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Further progress on licensing of mitochondrial donation follows public dialogue

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Further developments in the regulatory arrangements for mitochondrial donation are now in place, following the major public dialogue run by the Human Fertilisation and Embryology Authority (HFEA) in 2012 – 2013, with Sciencewise support.

The final stages of parliamentary approval came following a House of Lords debate on 24 February 2015. The debate included extensive mention of the consultation dialogue as part of the evidence base for the Government’s support for the regulations to be approved. For example, Lord Howe said the following in his introductory remarks (Hansard, col 1569):

“Over the last five years, there has been extensive engagement and consultation with the public on this issue, including, first, an ethical assessment by the Nuffield Council on Bioethics in 2012; secondly, a highly commended, respected and wide-ranging public dialogue and consultation exercise carried out by the HFEA in 2012-13; and, thirdly, a public consultation on draft regulations carried out by the Department of Health in 2014 … This process was commended in a recent letter to the Guardian from eminent scientists and Nobel Prize winners from the UK and across the world. The letter included this sentence: ‘the UK has run an exemplary and internationally admired process for considering benefits, risks, ethical issues and public consent, which must properly precede a change in the law’.”

The regulations to permit mitochondrial replacement then came into force on 29 October 2015 and the HFEA made plans to license and regulate mitochondrial donation. The development of these plans followed a further online survey and one-day workshop in London on 23 June 2015, to gain expert views. A two-stage licensing process was proposed – any clinic proposing to carry out either of the two techniques would need to apply to the HFEA for a license for the techniques, and then seek authorisation to undertake the treatment in the case of a particular patient. Clinics would also be required to submit information to the HFEA about the mitochondria donor, the patients being treated and sperm provider, and the treatment cycles. The HFEA developed consent forms, guidance for clinics, application forms for clinics to be licensed to use the techniques and to apply to use the techniques for specific patients. (

By February 2016, the only remaining steps that needed to happen before clinics could apply for the license were completion and publication of further research on safety and efficacy, followed by another scientific review and a final assessment of some safety tests that were recommended earlier. The HFEA confirmed the importance of the dialogue throughout the process: “the main outcome being that the public views have been reflected all the way along from developing draft proposals…  to signing off of the regulations and developing the licensing process.”(HFEA)

The HFEA also said: “The main point is that good evidence (which public dialogue brings) much reduces the risk of opponents challenging the policy development process, and so can avoid significant downstream legal costs”. (HFEA)

See related project page: Mitochondria Replacement