Bioethics Blogs

UK Seeks Regulatory Advice for

Doug Turnbull, Director of the Wellcome Trust Centre for Mitochondrial Research. Photograph: Christopher Thomond for the Guardian

How does one go about regulating the world’s first cross-generational biological experiment in human germline modification? The regulating body in charge isn’t exactly sure. They’re seeking input via an online survey by July 1, 2015.

The technique in question, called mitochondrial replacement or three-person IVF, would combine genetic material from three different people into a single embryo, causing permanent changes to the human germline, in the hopes of allowing a woman to have a child who resembles her in all but her mitochondrial disorder.

The UK actually has a law against genetically modifying human embryos for reproductive purposes, but a tireless push from a small group of the UK science elite over many years ultimately swayed Members of Parliament in both the House of Commons and the House of Lords to allow a limited exception to be made for only this technique, and for only the prevention of serious mitochondrial disorders.

Arguably, those campaigning for this political shift didn’t always fight fair – safety requirements such as clinical testing on non-human primates were discarded half-way through when experiments failed to work; the phrase “genetic modification” was redefined to diminish the severity of the techniques; the impact of mitochondria on a wide array of traits was repeatedly misrepresented; and evidence of serious safety and efficacy concerns was routinely downplayed, if not outright ignored.

Now, the Human Fertilisation and Embryology Authority (HFEA) faces the daunting task of having to determine a system to regulate these techniques within fertility clinics before the regulations come into force October 29, 2015.They are currently seeking views from experts.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.