The 14-day limit on human embryo research risks the UK losing its lead
The UK is a world leader in embryology (Mohamed Osama / Alamy Stock Photo)
4 min read
The government has committed to modernising the regulatory system so it can keep pace with emerging technologies, and the UK can fully unlock the benefits of innovation.
Nowhere is the need for agile regulation more evident than in the field of fertility and embryo research, governed by the Human Fertilisation and Embryology (HFE) Act 1990.
The government has committed to modernising the regulatory system so it can keep pace with emerging technologies, and the UK can fully unlock the benefits of innovation. Nowhere is the need for agile regulation more evident than in the field of fertility and embryo research, governed by the Human Fertilisation and Embryology (HFE) Act 1990.
The UK is seen as a world leader in this field. However, with scientific developments increasingly outpacing UK regulation, we are now at risk of losing that innovative edge.
In 2023, the Human Fertilisation and Embryology Authority (HFEA) recommended that the government modernise elements of the HFE Act. Despite the clear and timely benefits to the UK life sciences of targeted updates, the government has not yet issued a formal response.
Built on the landmark 1984 Warnock report, the 1990 legislation underpins our world-leading regulatory framework – strict yet permissive – that has supported scientific progress while upholding strong ethical standards and public values.
But over the last 35 years, science has evolved in ways that were unimaginable when the legislation was first drafted. Despite this, the HFE Act has only been updated once and now risks becoming a barrier to innovation. For example, it has become possible to culture human embryos beyond the 14-day limit. This has prompted calls from the scientific community to review the rule, arguing an extension could unlock new research capabilities.
To provide Parliament and government with robust evidence on whether the time is right for change, the Nuffield Council on Bioethics (NCOB) has launched a major review of the 14-day limit – examining the ethics, science and public values surrounding embryo research.
Meanwhile, other emerging technologies such as stem cell-based embryo models (SCBEMs) and in vitro-derived gametes (IVGs) have fallen into regulatory grey areas. SCBEMs in particular – recently examined by the NCOB – highlight the risks of inaction. These lab-grown models, created from human stem cells, mimic stages of early human development. They have potential to improve our understanding of miscarriage, infertility, developmental disorders, and the safety of medicines during pregnancy. However, they also raise complex ethical and legal questions, particularly as the models may increasingly resemble human embryos.
While many countries are exploring reform, none has yet taken action
The UK has been a step ahead of other countries in developing a code of practice for SCBEM research. But in the long term, there are key risks that this model of self-governance cannot address.
Namely, if scientific advances begin to outpace public acceptability, there is potential for a reactive decision by a secretary of state, or the courts, to classify SCBEMs under existing embryo regulations. This would impose rigid, one-size-fits-all restrictions, stifling innovation. This isn’t theoretical: Australia has already seen SCBEM research effectively halted due to a similar legal interpretation.
To avoid this, we’re calling on the government to future-proof SCBEM regulation through targeted updates to the legislation. Firstly, to legally distinguish SCBEMs from embryos. Second, to legally uphold ethical ‘red lines’ – such as a prohibition on implanting SCBEMs into humans or animals for reproduction. And thirdly, to introduce a regulatory ‘sandbox’ to enable flexible oversight of SCBEM research and act as a testbed to future-proof regulation in this area.
There are clear advantages to acting while technologies like SCBEMs are still in their infancy and before the risks become critical. With time on our side, government and Parliament has an opportunity to take an iterative approach – guided by robust ethical analysis and meaningful public engagement – to design a framework grounded in integrity and public values that gives the green light to responsible innovation.
While many countries are exploring reform, none has yet taken action. As a pioneer of fertility and embryology regulation, the world is watching to see how the UK responds.
The government now faces a choice: act early to ensure the HFE Act is fit for the future – backing the UK’s life sciences sector and reaffirming our international leadership – or risk falling behind.
Danielle Hamm is director of the Nuffield Council on Bioethics
