31 May 2022
Dear colleague
Important changes to storage rules following changes to the Human Fertilisation and Embryology Act 1990: New guidance, consent forms, Standard Licence Conditions and General Directions enclosed.
Action required.
I am writing to inform you about important changes that all clinics need to prepare for. This letter provides information about new consent forms, guidance, Statutory Notices, Standard Licence Conditions and General Directions which will come into force on 1 July 2022.
From 1 July 2022 legislation governing the storage of gametes and embryos in the UK will change. The Health and Care Act 2022 introduces amendments to the Human Fertilisation and Embryology Act 1990 (the 1990 Act) changing the current 10 year statutory storage limit.
Clinics must familiarise themselves with these new provisions. These amendments have been made in shorter than usual timescales which has meant that the HFEA has not had very much time to prepare and consequently, it has not been possible to allow clinics the usual three months advanced notice to prepare for these changes. We will however be engaging closely with the sector throughout the Transitional Period (from 1 July 2022 to 30 June 2024) to support the implementation of these important changes. We will provide further guidance, where needed, and will be hosting a series of training sessions and webinars later in Summer 2022.
These changes will enable patients to consent to embryos being stored for treatment purposes for up to a maximum of 55 years; gametes will be able to be stored for up to 55 years for treatment, research or training purposes, and embryos and human admixed embryos will be able to be stored for research or training purposes for up to 10 years. There are also new provisions relating to storage for posthumous use and in the event of mental incapacity.
Before the end of the Transitional Period, clinics will be required to take certain steps in relation to gametes and embryos already in storage on 1 July 2022 and cases where consent expires during the Transitional Period. The HFEA Clinic Practical Guide on legal changes to storage limits and guidance (see below) provides detailed information on the steps clinics must take during the Transitional Period and more broadly, to implement the changes.
From 1 July 2022 clinics will be required to use and comply with:
- New and revised consent forms
- New Statutory Notices [to follow in June 2022]
- New HFEA Clinic Practical Guide on legal changes to storage limits and guidance
- New and updated General Directions
- Revised Standard Licence Conditions
These new and revised documents should not be used in clinical practice until 1 July 2022.
1. New and revised consent forms
We have introduced a number of new consent forms and amended most of our consent forms. We are publishing the majority of these forms today and a number of others will be published in June however, please note these forms are only effective from 1 July 2022. Clinics must only start using these forms on 1 July 2022.
Some of the forms that we are publishing today are yet to be designed however the designed versions will be published in June.
New renewal of consent to storage forms
From 1 July 2022 onwards, it will be a requirement for patients who wish to store for any period of up to 55 years to renew their consent every 10 years. We have introduced new renewal of consent to storage forms for this purpose. Detailed guidance on when to use the renewal of consent to storage forms can be found in the HFEA Clinic Practical Guide.
RG - Renewal of consent to storage of your eggs or sperm for treatment
RE - Renewal of consent to storage of your embryos for treatment
Updated consent forms
Treatment and storage forms
MT - Your consent to your sperm and embryos created outside the body using your sperm being used in treatment (IVF and ICSI) or stored
WT - Your consent to your eggs and embryos created using your eggs being used in treatment (IVF and ICSI) or stored
WPT - Your consent to providing eggs or embryos created with your eggs for your partner’s treatment
MGI - Your consent to the use of your sperm in artificial insemination
WGI - Your consent to the use of your eggs in GIFT
GS - Your consent to the storage of your eggs or sperm
Donation forms
WD - Your consent to donating your eggs
MD - Your consent to donating your sperm
ED - Your consent to donating embryos
Surrogacy forms
WSG - Your consent to the use and storage of eggs or embryos for surrogacy
MSG - Your consent to the use and storage of sperm or embryos for surrogacy
In June we will publish updated versions of the WGI, MD including PNT, MD PNT, MMT, WDM, WMT (Mitochondrial donation) forms. We will also publish updated Record of information before obtaining consent forms. In due course we will publish an updated version of ‘Consent forms: a guide for clinic staff’.
Withdrawal of consent forms
The WC Form will be revoked from 1 July 2022 and instead, to make the process of withdrawing consent in different situations easier for clinics and patients, three new withdrawal of consent forms will be published for use from 1 July 2022 onwards.
