The draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 are now part of UK law. The Regulations were subject to the affirmative procedure and therefore required formal approval from both Houses of Parliament. Following the Commons vote 382 to 128 in favour, [3 Feb 2015 Vol 592(104) Col 160], it was the turn of the House of Lords, and the SI was approved following the rejection of Lord Deben’s “fatal amendment” by 280 to 48, [24 Feb 2015 Vol 759(106) Col 1569].
Introducing the draft Regulations, the Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con), explained [Col 1569]:
“[the] purpose of the Regulations is to enable women to have their own genetic children, free of terrible disease caused by disorders in their mitochondrial DNA. The Regulations do so by allowing healthy mitochondria from a donor to replace the unhealthy mitochondria in a woman’s egg or embryo.”
He briefly summarized the techniques involved, earlier parliamentary scrutiny of the draft SI, and the purpose of its various components, stating [Col 1570],
“Given the extensive scrutiny given to this issue during the life of this Parliament, I believe it is appropriate to allow this Parliament to decide whether to take the next step for mitochondrial donation, which can make meaningful progress to actually help families only with the passing of these Regulations. The two proposed techniques that would be allowed under these Regulations are maternal spindle transfer and pronuclear transfer. These replace the mitochondrial DNA, which contains a small number of unhealthy genes, with healthy mitochondrial DNA. Mitochondrial DNA is just 0.054% of our overall DNA. One important point to emphasise here is that none of the nuclear DNA, which determines our personal characteristics and traits, is altered by mitochondrial donation.”
The majority of the debate addressed the amendment moved by Lord Deben,
“To leave out from ‘that’ to the end and insert ‘this House declines to approve the draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 laid before the House on 17 December 2014 and calls on Her Majesty’s Government not to lay new draft Regulations until a joint committee of both Houses has been established and has reported on (1) the safety of the procedures permitted by the draft Regulations, (2) the compliance of the draft Regulations with European Union and domestic law, and (3) the key definitions used in the draft Regulations’.”
Lord Deben (Con) stated that he was not opposed to mitochondrial donation in principle, but with regard to the draft Regulations had reservations on two grounds: whether it was contrary to EU law, as had been suggested by “large number of Members of the European Parliament – from the right to the far left”; and in relation to its safety, following unsuccessful attempts at the use of one of the proposed techniques in China.
Lord Patel (CB) gave a short description of mitochondrial DNA disease and the two techniques that would be approved by the draft Regulations. With regard to the health and safety risks of some of the techniques, he agreed with Lord Deben that it is never possible to be certain that new medical procedures will be 100% safe or effective, although this applies to the whole of medicine—drugs, devices or surgery. Lord Winston (Lab) noted that there were very few available data for the first in vitro fertilization babies and that that was a step in the dark, as were pre-implantation diagnosis and sperm microinjection. He subsequently described his personal experience of the issues faced by patients, (Col 1591).
On the possibility of children being born infertile, the oral evidence to the HFEA was not on record on account of the niceties of academic publishing but it was indicated that it has now been sent to a journal for publication; the work referred to in China was a cytoplasmic injection not for replacing mitochondria, but for infertility treatment in older women, and used a procedure that was not allowed in the UK, [Col 1582]. Lord Patel concluded:
“In human embryos it has gone as far as it can to produce normal embryos, which, if implanted, there is no reason to believe would not develop into normal, healthy babies who would not carry the defective mitochondria. All we are doing today is allowing the regulator henceforth to decide, on a case-by-case basis, to issue a licence to those clinics for those mothers who request this treatment, and which are allowed to use both techniques that we currently know are safe while further research goes on”.
Lord Mackay of Clashfern (Con) gave his analysis of the legality of the draft Regulation, [Col 1600]:
“[u]nder domestic law it is clearly lawful since in 2008, this Parliament passed an amendment for the purpose of allowing such Regulations to be made. That is as clear as it can be, and you do not need to be a lawyer to think that it is possibly quite a good point … the courts are not very keen on reaching a conclusion that a deliberate action of Parliament is without point, so I feel very strongly that these Regulations in draft are lawful, within the domestic law of the United Kingdom.
“So far as I have understood the European treaties, they do not confer an authority as yet to interfere in the medical procedures within the member states. That is basic, and means that they cannot interfere or render unlawful a medical procedure such as the one proposed in these Regulations … no challenge, so far as I know, has been offered by the European Commission to the provisions in the 2008 Act—which of course would be the right place to challenge this, if it were unlawful ….
The second reason that I advance is that in the opinion of the noble Lord, Lord Brennan, a reference is cited to a treaty dealing with these matters which is outside the European Union. It has a number of members of the European Union as signatories, but it has not been signed by the United Kingdom, nor ratified of course by the United Kingdom, so it is not part of our law. That is the kind of law that deals with embryology in a way that might have been difficult for us if it had been part of the European Union.
… no amount of discussion in a Joint Committee can settle this matter. The only place it can be settled is in a court of law, either the domestic courts of the United Kingdom or, if necessary, the Court of Justice of the European Union in Luxembourg. In a sense, if that is a real point, the sooner the Regulations are passed the better so that they can be tested.”
The position of the Church of England was explained by the Lord Bishop of Carlisle, 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.”
A number of important points were raised during the four-hour debate, some of which are summarized above. Now that the Regulations have been approved, however, the most important consideration is how they will be applied. The Human Fertilisation and Embryology Authority, (HFEA) Briefing Note of October 2014 pointed out that Parliament’s approval of the draft Regulations does not, per se, directly lead to such treatments being offered in humans; the consequences are that mitochondrial donation now becomes part of the regulatory scheme set out in the Human Fertilisation and Embryology Act and administered by the HFEA. The Note states that the HFEA must now assess two things:
- that any clinic that wished 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 would 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 would, therefore, provide an opportunity for an assessment of the results of the further experiments suggested by the expert panel.”
“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 to patients in the near future.”
A subsequent post will summarize the law as it now stands.