The HFEA's monthly newsletter for clinic staff |
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| New ratings for treatment add-ons |
Earlier this month we launched our new treatment add-ons ratings to help patients make better-informed decisions about their treatment. The new ratings system - developed with patients and professionals in the fertility sector - has five categories giving detailed information for patients about whether add-ons increase the chances of success, as well as other outcomes such as the impact on miscarriage rates.
Decisions on the rating for each add-on was made by our Scientific and Clinical Advances Advisory Committee (SCAAC), comprising Authority members and external experts. More information about the process for allocating and reviewing ratings can be found in the SCAAC meeting papers. The minutes of this decision-making process, and the specific evidence used to inform these decisions, can be found in the description for each treatment add-on.
As well as the new ratings, the HFEA together with eight patient and professional bodies has re-affirmed its agreement that add-ons without strong evidence of their safety and/or effectiveness should only be offered in a research setting. Our Chief Executive, Peter Thompson said:
“In line with the HFEA Code of Practice, clinics must give patients a clear idea of what any treatment add-on will involve, how likely it is to increase their chance of a successful pregnancy and how much it will cost, and link to the HFEA ratings system.” |
Government announces the law will be changed relating to partner donation and gamete donation from those who have HIV with an undetectable viral load |
We welcome the news of the proposed changes in law which was announced 26 October.
Maria Caulfield MP (who has ministerial responsibility for the women’s health and sponsorship of the HFEA) said:
"I am pleased to announce that, following the advice from the Advisory Committee on the Safety of Blood, Tissues and Organs, the Government will be introducing secondary legislation to allow the donation of gametes by people with HIV who have an undetectable viral load; we will be introducing that as soon as we can. We will also be addressing the current discriminatory definitions of partner donation, which result in additional screening costs for female same-sex couples undergoing reciprocal IVF; again, amendments through statutory instruments will be introduced as soon as."
We do not know when the law will be changed but we will update licensed clinics as soon as we have more information. The current law remains in place until any changes are made. |
There are UK companies marketing at home fertility treatment kits and we want to remind clinics of their obligations related to home insemination, as well as emphasise the risks of procuring sperm through unregulated donation.
Centres’ obligations
The Code of Practice (9th edition) sets out the law and our guidance in relation to home insemination in ‘Interpretation of mandatory requirements 15B’, and paragraphs 15.4 and 15.5. This makes it clear that sperm should only be provided for home insemination in exceptional circumstances. We also want to clarify that clinics should only distribute sperm for home insemination in the course of providing treatment services, meaning that clinics have obligations with respect to:
- Provision of information – patients should be provided with information in line with the law and our guidance, including about who will be the legal parent(s) of any child born.
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The offer of counselling – including about the implications of using a donor to conceive.
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Information collection - the clinic will be required to collect information about the donor and the treatment for the national Register so that people born from donated gametes can have access to information about their genetic origins and be given identifying information about their donor once they reach 18. It is also through collecting this information on a central register that clinics can check that a donor’s sperm is not used to create more than 10 families in the UK.
Many home insemination kits enable patients to perform intracervical insemination (‘ICI’) at home and we would encourage clinics to provide patients seeking to conceive in this manner with enough information to fully understand their chances of success. Although the technique of ICI is included in the most recent NICE guidelines, success rates reported are from studies from several years ago. We would expect that clinics (and, where relevant, GPs) discuss the important factors that affect fertility, such as female age.
Unregulated sperm donation
We have significant concerns about encouraging patients to use donor sperm outside of a clinic setting. Procuring sperm in this way carries a number of serious risks for both the patient and for any future child, including: - Possible infection or serious genetic disease if the donor has not been properly screened.
- That the donor may be considered the legal father of the child.
- That there are no limits to how many families a private donor can donate to which possibly could result in a large number of donor-conceived siblings.
We would strongly encourage clinics to review the information on our website relating to home insemination with donor sperm and ensure that patients are supported to understand all the risks and implications if they are considering trying to conceive in this way. We have information for patients on our website about the legal implications of sperm donation that may also be helpful.
If you have any questions, please speak to your inspector. |
Important reminder about Donor Consent Withdrawal |
We would like to remind clinics of the importance of clear communication with patients about the possibility of donors withdrawing consent to the use of their gametes or embryo(s).
As you will know, donors can withdraw consent to the storage and use of their gametes and embryos up until the point of embryo transfer. This can be very distressing for patients with donated gametes or embryos created using donated gametes in storage. We are therefore reminding clinics to communicate this information in advance of treatment to patients who are seeking the use of donor material. The Code of Practice states: “5.30 The person obtaining consent should tell the gamete provider and recipient(s) that the gamete provider may withdraw or vary their consent up to when the gametes or embryo(s) are: (a) transferred to a woman. … The possible consequences of this should:
(e) be made clear to the gamete provider and the recipient(s) before the treatment begins, and (f) be set out in the written patient information included with the benefits in kind agreement.”
As set out in this guidance, clinics should inform patients of the possibility of donors withdrawing consent and when this can occur. Staff should be aware of the serious possible consequences for patients, for example for patients who may have already had a live birth with that donor and who have embryos in storage intended for sibling treatment. It is imperative that – in advance of treatment – staff have made this clear to patients so that they are prepared for this possible outcome.
Clinics should ensure their processes for information provision for patients considering using donated material include information about withdrawal of consent. This will allow patients to make informed decisions and to navigate any potential changes to their treatment plan. |
This year has been busy with, for example, new add-ons ratings, our work on law reform, finishing PRISM as well as preparing for Opening the Register and 2023. We have therefore decided to postpone the PR event for this year and will look to hold it again when there are important and significant issues to discuss with PRs. Our Chair, Julia Chain, will still be speaking at Fertility 2024 in Edinburgh, and hopes to see many of you there. We will keep you updated as plans for the next PR event progress.
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Job vacancy - Scientific Inspector
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We are currently recruiting a Scientific Inspector at the HFEA. If you are a scientist with recent laboratory experience and have worked in a senior role, we would like to hear from you.
The job description and details on how to apply can be found here. The closing date for applications is Sunday 26 November 2023.
If you would like more information about the role, please contact sharon.fensome-rimmer@hfea.gov.uk or louise.winstone@hfea.gov.uk |
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Clinics are required to ensure HFEA statutory notices are completed in compliance with the following mandatory requirements set out in the following General Directions: General Direction (GD) 0007:
1. Licensed centres must record any consent of a person whose consent is required under: (a) Schedule 3 and Section 33B of the Human Fertilisation and Embryology Act 1990 (as amended); and (b) Sections 37(1) and 44(1) of Part 2 of the Human Fertilisation and Embryology Act 2008 in the appropriate form listed in the schedule to these directions.
General Direction (GD) 0015:
1. Licensed centres must maintain a record relating to the renewal of consent to storage of gametes or embryos in accordance with paragraphs 11A and/or 11C of Schedule 3 of the 1990 Act, including:
(e) Statutory Notices stating that if consent to storage is not renewed before the end of the renewal period, the gametes and/or embryos will be removed from storage and disposed of;
(f) Statutory Notices to both gamete providers stating that consent to the storage of embryos is taken as withdrawn.
2. Licensed centres must be able to produce copies of the documents referred to in paragraph 1(a) to (f) upon request from an HFEA employee. Clinics can find these forms on the HFEA website. |
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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. You can view our privacy policy on our website. Click here to unsubscribe 2 Redman Place London E20 1JQ © Copyright Human Fertilisation and Embryology Authority, 2019 |
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