July 12, 2021

expert reaction to the WHO’s newly published recommendations and governance framework for human genome editing

Two reports by the World Health Organisation (WHO) Advisory Committee on Human Genome Editing provide the first global recommendations to help ensure that human genome editing is used for public health, with an emphasis on safety, effectiveness and ethics.

Julian Hitchcock, lawyer specializing in regulation of human genome editing, Bristows LLP, said:

“The Committee’s recommendations do not presume to make international laws, which are of course outside the powers of the WHO. Nor will the recommendations, if implemented, impact UK law which, for example, already outlaws heritable human genome editing. Nevertheless, the imprimatur of the Director General of the WHO would exert significant power to establish international norms of conduct which are subsequently adopted in national laws. It’s notable that the Committee specifically invokes the international moral authority of the WHO and its DG as demonstrated in connection with equitable vaccine access.

“I welcome the acknowledgement that governance and regulation must be adaptive to the pace of technological change, with a recommendation that the WHO’s Science Division review the recommendations in three years. In recommending an international afterlife, the report raises important questions about the scope of future WHO responsibility for the governance of genome editing. Importantly, it asks whether the work of its successor should be limited to immediate public health issues invoked by human genome editing, or whether it should include the use of non-human genome editing that has significant impacts for human health, as in food, environmental and energy security, and possibly the most interesting recommendation is the Committee’s call for the WHO Director General to invite the Secretary General of the United Nations, “to establish in the first instance, a United Nations interagency working group on frontier technologies”, in recognition that human genome editing is not the only emerging technology of importance. Some, however, may ask whether somatic genome editing, which is already regulated, if imperfectly, as a gene therapy, needs a bespoke governance framework, and whether an international organisation can in future make policy statements on the ethics of hereditable human genome editing that reflect the plurality of views, other than statements about access that apply to healthcare in general.”

Prof Dame Linda Partridge FRS FMedSci, Vice-President and Biological Secretary, Royal Society, said:

“We are pleased that the work of the International Commission on the Clinical Use of Human Germline Genome Editing, which was jointly convened by the Royal Society and the US National Academies, could help inform the deliberations of the WHO’s panel. The recommendations on ensuring greater international oversight of heritable human genome editing are particularly welcome.

“We look forward to taking forward the conclusions of these reports at the Third International Human Genome Editing Summit in March 2022.”

Dr Philippa Brice, External Affairs Director, PHG Foundation, said:

“Human genome editing has enormous potential for health benefits, in both medical research and in the treatment of serious and rare diseases, but could also pose real dangers, especially any drive for premature interventions to reduce the future risk of common diseases on the basis of genetic predisposition. Policy must navigate a careful path to ensure these amazing technologies help but do not harm people. The PHG Foundation welcomes this new governance framework and set of recommendations from the WHO, which provide an important starting point in the development of globally agreed standards for the implementation of gene editing and other emerging technologies, to help ensure that they are used safely, effectively, and ethically around the world.”

Dr Laura Blackburn, Head of Science, PHG Foundation, said:

“The framework clearly lays out the different circumstances under which genome editing can be used, outlining the key considerations for each of these illustrated by specific examples. This is a useful framework for ongoing discussions since the ethical, legal and regulatory issues differ depending on the medical context of genome editing use, and whether the changes being made are heritable or not.”

Prof Kathy Niakan, Mary Marshall and Arthur Walton Professor of Reproductive Physiology and Chair of the Cambridge Reproduction Strategic Research Initiative, University of Cambridge, said:

“I very much welcome the recommendations of the WHO Expert Advisory Committee on the governance and oversight of human genome editing. The Committee has outlined an incredibly helpful and practical governance framework that supports continued development of basic research and clinical applications of human genome editing while acknowledging the complex considerations and challenges in the application of emerging technologies across a variety of contexts. The Expert Advisory Committee’s recommendations for human genome editing registries will be especially important and I look forward to contributing to and supporting the basic and preclinical research registry.”

Dr Helen O’Neill, Lecturer in Reproductive and Molecular Genetics, Institute for Women’s Health, University College London, said:

“The report is the first to consider a wide breadth of realistic applications for human genome editing and to address appropriate measures for governance from an institutional, national, regional and international level. There is an acknowledgement that good governance (much like good science), is an ongoing and interactive process and the report seeks to identify methods of strengthening oversight for those working in human genome editing.

“Context is the most critical aspect of setting frameworks within scientific policy and this report identifies that not only are there different uses for human genome editing, but different groups and therefore different challenges that must be accommodated at each level of regulation and advocacy.

“The need for consistent, regular and revised meetings is essential and will give strength to the practical application of the intentions of this committee and report.”

Sarah Norcross, Director, Progress Educational Trust, said:

“PET is delighted that the WHO sees the potential of genome editing to avoid, prevent, treat and cure disease, and has set out how to harness this fast-moving technology safely and ethically.

“The five ‘special challenges’ and seven ‘scenarios’ set out in the WHO’s Governance Framework are especially helpful, in working through how to establish good practice. The examples of genome editing discussed are multifaceted, and the measures and considerations proposed for dealing with difficulties are well thought out.

“Where applications of genome editing are less contentious – for example, therapies involving postnatal somatic genome editing – the WHO has correctly emphasised that there is still a need for high standards and equitable access.

“We are glad to see recommendations for building upon the WHO’s Human Genome Editing Registry, which is already proving to be a valuable resource. We are also pleased to see a call for enabling confidential reporting, of concerns about instances of genome editing that are unregistered or unsafe.

“PET trusts that this work by the WHO will help research and clinical uses of genome editing to thrive, for the benefit of humanity.”

‘Human Genome Editing: A framework for governance’ and ‘Human Genome Editing: Recommendations’, two reports by the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, were published online at 13:00 UK time on Monday 12^th July 2021.

Declared interests

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

None others received.