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The HFEA's monthly newsletter for clinic staff

March 2024

Storage changes: End of the Transitional Period

The Transitional Period for the 2022 laws on the storage of gametes and embryos will come to an end on 30 June 2024. Clinics are reminded of actions they need to take before and after this date.

By 30 June 2023, clinics were required to contact patients with gametes or embryos in storage whose Consent Period ends during the Transitional Period or whose gametes or embryos were in storage without effective consent on 1 July 2022. Please see the February 2023 Clinic Focus for more information.

These patients now must give or renew their consent to storage of both gametes and embryos by 30 June 2024 for storage to continue. Where consent is not given or renewed by 30 June 2024, consent is taken as withdrawn and clinics have a legal obligation to remove the gametes or embryos from storage and dispose them at the appropriate time.

When no effective consent in is in place on 30 June 2024 clinics are reminded that the appropriate time to remove from storage is different for gametes and embryos.

Gametes

After the end of the Transitional Period, all gametes that were in storage before 1 July 2022 must either be in storage with effective consent or be removed from storage. Where there is no effective consent, gametes must be removed from storage and disposed of on 1 July 2024.

Embryos

All embryos that were in storage before 1 July 2022 must either be in storage with effective consent by 30 June 2024 or be removed from storage at the appropriate time, as set out below.

Where the Consent Period has ended, lawful storage of embryos can continue until 31 December 2024 (unless consent has been withdrawn by both of the gamete providers). However, consent cannot be given or renewed after 30 June 2024 and nor can patients use the embryos in treatment or consent for the embryos to be used for another purpose (such as research). This means that centres will be legally required to remove the embryos from storage on 1 January 2025 if consent is not renewed by 30 June 2024. Centres should remove embryos from storage before that date if both gamete providers withdraw consent. Where lawful storage can continue until 31 December 2024, clinics must issue an NWC(TP) Statutory Notice as soon as practicable on or after 1 July 2024 to inform patients that their consent has been taken as withdrawn.

Which consent forms should patients complete?

It is very important that clinics provide patients with the right consent forms at the right time.

Patients need to renew consent where they have reached the end of their Consent Period (that is end of the statutory storage period which was applicable before the amendments to the Act made on 1 July 2022). They should complete the appropriate renewal of consent form.
Patients need to give consent to additional storage where they have reached the end of any shorter period that they consented to. They should do this on the relevant treatment and storage form.
Patients need to give consent where they did not have effective consent to storage in place before 1 July 2022. They should complete the relevant treatment and storage form.

More information can be found on our website.

If you have any questions, please contact your HFEA inspector.

Update to Choose a Fertility Clinic (CaFC)

On 28 February 2024 we started the verification process for CaFC. This is the first CaFC update through PRISM and relates to treatments from January 2020 to December 2023, and live birth data from January 2019 to December 2022.

PRs and clinic staff registered for the PRISM user group will have already been notified about this. You can also view this communication on the PRISM homepage.

We commenced CaFC verification with a release of missing outcomes and early outcomes - these need to be fixed by clinics at the earliest opportunity. In the coming weeks we will be releasing further CaFC verification reports in batches and will give further guidance on how clinics should act on those reports. All clinics, whether entering data directly through PRISM or through an API solution from their system supplier, should access the verification reports on the PRISM homepage.

PRISM users will also notice that a new option for ‘CaFC downloads’ is available on the left-hand side of the PRISM homepage.

As outlined in December Clinic Focus, we are aiming to complete verification in the summer – with a provisional end date of 31 July 2024 - and to publish CaFC by the autumn. This means that clinics should be working towards completing all verification work by the end of July 2024. This date will be confirmed when the final verification report is published.

As we issue the verification reports we will communicate this to PRs, to the attendees of the fortnightly PRISM user group (2pm alternate Wednesdays), and we will post these on the message board section of the PRISM Homepage.

If you have any questions, please contact prismsupport@hfea.gov.uk, or you can speak directly to the team on the user group calls.

New External Advisers appointed to the Scientific and Clinical Advances Advisory Committee (SCAAC)

We are delighted to welcome three new highly regarded External Advisers to the Scientific and Clinical Advances Advisory Committee (SCAAC) following a competitive external process. Thank you to all the excellent and very high quality candidates who applied to these roles.

Ying Cheong, Peter Rugg-Gunn and Veronique Berman were appointed from 4 March 2024 for a term of three years and will provide expert advice to SCAAC on scientific and clinical advances in assisted conception, embryo research and related areas.

They bring in depth experience which will be invaluable when advising the Authority on its work in these areas.

Ying Cheong will be supporting the committee with expertise in Reproductive Medicine, Peter Rugg-Gunn with Developmental Genetics and Developmental Models, and Veronique Berman with Fertility Patient Support.

You can find more information about the SCAAC on our website, including the minutes of the February 2024 meeting.

Our latest clinical governance summary report

We have published our latest clinical governance summary report that covers some of the common non-compliances identified at inspections, reported incidents and complaints received from July to September 2023.

The aim of this report is to highlight key areas of practice where improvements can be made, or where learning and experiences can be shared to benefit other clinics.

