Further progress towards the application of mitochondrial donation
Following the 15 December announcement by the Human Fertilisation and Embryology Authority (HFEA) that it had approved “the cautious use of mitochondrial donation in treatment, we posted “Three-parent babies” in UK from 2017?” The HFEA has now announced that it has granted the first UK licence to the team at the Newcastle Fertility at Life , which indicated that, realistically, the first child to be born using this technique would be in 2018 at the earliest. However, the UK will not be the first country in the world to have children born through the three-person technique; a Jordanian couple and doctors in New York performed the procedure in Mexico and the resulting baby is understood to be healthy.
On 30 November 2016, an independent expert panel, convened by the HFCA to undertake a review of mitochondrial donation techniques, recommended that approval be given for their “cautious” use in “specific circumstances”. The panel’s report includes a comprehensive review of global developments in pre-clinical research into mitochondrial donation, including the safety and the efficacy experiments that the panel recommended be undertaken in its previous report (in 2014) before clinical use of the Maternal Spindle Transfer (MST) and Pronuclear Transfer (PNT) techniques be permitted.
The panel’s report represented the first of four remaining stages towards the potential use of the techniques in treatment. The next stage was the meeting of the HFEA board on 15 December 2016 at which the panel’s recommendations were accepted. Following this decision, clinics wishing to offer the treatment must apply to the HFEA. On the same day, the Newcastle Fertility Centre confirmed that “within 24 hours [it would] be applying for a licence to help patients who risk transmitting mitochondrial disease to their children”. The Newcastle team aims to offer treatment for up to 25 women a year affected by mitochondrial disease but the treatment could be held back if they don’t have enough healthy donated eggs; the Newcastle Fertility Centre is looking for healthy women who are up to 35 years old to consider donating their eggs to help this cause.
The third stage of approval is now completed for the Newcastle clinic; this involved the consideration, by two HFEA committees, of different aspects of its application. The Licensing Committee assessed the clinic’s suitability, looking at existing staff expertise, skill and experience at the clinic, as well as its equipment and general environment. The minutes relating to this HFEA decisions are available via the HFEA web site here.
The Newcastle clinic may now apply to the Statutory Approvals Committee for permission to treat individual patients, as required by the regulations. Once approved the final stage of treatment can begin.
Other clinics seeking to use these techniques must first obtain their own individual approval via the third stage of the process before seeking to patients.