CH(13) 01

1 August 2013

Dear Colleague

October 2013 update to the Code of Practice

On 1 October 2013, the Code of Practice will be updated, affecting a number of guidance notes, consent forms and General Directions. These changes reflect recent developments in policy and clarifications to existing guidance, details of which are set out in the following annexes:

The Revision Control sheet sets out the changes to the Code of Practice in more detail.

Surrogacy and legal parenthood

The most significant update relates to surrogacy and legal parenthood. We decided to take a fresh look at our guidance following feedback from the sector which suggested that intended fathers in surrogacy arrangements could acquire legal parenthood on birth of the child. We sought legal advice and have now amended our requirements to allow one of the intended parents commissioning a surrogacy arrangement to be recognised as the legal parent when the child is born, if certain conditions are met and the relevant consents are in place.

I want to take this opportunity to thank those of you who attended a recent workshop and gave us feedback. The changes are complicated and require new and amended guidance and consent forms. To help understand them, we have provided additional explanatory information on surrogacy and legal parenthood changes.

You should now:

  • review the new guidance and information on our website, and ensure staff are aware of the changes
  • review and amend patient information in line with these changes; and
  • prepare to use the new consent forms from 1 October.

    Witnessing

    Another substantial update relates to guidance note 18: Witnessing and assuring patient and donor identification.

    We decided to review our witnessing guidance following feedback from the sector and information from inspections. Because clinics vary in the number of patients they treat, the procedures they carry out, and the type of witnessing system that they use, the most effective way of conducting witnessing may vary slightly between clinics. As a result, we have amended our guidance to put an emphasis on centres taking responsibility for witnessing procedures in their local environment. Centres should also fully consider the risks of departing from HFEA guidance, which is in place to avoid a mismatch of gametes.

    You should now:

    • review the new guidance and consider the witnessing practices in your clinic
    • if necessary, amend your witnessing protocols and standard operating procedures following the changes to guidance.

    Obligations and reporting requirements of centres

    You may be aware that we are starting a project that will review the data that clinics submit to the HFEA, and the process for submitting it. Alongside this, we felt that it would be helpful to give you advice on collecting and recording information for the HFEA, and have therefore updated guidance note 32.

    You should now:

    • review the new guidance and consider what processes you have in place, or now require, when collecting and recording information for the HFEA.

    We have also made a number of other updates which are either clarifications to existing guidance, or are minor amendments to text or external references.

    As mentioned in previous correspondence, we have now withdrawn the print version of the Code of Practice and will no longer publish an index. We will continue to publish both an online and a PDF version of the Code via the HFEA website. These will be updated on 1 October 2013.

    If you have questions about the new Code of Practice, consent forms or General Directions, please contact your Inspector in the first instance, or email: code8@hfea.gov.uk

    Professor Lisa Jardine CBE
    Chair, Human Fertilisation and Embryology Authority



    Annex 1: Changes to guidance notes

    Main updates

    Guidance note 6 – Legal parenthood

    From 1 October 2013, it will be possible for one of the intended parents commissioning a surrogacy arrangement to be recognised as the legal parent when the child is born together with the surrogate mother, if certain conditions are met and the relevant consents are in place.

    The Interpretation of Mandatory Requirement box (6G) has been amended to set out the relevant conditions and legal positions for all those involved, including the surrogate mother, husband or civil partner of the surrogate mother and the intended parents. A decision tree to demonstrate different routes to legal parenthood is at 6.12.

    Other updates include:

    • Further advice on the information centres should provide to people seeking surrogacy treatment that involves nationals or residents of other countries (6.1).
    • Clarifying the meaning of legal parenthood and parental responsibility and the different legal position of the mother, the father/or other parent (6.2-6.4).
    • Highlighting that relevant consents to legal parenthood should be complete before sperm and egg transfer, embryo transfer, or insemination takes place (6.5).
    • Clarifying the legal parenthood requirements when a woman has a husband or civil partner, including that the centre ascertains whether the husband or partner consents to the treatment ‘as a question of fact.’ (6.6-6.9 and 6G).
    • Revising the Interpretation of Mandatory Requirement boxes, ‘Legal parenthood: unmarried male partner’ (6C) and ‘Legal parenthood: for female partner who is not a civil partner’ (6D).

    Guidance note 14 – Surrogacy

    Intended parents providing gametes in surrogacy arrangements are no longer required to be treated as donors (although for HFEA Register purposes we continue to require centres to register the intended parent(s) using the donor information form. You can learn more about this on our surrogacy and legal parenthood changes page)

    New guidance still requires centres to screen intended parents providing gametes in line with requirements for gamete donors. We also advise that all those involved in surrogacy arrangements be assessed in line with the welfare of the child assessment process before providing treatment (14A and 14.1).

    We have also included guidance advising centres to give all those involved in a surrogacy arrangement a suitable opportunity to receive proper counselling and to ensure that they have received information about legal parenthood under the HFE Act 2008 and other relevant legislation (14.2, 14.7 and 14.8).

    Guidance note 18 – Witnessing and assuring patient and donor identification

    Revised witnessing guidance now places more emphasis on centres taking responsibility for their witnessing procedures. Centres should also fully consider any departure from HFEA guidance. Where centres depart from guidance, they should ensure that they conduct a formal, documented, risk assessment and ensure that new procedures are monitored for their effectiveness (18.27 -18.29).

    Guidance which previously allowed centres to cryopreserve multiple patients’ gametes or embryos at one time, and to witness sperm preparation at only the start and end of the procedure, has now been removed. These two paragraphs were at odds with other sections of the guidance and could lead to a mismatch of gametes.

