The HFEA's monthly newsletter for clinic staff |
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Season's greetings from the HFEA - we wish you all the best for the new year. Thank you to clinics and colleagues for working with us during 2023, providing the best treatment and support to patients. |
Advance notice – fee increase effective 1 April 2024 |
The HFEA is funded by a mix of fees levied on the sector we regulate (currently 80% of our funding) and Grant In Aid (GIA) from the Department of Health and Social Care (DHSC) (currently 20%). As part of the DHSC’s Efficiency and Reform work, the HFEA must further reduce its reliance on GIA from 2024/25. Further detail will be provided once the balance of GIA and fees has been agreed with the DHSC, but we expect it to be a significant reduction of about £700,000 (around 75% of current GIA).
In addition to this, the cost of regulating the sector is increasing, driven by the continuing high level of inflation. These two things combined mean that we will need to increase fees by significantly more in 2024/25 than we have done over the past few years.
The Authority agreed in November to increase the fees for IVF to £100 and DI to £40 subject to continuing discussions with the DHSC and HM Treasury approval. We expect this to take effect from 1 April 2024 and will write to every clinic with formal notice of this as soon as we hear from the DHSC and the Treasury.
We have a very strong focus on efficiency and effectiveness, and this will be only the second fee increase since 2016. Furthermore, an Independent Review report published in November 2023 provided a number of recommendations relating to efficiency and effectiveness that we will take forward to ensure we continue to keep the financial burden of regulation on the sector as minimal as possible. This will include a review of how our fees are structured to ensure that the actual cost of regulation is charged as fairly and accurately as possible to licensed clinics. The review will begin in the 2024/25 business year.
As ever, it is important to be clear that HFEA licence fees are charged to licenced clinics and not patients. While some clinics choose to list the activity-based licence fee on patients’ bills, the HFEA does not and will not charge patients. |
Screening requirements for partner-to-partner donation |
We are providing an update following the Government announcement to change the law requiring additional screening for female same sex couples who wish to undergo partner to partner donation.
As the independent regulator of fertility treatment and research using human embryos, it is the HFEA’s responsibility to ensure that licensed clinics comply with current legislation. In the August 2021 Clinic Focus article, we outlined that the law currently requires female same-sex partner donations to be screened in line with gametes donors. The HFEA raised concerns about the additional costs and burden that this screening requirement involves with the Department of Health and Social Care.
In June 2023 the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) made recommendations to the UK Minister for Health, including to “remove additional screening requirements for female same-sex couples in an intimate relationship as there is no microbiological reason for this”. In October 2023 the Government announced that, following SaBTO advice, they would be amending the current definition of partner donation through secondary instruments and the Government have now made a commitment to bring forward secondary legislation during this final legislative session.
The HFEA prioritises aspects of inspection based on risks posed to gametes, embryos, patients and donors. Considering the recommendations made by SaBTO, and the Government intention to change this law during this legislative session, the HFEA has deprioritised the inspection of screening same sex females couples in line with licence condition T52, with immediate effect. |
Latest HFEA ethnic diversity in fertility treatment report published |
Our latest Ethnic diversity in fertility treatment report shows that although the average IVF birth rate per embryo transferred has increased across all groups, fertility treatment outcomes varied widely for Black, Asian and ethnic minority patients.
- Black patients had the lowest birth rates but continued to have the highest multiple birth rates of all ethnic groups in 2020-21
- Single Black and Asian patients started fertility treatment at 38-39 years, compared to 36.2 years for White single patients in 2017-21
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NHS-funded IVF cycles decreased most among Black patients in heterosexual couples, down from 60% in 2019 to 41% in 2021.
The disparities highlighted, including NHS funding, multiple birth rates, and age of treatment commencing, demonstrate a need for decisive and long-lasting actions to improve treatment outcomes for Black, Asian and ethnic minority patients. The HFEA, the Royal College of Obstetricians and Gynaecologists, the British Fertility Society and Fertility Network UK call for action to ensure that Black, Asian and ethnic minority patients and their partners are not left behind in access to and experience of fertility treatment.
Professor Geeta Nargund, member of the HFEA Authority, said:
“There is no room for the health inequalities that exist within fertility treatment.
“While it is good news that multiple birth rates in all groups have dropped, this new HFEA report highlights the health inequalities that still exist.
“It shows that there is a need for meaningful changes so that Black, Asian and ethnic minority fertility patients and their partners are not left behind in access to and experience of fertility treatment.”
You can read the full Ethnic diversity in fertility treatment 2021 report here. |
Vacancies for HFEA Scientific and Clinical Advances Advisory Committee |
We are looking to appoint three new external advisors to the Scientific and Clinical Advances Advisory Committee (SCAAC) which is a subcommittee of the Authority that consider advances in science and clinical practice which are relevant to the HFEA's work.
The vacancies include one new external advisor within each of the following areas of expertise: - Developmental genetics and developmental models
- Reproductive medicine
- Fertility patient support
External advisors are appointed to the SCAAC for a term of three years, with a maximum of two terms. A fee of £200 per day is paid to external advisors for their attendance and contribution to committee meetings.
The SCAAC meeting dates for 2024 that the successful candidate will attend are Monday 3 June (anticipated online) and Monday 7 October (anticipated in person at the HFEA office in East London). Travel and expenses will be paid in accordance with our travel and subsistence policy.
Further information and application details can be found here.
