2 June 2019
Following the UK’s decision to legalise three-person IVF in 2015, the US looks set to revisit its policy on human genome modification of embryos. If US legal restrictions are removed, it will represent a policy volte-face in just four years, and it will be significant in more ways than one.
In 2015, a provision in the federal spending bill that funded the US government in 2016 banned the Food and Drug Administration (FDA) from considering clinical trials that created or modified the human genome in embryos. This brought US policy in line with conservative policy adopted by other countries across Europe, which viewed human genome modification as the start of a slippery slope towards inequality and human genetic engineering.
However, a 2019 draft federal spending bill has in the last few days dropped the ban on human genome modifications of embryos. If the US bill is passed into law, it will enable the FDA to approve clinical trials for three-person IVF. It could also mark the start of a more liberal approach to human genomic science and practice in the US. This would coincide with rapid innovation in science and technology in the genomic sector offering great potential for power, influence and wealth not to mention the advent of genetic tests that can screen out embryos likely to have a low IQ or high disease risk.
In the UK, after considered debate, parliament passed regulations allowing mitochondrial donation (three-person IVF) in February 2015 and regulatory frameworks followed in the UK in October 2015. However, it was not until December 2016 that the Human Fertilisation and Embryology Authority (HFEA) finally approved this technique for use on a licensed basis at UK fertility clinics after an independent scientific panel published its fourth set of findings on the technology’s safety and efficacy. In doing so, the HFEA stressed this technology would be used cautiously on a case-by-case basis for a small number of people affected by rare genetic diseases.
The US is currently at a critical turning point and its policy decision on human genome modification will carry a very significant future scientific and commercial legacy. So far, this issue has sat within wide-ranging federal spending bills. In determining future law and policy on this issue, it is important that the US adopts a careful and considered approach. If there is to be a more liberal approach to policy, will this be supported by a co-ordinated legal framework? There has recently been much debate about abortion law and policy in the US and it would seem much less debate around human genome modification. The debate around genetics is set to intensify in the years ahead and let us hope more time is dedicated to this in the US and across the world sooner rather than later.
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