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The HFEA's monthly newsletter for clinic staff

 April 2024

Donor compensation for UK and overseas donors – new compensation rates from 1 October 2024

Compensation rates for egg and sperm donors will be increased to take into account inflation since the rate was first introduced in 2012.

The uprated amounts will be:

• UK sperm donors - £45 per clinic visit (from previous limit of £35)
• UK egg donors - £985 per donation cycle (from previous limit of £750)

Donors can continue to be compensated in excess of these amounts as long as the expenses are reasonable and in line with HFEA Directions.

Going forward, the HFEA will review donor compensation rates every five years, or when inflation has increased by 10% (as measured by the GDP deflator), whichever occurs sooner.

Overseas donors whose gametes or embryos are imported into the UK

The compensation rate for overseas donors is currently different from UK compensation rates. From 1 October 2024, the compensation rate for overseas donors will be the same as in the UK, as set out above.

Details of what evidence we will expect clinics to collect confirming that the donor has not exceeded the amount specified in HFEA Directions will be issued in the accompanying guidance.

Implementation

The new compensation rates will come into effect on 1 October 2024. We will issue new guidance and revised HFEA Directions in the Summer.  

This timeframe should allow clinics sufficient time to prepare for these changes (for example to revise and implement price increases and to update patient information and SOPs). Until then you are required to compensate donors in line with the existing requirements set out in HFEA Directions.

We would like to remind clinics of Code of Practice guidance that states donors should understand that donating gametes and embryos is voluntary and unpaid and that they may only be compensated in line with relevant HFEA Directions. All prospective donors must be given a suitable opportunity to receive proper counselling about the implications of donation.

More information on the background to this increase can be found in the Authority paper. 

Storage changes: End of the Transitional Period

The Transitional Period for the 2022 laws on the storage of gametes and embryos will come to an end on 30 June 2024. 

Clinics should ensure they have taken all necessary actions in preparation for this important date. Please see the March 2024 Clinic Focus for more information. Guidance relating to the 2022 storage laws can be found on the Clinic Portal. 

We have updated the Clinic FAQs on new storage legislation to further support clinics at the end of the Transitional Period.

If you have any questions, please contact your HFEA inspector.

High Court allows clinics to re-contact donor: The importance of consent and what this means for clinics 

In a recent case the High Court considered a very unusual case that raised issues about consent and donor confidentiality.

This article gives a brief summary of the case, the decision and implications for clinics going forward. 

Wessex Fertility Limited 

Facts of the case 

• An egg donor “Donor A” had ticked a box on an in-house donation form to indicate that she did not wish to be notified if it was discovered that she had a previously unsuspected genetic disease, or was a carrier of a harmful, inherited condition.
• Mr and Mrs H were treated using Donor A’s eggs and Mr H’s sperm and had a baby girl, AH. AH was born with a number of health problems including polydactyly, a cardiac abnormality and gross motor delay.
• The clinical geneticist responsible for AH’s care asked the clinic – Wessex Fertility - to contact Donor A to request that she provide a DNA sample. The sample would be used to carry out genetic analysis with the aim of establishing a genetic diagnosis of AH’s condition, which might assist the diagnosis and treatment of AH’s condition.
• Wessex Fertility sought a Court declaration that contacting the donor for this purpose was lawful despite the donor having refused to consent to being contacted in the event of an unsuspected heritable condition being discovered.

The hospital where AH was being treated, the Donor Conception Network and the HFEA were all Interested Parties. The HFEA’s role was to assist the Court in understanding the legal and policy framework governing donation and consent as was relevant to the case.  

The Court’s Decision 

The Court decided contact could be made in this case. One issue the Court considered was whether the in-house consent form signed by Donor A also covered the present circumstances; where it was not known whether the condition was heritable. The Court reasoned that even if the donor’s (refusal to) consent did extend to these circumstances, it was nevertheless justified and proportionate to contact her, provided that it was done in accordance with a detailed and agreed plan that was approved by the Court. The Court reasoned that any interference with the donor’s right to privacy was justified for the following reasons: 

1. There is ambiguity over whether the terms of the donor’s consent covered this exact situation;
2. The donor will retain the right to refuse to provide a DNA sample and can also decide not to know the results of any DNA test if she wishes;
3. The contact plan ensures availability of support for the donor;
4. General trust in fertility clinics is unlikely to be impacted by the decision (as the scope of the consent was not clear, it is not a situation where consent is being clearly undermined);
5. There is a significant potential benefit to the patient and others conceived through the donor’s donations; and
6. The child conceived through the donation could receive identifiable information about the donor when she turns 18 in any event.

Implications

This case highlights that there may be a difference between contacting donors to tell them that they carry a heritable condition and contacting donors to ask for more information or assistance (in this case, a DNA test) that could help a child born through their donation. Clinics who have in-house donor consent forms, may want to revisit these, consider the extent of any donor consent and, where necessary, explain this distinction to future donors, clearly documenting the donor’s wishes either on the forms themselves or in the donor’s medical notes. 

Alert reminders

• Alert 2024/06 – Class 3 Medicines Recall: Besins Healthcare (UK) Ltd, Oestrogel Pump-Pack 750 micrograms/actuation Gel
  
  Alert 2024/06 was issued on 28 March 2024
  
  
• Alert 2024/07 – Field Safety Notice: Medical Device Recall for Endocavity Probe Cover distributed by Medline

Alert 2024/07 was issued on 19 April 2024

If the PR at your clinic did not receive these alerts via email, please contact Business Support at HFEACompliance@HFEA.gov.uk to update your contact details. Please also make sure that the email address alerts are sent from, alert@hfea.gov.uk, has been whitelisted by your IT department.

For any questions about the content of the Alerts, please contact incident.reporting@hfea.gov.uk.

Regulation and governance of neural organoids in the UK

The Nuffield Council on Bioethics (NCoB) have published a policy briefing on neural organoids in research which includes an outline of the regulation and governance of neural organoids in the UK.

The NCoB briefing is available online here. 

Did you know?

Below are the most common statutory notice errors that have been recently observed during inspection:

1. Centres not using HFEA statutory notices but using their own forms.
2. Where embryos are in storage, statutory notices only being sent to the female gamete provider and not the male gamete provider. A notice must be sent separately to both of the gamete providers (where no donor gametes have been used) and copies kept on both gamete providers files.
3. Incorrect statutory notices being used: clinics should refer to pages 9 and 10 of the ‘how to use HFEA consent forms and statutory notices’ document located here.  
4. Incorrect expiry dates stated on the statutory notice. Expiry dates are the day before the freeze date anniversary or consent date where applicable, in the relevant year.
5. When using one statutory notice for multiple expiry dates which are close together, all expiry dates and all renewal period end dates not being listed separately.

A full set of Frequently Asked Questions is available to help clinics with the transition period and renewal consent process.

You can also refer to the HF&E Act 1990 (as amended) and Schedule 17 Health and Care Act 2022 – and General Directions 0007, 0012 and 00015.

Editorial statement

Clinic Focus is the official electronic newsletter of the Human Fertilisation and Embryology Authority, is produced by the editorial team of the HFEA and provides a monthly roundup of news and information for clinics and their staff working in the field of fertility treatment.

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