30 July 2024
Dear colleague
Update to General Directions on donor compensation, consent and authorised processes
I am writing to inform you that the following General Directions have been amended:
- General Direction 0001 gamete and embryo donation (changes come into force on 1 October 2024)
- General Direction 0007 Consent (changes come into force on 14 August 2024)
- General Direction 0008 Information to be submitted to the HFEA as part of the licensing process
I attach the revised General Directions below. Please read each section of this letter for information on the changes and the relevant implementation date.
Update to General Directions 0001 on gamete and embryo donation
General Direction 0001 setting out the mandatory requirements for clinics on compensation for gamete and embryo donation has been amended. The new requirements will come into effect on 1 October 2024.
These include increasing donor compensation rates to take into account inflation and bringing the compensation rate for overseas donors in line with UK compensation rates. We announced these changes in the April Clinic Focus. More information on the background to these changes can be found in the Authority paper.
The key changes are:
Updated compensation rates
From 1 October 2024 the compensation rates for egg and sperm donors increases to:
- 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.
Compensation for imported gametes and embryos
From 1 October 2024, a clinic considering importing gametes donated overseas, must ensure that the donor did not receive compensation for the donation of their gametes which exceeds the amounts specified in Directions, or the equivalent in local currency:
- for sperm donors a fixed sum of up to £45 per clinic visit.
- for egg donors a fixed sum of up to £985 per cycle of donation.
As is the case for UK donors, overseas donors can be compensated in excess of these amounts as long as the expenses are reasonable and in line with HFEA Directions.
Evidence required from overseas centres
If a clinic receives donated gametes from overseas, the clinic must keep a record, provided by the overseas centre, of the compensation received for the donation of the gametes. This record should include the fixed sum of compensation per clinic visit (for sperm donation) or per cycle (for egg donation) and record of any excess expenses given as set out in the Direction. This record must confirm that the donor has not exceeded the amounts specified in HFEA Directions, or the equivalent amount in local currency at the time of donation. If a clinic is unsure, the UK clinic must check with the overseas centre that the compensation provided was equivalent to the amount specified in HFEA Directions at the time of donation.
Implementation
These changes will come into effect on 1 October 2024.
Clinics should amend their donor compensation policies and donor/patient information in light of these changes.
Where applicable, clinics should also review their Third Party Agreements with overseas centres and amend their agreements in line with the changes to the compensation policy, as set out in the amended GD0001.
Code of Practice
Please note that relevant sections of the Code of Practice will be updated when the Code of Practice is next updated. Until then you should compensate donors in line with the revised Directions and guidance issued within this Chair’s letter.
Update to General Direction 0007 on Consent
In May 2024, the Health and Care Act 2022 (Storage of Gametes and Embryos) (Transitional Provision) Regulations 2024 (‘the 2024 Regulations’) came into force. The 2024 Regulations permit storage of the gametes or embryos of a small cohort of patients who died before 1 July 2022 for a longer period. We have published guidance to support clinics to implement this change in the Clinic Practical Guide on legal changes to storage limits and guidance. As a result, we will issue a new consent form: ‘Your consent to the creation of embryos (IVF and ICSI) with your deceased partner’s eggs or sperm or to storage of those embryos for up to 55 years (under the 2024 Regulations)’ (the ET(PH)). We have updated General Direction 0007 to incorporate the new form (and other minor changes following the end of the Transitional Period for the 2022 storage laws).
The form will come into force from 14 August 2024. This form must only be used in very specific circumstances where the partner of a person who died before 1 July 2022 wishes to create and store embryos using gametes that fall under the 2024 Regulations. We have updated Consent Forms: a Guide for Clinic Staff with guidance on how clinics should guide patients to complete the new form correctly.
Update to General Direction 0008 on Information to be submitted to the HFEA as part of the licensing process
Section D of General Direction 0008 sets out the application requirements to carry out a licensed activity using a new process that has not been authorised by the Authority.
Changes to Direction 0008 introduces requirements that a clinic applying for a new process must provide evidence that the new process does not render the tissues or cells clinically ineffective or harmful to the recipient, and confirmation that the evidence submitted has been validated.
It also introduces a period of mandatory reporting for newly approved processes during which clinics carrying out the new process are required to report certain requirements to the Authority as determined by the Scientific and Clinical Advances Advisory Committee (SCAAC). Clinics wishing to carry out a process subject to enhanced mandatory reporting can do so in accordance with the licence they hold, but they are required to inform the Authority via their inspector at least 28 days in advance of undertaking the process.
The changes follow a revision of the decision-making process for considering new applications, reconsideration and deauthorisation of Authorised processes.
Information on the background leading to these changes can be found in the March 2024 Authority paper. We announced these changes in the July 2024 Clinic Focus.
Implementation
The new rules will come into effect on 1 August 2024.
Clinics applying for a new process should follow the requirements set out in amended GD0008. Clinics wishing to carry out a new process subject to enhanced mandatory reporting must inform the Authority as specified in GD0008 and fulfil the additional requirements as determined by the SCAAC.
If you have any questions on any of the above changes, please speak to your inspector.
Yours sincerely,
Chair, Human Fertilisation and Embryology Authority