New guidelines, set out by the Human Fertilisation and Embryology Authority, explained…
This month the HFEA (the Human Fertilisation and Embryology Authority) set out proposals to modernise the regulation of fertility treatment and research involving human embryos.
The range of recommendations aims to update the UK’s 33-year-old fertility law, in a bid to ‘future-proof’ the industry and better reflect the significant changes in the fertility sector.
The HFEA’s recommendations cover four areas:
Patient safety and promoting good practice
Access to donor information
Consent
Scientific developments
Almost 7,000 people responded to the regulator’s survey, launched in April 2023. Here is a flavour of some of their important findings:
Patient safety and promoting good practice:
The general agreement was for the country’s regulator to have greater flexibility when it comes to clinic inspections, more flexibility in the appointment of clinic leaders, and for the institute to be granted use of financial penalties should they need them. With regards financial penalties, this would align the regulator with the Care Quality Commission, which fines poorly performing hospitals and care homes. However some concerns were raised on this matter of penalties, generally as to whether this may disproportionately impact smaller / NHS clinics and patients.
Access to donor information:
Under the original act, egg, sperm and embryo donors were granted full anonymity. That was until the law changed in 2005, allowing 18 year old donor-conceived people to access information about their donor. These existing rules state that children conceived via donor conception can apply for details that identify their biological parents only once they reach the age of 18. However, now the regulator wants to make it the law that fertility clinics tell donors, and recipients, that the donor’s identity could easily be discovered through DNA testing sites. Sites such as Ancestry DNA and 23andMe connect people across the world, who share DNA. Therefore the regulator want people to be aware of the full implications when entering into gamete donation. They also want those involved to have mandatory counselling about the implications before starting treatment.
Laura Biggs, MD of The Fertility Show, welcomed the decision:
“We firmly believe that all donors and donor recipients should be fully aware that DNA sites could reveal identities without donor knowledge and that donor’s should be offered counselling, so they fully understand all factors of donation before they proceed.”
Traffic light system and “add ons”
The HFEA’s traffic light list of add-ons was also updated in October. Fertility “add ons” are, in essence, optional or additional procedures or medications, promoting to improve your chance of success. You can choose to undertake these on top of your fertility treatment at additional cost. Examples include endometrial scratching, time lapse imaging of embryos, steroids and testosterone to name but a few.
The HFEA’s rating system has five-categories. These categories work to demonstrate whether the “add on” would be effective at improving outcomes, or not. The regulator has made their choice of rating based on evidence from scientific studies. The updated ratings also aim to show if a particular patient group would benefit from each add-on treatment.
In addition to the improved rating system, the HFEA has also launched a consensus statement mentioning that: “where there is no evidence to support safety and efficacy, treatment add-ons should only be offered to patients in a research setting with sound methodology and approval from a research ethics committee”. This has the backing of ESHRE, The European Society of Human Reproduction and Embryology (ESHRE).
For more information, head to the HFEA website: https://www.hfea.gov.uk/.
The Fertility Show work to bring you the latest information from the fertility sector across the year. We join the best exhibitors, clinics, advice groups, charities and alternative therapists together, giving you the chance to ask the important questions you need answering.
For more information about our live show, head here: https://www.fertilityshow.co.uk/ and for webinar and podcast information, visit our sister site: https://www.letsalltalkfertility.co.uk/ now.