Response to Horizon Scanning Questionnaire Issued by the Human Fertilisation and Embryology Authority's Ethics and Law Advisory Committee

14 February 2011

This policy document is a response submitted by the Progress Educational Trust (PET) to a Horizon Scanning Questionnaire issued by Human Fertilisation and Embryology Authority's Ethics and Law Advisory Committee (ELAC).

Questions 4 and 5 below refer to the Ethics, Law and Social Science Briefing (.pdf 277KB) published by the HFEA in December 2010. Responses to the Horizon Scanning Questionnaire were summarised by the HFEA (.pdf 158KB) in March 2011.

PET is grateful to Mary Yarwood for her contribution to this document.

1. What is your background?

Special interest group.

2. In your opinion, what are the most important ethical, legal or social issues currently impacting on the fertility and embryo research sector right now?

• Access criteria for NHS-funded fertility treatment (for example, whether and how these criteria should incorporate age, childlessness, lifestyle, previous fertility treatment in the private sector, and the patient being single or in a same-sex relationship).

• How and to whom gametes should be allocated in the context of a national shortage.

• Fertility problems caused by the increasing prevalence of late motherhood, and related conflicts of opinion.

• Surrogacy (which is not coherently regulated in the UK at present).

• Screening of gamete donors (for example, the inequity of this being more stringent than standard prenatal screening, the discrepancy between what types of screening different organisations and authorities require and recommend, and the fact that screening does not currently address psychological health in a coherent way – see our reponse to question 5 below).

• Sibling tracing (for example, whether and how the tracing of half-siblings should be encouraged and facilitated, now that donor codes are no longer to be disclosed to the parents of donor-conceived people).

3. In your opinion, what are the most important ethical, legal or social issues impacting on the fertility and embryo research sector in the near future?

• Whole genome embryo testing (for example, via array-comparative genomic hybridisation and single nucleotide polymorphism arrays) and its consequences for which embryos may be legally 'preferred' under the wording of the Human Fertilisation and Embryology Act 2008 (the prohibition on 'preferring' affected embryos is already difficult to interpret when there is both the genetic and the morphological health of the embryo to consider – whole genome embryo testing may make this prohibition impossible to interpret).

• How PGD and HLA tissue typing might be licensed in future, if the HFEA ceases to exist.

• Changes in the diagnostic categories relating to neurodevelopmental disorders (see our reponse to question 5 below).

• Pronuclear transfer to prevent transmission of mitochondrial DNA disease.

• Autologous egg donation via freezing and vitrification for 'social' (non-medical) reasons (for example, postponing motherhood or preserving fertility).

• Whether and how details of donor conception are included on birth certificates.

• Prisoners accessing fertility treatment while incarcerated, and how access should be regulated following the European Court of Human Rights' 2007 ruling in the case of Dickson v UK (including instances where the prisoner is not infertile, but requires assisted conception because of restrictions preventing sexual intercourse in prison).

• Whether inadvertent consanguinity due to donor conception should be countenanced when there is no associated morbidity (contrary to popular belief, consanguinity does not always or inexorably lead to morbidity).

4. Are there any particular issues raised in ELAC's Ethics, Law and Social Science Briefing which you think it is important for ELAC to consider?

ELAC's briefing mentions the Nuffield Council on Bioethics' Consultation on Human Bodies in Medicine and Research. The HFEA should avail itself of the important work that this consultation forms part of, not least because in the current political climate, the funds that the HFEA can devote to public engagement and consultation are limited.

Unfortunately, the timing of the HFEA's consultation Donating Sperm and Eggs: Have Your Say (which will form the basis of decisions to be taken at a July 2011 HFEA meeting) appears to preclude taking the recommendations of the Nuffield Council on Bioethics (due to be published in Autumn 2011) into account.

See, for example, the case of Helen Keeler, a woman who wishes to be an altruistic egg donor (at a time when there is a shortage of egg donors) but who has been repeatedly rejected as a donor (including at the four hospitals offering fertility treatment within a 40-mile radius of where she lives), due to the fact that one of her children has Asperger's syndrome. This is despite the fact that there exists no guideline specifically deprecating gamete donation by people who have, or whose family members have, autism spectrum disorders such as Asperger's syndrome. Rather, the rejection of Helen Keeler's offer to be an egg donor is an inevitable consequence of risk aversion on the part of non-specialist clinicians, combined with the fact that autism spectrum disorders are partially hereditary.

This points to a broader problem. Heritable neurodevelopmental disorders such as autism have increasingly become characterised as existing on a spectrum of severity, ranging from severe (and rare) to mild (and common) impairments. This tendency will continue with the forthcoming (fifth) edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, in which all autism spectrum disorders might be collapsed into a single category. Gamete screening guidelines need to stay abreast of these developments.

If these issues are not addressed, then clinicians will find themselves in the invidious position of trying to avoid litigation from people with conditions who wish to be gamete donors (alleging discrimination if they are refused), while also trying to avoid litigation from fertility patients (alleging negligence if their donor-conceived children develop conditions that donors were not screened for). The logical solution to this conundrum is to provide prospective recipients of donor gametes with information about the medical and family history of donors, and then let the recipient decide whether or not they consider this history problematic, thereby indemnifying the clinician.

6. Are there any issues which ELAC has previously discussed, but which you think need further discussion?

No.

7. If next year ELAC were to consider fertility preservation, information for patients consenting to their details being used for research, implications of the Equality Act 2010, and mitochondrial exchange, how would you prioritise these issues? What are your reasons for this order?

In descending order of importance:

• mitochondrial exchange;

• fertility preservation;

• information for patients consenting to their details being used for research;

• implications of the Equality Act 2010.

Mitochondrial exchange to prevent transmission of mitochondrial DNA disease is a priority issue, because this technique has great therapeutic potential, and yet its therapeutic applications are subject to regulatory impediment and widespread misunderstanding.

Human DNA is commonly associated with human personhood, and yet mitochondria carry no genetic information that defines any specifically human attribute. This results in ethical concerns that a child resulting from pronuclear transfer has 'three parents' (concerns that are as misguided, if not more so, as ethical concerns that the recipient of a donated organ has 'four parents').

Fertility preservation is also a priority issue, because of the increasing prevalence of late motherhood. This phenomenon brings attendant fertility problems and conflicts of opinion, including vituperative disparagement of older mothers, and the suggestion by some that it is unethical to enter one's dotage before one's children achieve adulthood (or even middle age).

Autologous egg donation via freezing and vitrification come under the auspices of this issue, because they are often used not only in the face of foreseeable fertility problems, but also as a 'just-in-case' precautionary measure. This is part of a broader interest in the idea of 'futureproofing' one's fertility, against both pathological infertility and the natural decline in fertility that occurs over the course of one's life.

While there is nothing intrinsically wrong with the ambition of futureproofing one's fertility, there is a risk that current techniques for so doing become subject to unrealistic expectations. There is no guarantee, at present, that preserved gametes or embryos can be used to ensure a future pregnancy. So anyone who defers parenthood, in the expectation that preserved gametes or embryos can be used to insure against future infertility, risks profound disappointment if every future attempt at fertility treatment is unsuccessful.

8. Do you have any further comments or suggestions for ELAC?

No.