Two major reports in the UK and USA have recently sanctioned as ethically acceptable genome editing of future generations for the treatment of serious rare inherited conditions.
This marks an important turning point in the application of recombinant DNA techniques to humans. The central question this paper addresses is how did it became possible for human genetic engineering (HGE) of future generations to move from an illegitimate idea associated with eugenics in the 1980s to a concrete proposal sanctioned by scientists and bioethicists in 2020?
In the USA, gene therapy emerged in clinical research on therapeutics and has been regulated as a medicinal product within a well-established and rigid structure that involves multiple agencies (e.g. FDA/ NIH). This has ensured that its development and governance has been kept firmly under the control of scientists and clinicians.
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In contrast, in the UK, IVF has not been governed as a medical therapy but within a novel and flexible framework involving a single centralized agency (HFEA). As a consequence, it has not been solely controlled by professional groups, and patients/ consumers have become influential actors in shaping policy…. This flexible regulatory structure allowed incremental changes to be made to policy and regulations and ultimately, the reframing of germline GEd as a reproductive technology.
