Call for moratorium on human genome editing – Expert Reaction

Scientists and ethicists from seven countries – including New Zealand – have called for a global moratorium on all clinical uses of human germline editing: changing heritable DNA in sperm, eggs or embryos.   

In a comment piece published in Nature, the researchers suggest a moratorium of five years, and a new international governance framework to guide any future use. The moratorium would not hamper research or editing non-germline cells, they say.

The SMC asked experts for their views on the comment piece. The comment piece and press material is available on Scimex for registered journalists. 

Co-author Professor Jing-Bao Nie, Bioethics Centre, University of Otago, comments:

“The birth of gene-edited twin girls was announced by a young Chinese scientist He Jiankui through one of four self-made promotional videos in English on YouTube (a website officially banned in China) on November 25, 2018. Three days later, at the Second International Summit on Human Genome Editing held in Hong Kong, He revealed that another woman was in the early stages of pregnancy with a genetically modified embryo. The experiments on embryos intended to be implanted and born, a well-kept secret until a few weeks after the twins’ birth, obviously violates international and Chinese ethical guidelines on embryonic genetic research, essential ethical norms of biomedical research, and the most basic rules of scientific investigation.

“Why then, did He dare to risk condemnation of the whole world (what Chinese would call ‘mao tianxia zhi da buwei’)? And why in China?

“These are extremely complicated questions that call upon many in-depth inquiries. From a broad sociological and historical perspective, He’s genetic misadventure is unsurprising. A series of political and social forces in China in the past several decades have created a fertile environment for Chinese researchers to undertake daring but unethical (or ethically problematic) ‘world firsts’. In many ways, He’s human experimentation constitutes one of the fruits of his personal ambition, nourished and directly supported by China’s authoritarian pursuit for a nation strong in science and technology. The drive to be a science superpower is part of an even grander Chinese dream chased by the party-government and Chinese society.

“The governmental strong drive for sciences, like ambition on a personal level, is definitely not intrinsically bad, and can lead to immense goodness for Chinese people and humankind. Yet, as manifested in the rising cases breaching scientific integrity, and especially He Jiankui’s human experiments, China’s science schemes have much to do with the developing mentality that ethics is merely secondary and instrumental for cutting-edge scientific investigation and technological invention. Ethical considerations and the ultimate moral goals of science and medicine can be compromised or alienated by the unchecked pursuit of personal ambition, financial interests, interests of the Party-governments and institutions, economic growth, or national glory.

“The case of He Jiankui’s transgression, as well as the authoritarian model of sciences, needs to be critically examined from bioethical and particularly socio-ethical perspectives. The moral stakes are high for China and the world.”

Jing-Bao Nie was a co-author on the comment piece. The above is taken from a blog post – the full version is here. He has also co-authored two pieces for The Hastings Center on the difference between Chinese and Western ethics, and the major ethical issues

Dr Hilary Sheppard, Senior Lecturer, School of Biological Sciences, University of Auckland, comments:

“A small, international group of leading scientists and ethicists have come together to call for a global moratorium on germline editing and the development of an international governance framework. In the light of the recent CRISPR baby scandal driven by the actions of the Chinese scientist Dr. He, this is a wise move. Arguably, this should have been in place a few years ago when it became clear that editing viable embryos was possible. There is no law to prevent germline editing in China although guidelines prohibit it. Therefore, even though many prominent international scientists were aware of Dr. He’s work, they were unclear if they should blow the whistle on the rogue scientist, and if so, to whom.

“A governance framework around this issue would provide much needed clarity. Would it have prevented Dr. He from carrying out his ill-informed experiments? Perhaps not in light of the fact that Dr. He allegedly recruited patients using coercion, forged documents and swapped blood samples to achieve his goals – each of these suggest extreme unscrupulous behaviour.

“Will it hamper research and use in the clinic? No – the moratorium will not apply to germline editing for research purposes or to the editing of somatic cells. The call to limit the clinical use of germline editing is proposed for a fixed and limited time of perhaps five years. This is warranted as many technical issues still need to be resolved to allow this method to be safely used in the clinic. In addition, it is still debatable whether there is a sufficient unmet need to warrant its use in the clinic. It is clear that many issues, both technical and ethical, remain to be resolved.

