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CMF response to the HFEA consultation, 'The Regulation of Donor-Assisted Conception'

Published: 4th February 2005

Introduction

One of CMFs aims is to promote Christian values, especially in bioethics and healthcare, among doctors and medical students, in the church and in society. Our interest in this review stems from our concern over the steady expansion of infertility treatments – by continual scientific development and the relaxation/extension of the legislation and guidance on infertility treatments. As Christian doctors we support the use of science and technology to prevent, treat and relieve the suffering of infertility but believe that this should be guided by sound ethical principles based on a profound respect for all human life and for marriage as the ideal context for sex, procreation and raising children.

Our responding to this consultation does not signify our acceptance of donor-assisted conception (DAC). We have concerns about DAC as it introduces a third party – whether anonymously or not – into the procreative relationship. Though we do not uphold gamete donation in principle, we recognise the need for clear regulation to protect future donors and recipients, and are responding to this consultation with that need in mind.

We also want to emphasise that the current growing demand for infertility treatment has been fuelled in large part by the lack of babies for adoption (which is in turn a result of the liberal abortion laws), and the rise in tubal infertility secondary to the epidemic of sexually transmitted diseases. We would therefore like to see far greater emphasis on promoting wise sexual choices, restricting abortion, preventing infertility, and promoting adoption as a good choice for childless couples and those with unplanned pregnancies.

Furthermore, we have grave concerns that gamete donation is being 'raised as an issue' within society because of the demand for embryos for research purposes. It is imperative that the recent moves by the HFEA to licence cloning research using human embryos in no way fuel an increased 'interest' by clinics to encourage and promote donation by any means.

Our main points in response to the questions of the consultation document are:

1. The best interests of donors must be paramount in everyone's minds when planning the regulation of donation.
2. The changes to donor anonymity are welcomed, and this opportunity should be used to encourage gamete donation as an altruistic activity that is not undertaken lightly.
3. The HFEA should not be involved in promoting donation. They must remain neutral, even if this means there is a shortage of gametes for DAC.
4. The gift concept towards donation as adopted in the Department of Health's new 'Give Life, Give Hope' initiative is welcomed, and must be maintained. For this reason any options that could act as inducements to donation should be shunned.
5. Particular interest should be given to those in socio-economic positions who may be induced into gamete donation by expenses, compensation or benefits in kind rather than donating of their own volition.
6. Any possible exploitation – particularly of women, for whom donation is not a procedure without risks - must be avoided at all costs, even if this means there is a shortage of gametes for DAC.

About CMF:

CMF has over 4,500 members throughout the United Kingdom and Ireland who are Christian doctors and who desire their professional and personal lives to be governed by the Christian faith as revealed in the Bible. We are interdenominational, have members in all branches of the medical profession, and through the International Christian Medical and Dental Association (ICMDA) are linked with like-minded colleagues in more than 90 other countries.

Our ethical code is based on the Judeo-Christian ethic as revealed in the Bible; and is broadly in conformity with historical ethical codes such as the Hippocratic Oath, Declaration of Geneva (1948) and International Code of Medical Ethics (1949).

In line with the Cabinet Office Code of Practice on Written Consultation, responses to this consultation may be made public unless confidentiality is specifically requested. Do you agree to the HFEA making your response publicly available? YES

Answers to specific questions in the consultation document

Screening of gamete and embryo donors (paragraphs 12 to 17)

Option 3

It seems intuitive that one of the HFEAs responsibilities should be to regulate the screening of donors. Section 25(2) of the HFE Act implies such a duty when it provides that the HFEA should produce guidance on issues pertaining to the welfare of the child. The welfare of children born from DAC is inherently affected by the donors. The new regulations to remove donor anonymity are for the welfare of the children born. Therefore the HFEA should continue to produce guidance and hold clinics accountable in this area.

It is imperative that this remains a tightly regulated area, with loss of their licence for clinics that do not adhere to the regulations. Donors will be best protected by regulation that considers their medical and social interests first. To ensure this it is necessary to have regulation, as there are many other factors that a clinic (and clinic staff) have in mind when dealing with donors – including the potential recipients, their own profits and employment, and any personal convictions that they may have regarding DAC.

To place donors' interests first, the HFEA must remain neutral on this issue – their function being to enable the process of donation rather than to promote it or recruit donors. If the new legislation regarding anonymity results in a reduction of 'donations' this is an issue for individual clinics and potential recipients to accommodate to, not for the HFEA to overcome.

Selection of donors by clinics and recipients (paragraphs 18 to 20)

Option 2

The welfare of the child to be born is best served by matching the donor to the family characteristics, so that the child will feel as much a natural part of the family as possible. Having characteristics that set the child apart from the parents/one of the parents could be psychologically difficult. There is the possibility of other children noticing, resulting in taunts of varying kinds. The child may also feel this difference within family gatherings etc.

