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United Kingdom: Germline / Embryonic

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Highly Regulated

Germline gene editing is permitted for research, but illegal for reproductive purposes.

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

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

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
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Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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