Reciprocal IVF and known donation for individuals living with HIV with an undetectable viral load: law and guidance

On 28 November 2024, the Human Fertilisation and Embryology (Amendment) Regulations 2024 come into force, affecting fertility treatment in two separate areas. The guidance below is to support clinics to implement these changes.

This guidance should be read in conjunction with the clinic’s licence conditions and up-to-date professional body guidance. The Code of Practice will be updated in line with the new requirements in due course.

1. Reciprocal IVF

Couples undergoing reciprocal IVF (or ‘shared motherhood’, where one partner provides eggs, or embryos created with their eggs, for their partner’s treatment) no longer need to be screened as donors. This is a change the HFEA has been calling for some time.

1.1. What are the legal requirements for screening in reciprocal IVF?

In the new law, ‘partner donation’ is between anyone who declares that they have an intimate physical relationship. Previously, this was limited by law only to heterosexual couples.

The change in the law means that couples undergoing reciprocal IVF should be screened as partners (and not donors), in line with Standard Licence Conditions (SLCs) T50 and T51.

When treating couples undergoing reciprocal IVF, clinics should refer to these SLCs, and HFEA and professional body guidance suitable for ‘partner donation’ (in other words, the same as for opposite-sex couples).

1.2. What actions do clinics need to take?

Clinics should update their internal processes in line with these requirements. This may include updates to:

Clinics should make all relevant staff and patients aware of the change. These updates will need to be made by the time the law comes into force on 28 November 2024.

Some patients may be part of the way through or about to begin reciprocal IVF treatment and in the process of undergoing these tests. In these cases, the clinic should contact the patients as soon as possible and where necessary revise their treatment plans.

1.3. What information do clinics need to give patients?

The law will come into force on 28 November 2024. Clinics should update their information including about costs associated with reciprocal IVF and should ensure that any patients about to begin or part of the way through reciprocal IVF treatment have up-to-date information in line with the law.

When you are updating patient information, it is important that you make patients aware that it may not be possible to export eggs or embryos created with their eggs for reciprocal IVF treatment abroad, depending on the law in the country where they wish to export (see paragraph 1.4).

The HFEA provides impartial information about fertility treatment and we have produced new patient information for couples considering or undergoing reciprocal IVF.

1.4. Can eggs or embryos be exported for reciprocal IVF treatment abroad?

This area of UK law may differ from the law in other countries. This means that patients wishing to export their eggs or embryos created with their eggs for reciprocal IVF treatment may not be able to do so depending on the law in the country where they wish to export to, or they may be required to undergo additional screening. It is very important that patients are aware of this before they commence treatment should they wish to export eggs or embryos in the future.

2. Known donation for individuals with undetectable HIV

2.1. Important information about the need for clinics to vary their licence before carrying out known donation for individuals living with HIV with an undetectable viral load under the new requirements

As set out in the October 2024 special edition of Clinic Focus, clinics must not carry out treatment involving known donation for individuals with undetectable HIV until their licence has been varied to include the updated Standard Licence Conditions (SLCs). Clinics should read this Clinic Focus article carefully for information about how their licence will be varied and refer to the specific conditions on your licence to understand which requirements apply to you.

Please see below the updated SLCs that will be applied once a clinic’s licence is varied. Until your licence is varied, this is for information purposes only:

Annex I: Standard Licence Conditions – GB – Treatment and Storage Licences

Annex II: Standard Licence Conditions – NI – Treatment and Storage Licences

For both GB and NI SLCs, the change is to SLC T52 and has been marked in red text for your reference.

Please note that while each clinic’s licence needs to be varied to carry out known donation for individuals with undetectable HIV in line with the new requirements, the changes in relation to reciprocal IVF (outlined in section 1) do not require a variation of the clinic’s licence and so can be carried out immediately when the law comes into force.

2.2. How can clinics vary their licence?

Each clinic with a treatment and storage licence will have their licence varied to include the updated Standard Licence Conditions in Annex I (for clinics in GB) or Annex II (for clinics in NI) at their next interim or renewal inspection (whichever is sooner), or when the clinic makes an application for the variation of its licence between inspections (for example to appoint a new Person Responsible). It will take around two years for all licences to be updated.

2.3. What do clinics need to prepare before offering this treatment?

As set out above, a clinic’s licence will need to be varied before they can begin offering this treatment.

If your clinic wishes to carry out known donation for individuals with living with HIV with an undetectable viral load in line with the new requirements before your next interim or renewal inspection (for example, if you have been contacted by patients wishing to start the donation process as soon as possible), you should speak to your inspector as you must vary your licence before any treatment can commence. It will usually take around 3 months from the time we start the variation process to issuing the clinic with the updated licence.

If this is not the case your licence will be varied in line with 2.2 above.

If you are planning on offering this treatment at the time your licence is varied you will need to submit evidence to your inspector that your clinic has processes in place to comply with the law and our guidance. If, after your licence has been varied, you do not plan to offer this treatment, you should discuss this with your inspector as the evidence will not be required. Should the situation change, before you accept any donors with undetectable HIV you should notify your inspector and provide the necessary evidence.

