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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.

Collecting expert views

Throughout June, we collected expert views about some of the operational aspects of the mitochondrial donation regulatory system. Our online survey ran until 6 July and we also held a one-day workshop in central London on 23 June.

We asked for 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.

Please note that the survey is now closed. The background document below provides some information on the issues dealt with in the survey.

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: 30 November 2016