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.
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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:
- appropriately justified
- supported by rigorous scientific and ethical review.
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.
If you have any questions, contact Sarah Rappaport
Understanding how genes, proteins and other molecules work together to perform the functions of life and what happens when these functions go wrong.
Science policy affects a broad range of issues, ranging from data sharing and gene editing, to intellectual property and regulation.
Regulation creates an environment where research and innovation can flourish.