2.4. What are the legal requirements for known donation for those living with HIV with an undetectable viral load?

The law allows people living with HIV who have an undetectable level (defined in the law as 200 copies/ml or less) viral load to donate gametes and embryos to known recipients.

This includes intended parents providing gametes for use in a surrogacy arrangement (see Interpretation of mandatory requirements 14A in the Code of Practice). In this guidance, ‘donors’ should be read as including intended parents providing gametes unless otherwise stated.

Clinics should refer to their licence conditions which set out how to assess whether prospective donors are suitable to donate – specifically T52 and T53.

The new requirements relating to individuals living with HIV are reflected in the updated Standard Licence Conditions (SLCs) – please see Annex I (for clinics in GB) or Annex II (for clinics in NI). However a clinic’s licence must be varied for the updated SLCs to apply to them - see paragraph 2.1 above.

The updated SLCs state that donors who are HIV positive can donate under the following conditions:

This change does not affect gamete or embryo donors where the recipient is unknown to the donor. These donors will still be required to be negative for HIV1 and 2.

2.5. What are the medical requirements to donate? How does this align with other health checks donors must undergo at the time of donation?

2.5.1. Medical requirements

The law states that donors must have a sustained ‘undetectable’ viral load (a plasma HIV RNA viral load of no more than 200 copies per millilitre) and have been receiving antiretroviral treatment for at least 6 months.

The centre should seek the prospective known donor’s consent to approach the relevant medical professional (for example their specialist HIV consultant) for information regarding their HIV viral load. The clinic must assure themselves that the prospective donor has a sufficiently low viral load as set out in SLC T52(j)(i). This SLC sets out that a prospective donor must have a plasma HIV RNA viral load of no more than 200 copies per millilitre at the following times:

This is to demonstrate a sufficiently low viral load over time. The clinic should obtain a review of the prospective donor’s relevant history to this effect. For example, specialist HIV consultants will typically monitor and review their patient’s viral load over time. Clinics should assess this review against the requirements in SLC T52(j)(i).

The requirements in relation to screening are set out in SLCs T52 and T53. For the updated SLCs, please see Annex I (for clinics in GB) or Annex II (for clinics in NI).

Where it is not possible to contact a specialist HIV consultant with knowledge of the prospective donor’s medical history, the clinic may need to arrange the appropriate laboratory tests.

The clinic should also obtain the prospective donor’s relevant history of antiretroviral treatment from the relevant medical professional (for example their specialist HIV consultant) and on this basis assure themselves that the prospective donor has been receiving antiretroviral treatment for at least 6 months before the donation takes place, as set out in SLC T52(j)(ii).

2.5.2. Co-ordination of viral load testing with donation and other health checks

As well as testing in relation to HIV status, the prospective donor will still need to undergo other screening tests as set out in the SLCs in Annex I (for clinics in GB) or Annex II (for clinics in NI) and in guidance. Viral load testing for HIV must take place at the right time in relation to donation and treatment, meaning:

It is important to note that a prospective donor must demonstrate that they have a sustained viral load of no more than 200 copies per millilitre (T52 j(i)) before donation takes place – in other words, before they provide the gametes for treatment.

The timeframe as set out in SLCs T52 and T53 is as follows:

Embryos can only be donated (including for treatment with a surrogate) where the donor underwent the required tests and was on antiretroviral treatment for a minimum of 6 months before they provided the eggs or sperm used to create the embryo. This means it will not be possible for embryos of an individual living with HIV created before the change in the law to be donated.

Please also see this timeline.

2.6. What does ‘known donation’ mean?

The law states that the donor and recipient must declare that they have a ‘qualifying relationship’. This means that those who have HIV with an undetectable viral load can only provide gametes or embryos as part of ‘known donation’. This is defined as gamete or embryo donation to:

This includes people who met through donor or surrogate introduction organisations.

The clinic must obtain proper consent from the recipient (see section 2.7).

2.7. How should clinics obtain consent from recipients?

‘Recipient’ refers to the patient or surrogate who will have treatment with the donated material – for example, the person who will be inseminated or undergo embryo transfer.

Clinics should refer to SLC T52(j)(iv) (in Annex I (for clinics in GB) or Annex II (for clinics in NI)) for information about the consent that is needed from recipients. Clinics should have documented procedures in place to ensure that sufficient information is provided for the recipient to make an informed decision and that this decision is recorded. Such information must include details about the health risks involved in being treated with the proposed donation.

The centre should ensure that recipients have discussed the implications of treatment as part of their preparation for treatment. We expect that the discussion of implications should be delivered by a qualified medical professional with appropriate knowledge of the health risks associated with receiving gametes or embryos created with the gametes of a person with undetectable levels of HIV, and that recipients have an appointment separate to the donor to receive this information. The discussion of implications should allow full opportunity for the recipients to ask questions and discuss any concerns.

