05 October 2023
Later in October/early November 2023 (depending on parliamentary time), we will publish an update to the 9th edition of the Code of Practice (version 9.4). The focus of this update is to incorporate legal changes that have come into force since the Code was last updated in 2021, and to provide additional guidance to build upon and clarify the information in the Code.
This Code of Practice update incorporates the following changes:
Legislative changes:
- Changes from the Health and Social Care Act 2022 which introduced amendments to the Human Fertilisation and Embryology Act 1990, changing the 10-year statutory storage limit for gametes and embryos.
- Legislation that has been put in place to allow CE marked medical devices to be placed on the Great British market beyond 30 June 2023.
Other changes:
- Reference to Alternative Dispute Resolution (ADR) schemes
- Cancelling a benefits in kind arrangement
- Counselling qualifications and equivalence
- Pre-employment health screening
- Provision of a chaperone for intimate examinations
- Medical and laboratory test guidance
- Safe-sedation practice
- E-consent platforms
- Rescue ICSI
- Corrections and minor clarifications
This update will affect 17 guidance notes. Details of these changes are set out in the following annexes:
- Annex i: Summary of changes to the Code of Practice in the 2023 update
- Annex ii: Updated ‘Revision control sheet’ (lists all updated areas of the Code of Practice)
- Annex iii: Changes to Code of Practice guidance notes
In Annex iii all content highlighted in yellow is to be removed and new content added as part of this update is set out in red.
To support this update, we will be publishing revised consent forms to give patients an opportunity to consent to storage, but not to use, in the event that they lose mental capacity, in line with the law. In the meantime, clinics should follow the interim advice set out in the June 2023 Clinic Focus.
When will the changes come into effect?
These changes will come into effect on the date of publication later in October or early November 2023 depending on parliamentary time. We will alert licensed clinics via a special edition Clinic Focus, and the revised Code will be updated on the Knowledge Base of the HFEA Clinic Portal and website.
What should you do now?
A summary of the changes included as part of this update are listed in Annex i. All changes to the Code of Practice can be found in Annexes ii and iii. Please read the updated areas and make sure that you and your colleagues are familiar with any changes that may be relevant to your clinic.
If you have any questions, please contact your inspector.
Yours sincerely,
Chair, Human Fertilisation and Embryology Authority