September 3, 2020

expert reaction to report from the International Commission on the Clinical Use of Human Germline Genome Editing

A report, published by the UK Royal Society, and the US National Academy of Science and National Academy of Medicine, set out guidelines on the Clinical Use of Human Germline Genome Editing.

This roundup accompanied an SMC Briefing.

Prof Peter Braude, Emeritus Professor of Obstetrics and Gynaecology, King’s College London, said:

“This is a detailed report with an excellent first chapter on the science of genome editing, which proposes an appropriately high bar for implementation (or not) of inheritable genome editing. Sadly, many countries do not have the wherewithal to comply with these high standards of oversight as they have few or weak regulations in place even for the practice of ‘routine’ Assisted Reproduction.

“We have already seen another heritable technology, mitochondrial replacement therapy (MRT), appropriately developed for the amelioration or prevention of inherited mitochondrial disease, being applied in countries like Ukraine and Greece, in the vain hope of overcoming infertility using mitochondrial ‘enhancement’. It is difficult to see why, in the absence of an enforceable international consensus, clinicians or their countries would be encouraged to follow these strict rules now when they have been complicit previously in providing unproven ART technologies to desperate patients willing to pay and try.”

Prof Dame Anne Johnson FMedSci, Vice President (International) at the Academy of Medical Sciences, said:

“The UK has a great track record of providing clear and robust regulation and legislation concerning IVF and other assisted reproductive techniques. This has been enhanced by involving patients and the public to explore views on how to balance access to the latest techniques with patient safety.

“The Academy of Medical Sciences welcomes today’s report on heritable human genome editing (HHGE) and the cautious approach that it recommends in this vastly complex and contentious area.

“I am pleased to see that inputs from public and patient groups are key themes in the report. Even if, in the future, HHGE techniques can be shown to be safe and effective, it is essential that a wider public conversation precedes any nation progressing to clinical use. This area of science could help a group of patients with no other options, but it is not one to be fast-tracked behind closed doors. It must be based on strong clinical data showing safety and efficacy, alongside thoughtful public debate that is clearly informed by the best possible scientific evidence.

“The Academy looks forward to learning how the recommendations on the international governance of heritable human genome editing in this report will fit with the upcoming recommendations from the World Health Organisation on the global governance of human genome editing. It is important to get this right.”

Dr Helen O’Neill, Programme Director, Reproductive Science and Women’s Health, University College London, said:

“This very extensive report outlines the potential intended uses, necessary considerations, and essential scientific and clinical prerequisites for a country considering the adoption of human germline genome editing (HGGE). Furthermore, it outlines the strict considerations for any individuals who would desire HGGE for their embryos.

“It is very evident that more research is needed to fulfil the strict criteria of the report – however, it cannot be said that the same standards were in existence or continue to be in practice for current IVF. Stating that, ‘A biopsy should demonstrate that the intended edit is present in all biopsied cells, with no evidence of unintended edits’ seems out of touch with the current practice of a threshold criteria for transfer of mosaic aneuploid embryos.

“Furthermore, in order to enable the necessary monitoring of human embryos following editing, it would seem sensible to address the legislative restrictions on culturing the human embryo beyond 14 days.”

James Lawford Davies, lawyer specialising in regulation of human genome editing, Partner, Hill Dickinson LLP, said:

“The report acknowledges that coordinated international oversight of HGGE would be very difficult, but it highlights the UK’s approach to the regulation of mitochondrial replacement techniques as a useful model for the development of national oversight in other countries. The successful regulation of mitochondrial transfer in the UK is testament to the robustness and strength of the UK framework. This success was built on a vital foundation of open dialogue between researchers, parliamentarians, policy makers and the public, and it is good to see that the report also encourages a similar transparency and engagement as HGGE continues to advance towards the clinic.”

Sarah Norcross, director of the Progress Educational Trust, said:

“The circumstances in which the world’s first genome-edited babies were born in 2018 were lamentable, both scientifically and ethically, and lessons needed to be learned. Unfortunately, this report goes too far in the other direction.

“The criteria the report sets out, for the first acceptable clinical use of germline genome editing in humans, are far too narrow.

“Furthermore, the report strays beyond its scientific remit. Much of the report – including a third of its recommendations – concerns governance, which is the focus of a separate genome editing project by the World Health Organisation.

“The World Health Organisation is still deliberating on the governance of genome editing, and should not feel constrained by this report’s governance recommendations if it sees fit to deviate from them.”

‘Heritable Human Genome Editing: A Report by the International Commission on the Clinical Use of Human Germline Genome Editing’ by Kay Davies, Richard Lifton et al. was published by The Royal Society and the National Academies Press at 15:00 UK time on Thursday 3rd September 2020.

Declared interests

Sarah Norcross: “Sarah is director of the Progress Educational Trust, a charity which improves choices for people affected by infertility and genetic conditions.”

None others received.