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09 February 1994

To : all Directors of Centres
HFEA Inspectors
9 February 1994

Dear Director

I am writing to bring all centres up to date with policy decisions recently made by the Authority, and to clarify our position on two issues which have lately been of great interest to the media. Our members and Executive are in touch with individual centres throughout the year. However, we recognise that it is important to ensure that all centres have a clear understanding of the Authority's views on policy and licensing issues which arise from time to time. We therefore intend that this should be the first of a regular series of six-monthly letters to keep centres in touch on matters of general interest or concern. This letter deals with four issues: cloning, using stored embryos produced from donors who have already produced 10 offspring, using donors of a different ethnic origin from recipients and the treatment of older women.

1. Cloning
You are no doubt aware that cloning an embryo by nuclear replacement is expressly forbidden by the Human Fertilisation and Embryology Act 1990 (HFE Act).  Cloning by splitting embryos is not prohibited by the law but may not be carried out without a licence from the HFEA. Last year we considered the issues surrounding cloning by embryo splitting.

The Authority has decided not to license the use of cloning by splitting embryos for treatment purposes, or for research directed towards the development of cloning for treatment purposes. This decision does not affect the licensing of embryo biopsy where there is no intention to develop removed cells into embryos for replacement in the womb.

2. Using stored embryos produced from donors who have produced 1Q offspring
Last year several centres reported to the Authority cases of couples wishing to use for themselves, or to donate for the treatment of others, embryos which had been in storage for some time. These embryos had been produced using the eggs of the couples7 female partners and the sperm of donors who were now known to have fathered 10 children. The centres were uncertain how to advise the couples since the Code of Practice makes it clear that "donated gametes or embryos should not normally be used for treatment once the number of live children born as a result of donations from that donor has reached 10".

The Authority has decided that, provided the stored embryos were produced in good faith at a time when the donor was not known to have produced 10 offspringf they may be considered an allowable exception to the Code of Practice limit. As always, the Authority should be notified whenever the limit of 10 is exceeded. It should be clearly understood that this does not represent a general relaxation of the limit of 10 offspring per donor. The Authority will be monitoring the situation to establish whether the limit of 10 children is being frequently exceeded at particular centres.

3. Using donors of a different ethnic origin from recipients
There have been several cases recently reported in the press of black or Asian women seeking egg donation. One woman, married to a white man in Italy, wished to receive the eggs of a white woman for social reasons. Another woman, in the UK, whose husband was of mixed race, was prepared to accept the eggs of a white woman since no eggs from a black donor were available.

The Code of Practice (para 3.20) says that centres should "take into account each prospective parent's preferences in relation to the general physical characteristics of the donor which can be matched according to good clinical practice". Matching of donors should be carried out sensitively in discussion between those seeking treatment and the centre. We recognise that a shortage of donors, particularly of donors from ethnic minorities, may constrain the choice available in some cases. However, the Authority would not regard it as good clinical practice if a licensed centre allowed a woman's preference for a child of different ethnic origin from herself, for social reasons, to determine the choice of an egg donor. Similarly, a woman seeking donor insemination should not be allowed to choose for social reasons a sperm donor of a different ethnic group from her partner.

4. Treatment of older women
The press has recently given a good deal of attention to the issue of whether older, particularly post-menopausal women, should be given fertility treatment.  You may remember that we mentioned in our last Annual Report that we would be considering this issue during the year.

It continues to be the view of the Authority that it is neither necessary nor advisable to fix an upper age limit for the treatment of women. Licensed centres are required by law to consider the welfare of the prospective child. The Code of Practice says that in doing so they should take account, amongst other things, of the age and medical history of the prospective parents and of their ability to meet the child's needs. The Authority believes that each case should be considered individually, bearing in mind the welfare of the child and all the implications for the couple concerned.

We have been reassured to find that according to our records no more than a dozen or so women over 50 years old have been treated using IVF in the last two years. None of these was over 52 and several used their own eggs. The Authority would be concerned if a centre were repeatedly treating elderly women, and we would expect such a centre to be prepared to justify this practice in terms of the welfare of the child.

Like all HFEA policies, these will be kept under review and will be amended or developed as we consider necessary in the light of changing circumstances. I will be writing to you again in about six months to let you know of further developments in Code of Practice or licensing policy.

Yours faithfully

COLIN M CAMPBELL
Chairman

Page last updated: 15 August 2012

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