The HFEA's monthly newsletter for clinic staff |
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New HFEA Data Research Newsletter |
The Transitional Period for the 2022 storage laws has ended |
The Transitional Period for the 2022 storage laws ended on 30 June 2024. Clinics are reminded of the law and guidance that now applies. Storage periods from 1 July 2024 onwards
Clinics should already have processes in place to manage storage and consent to storage beyond 30 June 2024. Please see the Code of Practice, guidance note 17 and the Clinic Guide.
There are some important points to be aware of: -
Clinics should be familiar with the renewal process, including the definition of Consent Period. For most patients the Consent Period is 10 years from the date the gametes or embryos were first placed in storage or the most recent renewal. The Consent Period will always be 10 years, even if the patient gives consent to a shorter period of storage on their consent form. Where the patient consents for a shorter period than the Consent Period their consent will expire when that period of time ends, and additional consent can be given up to the Consent Period. There are some exceptions for patients who had gametes or embryos stored before 1 July 2022 and for those who were under 18 at the time gametes were first stored - please see paragraphs 1.1 and 1.2 of the Clinic FAQs on new storage legislation.
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Only once patients reach the end of their Consent Period should they complete an HFEA renewal of consent form (ie, the RG or RE). Patients who gave consent to a period of less than 10 years of storage and who want to give consent to a longer period should complete the ‘Additional storage prior to renewal’ section in the relevant HFEA treatment and storage form (ie, the WT, MT, WPT or GS), or HFEA surrogacy form where relevant (ie, the WSG or MSG). Please see Consent Forms: A Guide for Clinic Staff for more information.
- Where a patient has given consent to a period of less than 10 years of storage, as the end of this period approaches the clinic should contact the patient to let them know that their storage is coming to an end. This should be done in good time to allow for the patient to give consent to additional storage, should they wish to do so.
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For patients reaching the end of their Consent Period, clinics must follow the steps of the renewal process. Please see the Code of Practice, guidance note 17 – in particular ‘Patients renewing consent to storage for own treatment’.
Consent forms and Statutory Notices
In 2022 we published versions of HFEA renewal of consent forms and some Statutory Notices specifically to be used during the Transitional Period. From 1 July 2024, clinics should discontinue use of these forms and notices and instead use the appropriate consent forms and Statutory Notices that apply after the Transitional Period has ended. We have updated the Consent Forms page of Clinic Portal to reflect these changes.
The discontinued consent forms and Statutory Notices are: - RE(TP)
- RG(TP)
- RNE(TP)
- RNG(TP)
- DFS
From 1 July 2024, clinics must use the NDE and NDG Statutory Notices (in addition to the RNE and RNG) for patients who have not renewed consent during their Consent Period to remind them that they need to do so before the end of the Renewal Period if they wish for storage to continue. Please see Consent Forms: A Guide for Clinic Staff for more information about how to use Statutory Notices.
Disposal of gametes and embryos
Following the end of the Transitional Period, clinics are required to remove gametes and embryos from storage where storage is no longer lawful. Please see our guidance in the June 2024 Clinic Focus.
For embryos, where the Consent Period ended during the Transitional Period but consent was not renewed, clinics should have issued the NWC(TP) Statutory Notice as soon as possible on or after 1 July 2024. These embryos can be stored until 31 December 2024 but should be removed from storage sooner if both gamete providers withdraw consent. It is not possible for patients to renew consent to storage or to use the embryos during this period. For gametes, where the Consent Period ended during the Transitional Period but consent was not renewed, clinics should have removed them from storage on 1 July 2024.
We will be issuing further guidance over the coming months. Please continue to check the new storage laws page of Clinic Portal for the latest updates.
Clinics are reminded that new regulations came into force in May 2024, allowing clinics to store the gametes and embryos of a small cohort of patients who died before 1 July 2022 for a longer period. Please see the May 2024 Clinic Focus and the Clinic Guide, section 11.
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Updates to General Directions 0001 and 0007 |
In addition to the changes to General Direction 0008 outlined below, we are updating two other Directions in line with information we have already issued. The General Directions will be amended as follows:
Please see this Chair’s Letter for full details. |
Updates to General Direction 0008 and the Authorised Processes list |
Updates to General Direction 0008 and the Authorised processes list will come into force from 1 August 2024.
The HFEA has a statutory responsibility to have an approval process for processes that fall within its regulatory remit which may affect the quality of tissues and cells. The Authorised processes list describes the processes clinics can use to carry out the licensable activities set out in the Act.
Revisions to the Authorised processes list have been made and the decision tree for authorising new processes has been updated. More information on this can be found in the Authority paper from March 2024. Updates to the Authorised processes list bring it in line with up-to-date clinical practice and terminology, ensure that the list is clear and consistent, and future proof the list such that small modifications to procedures/techniques fall under the relevant umbrella term.
Amendments to General Direction 0008 introduce additional requirements for the information submitted with applications for a ‘new’ process that has not previously been authorised by the Authority. Further details can be found in the Chair’s letter.
