International policy and ethics in human genome editing: An overview of position statements

Abstract

Background & Aim For more than two decades, scientists have been developing genetic engineering and manipulation technologies for industrial, agricultural and medical purposes. However, until recently, clinician-researchers have had with limited success in translating them into useful clinical applications. The expansion of gene modifying technologies in translational research is accelerating with the availability of easily accessible and inexpensive modification tools, such as the CRISPR-Cas9 system. This simple, cost-efficient, cut-and-paste tool has given rise to the moniker ‘gene editing’. Whether gene editing raises any fundamentally new or different ethical issues than those raised with earlier gene modifying technologies is unclear; especially around heritable germline modifications in humans. Yet, the controversy that exploded in 2018 around revelations that a Chinese scientist had (apparently) modified the CCR5 gene of twin baby girls suggests that, at least, some of those issues remain unresolved, and that any social consensus to move forward with this technology in germline applications remains far away. Methods, Results & Conclusion This paper provides an overview of the international science policy landscape emergent since CRISPR-Cas9 was first used to edit the genes of human embryos in 2015. I summarise key ethical and policy positions issued by major regulatory institutions in the US and the EU, starting with the 2015 Summary Statement of the International Summit on Human Genome Editing, which was subsequently reiterated by the organisers of the second meeting held in November 2018 where details of the children born with modified genes were presented. Positions generally held that the use of genome modifying technologies in developing somatic therapies was ethically acceptable and ought to be encouraged. However, while they agree that it remains technically premature to develop this technology for germline therapies, there are some discrepancies over the ethics of eventually doing so once safety barriers are overcome. I discuss these positions with reference to ethical frameworks that aim to encourage responsibility in the clinical translation of genome modifying technologies, and conclude with mention of guidance being developed at the World Health Organisation and the WHO Collaborating Centre for Bioethics in Singapore.