The HFEA's monthly newsletter for clinic staff |
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Upcoming deadlines for stored gametes and embryos |
Clinics are reminded that on 31 December 2024 there are two important legal deadlines relating to the storage of gametes and embryos and take appropriate actions where needed.
31 December 2024: deadline to dispose of embryos where consent was not renewed during the Transitional period
Clinics may have embryos in storage where the Consent Period ended during the Transitional Period (1 July 2022 – 30 June 2024) and consent was not renewed during this time. As set out in the March 2024 Clinic Focus and in guidance, lawful storage of these embryos can continue until 31 December 2024.
Clinics must dispose of these embryos as soon as is practicable after this deadline.
Following the end of the Transitional Period (on 30 June 2024), it is no longer possible for patients to give or renew consent, to use these embryos in treatment or consent for the embryos to be used for another purpose (such as research).
Where lawful storage can continue until 31 December 2024, clinics must have issued 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Statutory Notice as soon as practicable on or after 1 July 2024 to inform patients that their consent has been taken as withdrawn.
Clinics should remove embryos from storage sooner if both gamete providers withdraw their consent to storage.
31 December 2024: deadline to obtain an MPS for specific patients under the 2024 Regulations
On 10 May 2024, a new law came into force that allows a specific cohort of patients who died before 1 July 2022 to store their gametes and embryos for longer. Section 11 of the Clinic Practical Guide on legal changes to storage limits and guidance provides further information. As set out in the guide, for a subset of these gametes and embryos the clinic must obtain a statement of premature infertility from a registered medical practitioner (an ‘MPS’) by 31 December 2024 for storage to continue. For other gametes and embryos captured by the 2024 Regulations, clinics should refer to published guidance to determine if an MPS needs to be obtained for storage to continue and if so, how to calculate the relevant deadlines to obtain each MPS. It is very important that clinics identify and act on all relevant cases so that patients can benefit from the new legislation.
You can find full details about which gametes and embryos will require an MPS by 31 December 2024 (as well as guidance for all other material captured by the 2024 Regulations) in section 11 of the Clinic Practical Guide on legal changes to storage limits and guidance. In particular, please see sections 11.1, 11.3 and 11.6. The MPS form is available on Clinic Portal.
If the clinic does not obtain an MPS by 31 December 2024 for affected material as set out in the law, the surviving partner of the deceased patient may have significantly less time than under the pre-2022 law to use the gametes or embryos in treatment. |
October 2024 Scientific and Clinical Advances Advisory Committee (SCAAC) papers available
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The Scientific and Clinical Advances Advisory Committee (SCAAC) met on 7 October 2024. Papers from the meeting are available on the SCAAC webpage. The Committee discussed developments in several horizon scanning topics: Mitochondrial donation
The Committee considered progress in research on mitochondrial donation, including publications on maternal spindle transfer (MST) and pronuclear transfer (PNT), alternative approaches to mitochondrial correction, and research into the wider application of MST and PNT, such as for improving oocyte quality and rescuing developmental competence. The Committee was subsequently joined by the team at the Newcastle Fertility Centre at Life, currently the only clinic licensed to perform clinical treatment with PNT and research into MST, who gave an update on their mitochondrial donation work. Stem cell-based embryo models
Stem cell-based embryo models (SCBEMs) are not currently explicitly regulated by the Human Fertilisation and Embryology Act 1990. However, HFEA proposals to amend the HFE Act include introducing new ‘categories’ of cells to improve the HFEA’s ability to handle new scientific developments. To further develop these recommendations, the SCAAC discussed the anticipated scientific developments in research in this area and how best to incorporate SCBEMs should the HFE Act be revised.
In vitro derived gametes
As with SCBEMs, IVGs are not explicitly regulated by the HFE Act, they are however prohibited for use in clinical treatment under Section 3ZA, which stipulates the use of ‘permitted’ eggs or sperm for treatment. The Committee discussed progress in research and how the current definition of a gamete within the HFE Act could be updated to accommodate IVGs.
Scientific considerations relevant to the 14-day rule
At present the HFE Act limits the use of human or admixed embryos in research to 14 days or the appearance of a primitive streak (if earlier). As it now appears possible for researchers to sustain embryos beyond 14 days, the SCAAC discussed the potential benefits and drawbacks of extending the 14-day rule, focusing on the scientific and technical aspects. |
Chair’s Letter: changes to the law on screening for reciprocal IVF and known donation for those living with HIV with an undetectable viral load |
Reminder: New donor compensation rates from 1 October 2024 |
On 1 October 2024 new mandatory requirements for clinics on compensation for gamete and embryo donation came into force. These included increasing donor compensation rates to take into account inflation and bringing the compensation rate for overseas donors in line with UK compensation rates.
Please refer to General Direction 0001 and Chair's letter CH(24)02 for the new requirements in this area. If you have any questions, please contact your HFEA Inspector. |
Update to guidance on the 2024 Regulations for the storage of gametes and embryos |
We have published an update to the Clinic Practical Guide on legal changes to storage limits and guidance. This update is primarily to section 11, to provide additional support to clinics to implement the 2024 Regulations.
Please note that our guidance relating to patients who were prematurely infertile but where the clinic had not yet obtained a statement of their premature infertility from a registered medical practitioner (an ‘MPS’) when the law changed on 1 July 2022 has changed. Clinics who are storing the gametes or embryos of patients who died before 1 July 2022 and who meet the other criteria to fall under the 2024 Regulations (see paragraph 11.1) should review the updated section 11 to assess whether this change applies to them.
