On Monday 1 September, MPs took part in the debate Mitochondrial Replacement (Public Safety), scheduled by the Backbench Business Committee and led by Fiona Bruce, (Congleton, Con). The introduction of Regulations to permit the selective use of mitochondrial transfer was discussed in the Westminster Hall debate on 12 March 2014, reported here, where for the government, Jane Ellison, the Parliamentary Under-Secretary of State for Health, confirmed that that the regulations will be subject to the affirmative procedure and will be debated it in full on the Floor of the House.
However, neither debate forms part of the formal process of introducing the necessary Regulations under the Human Fertilisation and Embryology Act 1990, a draft version of which is included as Annex B to the Department of Health consultation. The Government response to the consultation was published in July 2014 and states:
“[t]he Government has decided to proceed with putting regulations before Parliament, subject to giving further consideration to the Expert Panel’s recommendations, refining the draft regulations to take account of changes identified during the consultation, and discussion with the HFEA about an appropriate approval process. The Government will consider the timing of the regulations in the light of these actions. The regulations will be subject to full scrutiny by the public and Parliament through the affirmative procedure.”
Yesterday’s debate was initiated on the premise outlined by Fiona Bruce, [1 Sep 2014: Vol 585 Col 93], that:
“In 2011, 2013 and 2014, the Human Fertilisation and Embryology Authority or HFEA assessed the safety of the procedures, and on every occasion it reported that further research was required before the public could be satisfactorily reassured regarding them. It described experiments as “critical”, with some not even having started in June 2014. It stated that:
“there are still experiments that need to be completed before clinical treatment should be offered. The panel considers that some of these experiments are critical and others desirable.”
“Even more concerning, it stated, was that “the process cannot be expected to guarantee safety or efficacy when applied for the first time in a clinic.”
In other words, to allow these procedures at present would be tantamount to experimentation.”
Summarizing the lengthy and lively debate, the Parliamentary Under-Secretary of State for Health (Jane Ellison) noted [1 Sep 2014: Col. 119] that a power to introduce regulations to allow mitochondrial donations was introduced in 2008, when Parliament agreed amendments to the Human Fertilisation and Embryology Act in anticipation of the current ground-breaking developments. The Government has requested the Human Fertilisation and Embryology Authority to convene a panel of experts three times since 2011 to review the scientific evidence on the safety and efficacy of the proposed donation techniques: all three reviews have indicated that the donation techniques—maternal spindle transfer and pronuclear transfer—would be effective, and all three reviews have found no evidence to indicate that either technique would be unsafe. Its chair has stated:
“In three years’ study the expert panel has seen no evidence which suggests that these new mitochondrial replacement therapies are unsafe.”
The Minister further stated:
“Mitochondrial donation is supported by both the chief medical officer, Professor Dame Sally Davies, and many clinicians and IVF experts, including, I am pleased to say, Professor Lord Winston, who has been quoted a number of times in the debate. Among other comments, he has made it clear that he supports the draft regulations and would vote for them.”
“On the issue of three parents, I mentioned—as have others—that we cannot reduce parenthood to a matter of 37 genes from a donor. It is about so much more than that, and our draft regulations refer to some of the safeguards in place.”
The debate concluded with the resolution:
“That this House takes note of the Human Fertilisation and Embryology Authority’s most recent scientific review into the safety and efficacy of mitochondrial replacement techniques which highlights concerns for subsequent generations of children born through maternal spindle transfer and pronuclear transfer; welcomes the recent comments of scientists including Professor Lord Winston that, prior to the introduction of such techniques, more research ought to be undertaken and a full assessment conducted of the potential risk to children born as a result; and calls upon the Government, in light of these public safety concerns, to delay bringing forward regulations on mitochondrial replacement.”
The technical and legal issues associated with mitochondrial transfer are summarized in our post “Three Person IVF” and the law. The views of Professor Lord Winston were cited by both supporters and opponents of the introduction of the IVF techniques at the current time, and included in the resolution. We will follow the progress of the Regulations through the affirmative procedure with interest, particularly any comments made by Professor Lord Winston.