Submission by L. O’Donovan, N. J. Williams and S. Wilkinson

 

The draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2019

Do you understand the regulations?

Yes – I understand what transplants will be excluded from opt-out

Any further comments (maximum of 150 words):

The exclusion list is not justified by the rationale outlined in the consultation: alignment with public expectations about posthumous organ donation. Exclusions on these grounds should be based on robust social science evidence regarding social attitudes/beliefs surrounding organ donation/transplantation/consent. Sufficient evidence, however, is unavailable. Thus, lists must be formulated on the basis of reasoned assumptions. It is not clear, however, that this is the case either. Ought eyes, for example, be excluded from opt-out given that 11% of NHSBT registrants refuse their donation? Should tendons, nervous tissue and rectus fascia be included while faces, hands and uteri are not? While the latter are ‘rarer’ recent publicity means that they may be better known than the former. Similarly, it seems strange to require a higher consent standard for toes than for eyes and hearts, given that the latter are two of the most emotionally significant organs.

Parts of the human body to be excluded from opt-out

Do you agree with the government’s proposed list of excluded transplants?

Yes

Further comments (maximum of 150 words – we cannot consider longer responses):

While we broadly agree with the list, exclusions should not be determined (or justified) on grounds of novelty and rarity alone.

Criteria used should take account of a broader range of considerations influencing individual donation preferences than that proposed. These may include:

• How willing would people be to donate if the donation-type in question was explained properly to them (even if they have not presently heard of it)?
• Is the transplant for which the organ/tissue will be used life-saving or quality-of-life enhancing?
• Could the organ/tissue be used for human reproduction (e.g. ovary, uterus, penis, testicle)?

Finally, rather than merely listing types of organ or tissue, it may be more appropriate (instead or as well) to a have a purposive list. This is particularly important for tissues like skin, which are used as dressings for wound healing and may therefore be used for ‘controversial’ purposes including elective cosmetic surgery.

Tissues to be excluded if they are part of a novel and/or rare transplant

Please tick which of the following should be excluded from opt-out if they are part of a rare or novel transplant:

Not Answered

Specific tissues to exclude if they are for use in an Advanced Therapy Medicinal Product (ATMP)

Please tick which of the following should be excluded from opt-out if they are retrieved for use in an Advanced Therapy Medicinal Product:

Not Answered

Any other comments

Any other comments on the regulations

Any other comments (maximum 200 words):

(1) The criteria proposed for removing novel and rare transplants from the excluded list are problematic. The consultation suggests that if a novel/rare transplant becomes standard practice or is in high demand, its exclusion will be reconsidered. However, while increased demand may motivate reconsideration of exclusions, it should not affect the decisions to include or exclude an organ, tissue or transplant. Such a decision should, as at the time of an original exclusion decision, be based on empirical data and (if unavailable) reasoned assumptions regarding the donation preferences of potential donors.

(2) The Organ Donor Register website should be amended to allow the public to record their donation preferences in relation to excluded organs and tissues. This is 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.

Finally, we direct you to an email which we have sent into the consultation address and a piece recently published on the Journal of Medical Ethics website, both of which contain more detail: https://blogs.bmj.com/medical-ethics/2019/07/10/englands-opt-out-policy-consultation-excluded-organs-and-tissues/

END

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