UK approves regulation on mitochondrial DNA donation

The UK has become the first country to approve regulations to allow mitochondrial donation – a new type of IVF that could prevent the transmission of mitochondrial disorders from mother to child.

Proposed regulations for the new techniques were laid before Parliament on 17 December 2014. On 3 February, the House of Commons approved the regulations by a majority of 382 MPs in favour, and 128 against. Yesterday (24 February), the House of Lords approved the regulations by a majority of 280 Peers in favour, and 48 against. The Council’s report was referenced several times during both debates.

In 2012, the Nuffield Council on Bioethics published its ethical review of novel techniques for the prevention of mitochondrial DNA disorders, and concluded that provided that the techniques were shown to be sufficiently safe and effective, and that families were appropriately informed and supported, it would be ethical for them to use them.

In addition to the Council’s ethical review, the process has been informed by a public consultation in 2012-13; three separate reports on the safety and efficacy of the techniques in 2011, 2013 and 2014; and a consultation by the Department of Health in 2014 about the detail of draft regulations, to which the Council responded.

Under the approved regulations, any use of the technique would remain subject to licensing approval by the UK fertility regulator, the Human Fertilisation and Embryology Authority (HFEA). Before a licence can be granted, the HFEA is required to give careful consideration to the safety and effectiveness of the techniques in the proposed context of use.

In its 2012 review, the Council made a number of further recommendations concerning the circumstances in which the techniques should be used, if they were to be approved. These include that:

• Information and counselling about the implications of these novel treatments must be provided to prospective parents by specialists with appropriate training and up to date information.

• Follow up and evaluation will be crucial to further knowledge about the outcome of these treatments. This could be supported by a centrally funded register of procedures performed in the UK that is available to researchers over several decade.

The approved regulation sees the authorisation of these techniques for the specific purpose of preventing the transmission of inherited mitochondrial disorders. This does not extend to techniques that might seek to alter any genes contained within the nuclear DNA – any such future technique would need to be considered separately.

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