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04 June 2001

Dear Colleague,

REVISED HFEA CODE OF PRACTICE

Enclosed is the fifth edition of the HFEA's Code of Practice, together with a copy of the Direction bringing it into force as required by s26 of the HFE Act. It has been approved by the Secretary of State and laid before Parliament.

This new edition of the Code of Practice has been completely restructured and includes updated policies and guidance that have been changed since the last edition was published in July 1998. There follows a brief explanation of the Code's new structure as well as an outline of the areas where policies have been revised.

The main structure of the Code has remained the same. The information is broken down into discrete chapters as in previous editions. These chapters relate to general issues such as consent, information, and records.

The structure of the Chapters has been altered so that the content of each chapter that relates to all patient/donor groups has been brought together under a general heading at the start of each chapter.

Other aspects that relate only to specific types of individual/patient groups have been put under the following headings:

• People seeking treatment
• People providing gametes and embryos for donation
• People seeking long-term storage of gametes and embryos
• People involved in egg sharing arrangements

In previous editions there was one chapter covering 'Assessing clients, donors and welfare of the child'. This chapter has been split into three to make it easier to use. The three new sections are:

• Assessing people seeking treatment and welfare of the child
• Assessing people considering donation and screening
• Confidentiality

In addition, the chapter that related to 'Storage of gametes or embryos for cancer patients' has been removed. Information relating to cancer patients and other patients eligible for long-term storage can now be found throughout the Code under the heading 'People seeking long-term storage of gametes and embryos'.

As well as these structural changes there have also been the following changes in policies and guidance.

Paragraph 1.6 has been amended to bring it in line with Caiman training changes and the General Medical Council's Specialist Register. Overall clinical responsibility for treatment services using in vitro fertilisation should now be held by someone who is on the GMC Specialist Register, having completed training recognised by the Royal College of Obstetricians and Gynaecologists. In addition, as outlined in paragraph 1.1, all clinical scientists working in licensed centres should be registered or working towards registration with the appropriate board of the Council for Professions Supplementary to Medicine.

In this new edition of the Code, the sections governing advertising have been amended. As detailed in paragraph 2.27, all advertising should conform to the guidelines of the Advertising Standards Authority. In addition, under paragraph 6.5(c) any data given in publicity material should be accompanied by the centre's own live birth rate per treatment cycle, as verified by the HFEA, as well as the national live birth rate per treatment cycle.

Since the publication of the last edition of the Code the HFEA has also undertaken a review of research licensing. As a result, the Code now sets out in paragraphs 6.8 and 6.9 the information that should be provided to people considering donation.

This fifth edition adds a new requirement that, where it is not possible to contact a patient's GP or consent to contact has been refused, centres should attempt to verify the identity of people seeking treatment and those wishing to donate gametes by alternative means. Where satisfactory identification is not provided in such circumstances, centres can now take this into account when deciding whether or not to treat the individual concerned. This requirement can be found in paragraphs 3.22 and 4.7 of the fifth edition of the Code of Practice.

Provisions regarding the screening and selection of people considering donation have also been amended. Screening provisions are outlined in paragraphs 4.10-4.18. Changes include the reduction of the upper age limit for sperm donors to 45 years, as detailed in paragraph 4.20. In addition, new paragraphs regarding the screening and selection of embryo donors have been added at paragraphs 4.18, 4.23 and 7.24 and the situation regarding the screening of those involved in surrogacy arrangements has been clarified in paragraph 4.19.

HFEA policy regarding the production of sperm at home has been altered to stress that this should only be done in exceptional circumstances and that where this is done it should be clearly noted on patient records. The policy surrounding the production of sperm at home can be found in paragraphs 9.15-9.18 and 9.28-9.29. In addition, the Code's guidance on home insemination has been clarified and can be found at paragraphs 9.21-9.27.

Centres should note that, as outlined in chairman's letter (00)11 of 8 November 2000, there has been a policy change regarding the way the limit often for donors is calculated. This is now to be calculated on the basis of the number of live birth events per donor rather than the number of children born. The sections of the Code that set this out are paragraphs 9.30 and 9.31.

Chapter 12 of the Code on clinics' records, has been extensively rewritten to reflect changes in the general UK legislation on data protection.

The HFEA's egg sharing guidance, sent out to all centres in September 2000, has been incorporated at appropriate points throughout the Code. In addition a new annex of guidance for egg sharing arrangements has been added at Annex A.

The Code also contains two further new annexes. Annex F lists professional guidelines and Annex G contains guidance on the payment of reasonable expenses for donors.

If you have any queries regarding any aspect of the Code please contact Jo Rippington at Paxton House on 020 75393328, or by e-mail on jo.rippington@hfea.gov.uk.  

Yours faithfully,

 

Ruth Deech
Chairman

Page last updated: 14 April 2009

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