The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 SI 572 came into force on 29 October 2015, and through Part 2, “provides for specified eggs and embryos, which contain donated mitochondria, to be permitted for use in assisted conception treatment under section 3(2) of the Human Fertilisation and Embryology Act 1990 (“the 1990 Act”) in certain circumstances.”
However, as pointed out in the Human Fertilisation and Embryology Authority, (HFEA) Briefing Note of October 2014, Parliament’s approval of the draft Regulations did not, per se, directly lead to such treatments being offered in humans; the consequences were that mitochondrial donation became part of the regulatory scheme set out in the Human Fertilisation and Embryology Act and administered by the HFEA, under which it is required to assess two things:
- that any clinic that wishes to offer mitochondrial donation is competent to offer it; and
- that each case of treatment is appropriate, using criteria set out in the Regulations.
The decision will rest with an HFEA committee and will be based on the evidence submitted and the latest scientific advice. The committee will, in effect, carry out a further assessment at the time of the application of the safety and efficacy of the proposed technique. This will, therefore, provide an opportunity for an assessment of the results of the further experiments suggested by the expert panel. Continue reading