The WHO, gene editing and ethics | BIA CEO, Steve Bates OBE

The World Health Organisation is today convening its first expert advisory committee on developing global standards for the governance and oversight of human genome editing. The aim of the two-day meeting, in Geneva, is to examine the scientific, ethical, social and legal challenges of gene-editing and create guidelines and standards for it.

The meeting follows a call last week by some 16 leading scientists from 7 countries: USA; China; Canada; France; Germany; Italy and New Zealand for a global moratorium on heritable genome editing.

This follows much reflection, in the scientific community and beyond, on news last year that a Chinese researcher announced the birth of twin girls whose DNA was edited in a bid to make them resistant to HIV.

The letter to Nature is a thoughtful contribution to the debate and suggests that “there should be a fixed period during which no clinical uses of germline editing whatsoever are allowed” and “this period would provide time to establish an international framework…as well as allowing for discussions about the technical, scientific, medical, societal, ethical and moral issues that must be considered before germline editing is permitted”.

The Nature letter does not call for global rules and there is a subtlety to their argument that recognises that, in future “nations may choose to follow separate paths” on this.

Leading global academies , including the UK Royal Society, US National Academy of Sciences, the US National Academy of Medicine added their perspective in a responding letter in Nature explaining they are leading an international commission  “to detail the scientific and ethical issues that must be considered, and to define specific criteria and standards for evaluating whether proposed clinical trials or applications that involve germline editing should be permitted. Dozens of scientific academies around the world are lending their support to the commission.”They  also stated they “welcome the establishment by the World Health Organization of an expert panel on human genome editing” with which they have agreed to liaise closely.  

It seems to me that the main novelty of the 16 scientists Nature letter is that their approach is an implicit criticism that, so far, the debates that have been had have been too narrowly focused within the scientific community, and they want to ensure this debate is had more broadly including actors beyond science. They argue that it “is essential to include those representing perspectives outside science and medicine — including people with disabilities, patients and their families, economically disadvantaged communities, historically marginalized groups, religious groups and civil society at large.”

I think this approach largely misses the UK history and perspective – where much work has been done across a range of institutions and civil society, to both discuss, and build a British ethical framework and consensus around this emerging area of science, much of it mediated through discussion of mitochondrial transfer and three parent babies both in the UK parliament and the UK popular press.

So I’ve been listening to a range of UK voices reacting to the proposal in Nature this week like Sarah Norcross, Director, Progress Educational Trust (PET), who said “A moratorium on the clinical use of germline genome editing is neither necessary nor useful.  In our work, we have found that people do not worry specifically about changing the germline. They are more concerned with whether or not specific applications of genome editing are medically warranted. This finding has also been borne out by several recent surveys of the public in the USA, the UK and elsewhere. We do not think a moratorium would have deterred He Jiankui, who acted secretively and in breach of a clear scientific consensus that germline genome editing should not be used in the clinic at this time. Moreover, He Jiankui's practices were scientifically and ethically unsound in so many different ways, that they would have been wrong regardless of whether or not they involved germline genome editing.”

And lawyer James Lawford Davies a Partner at Hill Dickinson who said “It is understandable that a moratorium is attractive to those working in countries which lack coherent regulation. In the UK, however, the law very clearly allows the use of genome editing in embryos for research, but equally clearly prohibits its clinical use in embryos. As such, a moratorium is unnecessary in the UK and may risk causing confusion about where the boundaries lie.”

and Prof Sir Robert Lechler, the President of the Academy of Medical Sciences said:

 “There is no doubt that genome editing technologies hold huge potential for the future health of patients, but I agree that the clinical use of germline genome editing should remain prohibited. There are currently just too many unanswered safety, ethical and scientific questions. I am pleased that the proposed moratorium does not wish to change the way scientists can use germline editing for research use, nor does it seek to prohibit genome editing in human somatic cells to treat diseases. Considerable progress has already been seen in these areas and it is essential that this kind of research and treatment development can continue. With this in mind, using the term ‘moratorium’ is unhelpful and any timeframe for a fixed term ban would be largely arbitrary. Instead, the scientific community should focus on learning from the initiatives currently being established.  I support the development of an international framework to provide guidance on the clinical applications of germline genome editing being set up by the US National Academies of Sciences and Medicine, together with the Chinese Academy of Sciences and the UK’s Royal Society. The Academy of Medical Sciences is pleased to be contributing to this commission and alongside the work by the World Health Organization on global governance and oversight of human genome editing, and wider public engagement activities, I hope that this will shine much-needed light on whether, and when, clinical applications of germline genome editing should proceed.”

 And Dr Beth Thompson, Head of UK and EU Policy, Wellcome Trust, who said “We agree with many of the principles outlined in the Nature comment. There must be robust national laws shaped by public consultations and informed by the latest science. Wellcome will support the work of the WHO and the National Academies of Science and Medicine to address these complex questions and develop an effective and inclusive approach.” 

 This is clearly an area for ongoing discussion, globally and nationally. What has been underplayed I think in the UK media discussion of this is that the UK benefits from substantial investment in thought, consensus building, and legislation in this area. Hence a call for a global ban for a period of years simply to enable other countries to have the type of debate that has been active in the UK for the past decade isn’t instinctively attractive to me.

Robin Lovell-Badge is a senior group leader and head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute, and is on the new WHO expert Advisory committee (acting in a personal capacity). I’m confident that he is well placed to bring the UK’s heritage of broader engagement to this group. 

The UK is fortunate to benefit from a democratically controlled, expert and scientifically informed, peer-reviewed regulatory environment, with a free press, that can navigate the risk/benefit profile of this and other emerging technologies. It’s a key reason scientists and researchers will want to work here and one we need to explain, nourish and cherish – whilst continuing to participate in the ongoing global discussions.