    Other updates include:

    • Clarifying that all samples should be labelled with full name and further identifier, and how to be able to uniquely identify a sample (18.22 – 18.23).
    • Guidance when using electronic witnessing systems (18.35 and 18.37) and removing the requirement to keep a hard copy of electronic witnessing in patient records, though we would expect centres to still have access to such information.
    • Witnessing protocols being in place when embryo biopsy is carried out (18.6).
    • Removing references to labelling lids as these can be easily moved around.
    • Emphasising that witnessing procedures which cannot be reversed must be witnessed before they procedure is carried out (18.7).
    • Staff should receive refresher training as centres deem appropriate (18.10).
    • Clarifying and making consistent terminology throughout the guidance note.

    Guidance note 32 – Obligations and reporting requirements of centres

    We have provided centres with advice on the collection and recording of information for the HFEA. New guidance at 32.1-32.5 puts a focus on the source of the information that is received, with the aim of improving the proportion of data that is input correctly the first time. We have also included a link to our policy on the Collection, Confirmation and Publication of Register data.

    We have moved licence condition T41 from guidance note 31 into this section, as it fits well with the rest of the new guidance. We have also copied over some extracts of text from the Human Fertilisation and Embryology Act 1990 (as amended) in the Mandatory requirements box in guidance note 30, to give more context to this guidance note.

    Clarifications to guidance

     

    Guidance note 5 – Consent

    We have made clear that the 12 month ‘cooling off’ period cannot be used to extend storage where it has already expired (5H).

    We have also drawn attention to the Chief Executive’s letter issued in May 2012 (below paragraph 5.3), regarding the extension of storage of gametes and embryos where one of the gamete providers is deceased. The text within the Interpretation of Mandatory Requirements box 5A has been re-ordered to make clear that where no consent exists, gametes should not be procured, stored or used.

    Guidance note 7 – Multiple Births

    Guidance at paragraph 7.2 has been amended to highlight findings that live birth rates do not increase with the transfer of three embryos whilst the risk of adverse perinatal outcomes does increase. A link to the paper which studied this has been included.

    Guidance note 8 – Welfare of the child

    Welfare of the child assessments should be carried out on those commissioning surrogacy arrangements. Paragraph 8.5 has removed the reference to commissioning couples in surrogacy being exempt. The link to the HFEA Welfare of the Child form has also been changed following an update in April 2013.

    Guidance note 11 – Donor recruitment, assessment and screening

    New guidance (11.22) states that centres should screen potential donors both before accepting them as donors and before using the donated gametes or embryos in treatment, as communicated to centres in the March 2013 clinic focus. We have also updated links to external organisations.

    Guidance note 15 – Procuring, processing and transporting gametes and embryos

    We have made clear that gamete providers who are not in an intimate physical relationship should be screened in line with requirements for gamete donors (15D). Links to external organisations have also been updated.

    Guidance note 17 – Storage of gametes and embryos

    Following amendments to the 2006 European Union Tissues and Cells Directive, a new Interpretation of Mandatory Requirements box (17A) states that patients and partners should be screened for HIV 1 and HIV 2, hepatitis B and hepatitis C every two years. This change was communicated to centres in the March 2013 Clinic Focus.

    We have also rectified a minor drafting error in Licence condition T51 in the Code.

    Guidance note 20 – Donor assisted conception

    Guidance at paragraph 20.1 (a) and (b) has been revised to remove the word ‘relevant’, to clarify that centres should share all non-identifying information about donors with those seeking treatment with their gametes or embryos. We have also updated references to external organisations.

    Minor updates

    Guidance note 3 – Counselling

    We have updated references to external organisations.

    Guidance note 10 – Embryo testing and sex selection

    The Interpretation of Mandatory Requirements box ‘Prohibitions in connection with embryo selection’ now correctly refers to section 13 of the Human Fertilisation and Embryology Act 1990 (as amended).

    Guidance note 22 – Research and training

    We have updated links to external organisations.

    Guidance note 31 – Record keeping and document control

    We have rectified a minor drafting error in Licence condition T39 in the Code. Licence condition T41 has been moved to guidance note 32.

    Annex 2: Changes to consent forms

    In a surrogacy arrangement, where the nominated parent is the non-biological father or the intended female parent, both the surrogate and the nominated parent must have given consent to him or her being the legal parent. New consent forms reflect this.

    • SPP - Your consent to being the legal parent in surrogacy 
    • SWP - Your consent (as a surrogate) nominating an intended parent to be the legal parent

    Currently the withdrawal of consent (WC) form does not include the option to withdraw or vary consent to legal parenthood for those involved in a surrogacy arrangement. The form also does not reflect recent legal advice that, in order for a woman to demonstrate that their spouse or civil partner does not consent to their treatment (ie., the surrogate’s treatment), they must be able to provide appropriate evidence that there is a factual basis for their lack of consent. In order to avoid overcomplicating the current WC form, we have developed three new forms:

    • WC - Withdrawal of consent (amended version) 
    • SWC - Surrogacy withdrawal of consent 
    • LC - Stating your spouse or civil partner’s lack of consent

    The MSG and WSG forms have been amended to bring them closer in line with patient treatment forms, highlighting the potential complexities of posthumous use and birth registration in surrogacy arrangements: 

    • MSG - Consent to the use and storage of your sperm or embryos for surrogacy 
    • WSG - Consent to the use and storage of your eggs or embryos for surrogacy

    Annex 3: Changes to General Directions

    General Directions 0007 – Consent

    The schedule in Directions 0007 has been updated to reflect the new and amended consent forms following changes to Surrogacy and Legal Parenthood.

    Downloads

    Code of Practice guidance notes

    Consent forms

    General directions


    Page last updated: 02 August 2013