General Direction 0008, paragraph 21 requires the “Person Responsible to notify the Authority, through the electronic portal located on the Authority’s website, of all processes undertaken in the licenced centre in carrying out a licenced activity”. Actions for clinics with a Treatment and Storage licence
Clinics that have a Treatment and Storage licence must submit this additional form that has an updated list of the Authorised processes performed under their licence in place of the list embedded in the Clinic Portal application.
Submission of the form is needed when making the following licence applications:
New licences - Licence Enquiry Form
- New HFEA Storage Licence
- New Treatment (IUI) Licence
- New Treatment (IUI DI) Licence
- New HFEA Treatment and Storage Licence
- New HFEA Treatment and Storage Licence with PGD
Renewals - Renewal HFEA Storage Licence
- Renewal of HFEA Treatment (IUI) Licence
- Renewal of Treatment (IUI DI) Licence
- Renewal of HFEA Treatment and Storage Licence
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Renewal HFEA Treatment and Storage with PGD and PGS Licence
Variations - Variation of Treatment (IUI) Licence
- Variation of Treatment (IUI DI) Licence
- Variation of HFEA Treatment and Storage Licence
- Variation of HFEA Treatment and Storage Licence with PGD, PGS
We are working on updating the Clinic Portal so this is an interim measure and will only be required upon submission of your next licence application if listed above. If you are considering applying for authorisation of a process which is not on the current Authorised processes list, please contact your Inspector for further information. |
Updates from the HFEA’s Annual Horizon Scanning Meeting 2024 |
Each year the HFEA hold a Horizon Scanning Meeting bringing together international experts and regulatory bodies.
The HFEA established a horizon scanning function in 2004 to identify developments in research and technology that could have an impact on the field of assisted reproduction or embryo research. As part of this function we hold an Annual Horizon Scanning Meeting during the European Society of Human Reproduction and Embryology (ESHRE) conference to discuss the latest developments in fertility treatment and human embryo research.
Outcomes of the Horizon Scanning Meetings feed into the work of our Scientific and Clinical Advances Advisory Committee (SCAAC). By identifying advances early, the HFEA can consider the legal, ethical and scientific implications as they arise.
This year attendees discussed developments relevant to genetic screening of the early embryo, the promise of organoids, future uses of artificial intelligence (AI) in the IVF lab, and emerging strategies in ovarian rejuvenation with invited speakers Professor Shai Carmi (Hebrew University of Jerusalem), Dr. Margherita Yayoi Turco (Friedrich Miescher Institute for Biomedical Research), Daniella Gilboa (AIVF), and Professor Emri Seli (Yale School of Medicine). Key discussion points from the meeting included:
- Genetic screening of the embryo with PGT for polygenic diseases: patient populations to whom it may offered; ethical considerations; technical limitations and challenges surrounding validation of the method
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Promise of organoids: clinical applications of female reproductive tract organoids; technical considerations related to method optimisation, good manufacturing practice for clinical implementation and in vitro model’s ability to mimic tissue architecture and physiology.
- AI in the IVF lab: regulatory challenges arising from fast paced developments in AI uses; validation, liability and standardisation considerations
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Ovarian rejuvenation: challenges with demonstrating efficacy of ovarian rejuvenation techniques and their applicability for certain patient groups
Minutes and papers from previous SCAAC meeting are available on the SCAAC webpage. |
Screening for haemoglobinopathies |
We would like to remind clinics of their responsibility to screen egg/sperm donors for haemoglobinopathies known to be prevalent in their ethnic background.
Donors must be screened in line with Licence Condition T52 which states that:
“T52. Prior to the use and/or storage of donor gametes and/or embryos created with donor gametes the centre must comply with the selection criteria for donors and the requirements for laboratory tests and storage set out below, namely:
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h. in certain circumstances, additional testing may be required depending on the donor’s history and the characteristics of the gametes donated (eg, RhD, Malaria, T.cruzi), and
i. genetic screening for autosomal recessive genes known to be prevalent, according to international scientific evidence, in the donor’s ethnic background and an assessment of the risk of transmission of inherited conditions known to be present in the family must be carried out, after consent is obtained. Complete information on the associated risk and on the measures undertaken for its mitigation must be communicated and clearly explained to the recipient.”
In addition to the minimum requirements set out in law, clinics should screen donors in line with the latest guidance from relevant professional bodies. The UK guidelines for the medical and laboratory procurement and use of sperm, oocyte and embryo donors states that in relation to haemoglobinopathies, clinicians should follow the procedures outlines by the British Society for Haematology.
If you are made aware that a child born from donor treatment at your clinic has been born with a haemoglobinopathy and the donor or recipient had not undergone the appropriate screening, this should be reported to the HFEA as an incident. |
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 October to December 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. |
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Each inspector has a portfolio of clinics - however inspectors often lead inspections for clinics that are not part of their portfolio. We appreciate that this might cause some confusion for PRs about who to contact regarding matters linked with the inspection.
To clarify: - Any queries that relate to the inspection, inspection report and licensing process (up to when you receive the minutes from committee) should be sent to the inspector who led your inspection.
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Any other general queries or requests for advice should be sent to the inspector who is the portfolio holder for your clinic. Post inspection actions, and after receipt of the minutes, should also be sent to the portfolio holder.
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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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