This change means that those who have HIV with an undetectable viral load may be able to donate gametes and embryos to known recipients (eg, to family or friends). This includes intended parents providing gametes in surrogacy arrangements. It will not affect gamete or embryo donors in general, who will still be required to be negative for HIV1 and 2.
Clinics should be aware that in order to implement the new HIV screening requirements they must have the conditions on their licence amended to reflect the new law. This is because Standard Licence Condition (SLC) T52(b) in its current form requires all donors to be negative for HIV1 and 2. There is no exception for individuals with undetectable levels of the virus:
“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:
…
the donors must be negative for HIV1 and 2, HCV, HBV and syphilis on a serum or plasma sample tested as follows, namely:
- HIV 1 and 2: Anti-HIV – 1, 2
- Hepatitis B: HBsAg and Anti-HBc
- Hepatitis C: Anti-HCV-Ab
- Syphilis: see (d) below
…”
Clinics must comply with the conditions on their licence and the change to the law in this area will not automatically update SLC T52. This means that it will not be possible for clinics to accept donors with undetectable HIV until the clinic’s licence has been varied to update this Standard Licence Condition with new wording.
Process for licence variations
In due course, all clinics’ licences will be varied to include the revised conditions and this will be done either following each clinic’s next renewal inspection or interim inspection (whichever is first), or when a clinic makes an application for the variation of its licence between inspections, for example if the clinic applies to vary its licence to appoint a new Person Responsible. All licences will be varied over approximately the next two years.
If your clinic wants to start the donation process sooner
Some clinics will want to begin the donation process for individuals with undetectable HIV before their next inspection or variation application. For example, if they have already been contacted by patients wishing to start the donation process as soon as possible. In all cases, the clinic must have a licence variation before proceeding. To begin this process, please contact your inspector as soon as possible. It will take approximately three months from the date we start to process a licence variation to the date the clinic is issued with an updated licence, provided the clinic has demonstrated that it has all the necessary documents and procedures in place. Please note that we will prioritise these licence variations based on need. Licences will be ‘varied without application’, a process that clinics may already be familiar with as a similar mechanism was used to update licences following the change to the law on storage of gametes and embryos in 2022.
We will issue further guidance on Clinic Portal to support clinics to implement these changes in due course.
