My Lords, I can confirm to my noble friend, and to the noble Lord, Lord Hunt, who asked a similar question, that the expert panel stated that the further experiments that it recommended could take place either before or after the passing of these regulations. However, they must be done before treatment can take place. I hope that that is sufficient reassurance.
The noble Lord, Lord Alton, and the noble Baroness, Lady O’Loan, spoke about the risk of ovarian hyperstimulation syndrome. OHSS is a well recognised side-effect of the drugs used to stimulate a patient’s or donor’s ovaries to collect multiple eggs for use in fertility treatments. The risks of OHSS are very well understood, with patients and egg donors carefully monitored. The HFEA’s code of practice requires women undergoing ovarian stimulation to be given information about the possible side effects and risks, including OHSS. Women are informed of the symptoms to look out for and are warned to contact their clinic if they feel unwell. Women donating eggs for use in mitochondrial donation will not be at any increased risk of developing OHSS.
The noble Lord and the noble Baroness both questioned the practice of paying for donated eggs. I submit that there is nothing sinister in that. Within the legal framework of the HFE Act, the HFEA sets the rates for compensation to donors of eggs or sperm; £500 for an egg donor is well within those limits. It certainly is not a sign that Newcastle University is anticipating the introduction of the regulations to allow mitochondrial donation. It is continuing its research and has an ongoing need for donated eggs for that purpose.
I turn now to the issue of definitions. In making the regulations, the Government have been clear about their approach, the definitions used and the source of their material. The Government’s consultation on the detail of the regulations set out very clearly: the definitions of scientific terms; the detail of the techniques that the draft regulations would cover; the terms that others might use, such as “genetic modification”; and the proposed approach to information for donors and those conceived through mitochondrial donation.
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My noble friend questioned why we do not consider these techniques to amount to genetic modification. Mitochondrial donation does not alter the nuclear DNA which defines personal characteristics and therefore, in our view, does not constitute genetic modification. In the absence of a universally agreed definition of genetic modification in humans, the working definition was developed with the Chief Medical Officer in order to bring some clarity to the discussion about these processes. Opponents have not been able to offer a scientifically based alternative and the British Fertility Society, among others, has been happy to adopt the Chief Medical Officer’s working definition.
My noble friend also asked why we have not separated the two techniques in these regulations. I say to him and to the noble Lord, Lord Hunt, that the expert panel convened by the HFEA stated in its 2014 report that,
“based on 2014 considerations the panel still believes that there is at present insufficient evidence to choose between PNT and MST as a preferred technique”.
The Government are therefore satisfied that there is sufficient scientific evidence to justify Parliament being asked to consider regulations to enable the use of two mitochondrial donation techniques in clinical practice. As I have said, it will be for clinicians in consultation with families to decide which technique would be best in each case. It is worth noting that the HFEA’s public dialogue showed a considerable level of public acceptability for both techniques.
My noble friend also referred to the ComRes poll and suggested that we had somehow unfairly dismissed it. The ComRes poll was commissioned by the CARE organisation—Christian Action Research and Education—which I understand opposes the introduction of mitochondrial donation. An evaluation of the survey was conducted by Pier Logistics and Gene Rowe Evaluations. The evaluators considered the survey to be a deeply flawed piece of work. They criticised the intentional use of what they described as,
“sensationalist, inflammatory and misleading language to characterize the debate”.
There was also considered to be:
“An unreasonable degree of selectivity within respondents’ informational options and the intimation of an exercise focused on the generation of self-ordained results”.
The evaluation summary commented that the survey was,
“a good example of poor public consultation”.
As I have already set out, there has been extensive independent consideration of these issues during the lifetime of this Parliament. Noble Lords should not have the mistaken impression that the Government have in any way been acting in haste, as suggested by the right reverend Prelate the Bishop of Carlisle and the noble and learned Baroness, Lady Scotland. Mitochondrial donation has been subject to,
“more scientific review of its proposed process than any other medical technology”.
That is a description by independent commentators.
I can confirm to the noble Lord, Lord Hunt, that Parliament gave extensive consideration to the amendments to the 1990 Act in 2007-08—an occasion
he and I remember well—including the regulation-making power that provides for these regulations. In addition to the scrutiny of the programme of assessment that I outlined earlier, the HFEA and I have offered briefing meetings for Peers to update them on the issues and more than 130 Parliamentary Questions have been answered on the subject in this House alone. Incidentally, there have been three debates in the House of Commons— not just the 90-minute debate on the regulations, where I should perhaps mention that the majority in favour was almost three to one.
The House allows for an affirmative debate to approve regulations and the Government have followed due process in establishing this, as soon as practical after the debate in the other place. I need to make it clear as well that it was never the intention to debate these regulations in the Moses Room. It was always quite rightly envisaged that we should consider them on the Floor of the House. As I have said, further delay would not be doing the right the thing for families who desperately want to have the choice to access these new techniques. Nor would it send the right signal to UK science, which has been researching in this area for very many years and reasonably wishes to see this work translate into help for patients.
My noble friend urges the House to send the matter to a Joint Committee. These issues have been considered by both the Commons Science and Technology Committee and the House of Lords Select Committee on Secondary Legislation. The Commons committee wrote to the Government stating that there was sufficient information for Parliament to make an informed decision and urged the Government to bring forward regulations.
I will now conclude. In introducing the regulations I outlined the rolling programme of work that has gone into assessing the safety and efficacy of these techniques, as well as their ethical and public acceptability. That process has, I believe, been admired and commended across the world. So much progress has been made in the lifetime of this Parliament that in the Government’s view it is right that Parliament should now have the opportunity to vote on whether to allow the families who wish to use these techniques to have children free of the devastating consequences, which we have heard about from noble Lords, within a robust regulatory framework. The request to the Department of Health to develop these regulations was made at the start of this Parliament in 2010. The subsequent in-depth consultation and assessment has taken place through the lifetime of this Parliament. It seems highly appropriate that we complete the task by approving the regulations today.