Draft UK regulations for mitochondrial donation released

19 December 2014

The UK Government has released the draft regulations under which mitochondrial transfer (three-person IVF) would operate following a change in the law. MPs are due to vote on amendments to the Human Fertilisation and Embryology Act that would legalise the use of this technique, subject to regulations enforced by the independent Human Fertilisation and Embryology Authority (HFEA).

Mitochondrial transfer uses special cloning techniques (pronuclear transfer or maternal spindle transfer)  to create embryos using donor eggs with healthy mitochondria, but the majority of the genetic material removed and replaced with that from the egg of a woman who carries diseased mitochondrial. The aim is to create children who are genetically the offspring of a couple, but without inheriting mitochondrial disease from the mother. Normal IVF using donor eggs could create healthy children, but they would not be genetically related to the mother.

If MPs vote in favour of the change in the law early next year, the UK will become the first country where mitochondrial transfer is legal, with the first procedures expected to take place in 2015, although earlier experimental procedures are reported to have taken place in China. Opponents have voiced both ethical and safety concerns; there is also some debate as to the legality of the procedure with respect to international law.

It is expected that Wellcome Trust Centre for Mitochondrial Research in Newcastle would be the first centre to offer the procedure, although another in London might follow. Clare Ryan of the Wellcome Trust commented: “In the end, this is about providing families reproductive choice – they are the ones who are in the best position to look at all the reproductive possibilities and make up their own decision”.

The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations  put before Parliament say that:

  • The HFEA must assess each case for a significant risk of disability or serious illness
  • Clinics would need a new licence to offer the technique
  • The woman donating her egg would not be related to the child
  • Any child born would have no right to information about the donor

Taken together, these regulations might mean that only the most severely affected cases (perhaps ten per year) would be permitted, although as the total numbers of affected couples are somewhat greater there may be pressure for this to increase over time. 

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