To promote learning from inspections we encourage you to use the areas outlined in this report as an opportunity to consider how your clinic might approach these issues.

Establishing the legal status of a marriage or civil partnership

Clinics must be clear on the marital status of patients as this will affect whether or not legal parenthood consent is required. A patient’s marital status - according to the law - is a key determinant of legal parenthood. In some cases, it may not be clear if patients are in a marriage or civil partnership that is legally recognised in England, Scotland, Wales or Northern Ireland. This could have serious consequences for patients and any child born as a result of treatment. Clinics must confirm a patient’s relationship status and record this correctly.

We are aware of situations where accurately determining marital status may be complex, for example:

Where patients have had a wedding ceremony that does not meet the legal requirements of the law. If this happens a patient’s marriage will not be legally recognised.
Where patient(s) believe themselves to be legally married when they are not.
Where patient(s) have married abroad and it may be difficult to establish whether the marriage is legally recognised, for example where relevant documentation is not available in English.

The Code of Practice states:

“General procedures for obtaining consent

6.7 The centre should record whether a person receiving treatment is married or in a civil partnership in their notes, and should explain to the person that this is relevant because relationship status is an important factor in determining the legal parenthood of any child that may be born, and is relevant when considering what consent forms need to be completed prior to treatment. If a person is having treatment with a partner, the centre should record whether they are married or in a civil partnership with one another (or with someone else). This may affect who will be the second legal parent of any child born following treatment and whether consent is required to make the partner (with whom treatment is being sought) the child’s legal parent.”

A copy of the marriage certificate will help to establish the legal status of a marriage, however in particular for marriages that took place outside the UK, this may not be sufficient. Clinics will need to assure themselves that the marriage certificate is legally recognised and where there are concerns, seek legal advice.

Clinics should have robust procedures in place so that any cases where the legal status of a marriage is unclear or complex are identified and handled appropriately. Steps to take may include:

Reviewing the information provided to patients about marital status and the serious implications for legal parenthood, including that it is possible to have a wedding ceremony that is not legally recognised as a marriage under the law.
Ensuring staff understand the legal requirements for a marriage, the implications for legal parenthood and are equipped to identify potential problems relating to patients’ marital status.
Updating SOPs if necessary to include actions staff should take when they are not sure whether a marriage is legally recognised or where patient(s) raise concerns about the legal status of their marriage or civil partnership.
Recording all relevant documentation and the information provided to patients.

Centres should be aware that the law may differ across different parts of the UK. Information can be found online relating to England and Wales, Scotland and Northern Ireland.

We are not able to offer specific advice on legal marriage or classify legal marriage scenarios as this falls outside of HFEA legislation. In complex cases, we would recommend clinics seek legal advice.

Alert reminders

Alert 2024/04 - Urgent information for clinics using Birr Bio Sciences lab products supplied by Hunter Scientific

Alert 2024/04 was issued on 20 March 2024.

Alert 2024/05 - Update: Birr Bio Sciences lab products supplied by Hunter Scientific

Alert 2024/05 was issued on 21 March 2024.

If the PR at your clinic did not receive these alerts via email, please contact Business Support at HFEACompliance@HFEA.gov.uk to update your contact details. Please also make sure that the email address alerts are sent from, alert@hfea.gov.uk, has been whitelisted by your IT department.

For any questions about the content of the Alerts, please contact incident.reporting@hfea.gov.uk.

Submission requirements for GIFT

There is no longer a requirement to submit an annual return for GIFT where the clinic has not carried out any procedures that year.

In line with General Direction 0005, clinics are required to submit certain information to the HFEA. In 2022, this Direction was updated and the requirement to submit GIFT data was removed.

Any clinics who carry out this procedure should speak to their inspector.

Did you know?

Before a clinic implements a significant change, including the implementation of an electronic platform for purposes including, but not limited to, consent taking, witnessing, traceability and timelapse embryo grading algorithms: the proposed system should be validated and documented (SLC T73).

As part of this validation process the centre should ensure they understand how data is stored, backed up, kept confidential and how it is retained for future reference. The clinic should understand if data will be deleted or archived and what access will be maintained over time.

Depending on the data being stored, the clinic may be required to keep data for a minimum of 30 years or longer in an appropriate readable storage medium and this may be requested by the Authority as evidence of compliance (SLC T103 and T104). The clinic should consider how it will maintain access to any electronic data if the platform were to cease being used by the clinic. All records must be clear and readable, protected from unauthorised amendment and retained and readily retrieved in this condition throughout their specified retention period in compliance with data protection legislation and clinics should consider how this is maintained as information technology systems develop and evolve.

Further information can be found in GD0012, SLCT 47 and SLC T48. Also, the Code of Practice - Guidance for centres considering introducing electronic methods of taking consent 5.30 to 5.37.

Editorial statement

Clinic Focus is the official electronic newsletter of the Human Fertilisation and Embryology Authority, is produced by the editorial team of the HFEA and provides a monthly roundup of news and information for clinics and their staff working in the field of fertility treatment.

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