Submission by L. O’Donovan, N. J. Williams and S. Wilkinson
Question 1. Group 1: The parts of the body to be excluded from deemed authorisation in all circumstances:
a) Are there any parts of the body in group 1 that should not be listed? Please explain below.
No
b) If there is anything that is missing from group 1, please comment here giving reasons why.
Given the centrality of an exhaustive list of exclusions, it is important that membership of the list is based on consistently applied and clearly articulated principles.
The inclusion of additional female and male sexual and reproductive tissues, arguably tissues of a more sensitive nature, follows the approach recently adopted by DHSC in England. The stated rationale for this explained in DHSC’s consultation response is to ‘make the list commensurate with the list of parts of the male reproductive system’ and to ‘give assurance and put beyond doubt that no part of reproductive organs and tissues will be covered by deemed consent’.
If this rationale is accepted, then further tissues such as the anus, rectum, breasts (including skin from the breasts) and nipples should also be excluded. This is because they may be viewed as dual- or multi-purpose in that they both serve other biological functions and may be seen as sexual and reproductive in much the same way as the perineum and prostate are (body parts proposed for exclusion in Group 1). These tissues may similarly be viewed as sensitive in nature. Given that ‘many [respondents] expressed concern about the transplantation of reproductive organs and tissues’ in the English consultation, including some but not all sexual and reproductive tissues seems inconsistent and unjustified. Even though many of these transplants are not yet surgically feasible, making the list of exclusions as comprehensive and as consistent as possible is desirable, as is ‘future proofing’ it to cover all reasonably foreseeable transplant types.
We also suggest that limbal stem cells, renal epithelial cells, liver cells, and pancreatic cells – if they are used for an advanced therapy medicinal product (ATMP) should be considered for inclusion in Group 1. It appears that consideration of cells used for ATMPs has been overlooked as this consultation does not refer to this type of transplant. While it is understood that the Scottish regulations will reflect the legislative framework in place in Scotland and will not replicate the English and Welsh regulations, it is nonetheless desirable to make the list of transplant exclusions as consistent and comprehensive as possible, covering all reasonably foreseeable transplant types. This is particularly important given that, the purpose of the excepted body parts regulations is ‘to make clear which parts of the body deemed authorisation does not apply to.’
Question 2. Group 2: The parts of the body to be excluded from deemed authorisation, if they are to be used in their entirety:
a) Are there any parts of the body in group 2 that should not be listed? Please explain below.
We suggest that the face should be included with the organs and tissues listed in Group 1. This would be a more cautious approach to a body part that may be regarded as particularly sensitive and evoke strong feelings due to the perceived link between the face and personal identity (feelings that arguably do not exist in relation to the other body parts listed in Group 2 such as the leg, arm, foot etc.). This would mean that tissues listed in Group 3 (blood vessel, bone, muscle, nervous tissue, skin and tendon) could then only be donated from this body part with express consent, as opposed to being permitted under ‘deemed authorisation’ as is currently the case as long as the face is not being donated in its entirety.
b) If there is anything that is missing from group 2, please comment here giving reasons why.
It is problematic to over-specify the tissues involved in face transplant as this gives rise to inaccurate descriptions of the relevant tissues that may be required for transplantation. It is explained in the consultation document that face means ‘the front part of the head, from the forehead to the chin and containing the nose and mouth but excluding the eyes.’ This description does not accurately capture all of the tissues and structures that may be transplanted as part of a face transplant depending on the needs of the recipient. For example, parts of the jaw, teeth and tongue may also be transplanted as part of a face transplant procedure (see the US case of Richard Norris). If government policy is to be specific and inform members of the public about all of the possible tissues that may form part of a particular transplant then it should seek to clarify this issue and elaborate on its explanatory definitions to provide accurate information.
Question 3. Group 3: Tissues which form part of body parts listed in group 2 to be included in deemed authorisation:
a) Are there any tissues that should not be listed? Please explain below.
No
b) If there is anything that is missing from group 3, please comment here giving reasons why.
No
Question 4. Do you have any other comments on this consultation?
The Scottish government’s decision to run the consultation for only six weeks and to seek the views of primarily the clinical community seems to run counter to the stated aims of designing and implementing policy which respects the wishes of prospective organ donors and reduces likelihood of mass opt-outs from those who object to the donation of particular rare/novel tissues. This is so for two reasons.
Firstly, compared to the 12-week English consultation on organ and tissue exclusions, the much shorter duration of the Scottish consultation means that fewer people may have had the chance to consider the relevant issues and participate, and the quality of responses may be reduced as a result. The six-week duration falls short of the usual recommendation that consultations run for at least 12 weeks, with no explanation justifying the shorter period provided. This issue is particularly acute because of the serious public health challenges arising from the COVID-19 pandemic (during which time the consultation was launched), especially and considering the target audience of the consultation – health care practitioners and their representatives.
Secondly, in emphasising that expert views were being sought, the opportunity to ascertain the donation preferences of all those affected by the new donation policy (i.e. including members of the public), was significantly limited. This more detailed and specific 2020 consultation on organ and tissue exemptions (as opposed to the broader 2016 consultation on moving to an opt-out system) should arguably therefore have sought the views of everyone affected by the policy, and have been conducted over a more reasonable time period. Even in the absence of a global pandemic, six weeks is too short to ensure that individuals are informed about, have the opportunity to consult with others on, and respond to, a consultation.
Finally, we suggest that the Organ Donor Register website should be updated to allow members of the public to record their donation preferences regarding excluded organs and tissues as well as routine transplants. This is particularly important given that proposed lists of exclusions may contain more than thirty specified transplants (depending on how organs and tissues are defined and categorised) and it is unlikely that family members will have discussed all the relevant exclusions with the deceased during their lifetime. This would be a better way to obtain consent for novel or rare transplants, ensuring both respect for individual autonomy and that the decision is not left to family members who may find it difficult to determine donors’ preferences regarding novel/rare organs and tissues.
END
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