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.

Comment

A number of misconceptions regarding the technique remain; however, some clarification was given during the House of Lords debate on 25 February:

• Lord Turnberg (Lab), [HL Hansard 24 February 2015 Vol 759(106) Col 1582. Referring to correspondence received, he said:

“References to GM crops and cloned animals are way out of line. Suggestions that mitochondrial transfer techniques are a form of cloning when they are nothing of the sort, or that they are on the slippery slope to genetic manipulation and designer babies when there is no conceivable link between them, are very unhelpful and not part of any reasoned discussion about the issues

• Viscount Ridley (Con) further explained, [Col 1587]:

“Describing mitochondrial donation as producing GM babies or, indeed, three-parent babies is using phrases that are wildly misleading. You cannot call someone with 0.1% of their genes and 0.054% of their DNA donated from somebody else the child of three parents. That is a misuse of the English language”

• and Lord Ribeiro, quantified the scope for the application of the draft Regulation, [Col 1605]

 “We are told that the numbers of those who will have severe disease is in the order of 10 or 20 per year”

Furthermore, the HFEA Briefing Note states:

“There are likely to be few very applications to carry out mitochondrial donation. At present, only one research team in the UK is likely to be in a position to offer it

Nevertheless, Christian Concern and a number of other groups remain concerned. The position of the Church of England was explained by the Lord Bishop of Carlisle during the HL debate, who indicated that over the last few years it had consistently taken “a fairly nuanced position on this subject” [Col 1585]:

“On the one hand, we are assured … that scientists are clear about both the safety and the efficacy of mitochondrial transfer. It is no different from giving a blood transfusion or changing the batteries, so there is no problem there. On the other hand, we are warned by scientists … that mitochondrial transfer is a form of genetic modification which does affect the germ line, albeit not the nucleus, and could have a potential impact on the traits of any children, and their children, born as a result of this procedure.

[…]

To reiterate, both personally and as a representative of the Church of England I am basically very much in favour of this development. However, I cannot ignore the compelling arguments against pushing this through in haste, and for that reason I am minded to vote for the amendment proposed by the noble Lord, Lord Deben.”

On 2 September this year, a group of leading UK research funders issued a statement calling for an urgent national debate on the ethics of genetically modifying human embryos and other tissues to prevent serious diseases, reviewed in our post of 8 September. With the Mitochondrial Donation Regulations now in force, this more contentious area will become the focus for debate. to patients in the near future.