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Declaration on genome editing released by biotech companies

2 September 2019
Appeared in BioNews 1013

Companies harnessing genome-editing technology have announced their own declaration on the use of the technology.

The 'Statement of Principles' was issued as a direct response to the controversy involving Dr He Jiankui, who claimed to have produced the world’s first genome-edited human babies last November (see BioNews 977).

Dr He's experiment caused international outcry as he used CRISPR genome-editing to make heritable changes to the embryos which produced the twin baby girls. He deleted a gene called CCR5, with the aim of 'HIV-resistant infants'.

Now 13 major companies are pledging not to use genome-editing in germline cells in a document released by the industry advocacy group Alliance for Regenerative Medicine (ARM), and to pursue clinically-validated therapeutic research in somatic cells under national or regional regulations.

'Gene editing is a rapidly developing technology that represents one of the most exciting developments in medicine,' said Janet Lambert, the CEO of ARM on the launch of the declaration.

She added: 'As with all breakthrough biotechnologies, we need to exercise caution and good stewardship in our research and development practices and ensure that work involving the genetic modification of cells takes place within the bioethical framework outlined in these principles.'

The declaration contains five points mainly focusing on the therapeutic potential of genome-editing in somatic cells, while stressing the industry's commitment not to pursue human germline editing.

'We, as therapeutic developers utilising gene editing technologies, are solely focused on somatic cell approaches to therapeutic treatments and cures for disease,' said the document. 'Unless and until ethical and potential safety questions with respect to germline gene editing are adequately addressed, we do not support or condone germline gene editing in human clinical trials or for human implantation.'

The signatories include the company co-founded by CRISPR pioneer, Professor Emmanuelle Charpentier, CRISPR Therapeutics headquartered in Zug, Switzerland; Editas Medicine in Cambridge, Massachusetts, co-founded by Professor Jennifer Doudna; and Sangamo in Brisbane, California.

Meanwhile, the World Health Organisation (WHO), approved the first phase of a new registry to track human genome editing around the world. This will include trials using both somatic and germline genome editing.

'Since our last meeting, some scientists have announced their wish to edit the genome of embryos and bring them to term,' said Dr Tedros Adhanom Ghebreyesus, WHO's Director-General. 'This illustrates how important our work is, and how urgent.'

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