The HFEA's monthly newsletter for clinic staff |
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Modernising the regulation of fertility treatment and research involving human embryos – HFEA proposals for law reform |
We have now published our proposals for modernising fertility law in the UK.
The 15 proposals aim to ‘future-proof’ the law, so it better reflects the significant changes in the size and structure of the fertility sector. They cover four areas where the law should be modernised in the interests of patients, professionals, and researchers: patient safety and promoting good practice, access to donor information, consent, and scientific developments.
We have also published a report on the public consultation outlining the range of responses we received.
The proposals aim to give the HFEA a wider and more effective range of regulatory tools to protect patients and promote their interests. The reforms also aim to decrease unnecessary regulatory burden and give a greater focus on serious non-compliances and fix a range of significant ‘technical’ issues that will provide greater certainty to clinics and patients.
The science surrounding research on embryos, as well as new technologies is developing at pace, bringing potential new treatment options as well as new ethical issues that the current law cannot address.
Consent in fertility treatment is more complex than other medical treatment and the proposals aim to simplify consent for most patients and make it easier to consent to research.
The proposals would also modernise access to donor information, reflecting the impact of the growth in social media and direct-to-consumer DNA testing. Our Chair, Julia Chain said:
“The current law does not reflect the range and type of fertility treatment on offer today, nor modern regulatory standards. We think there should be changes that will ensure the law can continue to effectively protect patients, as well as support the scientific advances that can help them have a much-wanted child. “Today most patients fund their treatment themselves, which has changed their view of this area of healthcare to being consumers with active choices to be made. Many UK regulators have a wider and more effective range of powers to improve compliance and protect patients and consumers than those available to the HFEA.
“Nowhere in this field has the pace of social and technological change been more rapid than in the growing popularity of direct-to-consumer DNA testing and social media, with a lasting impact on donor anonymity. We need to balance the law with what is taking place in reality.” |
Publication of the Independent review of the Human Fertilisation and Embryology Authority |
We welcome the Independent Review report published earlier this month. The report recognises our important work regulating fertility treatment and human embryo research as a discrete and specialised area of medical practice and scientific research.
The review’s conclusion is that the HFEA should remain as an executive non-departmental public body and that the HFEA meets all three Cabinet Office tests for continuing to exist – that we perform a technical function, that the function needs to be delivered with political impartiality; and that there is a need for the function to be delivered independently to establish the facts. We will review the recommendations in detail and discuss them at the next public Authority meeting in January 2024. |
Update on PRISM and the 10-family limit |
Clinic obligations for the 10-family limit
The HFEA expects clinics to follow guidance on monitoring and complying with the 10-family limit as set out in the Code of Practice (Guidance note 11, paragraphs 11.55 to 11.66).
Clinics should ensure that no more than 10 families are created (or any lower figure specified by the donor), through treatment at UK licensed centres using gametes (or embryos created using donated gametes) from a particular donor. To do this, clinics should have documented procedures to ensure that those gametes or embryos are not used or distributed for use in further treatment where that treatment will result in more than 10 families being created.
Current HFEA confirmation for 10-family limit enquiries
Clinics have previously been able to check the number of families of any particular donor with us, according to HFEA records. We have now developed new enquiry tools for the 10-family limit derived from PRISM. Although these tools are currently only available internally we are working to establish reports through PRISM that clinics can access directly. To request a 10-family limit check with the HFEA, please contact Register@hfea.gov.uk When requesting a check, please provide the donor number, their full name, and date of birth in an encrypted email. We aim to respond to your request within two weeks, however we ask that you please make your request at the earliest opportunity as we cannot guarantee last minute requests will be met. Request for clinic participation in HFEA 10-family limit alert pilot scheme
The new PRISM database allows us to explore new support functions for clinics concerning 10-family limits. We are researching mechanisms that will allow us to alert clinics if the PRISM database shows that a donor is ‘approaching’ their 10-family limit, or if a donor registers at a new clinic when they have already contributed to a large number of families at a different clinic.
To support this work, we are asking for clinics who would be prepared to take part in a pilot for 10-family limit alerts. We expect this pilot to last about six months and during this time we will work with pilot clinics and sperm banks to agree the alert thresholds and the best mechanisms to convey the alerts. When this work is complete, further details will be shared with all clinics in 2024 via Clinic Focus, providing a full briefing on how 10-family limit checks can be completed.
If your clinic would like to participate in this pilot scheme, please contact taiwo.okotore@hfea.gov.uk |
Exiting PRs – What clinics and PRs need to know |
The PR: ‘Responsible until replaced’
Each licenced clinic must have a person responsible (PR), who meets the minimum statutory requirements, has passed the PREP test and has been approved by a licence committee. The PR's name will be placed on a clinic's licence and licensable activities can only lawfully take place under the supervision of that named PR. The law does not allow a PR to delegate their responsibilities to a deputy or deputies and ultimately the PR is accountable for ensuring that all licensed activities at a clinic are conducted with proper regard for the legal and regulatory framework.
When the PR is suddenly unable to fulfil their responsibilities or wishes to leave
Activities permitted under a centre's licence are only permissible under the supervision of the named PR. If that PR is suddenly no longer able to perform their duties, for whatever reason, the licence holder (LH) is required to inform the HFEA as soon as possible and seek advice on continuing to provide licensable activities.
