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30 November 2007

Dear Colleague

Update to the Code of Practice

The Human Fertilisation and Embryology Authority (HFEA) has conducted a review of the 7th edition of its Code of Practice, in light of queries that have arisen from both centres and patients. As a result of this review a number of amendments to the Code have been agreed in order to provide for greater clarity of existing Standards and Guidance. I am therefore pleased to enclose the Code of Practice Update.

The Update contains revised pages that should be inserted into your hard copy Code of Practice with the old pages taken out and destroyed. A detailed checklist of the revised pages and instructions for incorporating them into the hard copy of your Code of Practice is enclosed with this letter. You should record on this checklist that you have updated your Code of Practice and retain the checklist in the front of the folder.  

The Update will take effect from 10 December 2007.

The online version of the Code of Practice incorporates all of the changes outlined in this letter.

The key changes are summarised below:

Minor amendments to the Standards to make references to Patients, Patient Partners and Donors more explicit for greater clarity
(S.3.1.28(b), S.7.7, S.7.8.10, S.9.4.3)

Under the EU Tissues and Cells Directive (EUTD) a ‘donor’ is defined as ‘every human source ? of human cells or tissues’. As a result, within the fertility sector a ‘donor’ could in fact be a patient or a patient’s partner. In transposing the EUTD requirements into the Code of Practice the majority of instances where this clarification was needed were addressed.

However, after a period of time using the new Code some queries have arisen where greater clarity is required to ensure that the distinction between donor, patient and patient partner is made, or to ensure that it is explicit that a requirement relates to all of these groups.

The Standards which have been clarified are:

• S.3.1.28 (b)
• S.7.7
• S.7.8.10
• S.9.4.3.

Minor amendment to the ‘annual reporting’ Standard
(S.4.2.12)

It was noted that Standard S.4.2.12 needed clarification in order to accurately reflect current reporting requirements and practice. Therefore, it has been amended to reflect the fact that IVF centres continue to report via EDI (except for certain small clinics, as agreed) and that IUI/GIFT centres submit an annual report.

Amendment to the ‘control of records’ Standard
(S.5.2.7)

Some queries have come forward from clinics regarding S.5.2.7 and the length of time that records should be kept. The standard licence condition A.3.2 states that records should be kept for 30 years and for such longer period as may be specified in Directions. Therefore, this reference to Directions is now included in Standard S.5.2.7 and a link to Directions D.1992/1, which require that certain records be kept for 50 years, is also included.

Amendment to the ‘statutory storage limit’ Standard and Guidance
(S.7.8.11, G.9.9.1)

It has been reported that some centres have found it difficult to access information regarding statutory storage limits. These are stated in licence conditions and in Guidance G.6.6.1, however these are not linked to a key paragraph in the Standards which makes it difficult to quickly reference all the information that is needed. Therefore Guidance G.6.6.1 (which sets out the limits) is now linked to Standard S.7.8.11 and G.9.9.1 to make it more explicit. Similarly, G.6.6.4 and G.6.6.5 (which relate to when extensions to the storage of gametes and embryos may be considered) have been linked to S.7.8.1.

Minor amendments to the wording of the ‘Eggs for Research’ Standards and Guidance
(S.8.4.1 – S.8.4.3, G.5.13, G.15.1.2, G.15.4) 

The Authority approved amendments to the policy guidance surrounding egg donors for research earlier this year. The new Standards and Guidance have been published and are now being incorporated into the Code of Practice, albeit with some further clarification to the wording. This is mainly to ensure that the donation of both gametes and embryos for research is covered by Standard S.8.4 and Guidance G.5.13.

Inclusion of ‘screening of donors for surrogacy’ Guidance
(G.4.9.1)

The 6th edition of the Code of Practice contained an explicit paragraph stating that gamete providers in surrogacy arrangements were expected to be screened in accordance with the usual requirements for potential donors. However, this provision was not directly transferred into the 7th edition, as it was thought that, bearing in mind the definition set out in the EUTD, gamete providers in a surrogacy arrangement would be treated as ‘donors’. However, this implicit approach has resulted in some confusion and queries from clinics even though there has been no change in policy. Therefore, the requirement to screen donors for surrogacy is now made explicit, in new Guidance G.4.9.1, to provide for greater clarity for clinics.

