The Royal Society of Edinburgh is pleased to respond to the Department of Health’s request for comments on the above report by Professor Sheila McLean. The RSE is Scotland’s premier learned society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled with the assistance of a number of Fellows with experience in this area.

Overall, Professor McLean should be congratulated on the review, and we are in agreement with the recommendations made as they equate well with the Society’s response to the original document. As the report states, gametes are not like other tissues for transplantation. They are not used for the benefit of the individual as transplant tissues are. It is their ability to produce another human individual that sets them apart and gives them a special status.

The specific areas of consideration are addressed below:

Recommendation 1
Arguments both from principle and from policy weigh heavily on the side of not reducing the quality of consent which is currently demanded by the common law. It is, therefore, recommended that, for the removal of gametes, unless one of the current exceptions to the general rule (e.g. necessity or best interests) can be established, the requirement that formal consent following adequate disclosure of information is legally necessary should remain (paragraph 1.13).

In our response to the original consultation, we noted that the basis of the 1990 Act is that an individual will always retain control over their gametes even after death. Effective consent in this respect safeguards this interest and minimises uncertainty. It was also noted that the substituted judgement would weaken this inherent right as envisaged within the Act, particularly as the limits to the interpretation of the wishes of the dead or dying individual would be unclear.

Subsequent comments on this report from one Fellow, however, have suggested the value of the substituted judgement test under certain circumstances. Quoting from these comments:

"The report mentions three "analytical tools" devised by the law whereby consent mightbe "inferred or imputed" when an individual is unable to give it formally: necessity, best interests and substituted judgement.

If these tools are devised to infer or impute consent, that must mean that they are devised as a method for inferring that the individual would consent, if he or she were in possession of the relevant facts - thus that consent can be imputed even though not actually given. …

Seen in this light, the test of necessity works by assuming that since the treatment is necessary the individual would consent were he or she to know its necessity, while the test of best interests similarly assumes that the individual would consent to the treatment were he or she to able to acknowledge that it is in his or her best interests. … The evidence the first two tests specify has no special degree of certainty; considered as evidence for consent it is fallible. In particular it is in general far from compelling to argue from the fact that an action is in the best interests of a person to the conclusion that that person would consent to it.

… Pointing out that evidence as to what an individual would have consented to may often be unclear is relevant only if there are no cases in which (i) the evidence is clear, and (ii) a decision made on its basis would clearly lead to a more desirable result than restricting oneself to the tests of necessity and best interests would.

It is easy to imagine such cases arising with the removal of gametes. Suppose a young husband is fatally injured and unconscious after an accident. It is well-known and easily documented that the couple had decided to have a child and were attempting to have one. The wife persists in her wish to have the husband's child.

In this case I believe:

(i) that it is desirable that the wife should be legally permitted to attempt to have her husband's child.

(ii) that the tests of necessity and best interests would rule out that legal outcome while the test of substituted judgement would secure it.

It could not be said, in the ordinary meaning of the words, that it would be in the best interests of the dying husband that the wife should have his child. To interpret the best interests test in such a way as to give the wife in this case legal permission would be to develop a specialised legal meaning of "best interest" - an undesirable way to proceed. [Therefore it would be desirable to use substituted judgement]."

Recommendation 2:
In the event of doubt as to whether or not the individual will recover, or doubt about whether or not fertility after recovery will be affected, where it is intended to use the 'best interests' test to authorise removal of gametes, clinical staff should be advised that recourse should be had to a court of law for determination of the lawfulness of the proposed removal (1.14).

In seeking recourse to a court of law, consideration should be given to the time involved, and thought given to the eventuality of the donor dying during the legal process. As was noted in our original response, requiring judicial review on each occasion could be impractical and the current indications are that the frequency of these situations in the future might be greater than previously envisaged.

Recommendation 3
The law should be amended to provide that, where a court has declared that it is in the 'best interests' of an incompetent person to have gametes removed pending their decision once competence is restored, the Human Fertilisation and Embryology Authority has the power to waive the consent requirements for storage for the duration of the incompetence of the donor (paragraph 2.6).

As there must be some doubt in an individual case as to whether the individual will survive, in the event that the individual dies, the gametes should be destroyed, as relevant consent will not have been obtained for their use. In the event that s/he survives, consent can be obtained for their continued storage and eventual use. This approach would appear to be justified on the basis of "best interests".

Recommendation 6
Consideration should be given to amending s.28 (6) of the Human Fertilisation and Embryology Act to secure, in the particular circumstances of these cases, the status of any child created after the death of the gamete provider. Arguably, providing such a child with a legal father is of symbolic rather than practical value, but it may be of significance for the child (paragraph 3.4).

There is clearly an unresolved issue about the status of male versus female children when they are created after the death of the gamete provider, and also about the law of succession in such children. It would be helpful if HEFA and others produced guidelines for use in HEFA approved clinics to ensure that donors are properly advised about the rights of any offspring conceived after their death. The HEFA and others should also seek to clarify the status of such children

Conclusion
In conclusion, Professor McLean has produced an excellent review and the Society would support the incorporation of her recommendations into the Human Fertilisation and Embryology Act 1990.

Additional Information
In responding to this inquiry the Society would like to draw attention to the following Royal Society of Edinburgh publication which is of relevance to this subject: Consent and the Law (December 1997).
April 1999

Further information is available from the Research Officer, Dr Marc Rands