If a PR no longer wishes to continue in their role as PR, the LH should apply to the HFEA to vary the licence and substitute a new PR. The proposed PR must have the requisite qualifications and experience (for details, see Code of Practice: Guidance Note 1) and have successfully completed the Person Responsible Entry Programme (PREP) test. The application form is submitted via the clinic portal. Once received by the clinic’s inspector, this is processed and scheduled for review by the executive licencing panel (ELP). The nominated PR cannot begin their post until they are approved by the ELP and the minutes are published. The PR named on the licence remains responsible until the licence is varied.
With this in mind, clinics should have a succession plan at all times, taking the necessary steps to prepare someone else to take up the role if a PR should unexpectedly become unable to fulfil their duties, or decide to leave their position. Unless there is an emergency situation, the HFEA expects adequate notice of a change in PR to be able to process the application. Failure to inform the HFEA if no suitable PR
A failure by a LH to immediately notify the HFEA that the PR is unable to carry out their duties (either temporarily or permanently) may be grounds to conclude that the LH is no longer suitable to act as a LH and could also be grounds for the licence to be suspended and/or revoked.
In addition, a licence committee can suspend and/or revoke a licence if it is no longer satisfied that the PR is suitable to supervise the licenced activity or if the PR dies or is convicted of an offence under the HFE Act 1990.
It is therefore in a clinic’s best interests, and indeed the patients’, to notify the HFEA immediately if a PR is no longer able to carry out their duties and to work with the HFEA to put an emergency plan in place. In an emergency, the HFEA will make every effort to assist a clinic in expediting the approval of a replacement PR. |
New leaflets for donors and their families to prepare for possible contact with donor-conceived individuals |
Professionals from organisations across the sector have developed five new leaflets which provide information and signposting for egg and sperm donors about the possibility of contact from any donor-conceived people born from their donations.
We welcome this new resource, which is particularly important now as the first donor-conceived people are able to request identifying information about their donors from October 2023 onwards, following the change to the law in 2005 allowing donor-conceived people, at 18, to access this information from the HFEA. We encourage clinics to signpost to and share these leaflets with donors, including newly recruited donors, for example, by including links to them on your webpages or written materials aimed at donors.
The leaflets cover topics including: ‘Preparing you and your family for the possibility of contact’, ‘Donor FAQs’, ‘Important information for people who have donated eggs, sperm or embryos in the past’ and also stories about what is it like to be contacted by donor-conceived adult children, from the donor, and relative of a donor, perspectives.
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HFEA Electronic Invoice Service |
From December 2023 clinics will be able to access their monthly billing invoices via the Clinical Portal.
Access and log in details will be provided by the clinic PR.
If you have any questions, please contact finance@hfea.gov.uk. |
October 2023 Scientific and Clinical Advances Advisory Committee (SCAAC) papers available |
The papers presented at the October 2023 SCAAC meeting are now available on the SCAAC webpage.
The Committee considered the topics of in vitro derived gametes, the impact of the microbiome on fertility treatment outcomes, and health outcomes in children born from assisted reproductive technologies (including culture media). Two external speakers from the University of Edinburgh and the University of Oxford presented on new developments in the field of in vitro spermatogenesis and in vitro oogenesis.
The Committee also considered whether artificial oocyte activation by calcium ionophore is a treatment add-on. In line with artificial egg activation using calcium ionophore being an HFEA authorised process, and the professional guidelines on best practice use of artificial egg activation published by the Association of Reproductive and Clinical Scientists (ARCS) and the British Fertility Society (BFS) in August 2023, artificial oocyte activation has been removed from the add-ons list. Further information on the removal of this add-on is available on the following page: Treatment add-ons with limited evidence | HFEA.
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Professional guidelines on best practice use of artificial egg activation |
Artificial egg activation using calcium ionophore is an HFEA authorised process for use in selected patients only, given the possible risks. Clinics offering this treatment should only do so for selected patients in line with published best practice guidelines.
In August 2023, the Association of Reproductive and Clinical Scientists (ARCS) and British Fertility Society (BFS) published professional guidelines on best practice use of artificial egg activation which states that: -
Artificial oocyte activation (AOA) should not be used routinely with ICSI as its safety, in terms of the potential developmental consequences and birth outcomes, has yet to be established.
- ICSI with AOA may be used where two previous routine ICSI cycle(s) have resulted in <30% or no fertilisation.
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Where AOA is used, patients should be advised that safety, in terms of the potential developmental consequences and birth outcomes, has not been established.
- Patients should be provided with safety data relating to the specific AOA technique used.
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As per General Directions 0010, licensed centres (primary centres) must maintain a written agreement with any provider of satellite or transport IVF. These agreements, together with related patient information, should be submitted to the clinic’s inspector before the start of any new service.
As per SLC T112, the centre must evaluate and select third parties on the basis of their ability to meet the requirements of these licence conditions and the guidance set out in the HFEA Code of Practice.
As per SLC T116, the centre must ensure that it is made a condition of any agreement with a third party, a satellite or a transport centre that the third party, satellite or transport centre will meet the requirements of the relevant licence conditions and the guidance set out in the HFEA Code of Practice. |
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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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