Inclusion of ‘non-mixing of sperm for treatment’ Guidance
(G.8.8)

The 6th edition of the Code of Practice had an explicit paragraph stating that ‘it is expected that women will not be treated with gametes, or with embryos derived from gametes, of more than one man or woman’. The 7th edition does not include this explicit provision because there is a treatment form that identifies the sperm provider in each treatment cycle that must be completed, and therefore it is implicit in the requirements. However, some patient queries have been received in relation to this matter so a more explicit provision is included as a new paragraph under Guidance G.8.8.

Amendment to the ‘screening for aneuploidy’ Guidance
(G.12.4.1)

The HFEA’s Regulation Committee had previously agreed that PGS for aneuploidy should be permitted in cases where the male partner’s sperm has higher than normal levels of aneuploidy. Therefore, Guidance G.12.4.1 is amended accordingly.

Licence condition A.13.9 (c) states that PGS for aneuploidy may only be used in the treatment of certain categories of patient, therefore it will also be updated to include where the male partner’s sperm has higher than normal levels of aneuploidy. However, to avoid the significant administrative exercise of reissuing licences to centres this clarification is being notified to centres via this letter and the amendment will be incorporated into new/renewed licences as they arise. The on-line version of the Code will also be updated accordingly.

Minor amendments / typographical corrections to the witnessing guidance (G.13)

Guidance relating to the witnessing of sperm preparation tubes has been clarified and a revised form of words for G.13.1 ‘NOTES’ has been drafted to reflect this. A further clarification as to the carrying out of the risk assessment of an electronic witnessing system has also been agreed. In addition, a number of minor typographical corrections have been identified in the witnessing guidance under G.13.

Updating of references to Direction 2006/6

Direction 2006/6 has now been superseded by the Direction 2007/7. References to D.2006/6 have therefore been updated in the Code of Practice (S.4.2.12, S.5.2.8, S.7.7.4).

Clarification of licence condition A.7.1 (Partner-donated sperm (stored)).

Through the process of reviewing the Code, and in light of queries that have arisen, it has become apparent that standard licence condition A.7.1 needs to be revised slightly in order to accurately reflect current policy. We have confirmed with the Department of Health that, under the EUTD, Patient Partners whose sperm is to be used in cases of direct use do not need to be screened, even though as part of the treatment (eg IUI) the sperm may be processed.

It is only in cases where the sperm is to be stored (which is usually preceded by processing) that Patient Partners need to be screened. As this has been the intention since the implementation of the EUTD (ie there has not been any change in the policy), it is proposed that the licence condition A.7.1 should be clarified so that it reads:

“A.7.1 Partner-donated sperm (stored) – In relation to partner donated sperm, which is to be processed and stored, the Centre shall comply with the following selection criteria and requirements for laboratory tests?”.

In order to avoid the significant administrative exercise of reissuing licences to centres this clarification is being notified to centres via this letter. It is not included in the hardcopy update. This licence condition amendment will be incorporated into new/renewed licences as they arise. The on-line version of the Code will also be updated accordingly.

On-line Code of Practice

The HFEA’s on-line Code of Practice has also been updated with the revisions outlined above. A number of minor typographical corrections and amendments, internal link changes and keyword updates have also been made to the on-line version but are not reflected in the hard copy in order to reduce the amount of paper being sent out. These additional amendments are as follows:

• S.6.5.1 (2nd line) remove ‘systems’
• S.7.1.1 (4th line) insert ‘and’ to read ‘embryos, and meets the needs and requirements of the user’
• S.7.3.2 (c) (last line) insert ‘for’ before research.
• S.7.8.2 Last paragraph. Insert full stop at end of followed (4th line). Remove ‘and’ and capitalise ‘The’
• S.8.2.2 (b) replace ‘is informed’ with ‘are informed’.
• G.6.8.1 (first line) insert ‘an’ to read “?that an egg provider’s”
• Correct G.7.2.8 online reference to state ‘Individual counselling’.
• Remove G.9.4.2 as this is a repetition of G.9.4.1.

Similarly, the two minor amendments to standard licence conditions explained above (A.7.1 and A.13.9 (c)) have only been included in the on-line version of the Code.

Further information
For further information about the Update to the Code of Practice please contact your inspector.

Yours faithfully  

Walter Merricks
Interim Chair

 

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*******Code of Practice update checklist for hard copy (24 Kb)

Page last updated: 23 August 2012

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