“One good thing that has emerged from this fiasco is the knowledge that the international scientific community will not tolerate unethical research and that they are actively looking for solutions to prevent it in the future.”

No conflict of interest.

Professor Peter Dearden, Director of Genomics Aotearoa, Professor of Genetics at University of Otago, and Vice President of the Genetics Society of Australasia comments:

“The call for an international moratorium on clinical uses of germ-line editing in humans is important and timely. CRISPR-cas9 technologies are relatively easy to use, and have been shown to be effective in humans. This raises the possibility that germ-line editing could be commonly used to permanently edit the human genome to manage disease, or to improve human characteristics. This raises challenging ethical and societal issues that must be generally addressed. A moratorium while those discussions proceed is critical. I fully support this call.

“Problematically, however, most scientists believe that such a moratorium already exists. That gene edited children have been born in China shows that moratoria are not effective to stop illegitimate behaviour. The case in China is a salutary one. The scientist involved appears to have broken laws and regulations and behaved at the least unethically, at most illegally. That China has tightened its regulations, and sanctioned the scientist is good news; clearly they also the recognise the need to think carefully about gene editing in humans.

“I hope this moratorium is achieved and effective. Perhaps, however, we should be asking how it is a highly trained, internationally educated, scientist could feel that they have the right to ignore international opinion, ethical standards and law? Solving that problem may be one way to assure that this proposed moratorium is effective.”

No conflict of interest.

Our friends at the UK and Australian SMCs gathered the below comments.

Associate Professor Ainsley Newson, Sydney School of Public Health, University of Sydney, comments:

“This is a promising proposal. It puts forward a nuanced rationale for a moratorium on clinical use of heritable genome editing. The agreement would be driven by voluntary and transparent commitments from individual countries, with light-touch oversight from an international body.

The proposal covers not only the technology itself, but also procedures for reporting inappropriate activity. It will also set the tone for how debate on heritable genome editing should proceed: in the public domain, with time for in-depth discussion to identify core values, in consultation with many different groups.

That said, getting this right won’t be simple. Drafting will need to be precise and barriers to quality public engagement will need to be addressed.

Proportionality is also important: we need to have this debate without over-hyping the potential of genome editing or framing its use as inevitable. Genome editing is an exciting and technically dazzling technology, but it remains one very small contributor to the urgent problem of global health equity and opportunity.”

No conflict of interest declared.

Dr Dimitri Perrin, senior lecturer, Science and Engineering Faculty, Queensland University of Technology, comments:

“Clinical use of heritable gene editing would be premature, so a moratorium would be welcome. Ensuring voluntary commitments, and then that they are enforced, is not easy, but not putting anything in place would be a worse outcome. The call reiterates clear criteria that must be met for heritable editing to become a viable option in specific circumstances, but it also proposes a framework to shape the global discussion on human gene editing. Ultimately society has a whole will decide which applications of gene editing are acceptable, in health as well as in other domains. More than ever, engagement and education around advanced biotechnologies is crucial.”

No conflict of interest declared.

Prof Sir Robert Lechler, President of the Academy of Medical Sciences, Academy of Medical Sciences (AMS), comments:

“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.”

No conflict of interest declared.

Dr Helen O’Neill, Programme Director, Reproductive Science and Women’s Health, University College London (UCL), comments:

“This letter serves to ignore rather than reiterate that a global ban is already in existence and only attempts to address what would happen in the case of another extreme scientist.

“Currently, there are (as there was in China) legal and ethical measures in place globally which regulate the use of gametes and embryos. Let’s not forget that He Jiankui broke many rules, and was aware of this by choosing to do his work outside of the auspices of the university (and taking unpaid leave). It was not that he did this because the law allowed it.

“The main problem I have is that what [the authors] are saying reflects the many previous agreements of all interested or invested organisations but naming a ‘moratorium’ sheds a negative light on the potential for germline genome editing. This will have huge consequences for research funding, many of the bodies requiring the proposal to be ‘clinically translatable’.”

No conflict of interest declared.