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16 July 1998

Dear Director

REVISED HFEA CODE OF PRACTICE

I attach the fourth edition of the Authority's Code of Practice, together with a copy of the Direction bringing it into force on 20 July 1998. 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.

The main issue which has been included for the first time in this revision is the genetic testing of both gamete donors and patients. When the last revision of the Code of Practice was published I wrote seeking your views on the screening of gamete donors for cystic fibrosis. Although the HFEA received only a small number of responses, all were broadly in favour of screening donors subject to information and counselling being available and the geographical variations in the mutations which cause cystic fibrosis being taken into account. These responses underlined the complexity of genetic testing as an issue and the HFEA decided that the screening of donors should not be considered in isolation. As a result new sections at 1.11, 3.49-3.51, 3.59, 3.60, 4.4 c & d, 4.5 c, and 6.18 give guidance on: staff at clinics; testing patients and donors; information; and, counselling.

The HFEA is discussing with the Advisory Committee on Genetic Testing (ACGT) the need to produce additional guidance on genetic testing of gamete donors. In 1996 the Government established the ACGT which is the body responsible for advising Government and others on genetic testing taking into account ethical, social and scientific aspects. The guidance currently being dicussed is likely to address in more detail issues surrounding the information which should be provided to patients and donors, the accreditation of the laboratories which clinics employ to carry out genetic tests and, in the case of cystic fibrosis, the mutations which should be tested for. This guidance will not form a part of the Code of Practice, but would assist clinics in complying with the new guidance.

Other issues which have resulted in guidance in the third revision are the change to the statutory storage period for embryos, recruiting gamete donors through an agency and the treatment of HIV positive patients. Attached to this letter is a summary of all the changes to the Code with an indication of the issues they deal with. This should help to identify quickly the changes which affect your clinic.

I hope you find the new Code of Practice helpful.

 

Yours faithfully,

 

Mrs Ruth Deech
Chairman

Page last updated: 14 April 2009

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