Applications close midday on 17 January 2024. |
Screening for partners who are not providing gametes for a treatment cycle |
We are aware that in some situations, clinics require partners to undergo additional screening even where they are not providing fresh gametes for that cycle of treatment. We have received a number of queries about this from patients, and so we would like to remind clinics of the requirements that exist for partner screening, and of their obligations around information provision for screening.
As set out in guidance note 15 of the Code of Practice, when a person returns to provide gametes for a fresh cycle of their partner’s treatment and more than two years has passed since they last provided their gametes for treatment, it will be necessary to re-screen them. However, we are aware that some clinics request additional screening for the partner (excluding donors) even where they are not providing gametes for that cycle of treatment. This may be for couples returning for a frozen embryo transfer and/or where the partner is not providing any gametes for treatment (eg, where they are using the patient’s eggs and donor sperm).
We expect clinics to carry out screening tests based on up-to-date professional guidelines, in addition to the law and the Code of Practice. Neither the law nor the Code of Practice require partner screening in addition to the screening set out above. In other words, screening is not a requirement for partners not providing fresh gametes for that cycle of treatment. Clinics should ensure that any additional screening is warranted by best practice guidance and, where they request additional tests, we would expect them to provide patients and/or their partners with proper information and to explain that such tests are in addition to what is required by law and guidance.
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New HFEA dashboard available |
Earlier this month our first ever HFEA dashboard went live on our website. Our dashboard gives users the opportunity to explore HFEA data and find statistics on their own areas of interest and is part of our commitment to improving transparency and accessibility in the data we collect from clinics.
The HFEA dashboard is produced from data collected from licensed fertility clinics in the UK and covers the period from 1991-2021, where data is available.
The dashboard pages contain information on: - All cycles – Information on the number of treatment cycles and the number of patients, split by different treatment types.
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IVF and ICSI cycles – Information on the number of In Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI) cycles and live births.
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Donor insemination - Information on the number of Donor Inseminations (DI) cycles and live births.
- IVF birth and pregnancy rates – Information on IVF and ICSI birth and pregnancy rates per embryo transferred and per cycle.
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Sperm and egg donors – Information on the number of people becoming egg and sperm donors.
- Funding – Information on the number and percentage of NHS and privately funded treatments.
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Egg freeze and thaw – Information on the number of patients freezing and thawing eggs, and the average age when these cycles occur.
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Multiple births – Information on the multiple birth and multiple embryo transfer rate.
The HFEA dashboard is published as a beta version while the final product is finalised. Work is ongoing to ensure the clarity of statistics and to confirm that contents meet the requirements of users. You can find out more and access the dashboard here. |
Update on Choose a Fertility Clinic |
The roll-out of PRISM and the transfer of data to the new Register has meant that we have been unable to update clinic level data on Choose a Fertility Clinic (CaFC) for some time. Below we’ve set out the key next steps for this important task.
During 2024 we will be publishing the first CaFC update to be derived from information submitted from PRISM, and in January we will start to issue verification documents that will help clinics check their data in advance of sign off and CaFC publication.
In relation to CaFC, clinics should note the following: - The CaFC dataset will include treatments up until December 2023, and outcomes to December 2022.
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Whilst the verification period for this first CaFC through PRISM will open in January 2024, we will keep the verification period open until Summer 2024 with a view to signing off data and publishing in Autumn 2024.
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We will send all verification documentation to Clinic PRs. If you are a member of clinic staff who has traditionally been responsible for checking CaFC data, please make sure that your PR knows to provide this information to you once they receive it.
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We will provide full documentation with the verification reports. We will start by issuing verification reports for earlier years and then for the current (2023) year once all data has been submitted by the sector.
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We will aim to work directly with those clinics who may need support to get their data ‘CaFC ready’. If you need support, please contact Taiwo.Okotore@hfea.gov.uk.
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The fortnightly clinic user group calls (alternate Wednesdays at 2pm) will be an opportunity to speak to us directly concerning CaFC, as well as any queries relating to PRISM. Please continue to contact prismsupport@hfea.gov.uk for any PRISM queries or if you do not have an invite to this user group.
We will issue further information on CaFC when we send the first verification reports to PRs, early in the New Year. |
Our latest clinical governance summary report |
We have published our latest clinical governance summary report that covers some of the common non-compliances identified at inspections, reported incidents and complaints received from April to June 2023.
The aim of this report is to highlight key areas of practice where improvements can be made, or where learning and experiences can be shared to benefit other clinics. To promote learning from inspections we encourage you to use the areas outlined in this report as an opportunity to consider how your clinic might approach these issues. |
Job vacancies within our Opening The Register team |
We are advertising for two Donor Information Officers (one permanent and one on a fixed term basis) to work within our small team on the Opening The Register (OTR) function.
This team manages requests from donors, donor-conceived individuals and their parents for information about donors, siblings and outcomes held on our Register in line with the HFE Act.
Further information, and links to apply, are available on our website.
If you would like more information about either role, please contact Opening.TheRegister@hfea.gov.uk. |
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There are several types of licence renewal applications available for Persons Responsible (PRs) to select in the Clinic Portal. For example, if your clinic undertakes treatment and storage with embryo testing there is a specific application for clinics to complete that is different to the application for renewing a treatment and storage licence. It is important that prior to completing a licence renewal application, PRs select the correct licence type, as this is subsequently submitted to a licensing committee for consideration along with the renewal inspection report.
If the wrong licence application type is issued, this could result in the wrong type of licence being granted and this could impact on the treatments clinics are able to offer.
General requirements relating to all applications to the Authority are set out in General Directions 0008. |
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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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