The World Health Organization (WHO) will to develop global standards of governance for human genome editing. This is a welcome move. Although the committee has no powers to enforce compliance 鈥� it is still a matter for individual nations to decide on regulations, with 鈥� the WHO committee鈥檚 recommendations will be influential and far-reaching in their ambition. But I hope committee members will bear a few points in mind in their discussions.
The first is safety. It is likely that the WHO meeting will focus on inheritable edits to human embryos, known as germline genome editing (GGE). The issue of GGE was thorny enough even before reports of the birth of twins with edited genomes in China 鈥� an intervention widely condemned as clinically unjustified and reckless.
The criticism partly stemmed from numerous mice studies suggesting that we cannot rely on genome-editing tools like CRISPR-Cas9 to make precise and predictable changes to DNA in every embryo. The conclusion is that genome editing cannot yet safely be performed on fertilised eggs for use in assisted human reproduction. But it might be safe at some point. The WHO can define standards for the evaluation of safety and efficacy in preclinical research on GGE.
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The importance of agreeing such standards relates to another factor: human embryo research, including that involving genome editing, is central to improving success rates in IVF clinics and furthering our ambitions in regenerative medicine more generally. We must make the case for such research and resist any temptation to prohibit it through fear of what we may learn. That would simply be an unwarranted, knee-jerk response to the reports from China.
It is worth emphasising this because of point two: germline interventions are already lawful in some jurisdictions. In the UK, preimplantation genetic diagnosis (PGD) is regulated by the Human Fertilisation & Embryology Authority. PGD involves screening embryos for genetic abnormalities so only 鈥渉ealthy鈥� ones are used in assisted human reproduction. It may not involve actively altering DNA in the way CRISPR-Cas9 does, but PGD is a germline intervention nonetheless. So, the way it is regulated, and the social, legal and ethical issues it raises, should be core comparisons when evaluating GGE.
Agile regulation
Which leads on to point three: intelligent governance is vital if GGE becomes lawful in the UK and elsewhere. Regulation should be seen as a way of facilitating responsible innovation, not just prohibiting it. But for this to be realistic, the infrastructures of regulation must be sufficiently agile to cope with rapid scientific, technological and societal change.
The pace of current scientific and societal change increases the importance of point four: engagement. We should avoid introducing genomic technologies in the face of significant public opposition: history tells us this wouldn鈥檛 end well. But how does our society offer (or withhold) its informed consent for such innovations? We need a big conversation about GGE and other genomic technologies, discussing how we might protect those individuals most vulnerable to the introduction of GGE and hearing their concerns.
This requires us to re-examine why an edited genome might be considered an affront to human dignity, given the myriad other ways we routinely control human futures in our societies. Clear scientific and ethical language is required, as are transparency, sensitivity to diversity and a steady hand. Resorting to familiar but misleading tropes 鈥� or glibly invoking dystopian future scenarios 鈥� won鈥檛 help: there are no shortcuts to consensus.
