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The HFEA's monthly newsletter for clinic staff

September 2023

Important reminder about consent to storage

The last date for clinics to contact patients who needed to give or renew consent during the Transitional Period was 30 June 2023. This is a reminder of the actions clinics should have taken by then.

By 30 June 2023, clinics must have issued the relevant consent forms and/or Statutory Notices to the following patients:

Patients whose Consent Period ends during the Transitional Period (1 July 2022 - 30 June 2024)
Patients who had gametes or embryos in storage without effective consent on 1 July 2022.

Patients wishing to give or renew consent to storage of their gametes or embryos must do so by 30 June 2024. If consent is not given or renewed by this date, their gametes or embryos must be removed from storage and disposed of in line with the following processes:

Gametes should be disposed of as soon as is practicable from 1 July 2024.
For embryos, where consent has not been renewed by this date, clinics must notify patients that their consent has been taken as withdrawn. The HFEA NWC(TP) Notice has been created for this purpose. Embryos may be stored for a further 6 months until 31 December 2024 after which they must be removed from storage and disposed of. This should take place as soon as practicable from 1 January 2025. However, consent cannot be given or renewed during this additional 6-month period.

The storage of the gametes or embryos up to the end of the transitional period (i.e., 30 June 2024) will not be unlawful merely because there is no effective consent to storage by the relevant person. However, material for which there is no effective consent to storage should not be used in treatment. Storage of embryos is also not lawful where both gamete providers have provided the clinic with written and signed withdrawal of consent (ie, on an HFEA WCS form).

For patients who wish to give or renew consent, clinics should follow the published guidance and ensure that consent forms are properly completed.

If you have any questions, please speak to your inspector.

Opening the Register (OTR) support resources, and a reminder about clinics releasing non-identifying information to donors

Earlier this month we issued a special edition of Clinic Focus providing an overview of the HFEA Opening the Register (OTR) process and Register information, as well as clinics’ responsibilities. It also highlighted our ‘Clinic FAQs: Access to identifying information about donors for donor-conceived people from late 2023 onwards’, a new resource we recently published to help support clinics.

In addition, this month we’ve published FAQs for donors, donor-conceived people and their parents - providing guidance about access to identifying information about donors for eligible donor-conceived people.

While many donors approach the HFEA directly, donors can also request information about a child conceived from their donation by contacting the clinic at which they donated. Below we’ve provided information about releasing non-identifying information about donor-conceived children to donors, as a reminder for clinics.

Clinics should not proactively provide this information to donors without request. Donors must have requested this information before the clinic provides it.

When clinics are releasing non-identifying information to a donor, the PR is ultimately responsible for ensuring the accuracy of the information provided. Donor Coordinators should check the information with the PR of the clinic before sharing this with the donor.

When considering the release of any relevant information, clinics should ensure that disclosure would not breach the Data Protection Act 1998 or any confidentiality rights.

This is set out under 31ZD (1) – (9) Provision to donor of information about resulting children of the Human Fertilisation and Embryology Act 1990 (as amended), at the request of a donor the centre should provide non-identifying information as specified by paragraph (3):

(3) The donor may by notice request the appropriate person to give the donor notice stating—

the number of persons of whom the donor is not a parent but would or might, but for the relevant statutory provisions, be a parent by virtue of the use of the gametes or embryos to which the consent relates,
the sex of each of those persons, and
the year of birth of each of those persons.

In this instance the appropriate person should be read as the Person Responsible (PR) at the recruiting centre.

The legislation is supplemented by guidance in the Code of Practice. Guidance Note 11 paragraphs 11.38 to 11.40 sets out the additional information that should be provided to donors when giving information about children born as a result of their donation.

If you are unable to provide this information directly, please signpost to the HFEA’s Opening the Register service.

Data submission

By law, clinics have a duty to submit data to the HFEA Register about fertility treatments taking place and babies born as a result of treatment.

10 family limit reporting is currently being developed in PRISM - once the functionality has been tested, we will issue further communications in Clinic Focus. In the meantime, please ensure you do not breach the 10 family limit by checking with the recruiting centre or the HFEA to confirm the number of families created.

Update to the 9th edition of the Code of Practice

We are finalising the update to the 9th Code of Practice, due to be published late October/early November.

As set out in the July 2023 and August 2023 editions of Clinic Focus, this update will primarily incorporate amendments to the HFE Act 1990 made by the Health and Care Act 2022 regarding the storage of gametes and embryos. We will also amend other areas of the guidance as set out in those articles.

A Chair's Letter will be published with full details of the changes that have been made to the Code and will be circulated soon.

If you have any questions, please contact enquiriesteam@hfea.gov.uk.

Consent forms must not be completed before their official publication date

We’d like to remind clinics that it’s vitally important that patients and donors do not complete consent forms before the date that the consent form comes into force.

When consent forms are updated, we make them available to clinics to view for information purposes before they are published. This gives clinics the opportunity to incorporate new forms into clinic practice. For example, on 31 May 2022 we made new consent forms available relating to the 2022 storage laws - this came with clear instructions that the forms should not be used in clinical practice until 1 July 2022 - the date the new laws came into force. We are aware of a small number of cases where consent forms that came into force on 1 July 2022 were completed before this date.

Before accepting a patient or donor who has completed consent forms elsewhere, clinics should ensure that the consent forms have not been completed prior to the date the form came into force. It would not be advisable for a clinic to accept donated material in cases where the donor gave consent before 1 July 2022 on a form that did not come into force until 1 July 2022 since they would not have given consent in line with the laws that were in place at the time.

You can find the version number and date the consent form came into force at the bottom of each page of the form.

Did you know?

Clinical emergencies can happen in fertility clinics. A respiratory arrest during an egg collection at a fertility clinic was recently reported to the HFEA. When did you last review and/or evaluate your local clinical emergency SOP and evacuation procedure?

We have observed some great practice in clinics with dummy emergency scenario exercises being performed at regular intervals. Are you organising any at your clinic?

Further guidance can be found at Resuscitation Council UK and the Academy of Medical Royal Colleges ‘Safe sedation practice for healthcare procedures - An update’ (2021).

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.

No part of this publication may be reproduced without prior permission.

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