Human genome editing and moral leadership: findings of the WHO Expert Advisory Committee

In 2019, the World Health Organization convened an Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. On Monday it published its findings in three reports: a position paper (summarising the findings), a set of recommendations and a framework for governance. These documents represent a significant contribution to the literature around genome editing that has emerged since about 2015, which includes a number of major reports and a steady stream of statements and position papers emanating from learned societies, professional bodies, national ethics committees and ad hoc groups. [1] The WHO report is both the latest of the ‘big reports’ and the last in the pipeline. For now.

The scope of the ‘big reports’ on human genome editing differs: the WHO covers laboratory research, medical uses and reproductive uses, or ‘somatic’, ‘germline’ and ‘heritable’ genome editing. The reports also have different emphases. The Nuffield Council has, naturally, been concerned with ethical, social and political matters. There was an implied division of labour between the International Commission (which reported in 2020) and the WHO Committee, the former dealing with the technical, scientific and medical conditions for responsible translation of heritable genome editing, if (always ‘if’) it were ever considered acceptable and the latter with how to govern such procedures. But the International Commission inevitably encroaches into the area of governance and both theirs and the WHO’s reports are shot through with ethical assumptions and aporias. This is not a criticism – it is just a demonstration of the inextricability of these different perspectives.

There is a much to applaud in the new WHO documents. The recommendations are eminently reasonable, clearly articulated and have a logical structure. There are important practical recommendations concerning the establishment of a registry for clinical trials and basic research, and for coordinated systems for whistleblowing. The documents also contain a governance framework for human genome editing, although it is less a framework than a delicatessen of useful heuristics and approaches for a variety of contexts, and there is little in it that is really peculiar to human genome editing.

Perhaps the most important recommendations are the ones that enjoin the WHO Director General to bring the WHO’s moral authority to bear in order to shore up a flaking international consensus and make the case for more coordinated prospectus. This would involve, firstly, the Director General making a clear but careful statement, balancing an affirmation of the value of research and setting priorities for well-governed and equitable introduction of somatic editing while reaffirming the earlier statement that “it would be irresponsible at this time for anyone to proceed with clinical applications of human germline [i.e. heritable] genome editing.”

Of course, any statement that includes the phrase ‘at this time’ need not necessarily apply tomorrow. But the question of when ‘this time’ comes to an end and of when we might enter a new time of heritable genome editing is not merely a question of duration. For the judgement to cease to apply something relevant and significant will have to have changed. What must change is not one thing but includes, implicitly, well-evidenced technical refinement (on which the International Commission focussed), the institution of effective governance (for which the WHO provides a framework and heuristic[2]), and societal and ethical resolve.[3]

This foregrounds a second aspect of WHO leadership in the recommendations, namely the injunction to articulate “the consequences of failing to address the ethical issues before us if we develop and use technologies without prior careful reflection and intentional collaborative decision-making.” It is on this, it seems to me, that the moral authority of the WHO is staked for, if this is not delivered, or if it is not convincing, it is possible that little of the rest will have been worth the candle.

If the WHO can make out the case, however, then in doing so it will have succeeded in rebalancing the international discourse on human genome editing in the direction of international cooperation and it will have opened the space into which its further recommendations (on collaboration in governance, participation in registries, whistle blowing, cross border research etc.) play.

Global leadership from a body such as the WHO offers the prospect of a more inclusive coalition of actors than can be brought under a single legal jurisdiction. But in contrast to establishing international legal conditions (such as those established by the Council of Europe via the Oviedo Convention [4]), maintaining cooperation requires continually affirming the situation ‘at this time’. And this continual affirmation requires substantial commitment.

The Committee’s recommendations propose an ‘extensive review’ in no more than three years, taking into account “scientific, technological and societal changes, adequacy of implementation and assessment of impact, and potential future needs or concerns”. By the time the recommendations have been fully disseminated, capacity building undertaken, the eight recommended international meetings convened, the set of guiding principles and values developed, and given the necessity of engagement and planning, and the proposed 18-month timeframe for the review, this describes, in effect, a continuous long term work programme. This would propel the WHO Science Division into becoming a major presence in the international governance of ‘frontier technologies’ (and their distinct and branching temporalities). If the recommendations are accepted, this would be a significant step for the WHO and a powerful statement about the increasing global significance of emerging biomedical technologies, in a context of challenges to human health and wellbeing of titanic global significance.

Pete Mills is speaking at the Progress Educational Trust event 'Changing the Human Genome: What Next for Germline Genome Editing? on Wednesday 14th July 5.30-7.30 pm. This event is free to attend online.

Footnotes

[1] These major reports include our own Nuffield Council reports of 2016 (Genome Editing, an ethical review) and 2018 (Genome editing and human reproduction: social and ethical issues), the 2017 report of the US National Academies of Sciences and of Medicine and last year’s report from the International Commission convened by the US National Academies of Medicine and Sciences and the UK’s Royal Society. Substantial reports have also been issued by the Deutscher Ethikrat, the French CCNE and (recently) the European Group on Ethics, the last two having a much broader scope than human applications.

[2] This supports the recommendations in the joint statement of the Nuffield Council, the Deutscher Ethikrat and the French CCNE: ‘Recognising that heritable genome editing raises profound ethical issues of international scope, that many jurisdictions do not have effective legal controls in force, and that there is no international authority capable of enacting universal measures, we call on all jurisdictions to bring heritable genome editing unambiguously within the control of relevant public authorities and to make its abuse subject to appropriate sanction.’

[3] The recommendations propose the development of an outward facing “set of officially endorsed and clearly defined ethical values and principles” to guide their work. Plenty of such principles already exist, but it is not so much the principles but the work that is done with them that is important, particularly given that principles may often support divergent or even contradictory ends.

[4] The Council of Europe’s Bioethics Committee (DH-BIO) has recently affirmed that it is not appropriate at this time to review Article 13 of the Oviedo Convention (which prohibits intentional modifications of the human genome that could be passed on to any descendants) although it is working to clarify the interpretation of this Article in the present circumstances. (Declaration: the author of this blog is a member of the drafting subgroup of DH-BIO charged with clarifying guidance on Article 13 of the Convention.)