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Reported by Kate McNeil, CSaP Communications Coordinator and Jonny Hazell, Senior Policy Advisor at the Royal Society
Genome editing technologies are a 21st century innovation that enables much faster, easier, and cheaper modification of DNA sequences compared with previous generations of genetic modification technologies. They are also much more precise than previous genetic technologies, as genome editing works by targeting specific sequences of DNA. Even so biology does not allow for complete control over editing outcomes. Consequently, there remains a risk of disrupting a separate genetic sequence from the one being targeted, or that the intended edit to a genetic sequence is not made as desired.
In the autumn of 2020, members of the CSaP Policy Leaders Fellowship gathered to hear from experts working at the cutting edge of genome editing research, with the goal of understanding the state of these technologies. Throughout the discussion, the policy leaders heard from four University of Cambridge academics – Dr Simon Bullock, Professor Anne Ferguson-Smith, Dr Kathy Liddell, and Professor Kathy Niakan – about the potential applications of genome editing technologies and the regulatory frameworks which govern their use.
Applications of Genome Editing
By making modifying DNA easier and more precise, genome editing has greatly expanded the range of products that can be produced by manipulating genetic material. In a major breakthrough, it has enabled medical applications based on changing human DNA, with multiple current clinical trials for products intended to cure genetic diseases. Genome editing has also accelerated the process of developing new plant and animal varieties, with major potential ramifications for agriculture. For example, genome editing products increase the feasibility of producing varieties with characteristics that address societal concerns, such as reduced dependency on both synthetic inputs for plants and antibiotics for animals. Other areas for the potential application of genome editing include biodiversity conservation – where gene drives could be used to remove invasive species from vulnerable ecosystems – and developmental research into the characteristics in plants, animals, and the first 14 days of human development.
Regulation
Genome editing is challenging existing regulatory frameworks for genetically modified organisms and prompting the development of new frameworks for previously inconceivable applications. The only current application that is easily accommodated by existing frameworks is somatic genome editing to treat genetic disease as this is effectively covered by protocols for advanced medical technologies. Meanwhile, germline genome editing – which results in heritable changes - is explicitly prohibited in all countries that have a policy covering the technology, including the UK.
In the context of applications in humans, there are several distinct regulatory challenges which lie ahead for both somatic and germline genome editing. This includes the potential future need to reform the rules limiting embryo research as scientists develop germline genome editing and the ethical and regulatory questions arising from whether to allow genome editing to enhance so-called characteristics such as physical appearance or cognitive ability. In the context of plants and animals, the big question is whether these should be regulated as genetically modified organisms (GMO).The United Kingdom is presently holding a public consultation on this to determine the future of its approach following Brexit.
Participants in the Policy Leaders Roundtable suggested that one possible approach for a future UK regulatory framework would be to focus on the outcomes realised with genetic technologies rather than the technologies themselves. Such an approach would also be resilient to the emergence of new technologies or new uses of current technologies, such as producing desired outcomes through epigenetic manipulation rather than genetic manipulation.