UK legislation and regulation governing the use of gene editing

UK legislation and regulation governs research and treatment involving different types of human tissues and cells.

Somatic cells

Somatic cells are all the non-reproductive cells in the body ie all cells except for sperm and eggs.

Editing somatic cells in a research or clinical context is overseen by the Human Tissue Authority (HTA). This was created by the Human Tissue Act 2004, which regulates issues relating to human bodies, organs and tissue for research and transplantation.

Somatic therapies - eg where cells are removed from a patient and edited in a lab to correct a harmful mutation - are regulated by the HTA and licensed by the Medicines and Healthcare products Regulatory Agency

There is already some work using somatic therapies in diseases including HIV, sickle-cell disease and haemophilia, and there is emerging potential for cancer therapy. 

Germ cells and human embryos

The Human Fertilisation and Embryology Authority regulate the editing of human eggs and sperm (known as germ cells) in a research context, including human embryos up to 14 days old. This is permitted where the research is:

Editing of germ-cells or embryos in a clinical context is prohibited under UK law and is unlikely to be allowed in any European jurisdiction at present.

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Genetics, genomics and molecular biology

Understanding how genes, proteins and other molecules work together to perform the functions of life and what happens when these functions go wrong.

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