Statement on mitochondrial donation

As the UK’s regulator of the fertility sector, the HFEA will now develop a licensing framework through which applications can be considered from clinicians wanting to offer the two techniques set out in the regulations [1]. This will be a rigorous and robust process, which will draw on expert input from a range of sources and build on the already tried and tested licensing system the HFEA operates across the UK for families affected by genetic disease.

The regulations clearly set out how the HFEA must issue a specific licence to carry out mitochondrial donation treatment beyond any existing permission a clinic has to conduct IVF or other treatment. In considering applications, the regulations require the HFEA to assess the existing staff expertise, skill and experience at the clinic, as well as its equipment and general environment.

Each application will be decided on a case by case basis and in accordance with the latest scientific advice. An HFEA committee will determine whether individual patients and families have a particular risk of an abnormality in their mitochondrial DNA; and whether there is a significant risk that a child born with that abnormality will have, or will develop, a serious physical or mental disability, a serious illness or another serious medical condition.

Sally Cheshire, Chair of the HFEA, said:

“After many years of scientific and ethical debate, Parliament has decided today to permit the use of mitochondrial donation to give families with serious mitochondrial disease the possibility of having their own healthy genetic children. Britain is the first country in the world to permit this treatment, and it is a testament to the scientific expertise and well-respected regulatory regime that exists across the UK that Parliament has felt able to approve it. The HFEA now have to develop a robust licensing process, which takes into account on a case by case basis the technical and ethical complexities of such treatments to ensure that any children born have the best chance of a healthy life.

The HFEA has a long tradition of dealing with medical and scientific breakthroughs, ensuring that IVF techniques, pioneered in the UK and now practised across the world, can be used safely and effectively in fertility treatment. The British public can have confidence in our robust regulatory system. We will consider these latest techniques to prevent mitochondrial disease in the same careful and thorough way, so that the families of those affected, the clinicians who treat them and the wider public can have the same level of confidence in how we regulate mitochondrial donation.

Our patients are always at the heart of what we do and the families affected by the often devastating symptoms of mitochondrial disease should be no different. Our goal remains that everyone affected by assisted reproduction receives the highest quality care and support possible.”