Regarding option 1, it is undesirable to create an environment within which parents can 'pick' characteristics for their child. This could get carried to extremes, and therefore having specific guidance to curb this is best. Additionally, it is best to avoid creating a 'rights' mentality within parents, where they think they can demand treatment and the characteristics of the child etc.

Limiting the number of children per donor (paragraphs 23 to 25)

Option 2

Aiming for the minimum number of families using a donor is the ideal solution. Although the likelihood of consanguinity between donor half-siblings is small, it is still relevant, and should therefore be minimised as much as possible. For this reason, using a donor only once or twice at a specific clinic might be best, and then 'swapping' donors with other clinics.

Additionally, that children will in future now be able to trace their donor-parent means that they are more likely to find out about their half-siblings through the donor. In this light 10 families seems too many. Assuming two children per family, for arguments sake, this would make for 18 other children the child must somehow 'deal with' psychologically. Ideally we would like to see the number of families set at between 1-4 (inclusive), leaning to the lesser amount as much as is possible (given the demand for donors).

Payment of expenses to donors (paragraphs 31 to 32)

Option 1 or 3

It is important to set a maximum value, so that the amount of 'expenses' claimed could not be seen as an inducement to donation. One of our greatest concerns regarding 'expenses' is the issue of inducement.

We agree with the previous statement in 1998 (cited on page 11 of the consultation paper) that, 'respecting the potential for human life inherent in a donation made with the specific intent of producing children is inconsistent with placing a monetary exchange value on gametes or on the service provided by gamete donation'. We are glad that current law and the EU Tissues and Cells Directive requires that donation remains voluntary and unpaid.

There is a possibility that expenses could act as a form of inducement to some men women – perhaps particularly vulnerable women (the socially/economically disadvantaged, foreign women (in this country, abroad), asylum seekers, students). For this reason, if expenses are to be reimbursed it is essential that they only reflect the actual financial cost that the donor has incurred. This would firstly cover travel expenses, where the donor has incurred travel that would not be in their ordinary routine. For sperm donation we do not envisage that any other costs need be reimbursed. For women, since egg donation is a more timely procedure and may require time away from work, there is the issue of covering loss of earnings. We are not convinced that that is the best way forward and our concerns are outlined under question 6.

Overall we would prefer to see no reimbursement to donors. Now is an opportune moment in the regulation of gamete donation to counteract any pressure towards payment. As the regulations removing donor anonymity come into action on April 1, it is likely that the 'demographic' of donors will shift – as has been seen in Switzerland – towards the slightly older and perhaps more responsible person. This seems like a good time to remove expenses, so that the altruism of the donation is ensured and the possibility of exploitation of the donor removed once and for all. Within the new demographic it is more likely that people are donating for 'gift' reasons alone, and it would be good to ensure this.

Compensation for inconvenience – sperm donors (paragraphs 36 to 37)

Option 1

It seems like a minimal inconvenience. Therefore, to ensure altruistic motivation it is desirable to keep 'compensation' out of the question. As argued in the final paragraph of question 4, now would be a good time to change the trend in relation to expenses/compensation.

Compensation for inconvenience – egg donors (paragraphs 38 to 40)

Option 1

Expenses are covered by question 4, so it is assumed that 'compensation for inconvenience' alludes to a different idea, namely that of appeasing women for the trouble they go to in donating eggs.

It is advisable to have no such compensation in order to maintain the gift concept of donation that is at the core of the Department of Health's new 'Give Life, Give Hope' campaign. Compensation will have different value for different women depending on their socio-economic circumstances. Therefore, while a maximum level of, for example £700 might provide little incentive to a high earning woman, and therefore her altruistic motives would still be maintained, to other women it would be a significant motivating factor. Such inducements could only be avoided by setting the levels of compensation differently for different women, but then this would have the effect of putting a lower monetary 'value' to the eggs of women from lower socio-economic backgrounds, and is therefore not to be recommended.

The whole system is difficult to manage effectively and coherently without the introduction of inducement at some level. Therefore it is by far preferable if compensation is left out of the equation and thus altruistic motivation ensured.

Apart from the motivation of the woman, we are also incredibly concerned that exploitation of women should be avoided at all costs, including an egg 'shortage'. The risks of egg donation – both physically (such as Ovarian Hyperstimulation Syndrome (OHSS)) and emotionally – demand that such a procedure should not be undertaken unless it is in the woman's best medical interests. It is impossible that this should ever be the case, and therefore, in many ways, egg donation should be ruled out as a medical procedure. Certainly, if it is to happen, altruistic motivation must be ensured.

