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15 December 1995

Dear Director

REVISED HFEA CODE OF PRACTICE

I attach the second revised edition of the Authority's Code of Practice, together with a copy of the Direction bringing it into force from Monday, 18 December 1995. It has been approved by the Secretary of State and laid before Parliament. It may be helpful if I outline the areas where the Code has been revised.

You will notice two major additions to the Code of Practice. A new section has been added to the Code at Part 9 which draws together all the guidelines relevant for clinics that store gametes and embryos for cancer patients. The Code has also been amended at section 3.21 to include general guidance on parental orders in surrogacy cases and the Regulations implementing section 30 of the Human Fertilisation and Embryology Act 1990. More detailed information on parental orders is given in a new Annex B.

The Code of Practice guidelines on the welfare of the child have also been reviewed with a new section at Part 3.14 giving more general guidance, requiring clinics to have clear written procedures, and stressing the need for a "stable and supportive environment". Paragraph 3.17 has been expanded to give more prominence to the need to consider a patient's age.

You will also find two changes intended to make the Code easier to use: An index has been added and references to the sexes separately as "he/she" or "his/her" have been replaced by the joint term "they" or "their" throughout.

The process of revising the Code of Practice is an ongoing one. Already there are issues that have been identified for possible future inclusion. Attached to this letter there is an Annex asking for your views on the upper age limit for semen donors and screening of donors for cystic fibrosis. Your comments on both of these issues would be welcomed by the Authority.
 
 
I hope you find the new Code of Practice helpful
Yours faithfully

 

Mrs Ruth Deech
Chairman
 
ANNEX

HFEA Code of Practice - issues for consultation

1. Upper age limit for sperm donors
Currently the Code of practice states that gametes should not be taken from male donors over
the age of 55, unless there are exceptional reasons for doing so.

A paper published in 1991 by Bordson and Leonardo1 reviewed the available data and concluded that there was a correlation between paternal age and the incidence of serious non chromosomal birth defects, especially those arising from new autosomal mutations. This review prompted the then American Fertility Society (AFS) to give an upper age limit of 40 in its guidelines on sperm donation, and the British Andrology Society (BAS) is now considering whether a similar upper age limit should be recommended in respect of sperm donation for therapeutic donor insemination. Recent work by CECOS in France, as yet unpublished, appears to show that the risk of having a Down's syndrome pregnancy also increases with paternal age.

Since 1991, out of a total of 2207 semen donors, the following numbers of donors over the age of 40 have been recruited:

Age 40-45 - 106 donors
Age 46-50 - 26 donors
Age 51-55 - 11 donors

The Authority invites comments on whether the Code of Practice should be revised to restrict the upper age limit of semen donors to 40.

1 Bordson BL, Leornardo VS. The appropriate upper age limit for semen donors: a review of the genetic effects of paternal age. Fertility and Sterility, 1991; 56:397-401
 
2. Screening for cystic fibrosis

The Code of Practice requires clinics to follow the British Andrology Society (BAS) guidelines on screening of semen donors for donor insemination. The BAS guidelines do not make screening for cystic fibrosis mandatory.

Screening for cystic fibrosis has been a matter of recent media attention with reports of the birth of a baby conceived through donor insemination and affected by cystic fibrosis. The baby was conceived in 1991, when few donors were tested. In addition, a firm is now marketing a mail-order genetic test for cystic fibrosis.   Also, a letter appeared in the British Medical Journal in which a licensed clinic advocated the compulsory screening of semen donors.2 They retrospectively tested 22 sperm donors and found 2 of them to be carriers.

The issues surrounding the screening of cystic fibrosis make it a complex area: the implications for donors who are screened; the principle of screening for a genetic disease; and the availability of a test that it is estimated only detects 85% of carriers.

The Authority has asked the BAS for their view on screening donors for cystic fibrosis. The Authority will also welcome comments from licensed clinics and other interested organisations.

2 Findlay I, Cuckle H, Lilford RJ, Rutherford A, Quirke P, Lui S. Screening sperm donors for cystic fibrosis. British Medical Journal, 1995; 310:1533.
 
DIRECTIONS GIVEN UNDER
THE HUMAN FERTILISATION AND EMBRYOLOGY ACT 1990

Bringing into force the Code of Practice (second revision)

Ref. D. 1995/1

These Directions are: GENERAL DIRECTIONS

Section of Act providing Section 26(5)
for these Directions:

These Directions come into
force on: 18 December 1995

These Directions remain
in force: Until revoked

Code of Practice

1. These Directions revoke Directions Ref. D. 1993/1.

2. The second revision of the Code of Practice provided for under Section 25 of the Human Fertilisation and Embryology Act 1990 shall come into force on
18 December 1995.

Date 15 December 1995 
Ruth Deech
Chairman

EXPLANATORY NOTE

Section 25(6)of the Human Fertilisation and Embryology Act 1990 provides as follows:

"A failure on the part of any person to observe any provision of the code shall not of itself render the person liable to any proceedings, but –

a. a licence committee shall, in considering whether there has been any failure to comply with any conditions of a licence and, in particular, conditions requiring anything to be "proper" or "suitable", take account of any relevant provision of the code, and

b. a licence committee may, in considering, where it has power to do so, whether or not to vary or revoke a licence, take into account any observance of or failure to observe the provisions of the code."

Page last updated: 17 August 2012

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