WCS - Withdrawing your consent to the storage of your own eggs, sperm and embryos
WCU - Withdrawing your consent to use of your eggs, sperm or embryos in someone else’s treatment
WCP - Withdrawing your consent to legal parenthood
Revoked consent forms
From 1 July 2022 the following consent forms will be revoked:
LGS - Your consent to extending the storage of your eggs or sperm beyond 10 years
ES - Your consent to extending the storage of your embryos beyond 10 years
CVS - Your consent to extending the storage of your eggs, sperm or embryos to 12 years as a result of the COVID-19 pandemic
WC - Withdrawing your consent
SWC - Surrogacy - withdrawing your consent
2. New Statutory Notices [to follow in June 2022]
The amendments to the 1990 Act set out defined timeframes called the ‘renewal period’ and ‘consent period’ and require clinics to issue notices to patients regarding the storage of their gametes or embryos at defined points before, during and after these periods. The use of HFEA Statutory Notices is mandated by General Direction 0007. Detailed guidance on when to use these Statutory Notices can be found in the HFEA Clinic Practical Guide. Copies of the Statutory Notices will be published in June 2022 and will be available on the ‘New storage laws’ page on the Clinic Portal.
Statutory Notices
RNG - Request to renew consent to storage of eggs or sperm within the renewal period
RNE - Request to renew consent to storage of embryos within the renewal period
NDG - Notification that eggs or sperm will be removed from storage and disposed of if the patient does not renew consent to storage before the end of the renewal period
NDE - Notification that embryo(s) may be removed from storage and disposed of if patients do not renew their consent to storage before the end of the renewal period
NWC - Notification to each person whose eggs or sperm were used to create embryo(s) that consent to storage has been withdrawn
3. New HFEA Clinic Practical Guide on legal changes to storage limits and guidance
The HFEA Clinic Practical Guide on legal changes to storage limits and guidance contains detailed information and guidance for clinics on how to comply with the new requirements. It includes guidance on obtaining consent to storage of gametes or embryos for patients storing for the first time, the process to follow when consent is renewed, what steps clinics must take with respect to gametes and embryos already in storage on 1 July 2022, and detail about the new duty on clinics to dispose of gametes or embryos if consent is not renewed.
Clinics should follow the new guidance within the HFEA Clinic Practical Guide for all information related to the new storage limits. The HFEA Code of Practice will be updated in due course to reflect these changes. Until the Code has been updated, we will strike-through any existing guidance that has been superseded by the storage changes from 1 July 2022.
Clinic Practical Guide on legal changes to storage limits and guidance
4. New and updated General Directions
General Direction 0007 - mandates the use of the new consent forms and Statutory Notices.
General Direction 0012 - revised to reflect the new requirement to retain copies of all Statutory Notices issued to patients in addition to copies of consent forms.
General Direction 0015 - introduces requirements on clinics to retain records relating to renewal of consent, to obtain and retain certain information about gametes and embryos when they are transferred from one clinic to another, and to record certain information relating to consent to storage for training and research purposes.
5. Revised Standard Licence Conditions
Section 14 of the 1990 Act, as amended by the Health and Care Act 2022, sets out conditions that apply to every clinic’s licence. These amended conditions apply to all licences by operation of the law and, on 1 July 2022, when the revised section 14 comes into effect, clinics will be required to comply with those conditions even though they will not be reflected in the licence until it is reissued at a later date.
It has also been necessary to make minor consequential amendments to a small number of the other Standard Licence Conditions, the discretionary conditions the HFEA has determined should be included in all licences.
In due course, all licences will be varied to include these revised conditions and this will be done either following the clinic’s next renewal inspection or interim inspection (whichever is first), or when a clinic makes an application for the variation of its licence, for example if it applies to vary its licence to appoint a new Person Responsible.
Any clinics that will be operating under Special Directions on 1 July 2022 will be issued with revised Special Directions. This is to ensure that, on the face of the Special Direction, it is clear that there is a requirement to comply with the revised Standard Licence Conditions, General Directions and other relevant requirements of the Health and Care Act 2022 which would apply if the clinic had a valid licence.
Revised Standard Licence Conditions
Next steps
We appreciate that these storage changes will have a significant impact on clinic practice and will require clinics to make a number of changes within a short timescale, for example, to their standard operating procedures, bring forward systems, patient information and training for staff. To help support clinics through the Transitional Period we will be providing further information and training materials concerning the new storage rules, including hosting a number of training seminars and webinars, to help clinics understand and implement the new changes.
The information contained within this letter can also be found on our ‘New storage laws’ page on the Clinic Portal.
If you have any questions, please speak to your inspector.
Yours sincerely,
Chair, Human Fertilisation and Embryology Authority