• Directions
• Chair's letters
  • 2013
  • 2012
  • 2011
  • 2007-2010
  • 2003-2006
  • 1999-2002
  • 1995-1998
  • 1991-1994
• Chief Executive's letters
• Multiple Births Minimisation Strategy: achievements and compliance
• Frequently used guidance
• Do I need to be registered by either the CQC or licensed by the HTA?
• Retrieval of storage of gametes where patients are unable to consent
• Surrogacy and legal parenthood – changes from 1 October 2013

24 May 2007

Dear Colleague,

7th edition of the HFEA Code of Practice

I have the pleasure of enclosing the seventh edition of the HFEA's Code of Practice, together with a copy of the Directions bringing it into force as required by section 26 of the HF&E Act 1990.  The Code has been approved by the Secretary of State for Health and laid before Parliament and will come into force on the 5th July 2007. 

There have been substantial legislative changes, both domestically and within the EU since the 6th edition of the Code of Practice was published in March 2004 and we have also undertaken some major policy reviews.  The Guidance and HFEA Assisted Conception Standards have been consulted on extensively and the Standards and Guidance have been incorporated in to the 7th edition of the Code Practice.

For this to be possible the structure of the Code has undergone significant changes.  It now consists of two parts:

Standards:contains specifications that centres are required to show they can meet, including those required for compliance with the new legislation,

Guidance: how these specifications should be met (consolidating much of the content of the 6th Code of Practice).

The Code will be available in both hard copy and as a fully interactive online version, with external links to the underlying legislation, guidance from the professional bodies and internal links between standards and the relevant guidance.  The online version is available on the HFEA website: www.hfea.gov.uk/codeofpractice 

In addition to the structural changes to the Code there are also policy changes which have been included in this edition of the Code, these are:

Witnessing guidance

The witnessing policy was reviewed to take into account traceability requirements of the EU Tissues and Cells Directive, use of electronic systems for witnessing (bar coding and radio frequency identification) and causes of witnessing related incidents reported to the HFEA.

General Directions D.2004/4 on records of witnessing clinical and laboratory procedures will be revoked when the Code comes into force on 5th July 2007.  This will be replaced by a new Standard and Guidance to come into force at the same time.
The model protocols are available on the ***HFEA website: http://www.hfea.gov.uk/en/1502.html

Transferring gametes and embryos within Gibraltar and the European Economic Area (EEA)

The transposition of the EU Tissues and Cells Directive into UK law has necessitated a revision to the guidance on the import and export of gametes and embryos within the EEA and Gibraltar.  The new guidance places responsibility on the Person Responsible (PR) to ensure that certain requirements are met before transferring gametes or embryos in to the UK from the EEA.  The requirements are set out in the new Guidance (G.9.8).

General Directions D.2001/1 will be revoked and replaced with D.2007/4, coming into force with the new Code.  New forms for notifying the Authority of transfers are included in the pack and these can also be downloaded from the HFEA website: ***http://www.hfea.gov.uk/en/1336.html

Provision of Information to Patients

Since the Code of Practice went to press a new standard licence condition has been introduced for all treatment licenses.  This states that:

A.2.10 No treatment services will be provided unless the woman and man being provided with the treatment services have been given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps and have been provided with such relevant information as is proper.

This condition relates to S13(6) of the Human Fertilisation and Embryology Act 1990, Standard S.7.4.1 and the Guidance at G.5.3.1.

The new condition ensures that all licensed centres, including those licensed for the first time as a result of the implementation of the EU Tissues and Cells Directive, are working to common requirements on the provision of information to patients.

It is also necessary to draw attention to two clarifications of HFEA policy issues:

Limitations on the number of eggs or embryos that may be transferred

Current HFEA guidance sets out the numbers of eggs and embryos that may be transferred (Code of Practice 7th edition, G.8.5.1-2).  This guidance will apply to all licensed centres, including those centres that previously did not require a licence.

Sex selection for social reasons
HFEA Guidance states that sex selection of embryos and gametes may not be undertaken for social purposes and in addition, sperm sorting by the gradient method cannot be used for medical purposes.  This also applies to all licensed centres. 

Directions

In the course of revising the Code the Directions currently in force were reviewed and revised to ensure consistency.  This does not represent any changes to HFEA policy.  The General Directions on adverse incidents, transfers between UK centres and gametes and embryos in the course of carriage have been updated.  They are also included in this pack.

Further information

For further information about the content of this letter please contact your inspector.

Ordering copies of the Code

Should you require further copies of the Code please contact the HFEA either by telephone: 020 7291 8200 or email: code@hfea.gov.uk

Yours sincerely,

Shirley Harrison
Chair

Page last updated: 23 August 2012

• Send to a friend