reassurance (8 Indiv, 19 Educ), and that this appeared appropriate in the contemporary circumstances of dispersed families (25 Educ, 34 Prof Rep), diverse family relationships (34 Pub Rep) and the increased numbers of live donations (25 Educ).

One note of caution was expressed, however, that extending scrutiny to all live donations may require considerably increased resourcing (10 Educ).

The consultation asked:

IF SCRUTINY OF LIVE TRANSPLANTS IN SCOTLAND WERE EXTENDED TO COVER CASES WHERE THE DONOR AND RECIPIENT ARE GENETICALLY RELATED WOULD THIS REMOVE THE CURRENT NEED FOR RELATED DONORS TO PROVE THEIR RELATIONSHIP BY GENETIC BLOOD TESTING?

This question attracted relatively little comment with 26 responses of relevance. Of these, a slight majority (58%) considered that extending scrutiny of live transplants to such cases would remove the need for genetic blood testing to prove the relationship. However, a substantial minority (42%) thought that this need would still remain.

A variety of reasons were provided by those arguing for the retention of the need to prove the genetic relationship. These were:

• Should retain the need if it is current good practice (14 Pub Rep, 15 Pub Rep, 33 Pub Rep)

• Still will need to ensure suitability of organ/tissue (41 NHS/Med, 49 Legal)

• May still be useful to know precise genetic linkage (50 Legal)

• Sensible as a precaution to prevent any "queue jumping" by unrelated donor/recipient (42 Indiv)

• To provide the necessary evidence to the Inspectorate (25 Educ)

• It's the simplest way to prove the relationship (10 Educ)

The consultation asked:

WOULD IT BE POSSIBLE NOT TO MAKE SUCH A CHANGE IN SCOTLAND IF IT IS BEING IMPLEMENTED IN THE REST OF THE UK?

Although 22 respondents addressed this issue, most regarded it as a rhetorical question. The common argument was that although in theory it would be possible not to make such a change in Scotland, in practice a different system would not be sensible. Typical comments were that separate arrangements would be " farcical" (21 Indiv) and " inappropriate" (Educ 52) and " difficult" (45 NHS/Med).

Many respondents argued for consistency in approach across the UK (2 Prof Rep, 14 Pub Rep, 15 Pub Rep, 59 Indiv) so as not to impede the free movement of organs across jurisdictions (27 Educ).

7.2 EXTENSION OF ROLE OF INSPECTORATE TO SCOTLAND?

The consultation stated:

The legislation proposed for the rest of the UK will make provision for ULTRA's functions to be absorbed by the Inspectorate for Organs and Tissue for Human Use. This development gives rise to 3 possible options for Scotland:

• the creation of a separate body for Scotland; or

• the retention of ULTRA, the existing body, for Scotland; or

• the extension to Scotland of this element of the functions of the Inspectorate for Organs and Tissue for Human Use

The consultation asked:

SHOULD THE ROLE OF INSPECTORATE FOR THE REST OF THE UK BE EXTENDED TO SCOTLAND FOR THESE PURPOSES, OR SHOULD A SEPARATE BODY BE CREATED IN SCOTLAND TO TAKE ON THIS RESPONSIBILITY?

Overall, 43 respondents addressed this issue. Of these, 86% were in favour of extending the role of the inspectorate for the rest of the UK to Scotland. Ten per cent of those who commented favoured the creation of a separate body in Scotland to take on this responsibility. The remaining 2 respondents argued for a shared inspectorate only if Scotland shared relevant laws with the rest of the UK, otherwise a separate body was recommended (11 Indiv, 30 Prof Rep). One comment was that a UK-wide inspectorate with Scottish representation would be appropriate (24 Prof Rep).

The only reason cited for extending the role of the inspectorate to Scotland was that the relatively low number of cases of donors in Scotland did not justify a separate body (10 Educ, 20 Pub Rep, 25 Educ, 55 NHS/Med).

Two reasons were provided in favour of a separate body in Scotland. Firstly, it was argued that it may be difficult for a single body to have to deal with more than one legislative framework (29 Acad). Secondly, it was considered that a separate body for Scotland would be consistent with a separate Scottish Health Service (33 Pub Rep).

7.3 PAIRED AND ALTRUISTIC LIVE DONATION

The consultation stated:

Live kidney donation could be increased by paired donation, which is when two potential pairings, hampered by blood group incompatibility, mutually benefit by kidney exchange between the pairings (for example, donor A, who is incompatible with recipient A, gives to recipient B, and donor B gives to recipient A). At present, this type of arrangement would not be approved by ULTRA. A further possibility is "altruistic" donation, when a member of the public expresses a wish to donate a kidney to the national pool of potential recipients. Again, this would not be approved by ULTRA at present.

The consultation asked:

SHOULD PAIRED AND ALTRUISTIC LIVE DONATION BE POSSIBLE IN SCOTLAND?

Overall, 46 respondents addressed this question. There responses are categorised below:

Although most of those who commented were in favour of both paired and altruistic live donation, a few highlighted their concerns that altruistic donation should be permitted only under certain circumstances. These comprised preceding any final decision by the donor with "extensive counselling" (43 Prof Rep); ensuring any donation had been based on valid motivation (22 Acad) and according to strict criteria (28 NHS/Med, 31 Prof Rep); ensuring any payment to the donor was set at a regulated price (42 Indiv); and making clear the difference between altruistic donation and unlawful organ trafficking (46 Educ). It was remarked that legislation would need to be carefully drafted to prevent misuse of the provisions (25 Educ) and any " attendant scandal that would follow inappropriate actions in this area" (45 Indiv).

Other respondents commenting on both altruistic and live donation recommended that scrutiny and monitoring accompany the operation of the provisions (1 Indiv, 22 Acad) with safeguards built in (10 Educ, 58 Indiv). Another view was that such donation should be possible subject to Inspectorate permission (23 Faith). A final comment was that although the respondent supported both paired and altruistic live donation, they were not sure that in practice the necessary specialist skills were available in Scotland (32 Pub Rep).

Amongst those opposing the proposal, one reason provided was that according to Jewish Law, no procedures to facilitate organ/tissue donation may be carried out prior to death (48 Faith).

SUMMARY POINTS

• All but one of those who responded (98%) were in favour of extending the scrutiny of live transplants to cover cases where the donor and recipient are genetically related

• The most common reasons cited in favour of such an extension were consistency with the rest of the UK and that it would ensure that donations had been made free from pressure and coercion

• A slight majority (58%) of the relatively few who commented considered that extending scrutiny of live transplants in these cases would remove the need for genetic blood testing to prove the relationship

• Most of the few respondents who commented considered that although in theory it would be possible not to make such a change in Scotland if it was being implemented in the rest of the UK, this would not be sensible

• Most of the respondents who commented (86%) favoured extending the role of the inspectorate for the rest of the UK to Scotland

• 76% of those who provided a view supported both paired and altruistic live donation in Scotland with a further 9% of respondents favouring paired donation only

• Many supported altruistic live donation only under certain conditions such as following extensive counselling or according to strict criteria, to prevent any misuse of the provision

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