There are minor updates to other areas of the guidance, including to update the guide following the end of the Transitional Period and regarding consent to posthumous storage and use. |
Choose a Fertility Clinic (CaFC) update |
We are now eight months into the verification process for the first update of Choose a Fertility Clinic (CaFC) through PRISM. Once complete, this will provide patients with data on treatments from January 2020 to December 2023, and live birth data from January 2019 to December 2022. This is a large verification exercise involving approximately 420,000 cycles in which we have identified approximately 45,000 errors and/or missing items of information from 96 clinics.
We commenced the verification for CaFC in February 2024 and wrote to PRs in July, advising that whilst some clinics have done very well in addressing missing outcomes, others still have a large amount to address. We also started sharing fortnightly CaFC tracking reports with those clinics with a large number of CaFC errors. Since then, the number of clinics in that category has fallen from 40 to 24. We will continue to work closely with those clinics with high error levels.
There are now a large number of clinics that have addressed their CaFC errors, and many of those clinics are ready or close to ready for CaFC publication. We thank these clinics and recognise their hard work to date and ask for their patience going forward as the remaining clinics work to resolve their outstanding errors.
With the introduction of PRISM we’ve written a new set of reports to enable clinics to verify their data. While clinics have long had verification reports relating to missing outcomes, a number of reports have yet to issue. The most important of these involves embryo thaws with missing storages linkages, mainly through some API suppliers. If, when reporting a thaw, clinics don’t provide an accurate link to the embryo’s storage, then we are unable to accurately report the CaFC details around frozen transfers for that clinic, and we are also unable to report on any subsequent OTR request for that frozen transfer if it arises in the future.
We aim to produce a report in the next few weeks which will describe these to the sector; the number involved, the cause of the error and the rectification which either they (or potentially their system supplier) need to undertake. From provisional data we think there are about 20 clinics in the sector for whom a large number of missing storage links will need to be addressed, and we will liaise directly with those clinics concerned.
As previously advised, we will confirm that final timescales for full CaFC sign-off and publication for this period once we have released all the verification reports.
If you have any questions, please contact prismsupport@hfea.gov.uk, or you can speak to the team on the fortnightly user group calls. |
Summary of post inspection feedback findings |
In 2022 we introduced an online post inspection survey form to help us gather feedback and improve our inspection process. We’ve been analysing the responses received, and provide a summary below of the period from February 2023 to April 2024, in which responses from 25 clinics were reviewed. We identified the following themes within the questionnaire in relation to the inspection process, inspectors support and feedback given within the report. In summary: -
100% of respondents agreed that clinics were given the opportunity to discuss and understand inspection findings and areas for improvement during the inspections team feedback.
83% of respondents agreed that the inspection promoted learning an improvement to the way they work.
100% of respondents agreed that the Lead inspector informed the clinic of the next steps in the inspection process. 96% of respondents agreed that the findings within the inspection report were accurate and clearly presented.
Post inspection feedback is important as it helps us shape and improve our inspection process so we thank you for taking the time to submit feedback via the survey link provided to you. If you have any questions, please contact your clinic inspector or the Chief Inspector. |
New British Fertility Society and Journal of Human Fertility podcast |
The British Fertility Society (BFS) and the Journal of Human Fertility have launched a new podcast discussing the latest articles published in Human Fertility, as well as the latest BFS policy and practice papers. You can listen in via the link below and keep up to date with the latest developments by following them on Spotify. Podcasts published so far include: - An introduction from the editor-in-chief.
- Introducing our special China edition.
- Evidence based management of patients with endometriosis undergoing assisted conception: British fertility society policy and practice recommendations.
- Best practice for embryology staffing in HFEA licensed assisted conception centres-guidance from Association of Reproductive & Clinical Scientists.
- Venous thromboembolism with medically assisted reproduction: British Fertility Society policy and practice guidance for assessment and prevention.
- Psychological well-being and family functioning following identity-release gamete donation or standard IVF: follow-up of parents with adolescent children.
You can access all current and future podcasts here. |
- Alert 2024/16 – Field Safety Notice: [Ultragel Medical Kft, AquaUltra Clear Ultrasound Transmission Gel]
Alert 2024/16 was issued on 21 October 2024
If the PR at your clinic did not receive this alert 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. |
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Syphilis Screening
Data from the UK Health Security Agency (UKHSA) shows record levels of syphilis diagnoses in the UK which have recently increased by the greatest amount since 1948.
Data from 2022-2023 shows increases have been relatively higher among heterosexual individuals, with the number of diagnoses remaining greatest among Gay, Bisexual and other Men-who-have-sex-with-men (GBMSM) and people aged 25 to 34 years old.
Where donors, or patients, have a history of syphilis or other sexual transmitted infections (STI), careful assessment should be taken by the clinic. Clinics should establish when the infection took place and if effective treatment was given.
Clinic’s protocols should be robust and take into account where both a historical or a new infection is detected. The interpretation of syphilis serology can be difficult and may require advice from a medical microbiologist or specialist consultant in STIs/Genitourinary Medicine (GUM). Clinics should carefully consider whether treatment or donation is appropriate in such cases. Congenital syphilis causes serious adverse birth outcomes which are preventable with good screening practices. |
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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. No part of this publication may be reproduced without prior permission. You can view our privacy policy on our website. Click here to unsubscribe 2 Redman Place London E20 1JQ © Copyright Human Fertilisation and Embryology Authority, 2019 |
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