Clinic Portal
30/06/24: The Transitional Period comes to an end today (30/06/2024). For further guidance please see the March 2024 Clinic Focus.
10/05/24: We have updated the Clinic Practical Guide on legal changes to storage limits and guidance following a change to the law on posthumous storage of gametes and embryos for a specific cohort of patients who died before 1 July 2022.
18/04/24: We have published an update to the clinic FAQs on the new storage legislation with further guidance to support clinics as we reach the end of the Transitional Period (1 July 2022 – 30 June 2024)
28/10/22: We have today published clinic FAQs on the new storage legislation, based on the questions we have had from clinics since the new legislation was enacted.
26/08/22: We have today published new versions of the mitochondrial treatment and mitochondrial donation forms updated to reflect the new storage law.
09/08/22: New version of the WT form issued on 8 August 2022
This update relates to an email sent to all PRs regarding a new version of the WT form published (issued on 8 August 2022)
We have been made aware of an error in question 7.4 on the Your consent to your eggs and embryos created using your eggs being used in treatment (IVF and ICSI) or stored (WT) consent form. We have therefore today issued an amended version of the WT form (version 12).
The change relates to how long a patient can consent to the storage of their embryos for training purposes in the event that they lose mental capacity. The new storage legislation allows for patients to consent to the storage of their embryos for training purposes in the event of their mental incapacity for up to 10 years from the date they sign their consent form (not 10 years from the date of being certified as lacking capacity). This has now been corrected on the newly-issued version 12 of the WT form. The equivalent question on the MT and other treatment forms is correct.
Further guidance on storage for training purposes in the event of mental capacity can be found at section 3.5.7 of the Clinic Guide.
Going forward centres should ensure that they use version 12 of the WT form which is now available on the Consent forms page of the clinic portal. Please do not continue to use version 11 of the WT form. We apologise for any additional burden this may cause centres.
Given the nature of this change and the very narrow cohort of patients this would affect, we do not expect centres to re-consent patients that have used version 11 of the WT issued on 1 July 2022.
If you have any questions, please contact your Inspector.
01/08/22: On 1 August we issued a Special Edition Clinic Focus with details of further documentation we have published to support centres in implementing storage changes.
26/07/2022: We have updated the Statutory Notices published in July 1 2022 so that these PDF documents can now be edited, as appropriate, by centres using them to contact patients about renewing consent.
We are providing some further guidance for centres using new consent forms to re-consent patients with gametes or embryos already in storage on 1 July 2022. This is in response to feedback and queries we have received.
Storage will continue to be lawful if consent was given using the old consent forms until the defined renewal period. However, if patients wish to re-consent to storage under the new law before their consent expiry date, they can do so. The primary purpose of the new treatment/storage forms is to record the consent of patients storing gametes and embryos from 1 July 2022. However, the forms can also be used to re-consent patients in the above circumstances.
The new consent forms are designed to ensure patients can document their wishes in accordance with the requirements of the new law which came into effect on 1 July 2022. Patients can use these forms to record initial and additional consent to storage (for further guidance on ‘additional storage’ please see section 10.5 of the Clinic Guide). When using these forms for patients with gametes or embryos already in storage, centres will need to make sure that the patients are clear on what they are giving their consent to, when their consent period ends and when they will be contacted to renew their consent or asked about additional consent. As is the case for any consent, centres must provide patients with relevant information and an opportunity to have counselling prior to completing these consent forms.
Patients with gametes or embryos stored within the first 10-year storage period
We recommend that patients who have gametes or embryos already in storage on 1 July 2022, that are still storing within their first 10-year storage period, can complete the section ‘Storage for the first time’ (e.g. section 4.1 and 4.2 of the MT and WT forms). Patients can give their consent to storage for a period of up to 10 years, or a lesser period if they so wish. This consent will then supersede the consent previously given. When taking consent, it will be important to understand whether the patient wishes to simply reflect the period of storage they have previously consented to, or whether they are changing their period of storage. In either case, centres must keep in mind that storage periods begin on the first date of storage and if consent is given for 10 years then the renewal process will need to commence 12 months before the consent period expiry date (10 years after being first placed in storage).
Patients already subject to a period of extended storage
Patients who have gametes or embryos in storage on 1 July 2022 already subject to a period of extended storage of more than 10 years since date of first storage (e.g. due to completion of a CVS form or satisfying the requirements for extension under the 2009 Regulations) should complete the section ‘Additional storage prior to renewal’. This is because the consent expiry date is the date the extended period of storage ends (in the case of those extending under the 2020 regulations, 12 years from date of first placed in storage or under the 2009 regulations the date of the MPS expiry) and defines when the renewal process begins. Patients should select ‘Yes’ to question 4.3 and where they are asked to ‘Specify the number of years’ should enter zero years. Centres should make clear to patients that the consent expiry they previously had in place will not change, and this should be documented in their medical record. Centres will then be required to start the consent renewal process 12 months before the consent expiry date.