The only instance in which donation could be construed in the woman's best medical interests would be if she were in an egg sharing scheme. However, even then, we are not convinced of the ethical acceptability of such schemes. The possibility that the donated eggs will result in a successful pregnancy while the woman's own treatment will not raises issues: if the woman knows about this the psychological impact, but even if she doesn't know, the outcome of the procedure – that she has undergone it for another's benefit, while actually intending it for her own, is difficult to justify in terms of her best interests. This is accentuated by the fact that the incentive for participating in an egg sharing scheme is often financial (reduced cost of treatment for the donor woman).

Benefits in kind (paragraphs 42 to 45)

Option 4

We have reservations about egg sharing schemes, as outlined in the final paragraph under question 6. Option 4 is simple and desirable for a number of reasons. It eliminates the psychological concerns should IVF be successful for the recipient of the scheme but fail for the donor. It ensures that there is no coercion or inducement for women to donate eggs. Also, the process is discriminatory towards the lower socio-economic groups who are more likely to engage in egg sharing given the nature of the inducement (reduced cost of treatment). Given the NICE guidelines that all couples eligible for treatment should get one free cycle, and three at full implementation of the guidance, it is unnecessary for egg sharing schemes to be promoted. If women altruistically (without any inducement) want to donate eggs in this way then that should be made possible.

If option 1 is to be adopted it is preferable for treatment to occur in the same cycle as donation so that risks to the donating woman are minimised.

No

For women it is even less desirable that egg donation should occur in order to receive an operation that is unrelated to the donation procedure. A woman would be exposing herself to the risks of OHSS without any medical benefit to herself. Sterilisation operations are available freely on the NHS, and if the NHS cannot meet demand for operations, that issue needs to be dealt with, rather than seeking 'solutions' by inducing women into egg donation. If the woman desiring a sterilisation wishes to donate eggs first, that is a separate concern, and her altruistic decision to donate should not be confused by 'benefits in kind'.

Similarly for men, when sterilisation is available freely on the NHS, an inability of the NHS to meet requirements should not become a way to induce men into sperm donation.

Supply of gametes and embryos by one licensed centre to another (paragraphs 46 to 48)

Option 2

Gametes should not be bought or sold between centres. Given the altruistic nature of donation, and the Department of Health's desire to promote the concept of 'gift' in donation, it would be hypocritical and exploitative of the donors if clinics were to profit from selling gametes to another centre.

Ideally the payments for the 'supplying centre's costs and expenses' should be kept to a minimum. The receiving centre should arrange for the shipping themselves and therefore cover this cost. The supplying centre then has only to make the gametes available for shipping at the arranged day and time. This is a minimal inconvenience, and it is therefore difficult to see that the supplying centre should receive any money from this venture. Ideally, free transport of spare gametes between centres should be promoted so that the altruistic nature of the donation process is maintained.

Obtaining gametes from abroad (paragraph 49)

Option 1

The import of gametes should be stringently controlled and avoided where possible. If gametes are to be imported it is imperative that this is done on a case-by-case basis, so that the HFEA can ensure the quality of the gametes, and the lack of exploitation in how they were obtained. Limiting imports to specific cases ensures that this is only done where a case specifically requires gametes from abroad – an example would be for reasons of ethnic origin. Gametes should not be imported merely to make up for the 'shortage' in this country.

Additionally, the changes in regulations regarding anonymity would be made ridiculous if this were to result in 'buying' gametes from abroad, and therefore stymieing the child's future endeavours to gain information about or have contact with their donor-parent. The whole point in changing the law on donor anonymity is to encourage openness, remove the stigma of donation, and for the child's welfare. For these reasons gamete import should be discouraged unless proven necessary in a specific case.

It is unrealistic to expect UK centres and foreign clinics to demonstrate that the recruitment of donors abroad has been free from exploitation.

Best practice in recruitment of gamete donors (paragraphs 56 to 59)

No comment

Effect of options chosen

If the measures we have outlined were implemented gamete donation would be upheld as an altruistic action that donors undertake of their own volition, without inducement. Donors would be protected from exploitation. Society would therefore be assured of the Government's ongoing protection of its members, and couples using donated gametes would be able to do so knowing that they are receiving a very special gift.

For further information:

Steven Fouch (CMF Head of Communications) 020 7234 9668

Media Enquiries:

Alistair Thompson on 07970 162 225

About CMF:

Christian Medical Fellowship (CMF) was founded in 1949 and is an interdenominational organisation with over 5,000 doctors, 900medical and nursing students and 300 nurses and midwives as members in all branches of medicine, nursing and midwifery. A registered charity, it is linked to over 100 similar bodies in other countries throughout the world.

CMF exists to unite Christian healthcare professionals to pursue the highest ethical standards in Christian and professional life and to increase faith in Christ and acceptance of his ethical teaching.