PGT-P in the UK: The public needs more from the HFEA

In his article 'Why PGT-P is not lawful in the UK', Peter Thompson, chief executive of the Human Fertilisation and Embryology Authority (HFEA), argues that preimplantation genetic testing for polygenic traits (PGT-P) is 'unproven', citing the American Society of Reproductive Medicine (ASRM)'s view that 'PGT-P is a nascent and unproven technology that should not be used clinically at this time' (see BioNews 1325).

UK law does not impose a free-standing 'clinical proof' statutory requirement before a technology can be used, and there is no statutory definition of 'proven'. Evidence thresholds are a matter of regulation and clinical governance, not statutory prohibition.

Egg freezing illustrates this distinction: the ASRM considered it experimental until 2012, yet the HFEA's report Fertility Treatment 2014 showed that since 2005 the number of women freezing their eggs in the UK had increased substantially with 'growth of 25 percent to 30 percent year on year' and at least 900 UK egg freezing cycles between 2010-2012, rising to 2567 cycles in 2019 and 6932 cycles in 2023.

PGT-A was similarly given a red rating by the HFEA's Scientific and Clinical Advances Advisory Committee (SCAAC) in October 2019 (indicating that 'there are potential safety concerns and/or, on balance, findings from moderate/high quality evidence show that this add-on may reduce treatment effectiveness'), with a comment that 'there is a lack of evidence of benefit and some evidence of harm'. Yet by July 2023, SCAAC classified PGT-A as 'green for reducing the chances of miscarriage for most fertility patients'. Despite initial caution from the SCAAC, PGT-A is offered in most HFEA-licensed clinics in the UK.

This pattern suggests that regulatory caution and clinical adoption do not always move in step, and that a structured evidence-review mechanism within the HFEA framework may assist in aligning the two, with a focus on the benefit to patients.

Thompson endorses the ASRM's concern that 'the technology risks misleading patients by overstating what polygenic risk scores can reliably determine.' This concern does not reflect the full picture. Polygenic risk score methodology has advanced materially since the framework for embryo testing was last considered, and studies have examined the predictive capacity of such scores in adult cohorts.

Transparent patient counselling, informed by current evidence, is the appropriate mechanism for managing expectations, as it is across all areas of reproductive medicine where probabilistic information is used. The evidence base in this field continues to develop and warrants ongoing regulatory engagement rather than categorical prohibition.

Thompson also states: 'patients do not automatically have a right to the embryo's full sequence of raw genetic data under UK's data protection laws.' This analysis requires careful scrutiny. Under Article 15 of the UK General Data Protection Regulation (GDPR), genetic data linked to an identifiable patient are special category personal data (as defined in Article 9), and patients generally have a right of access to their personal data.

The HFEA Code of Practice is clear that 'All organisations who process personal data, which is any information from which an individual can be identified either directly or indirectly, must ensure they comply with the UK GDPR and the DPA 2018 when using that data.'

There is an unanswered critical legal question as to the extent to which embryonic genetic data constitute the patient's personal data (as opposed to data about a separate biological entity), in particular where HFEA regulatory restrictions limit its clinical use. This is a nuanced question at the intersection of the Human Fertilisation and Embryology (HFE) Act 1990 and UK GDPR, on which there is no definitive guidance from the UK courts or the Information Commissioner's Office.

Additionally, the assertion that regulatory restrictions on clinical use extinguish or override data protection access rights is not self-evidently correct and warrants further legal analysis.

Peter Thompson's article may also be seen as mischaracterising the law on embryo testing. PGT-A, for example, is permitted under HFEA licensing without there being a preexisting familial heritable condition. This demonstrates that regulatory uncertainty about evidential sufficiency does not automatically translate into statutory prohibition. This distinction between evidence thresholds and legal permissibility is central to the debate about PGT-P.

Concerns about equity, autonomy, and bias highlight the need for careful consideration of whether and how such technology should be regulated. Technology and societal understanding have moved on since 2008, when the embryo testing framework within the HFE Act 1990 was last substantively amended (though it should be noted that regulations and HFEA guidance are updated more frequently).

The HFEA's current position on PGT-P reflects the HFEA's interpretation of a statutory framework that has not been revisited in this area since 2008.

The question of whether PGT-P should be available to patients in the UK is not one that can be resolved by regulatory interpretation alone. The statutory framework governing embryo testing was carefully constructed by Parliament in 2008, and any substantive reconsideration of its scope – in light of the material advances in polygenic science and the evolution of clinical practice since that time – rightly belongs to Parliament.

What is clear is that the current position, in which regulatory caution forecloses access to a technology that is already in routine clinical use in comparable jurisdictions, does not serve patients well and deserves open, evidence-driven scrutiny.

Constructive engagement between clinicians, scientists, patient advocates, regulators, and policymakers – grounded in the most current evidence and a shared commitment to patient welfare – is the route most likely to produce a framework that is both legally sound and genuinely responsive to the needs of those seeking fertility treatment. That is the conversation this statement seeks to encourage.