Mitochondrial replacement

In February 2015 Parliament approved regulations to permit the use of Maternal Spindle Transfer (MST) and Pronuclear Transfer (PNT) to avoid serious mitochondrial disease.

When the regulations come into force on 29 October 2015, we will license and regulate mitochondrial donation.

We have designed a proposed system to do this. Before a clinic will be able to carry out either of these techniques it will need to follow a two-stage licensing process: it will need to apply to us for a licence for PNT and/or MST and then seek authorisation to undertake the treatment in the case of a particular patient.

Clinics will also be required to submit information to us about the mitochondria donor, the patients being treated and sperm provider, and those treatment cycles.

We want your views

We would like your expert views about some of the operational aspects of this system. We would like to hear views (particularly from HFEA licensed clinics, relevant patient groups/charities, mitochondrial disease centres, and those with expertise relevant to mitochondrial genetics and inheritance) on issues, such as:

  • what the patient case-by-case application process will look like
  • what mechanisms should be in place for follow-up, and
  • other requirements, such as donor screening requirements and staff competency.

We are seeking your expert views via an online survey and a one-day workshop in central London on 23 June 2015. The workshop will run from 11am (registration from 10.30am) until 4pm.

How do I complete the survey?

Before completing the survey please read our plans in the background document below. This is designed to get you thinking about our proposals and key questions to consider.

Having read our plans, please complete our online survey by 6 July 2015.

How do I sign-up for the workshop?

To register for the workshop please email with your name, role, clinic/organisation and contact details. Please register before 10am on 17 June 2015.

Please note that if the workshop is oversubscribed we may need to limit the number of clinic staff that can attend from any one clinic.

What is mitochondrial donation? Lay summary

The following lay summary explains some of the more complex issues involved in what is a specialist and rapidly moving area of biomedicine.


Page last updated: 18 June 2015