31 October 2024
Dear colleague
I am writing let you know about changes to the law affecting the screening required for some fertility treatment and gamete and embryo donation that will come into force in November 2024. This letter sets out important information you need to know in order to carry out treatment and donation in line with the new requirements.
The changes relate to two separate aspects of treatment - reciprocal IVF and known donation from individuals who have HIV with an undetectable viral load.
1) Reciprocal IVF (partner to partner donation)
The change in the law means that couples undergoing reciprocal IVF must have the same screening carried out before treatment as heterosexual couples providing their own gametes for IVF. As set out in the October 2024 special edition of Clinic Focus you can implement this change immediately - no further action is needed.
We have published guidance for clinics on Clinic Portal and we have published new patient information about reciprocal IVF which includes information about the change.
2) Known donation from individuals with undetectable HIV
This change in the law means that individuals who are living with HIV and who have an undetectable viral load can donate gametes and embryos to known recipients. This includes intended parents providing gametes or embryos as part of a surrogacy arrangement. Clinics can only begin to implement the changes in such circumstances where their licence conditions have been updated - please see below.
It is important to note that there are no changes for donors providing gametes or embryos for the treatment of ‘unknown’ recipients. Clinics should continue to screen these donors in the same way as usual.
Re-licensing and updated Standard Licence Conditions
In the October 2024 special edition of Clinic Focus we explained that clinics cannot begin the process of donation from individuals with undetectable HIV immediately when the law changes. Clinics must have their licence varied to incorporate updated Standard Licence Conditions before they can do so. Clinics’ licences will be varied without application at their next interim or renewal 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.
Clinics wishing to carry out known donation in line with the new requirements sooner (for example, because they have been contacted by patients wishing to have treatment) should contact their inspector to begin the process.
The up-to-date Standard Licence Conditions are available on Clinic Portal. It is very important that clinics follow the specific conditions on their licence.
New guidance and patient information
We have issued new guidance to support clinics to implement these changes. Any clinics considering contacting their inspector to update their licence may wish to review this guidance in the first instance.
We have also produced patient information here.
If you have any questions on any of the above changes, please speak to your inspector.
Yours sincerely,
Chair, Human Fertilisation and Embryology Authority