Gene editing research in human embryos is permitted, but requires a license from the Human Fertilisation and Embryology Authority (HFEA). Gene editing for reproductive purposes is illegal. In 2016, HFEA permitted the first sanctioned studies applying CRISPR to human embryos, although scientists are permitted to only study embryos for research purposes and are prohibited from transferring them for pregnancy and birth.
Human gene editing is regulated by the HFEA through the 1990 Human Fertilisation and Embryology Act. Updates in 2008 to the Act created a regulatory pathway that allows for non-reproductive human embryo gene editing. Under the Act, research is only allowed on embryos of up to 14 days of age and requires an HFEA license. Implanting edited embryos or using them for treating patients is prohibited. Two EU regulations, Directive 2001/20/EC and Clinical Trials Regulation (CTR) EU No 536/2014, also prohibit germline gene editing in gene therapy clinical trials.
In 2015, the HFEA decided that mitochondrial replacement therapy, popularly known as ‘three-parent IVF’, is “morally permissible” if it is in the future child’s interests and does not add to the kinds of inequalities that already divide society. The UK government does not regard the mitochondrial donation techniques as genetic modification and instead decided to regulate them separately.
Products/Research
- “Three person baby”: In 2017, the Human Fertilisation and Embryology Authority (HFEA) the first license for mitochondrial replacement therapy, to correct faulty mitochondrial DNA, was granted to the Wellcome Centre for Mitochondrial Research at Newcastle University.
- Human development research: In 2016, the HFEA granted permission for the first time to use CRISPR gene editing in human embryos, for research purposes only.
Regulatory Timeline
2018: The Nuffield Council on Bioethics declares that “changing the DNA of a human embryo could be ‘morally permissible’ if it is in the child’s best interests.”
2016: The Human Fertilisation and Embryology Authority (HFEA) approves CRISPR gene editing research for the first time but banned the transfer of embryos for pregnancy or birth.
2015: Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 become law, allowing mitochondrial replacement therapy to correct faulty mitochondrial DNA.
2008: Human Fertilisation and Embryology Act 2008 passed, which allows researchers to obtain a license from the HFEA to edit human embryos for research purposes only.
1999: Council of Europe, an international organization distinct from the European Union, Convention on Human Rights and Biomedicine declares “an intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.”
1990: Human Fertilisation and Embryology Act 1990 passed, creating the Human Fertilisation & Embryology Authority of the United Kingdom. While the act contains human germline regulations, it includes no specific language on germline gene editing.
NGO Reaction
The Anscombe Bioethics Centre, a Catholic bioethics institute in the UK, argues that germline gene editing is “destructive” and “unethical experimentation on human beings at the earliest stage of their development.” The institute believes that gene editing would be legitimate “only where it is safe and beneficial for the individual patient and not where it aims to affect future generations.”
Additional Resources
- Genes and Science’s FAQ on gene editing
- Library of Congress summary of England gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