If patients have already re-consented using the new consent forms and have entered an ‘additional’ storage period, they do not need to re-do these forms. However, patients should be clear when their consent period ends i.e:
Any discussions should be clearly documented in the medical records and in the bring forward system.
If patients decide to re-consent they must also be given the opportunity to review their previous decisions and vary their consent.
Centres should ensure that patients are aware of when they will be contacted to renew their consent. Centres must make sure that patients are contacted to renew their consent to storage at the correct time.
If you have any further questions, please contact your inspector.
07/07/2022: Following feedback we have received from clinics about the new renewal of consent forms (RG and RE forms) and how they should be completed during the transitional period, we are working on producing two new renewal forms for clinics to use during the transitional period. We will aim to publish these within the next couple of weeks.
Clinic Practical Guide on legal changes to storage limits and guidance
Slide presentation on storage changes: key messages
From 1 July 2022 new laws come into force in relation to the permitted storage periods for gametes and embryos. These changes to the HFE Act supersede all previous storage regulations.
The changes to storage from 1 July 2022 have important implications for the storage of gametes or embryos of deceased patients currently being stored subject to an extension of storage under the 2009 Regulations, and deceased patients eligible for such an extension.
As these patients are deceased, it will not be possible to obtain a renewal of consent in line with the new legal provisions for storage of their gametes or embryos coming into force on 1 July 2022. Nor will it be possible for the storage of this material to be extended under the 2009 Regulations as these are being revoked on 30 June 2022. Ongoing use and storage will therefore, without action being taken, become unlawful 10 years after the patient’s most recent MPS or, where there is no MPS in place, up to 10 years after the patient’s date of death (depending on the length of the effective consent in place).
Action needed
We are strongly encouraging centres to consider completing an initial MPS or a further MPS, where appropriate, before the new storage legislation comes into effect on 1 July 2022 for:
This is to enable the named partners of deceased patients whose material is currently stored under the 2009 Regulations or who would have qualified for extended storage under the 2009 regulations to have as much time as possible to use it in treatment under the new rules. Please see flowcharts on HFEA New Storage Laws webpage for examples.
The MPS must be in place before the law changes on 1 July 2022.
Centres are reminded that gametes and embryos can only be used in treatment after a patient’s death if they have consented to posthumous use.
In order to satisfy the requirements for extension of storage for more than 10 years under the 2009 Regulations, the patient must have provided effective consent to storage for a sufficient length of time, and have a valid MPS in place (completed within the relevant period). The consent period will be determined by the shorter of these two requirements. For example, if gametes were stored on 25 September 2015 with 15 years consent to storage (total storage to 24 September 2030), even if an MPS is completed on 28 June 2022 (with effect to 27 June 2032) the gametes can only remain in storage until 24 September 2030.
This does not apply to deceased patients where there is no effective consent to storage in place on or before 30 June 2022 (i.e. an MPS has not been completed within the relevant period or consent is not in place).
We appreciate that we are providing centres with very little time to take action in relation to these cases. As you will be aware it is the Department of Health and Social Care, not the HFEA, who has drafted the legislation and unfortunately we have no influence over the timetable for implementation. We are aware this is creating extra work for centres, however, we are obliged to contact centres and recommend action where this could benefit patients, as we receive clarification.
On 1 July 2022 new laws governing gamete and embryo storage in the UK come into effect.
On 31 May 2022 we published a range of new and revised consent forms to reflect these legal changes. The new and revised consent forms will not come into effect until 1 July 2022 and should not be used until that date.
We appreciate centres will be seeing patients and donors between now and 1 July 2022 and taking consent for procedures due to take place on or after 1 July 2022. Patients and donors who store gametes or embryos from 1 July 2022 will be subject to the new storage regime.
However it is important that centres do not use the new and revised consent forms before 1 July 2022. We are likely to be making minor changes to some of the forms in light of feedback from centres, so the versions of these forms published on 31 May are for centres' information only. The final versions will be available for centres to use on 1 July 2022. Until 1 July 2022 centres should therefore use the consent forms currently in effect, which are available on the HFEA website.
Patients and donors should nevertheless be provided with information about, and counselled on, the new storage regime, and this should be documented in the patient or donor’s medical notes. For example, patients storing gametes or embryos for use in their own treatment should be made aware that they will be asked to renew their consent to storage in 10 years, if appropriate.
We recommend that centres ask patients and donors who are due to store gametes or embryos on or after 1 July 2022 to complete the new consent forms effective from that date, even if they have recently completed the currently available forms. If new consent forms are not completed after 1 July 2022, patients will not be able to benefit from new provisions relating to posthumous use and storage of gametes and embryos, or use and storage of gametes and embryos in the event of mental incapacity. Whilst we recognise that this may involve an additional burden for patients, donors and centres, it is the most robust way of ensuring patients and donors have given consent to storage under the new law.
Guidance for clinics where consent to storage expires before 1 July 2022 - Update 1