HFEA permits cautious use of mitochondrial donation in treatment, following advice from scientific experts

This means that specialist IVF clinics wanting to offer maternal spindle transfer (MST) or pronuclear transfer (PNT) to patients may now apply to the HFEA for permission to do so.

The decision comes two weeks after an independent expert scientific panel convened by the HFEA published its fourth review into the safety and efficacy of mitochondrial donation. The panel recommended that the technique can be used cautiously for risk reduction treatments in certain cases where alternative treatments would be of little or no benefit to mothers at risk of passing mitochondrial disease onto their children [1].

HFEA Chair, Sally Cheshire, said of the decision:

“Today’s historic decision means that parents at very high risk of having a child with a life-threatening mitochondrial disease may soon have the chance of a healthy, genetically related child. This is life-changing for those families.

“After a lot of hard work and invaluable advice from the expert panel, who reviewed the development, safety and efficacy of these techniques over five years and four reports, we feel now is the right time to carefully introduce this new treatment in the limited circumstances recommended by the panel.

“Although it is tempting to rush ahead with new treatments, the UK approach of testing public opinion, putting the issue to parliament and carefully monitoring laboratory research has proved to be the most responsible and sustainable of introducing new, cutting edge treatments into the clinic. Such an approach has allowed us to balance innovation with safety, maintaining public trust as we go.”

END QUOTE

Parliament passed regulations permitting the use of MST and PNT in February 2015, and the regulatory framework has been in place since October 2015, but clinics had been advised to wait until after the HFEA had considered the panel’s recommendations before applying for permission to offer mitochondrial disease to patients. Thus the Authority’s decision represents another step towards the potential use of the techniques in treatment.

Now, clinics must apply to the HFEA for permission to offer mitochondrial donation to patients. The HFEA’s Licence Committee will first assess a clinic’s suitability, looking at existing staff expertise, skill and experience at the clinic, as well as its equipment and general environment. Once this stage has been passed, licensed clinics may then apply to the Statutory Approvals Committee for permission to treat individual patients, as required by the regulations [2]. Only when these committees have both approved the application can the final stage – treatment – begin.

ENDS

Notes to editors:

[1] Find the Panel’s report and accompanying press release

[2] Find the full regulatory framework