Remarks from the Fertility Regulator

The fifth session of the 2025 PET (Progress Educational Trust) Annual Conference concluded with a keynote address by Julia Chain, chair of the Human Fertilisation and Embryology Authority (HFEA) – the UK's regulator of fertility treatment and embryo research. Chain reflected on and responded to the preceding five conference sessions, and the text of her presentation can be read on the HFEA website.

She began with a reflection on expanded carrier screening (ECS) and the question of whether this should be more widely used. There are currently no national guidelines in place, but these are forthcoming (see BioNews 1320a). Should we do it – or do more of it – just because we can?

Moving on to PGT-A, recognised by the HFEA as a fertility treatment 'add-on', Chain reflected that the debate had been lively. She reminded us that PGT-A (and add-ons more generally) would continue to be a controversial topic (see BioNews 1320b). The HFEA – which rates add-ons with an expanded version of its initial 'traffic light' system (see BioNews 983, 1212 and 1226) – classifies PGT-A, uniquely, as red (potential safety concerns or negative effect on treatment) and green (can be effective) and grey (insufficient evidence meaning no rating), depending on what it is being used for.

Reflecting on the keynote speech of Professor Alan Handyside (see BioNews 1320c), Chain acknowledged that PGT-M and PGT-SR were far less controversial than PGT-A (to say nothing of PGT-P). In fact, she said, PGT-M and PGT-SR had been 'a real success story for UK fertility treatment', with a huge expansion in the number of inherited conditions for which testing is licensed. However, new complexities still arise even in relation to these techniques, partly as a consequence of the move to whole genome sequencing. Again, new guidance was promised for 2026.

Chain was more forthright about PGT-P, reiterating her statement from earlier in the day (see BioNews 1320d) that it is illegal in the UK and therefore cannot be offered by licensed clinics. However, there is the challenge of patients obtaining the genomic data of their embryos from UK clinics, sending this data to other jurisdictions (especially the USA) for PGT-P, and then asking UK clinics to transfer specific embryos on the basis of the test results (see BioNews 1319). The HFEA made it clear, both during the conference and beforehand, that UK clinicians should not use PGT-P results to decide which embryo(s) to transfer. But what if it is the patient choosing?

Reflecting on Professor Dagan Wells' presentation about mitochondrial donation (see BioNews 1320d), Chain pointed to an important distinction between the two different applications that Professor Wells discussed. In relation to the use of mitochondrial donation to avoid the transmission of mitochondrial disease, Chain reflected on this year's happy news that eight healthy babies with donated mitochondria have been born in the UK (see BioNews 1298a and 1298b). This long-awaited news came ten years after the UK became the first country in the world to legislate to permit mitochondrial donation (see BioNews 711, 744, 764, 770, 785, 792 and 826).

When it comes to the other application of mitochondrial donation discussed by Professor Wells – as a treatment for (certain forms of) infertility (see BioNews 984 and 995) – Chain reminded us that this is not currently permitted in the UK. 'It's worth remembering that only people who are at a very high risk of passing a serious mitochondrial disease onto their children are eligible for this treatment in the UK', she said.

Chain also discussed gamete donation, reflecting on the earlier talk by genetic genealogist Debbie Kennett, and the fact that direct-to-consumer genetic testing has 'driven a coach and horses through our notions of anonymity and undermines the integrity of the current legislative framework'. This is one of the reasons why the HFEA has argued that families should be able to access information about the identity of a donor from the child's birth onwards, she added.

Chain pointed out that the HFEA has made a number of recommendations to the Government for substantial reform of the Human Fertilisation and Embryology Act, on the basis that the current legislation is outdated and cannot keep pace with modern developments (see BioNews 1216a and 1216b). I suspect that most of those in the audience – whatever their views on the various other issues that had been debated throughout the day – agreed with that particular sentiment.

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PET would like to thank the sponsors of its conference (the British Fertility Society, ESHRE, PRECAS, Remaking Fertility, the Adelphi Genetics Forum, the Anne McLaren Memorial Trust Fund, Born Donor Bank, CooperSurgical, Ferring Pharmaceuticals, Merck, Salve, Theramex, Xytex, Juno Genetics and the Institute of Medical Ethics.).