Following this discussion the clinic must make a record that the recipient:

  1. reasonably believes, on the facts known to them at the time, that the donor has tested positive for HIV;
  2. understands the health risks involved in being treated with the donation; and
  3. consents to being treated with the donation in light of these matters.

Clinics should develop an in-house form to capture this consent. This form should be signed and dated by the recipient and stored with the recipient’s medical file.

Please refer to the Code of Practice, Guidance Note 4 – Information to be provided prior to consent, Guidance Note 14 – Surrogacy and Guidance Note 20 – Donor assisted conception for further guidance on the information that should be provided to patients and surrogates, as appropriate.

2.8. How should donor samples be stored?

Clinics offering treatment and donation for individuals with undetectable HIV may need to store the donated gametes or embryos.

In relation to storage, the law (Second Directive (Annex III, para 2.3)) states that:

“where HIV 1 and 2, hepatitis B or hepatitis C test results are positive or unavailable, or where the donor is known to be a source of infection risk, a system of separate storage must be devised”

To comply with this legal requirement clinics must devise a system to safely store samples from HIV positive known donors or intended parents who have undetectable levels of the virus separately from other samples. The clinic should document the system they adopt and demonstrate that they have followed best practice procedures to minimise the risk of transmission or cross-contamination.

Please see the Association of Reproductive and Clinical Scientists (ARCS) – guidelines on good practice in clinical embryology laboratories 2024 and the Code of Practice – in particular guidance notes 11, 15 and 17.

2.9. Can gametes or embryos created with gametes from donors with undetectable HIV be exported or transported to another UK clinic?

This area of UK law differs from the law in the European Union (EU) (in other words, in the EU individuals living with HIV may not donate gametes and embryos), and it may also differ from the law in other countries.

This means that patients or intended parents wishing to export gametes or embryos created with the gametes of someone with undetectable HIV for use in future treatment may not be able to do so. It will depend on the law in the country where they wish to export to. It is very important that patients and intended parents are aware of this before they commence treatment should they wish to export sperm, eggs or embryos in the future.

In addition, patients or intended parents may wish to transport stored gametes or embryos to another clinic within the UK for treatment. As set out in 1.2 above, it will take approximately two years for all UK clinics to be able to offer donation in line with these requirements. Should patients or intended parents wish to transport gametes or embryos to a clinic whose licence has not yet been varied, the clinic should be aware that the receiving clinic may need to apply for a licence variation and/or set up new processes before they can begin to store or carry out treatment. This may delay transport and treatment.

2.10. What information do clinics need to give donors and intended parents in surrogacy arrangements?

Before the start of the donation or surrogacy process, clinics should provide prospective donors living with HIV with an undetectable viral load and who wish to provide gametes or embryos with sufficient information, including:

  1. The requirement that the donor and recipient declare they have a qualifying relationship and for the recipient to consent to treatment,
  2. The details of the tests required to demonstrate that an individual living with HIV is able to donate, and when these tests must take place in relation to the time of donation and the other tests required for donation, and
  3. The need for the donor to be on antiretroviral treatment for at least 6 months up to and including the date of donation.

For intended parents in surrogacy arrangements, clinics should provide relevant additional information, including:

  1. That the law to allow individuals living with HIV who have an undetectable viral load to donate gametes and embryos differs from the law in the European Union and may be different in other countries. Clinics should inform intended parents that it may not be possible to export any gametes or embryos they create for use in treatment with a surrogate abroad in the future. There may also be delays to transporting gametes or embryos within the UK, depending on the receiving clinic’s licence (see paragraph 2.1), and
  2. Relevant information about the cost of treatment.

This information should be delivered in addition to general information about donation, particularly in Guidance Note 11 of the Code of Practice, or (where relevant) information for intended parents in surrogacy arrangements in Guidance Note 14 of the Code of Practice.

Information about the law in this area for donors, recipients and intended parents is available on the HFEA website.

2.11. What information do clinics need to give recipients?

Before the start of the donation process, clinics should provide recipients with sufficient information about the law in this area, including:

  1. The requirement that the donor and recipient declare they have a qualifying relationship and that the recipient consents to treatment,
  2. The details of the tests required to demonstrate that an individual living with HIV is able to donate, and when these tests must take place in relation to the time of donation and the other tests required for donation,
  3. The need for the donor to be on antiretroviral treatment for the timeframe specified in the licence conditions,
  4. That the law to allow individuals living with HIV who have an undetectable viral load to donate gametes and embryos differs from the law in the European Union and may be different in other territories. Clinics should inform patients that it may not be possible to export any donor gametes or embryos they create with donor gametes for use in treatment abroad in the future. There may also be delays to transporting gametes or embryos within the UK, depending on the receiving clinic’s licence (see paragraph 2.1), and
  5. Relevant information about the cost of treatment.

This information should be delivered in addition to the information in paragraph 2.7 and general information about treatment and donor-assisted conception, particularly in Guidance Notes 4 and 20 of the Code of Practice.

Where the recipient is a surrogate, you should also refer to Guidance Note 14 of the Code of Practice.

Information about the law in this area for donors, recipients and intended parents is available on the HFEA website.