Human Fertilisation and Embryology Bill [Lords]
Dawn Primarolo: This has been an interesting debate. There have been quite a few misunderstandings about the intention of the clause, which I hope that I can clarify.
Mitochondrial diseases are a collection of life-threatening conditions caused by mutations in the small amount of DNA found in the mitochondria. The mutations affect children and cause illnesses and other conditions such as fatal liver failure, stroke-like episodes, blindness, profound muscular weakness and diabetes. Research is currently being carried out under an HFEA licence to look at ways to avoid mitochondrial diseases.
In recognition of the severity of those conditions and the potential of this research to provide an effective treatment, the Bill provides, through a regulation-making power, for eggs or embryos that have had applied to them a specific process to avoid serious mitochondrial diseases to be considered as permitted and therefore used in treatment. The particular process and the particular circumstances in which it would be appropriate would be detailed in the regulations, and I want to come back specifically to how we would proceed with such regulations. First, I shall deal quickly with the amendments.
Amendment No. 1 adds the words or life-threatening, so that the technique could be used to treat serious or life-threatening conditions. I say very gently to the hon. Member for Boston and Skegness that, as I currently see it, that does not add anything to the Bill, which already allows for serious conditions, and clearly, life-threatening conditions are serious. The amendment seems unnecessary at that level, but it would also limit the way that the technique could be applied by restricting it to eggs only. That would mean that, if should it transpire, following research, that the best way to avoid serious mitochondrial disease would be through modifying recently fertilised eggs which would therefore, according to the definition in the Bill, be embryosit would not be possible.
If the regulating power were removed, there would be no flexibility to return to it in future. I want to be absolutely clear that the Bill provides limited powers for secondary legislation to ensure that the definitions of gamete and embryo are clear, and strictly limited powers to allow for the treatment of mitochondrial diseases at the embryonic stage. They are all affirmative resolutions by both Houses. There has clearly been some comment about what would precede the debates in both the Houses, and I shall come to that shortly.
Amendment No. 3 would amend new schedule 3ZA by including in the types of treatment for which counselling must be offered a specific reference to
On the relating power included in clause 3
Dr. Harris: Can the Minister clarify that there would not need to be counselling of the person providing the mitochondria in such a process, but just the couple having the child?
Dawn Primarolo: At this stage I am referring just to the couple. I am coming on to the regulation-making power, what it can do, how we would proceed, the sort of questions that may be raised, and why it is not currently possible to put that into the Bill because of the process of the research.
The regulation-making power in the clause is to make secondary legislation, and it is about helping couples to conceive a child without a serious medical condition. It is not about reproductive cloning on which the Government are absolutely clear and committed to a ban. The Bill makes crystal clear the definitions of what is a permitted embryo and therefore what can be placed into a woman.
To date, research is looking at transferring genetic material from a recently fertilised egg from the couple seeking treatment into a donor egg with the genetic material removed. That does not involve somatic cell material. It is not anticipated that it would. The commitment to the ban on reproductive cloning and oversight of the technique as a whole would be ensured by setting out the specific process in regulations, and those regulations would be subject to the affirmative procedure.
Dawn Primarolo: Will the hon. Gentleman be a little patient? He raised a lot of important issues in respect of how we will proceed with the regulations, and I intend to answer them.
It is not clear whether the research will demonstrate more success with eggs or embryos, hence the matter of whether it is specifically in the Bill. Although to date it focuses on very recently fertilised eggs, which under the Bills definition would be an embryo, we cannot rule out the possibility that eggs may offer the most successful treatment. It is therefore essential that the possibilities are not limited and that all treatment options are left open by ensuring that the prescribed process could be either for eggs or embryos.
In addition, details relating to the circumstances of mitochondrial donation can be provided for under the regulations as and when they are drafted and consulted onboth points made by the hon. Members for South-West Devon, for Southport and for Oxford, West and Abingdon. That would include consideration of whether all the donor information would apply to the mitochondrial donors. There is also scope to
Returning to the point made by the hon. Member for Salisbury about the importance that Parliament sets on broad parameters and the way that we have proceeded in all the debates since 1990, the first step would be to prepare draft regulations for consultation. Because of the issues that will be raised, a full consultation would be undertaken in much the same way as we have done in respect of many aspects of the Bill.
The results of the consultation would be considered. Amended drafts would be made available, if necessary for further consultation before matters came to this House and the other place for debate and affirmative resolution. Because there are so many questions that we cannot yet answer, the Bill provides for the principle, but not the meansthe regulations. They can be drafted only when the research is at a more advanced stage. That satisfies the dual principles that Parliament seeks to achieve. We want to approveand rightly sothe specific details of the techniques prescribed in the regulations.
The regulating power would allow for consideration and consultation. It would be necessary to gather the views of the public, ethicists and relevant stakeholders on the appropriateness of using donor eggs for that specific process. That would need to be considered at that stage. The Bill provides the flexibility for further consideration by the public and Parliament, and for the specific details of the techniques to be specified in regulations. More importantly, the Bill allows that once the safety of the technique is established and not before. The provisions of the Bill will provide opportunities for couples to have a child safe in the knowledge that they will not suffer from serious mitochondrial conditions that may affect their families. That is precisely the intent. On that basis, I hope that the hon. Member for Boston and Skegness will reflect on the fact that his amendments would weaken the intent and curtail the debate so that it can be held at the appropriate time, when we have more accurate indications of the science and what we might be agreeing to.
Dr. Pugh: The Minister used the phrase crystal clear. My point is that it is not crystal clear from the phrasing of the Bill that interference with somatic cells of the nucleus is prohibited. In fact, as the Bill is written, it is allowed. She has said that regulation will preclude that, but regulation is not legislation, and she might not be the regulator in the future. Would she confirm that? I know what the Governments intentions are and I know what the regulations are likely to address if she is the Minister, but the Bill as it stands allows what I said, even though it does not want to do so.
The second point that I want to make, briefly, is about the scope of regulation, which the Minister has not really responded to. We are debating a Bill about human fertilisation and we are allowing embryo,
Dawn Primarolo: I said to the hon. Gentleman that I did not agree with his interpretation. More people take my view than take his. This is precisely the type of debate that has taken place since the 1980s about interpretations of what is possible and of the law. I believe that the fears that he holds will not come to pass, and I am convinced that the Bill protects that. I am grateful for what he says about what he believes will be done if I am the Ministerthat would be the casebut I have absolute confidence that every parliamentarian in the House, whoever happened to be the Minister at the relevant time, would ensure that the scrutiny of the proposals was commensurate with the clear wishes of the House.
Dawn Primarolo: Just a minute, please. The clear wish of the Housein the past, now and in the futureis for the issues to be scrutinised thoroughly. The reverse would be true if we tried to put an incomplete definition in the Bill that did not stand the test of time because it was drafted before the knowledge was available.
Dr. Harris: I am grateful to the Minister for giving way to Opposition spokespeople who are probing her. I am grateful for her answer, which is clear as far as it goes. I raised a specific point that was made more generally by two other members of the Committee. Even if she proposes to do nothing about it, will she accept the principle of what regulations could provide, even if that is not her intention or, in her judgment, the intention of any future Minister? Is it her view that the provisions might permit a process designed to prevent the transmission of serious mitochondrial disease transmitted by nuclear DNA, not just by mitochondrial DNA? If she accepts that that is possible, and that people might therefore think that it is possible in the future by regulation, does she see any merit in having a look at that before Report to determine whethervery carefully and so as not to preclude any scientific advancethe provision could be narrowed sufficiently to make it absolutely clear to those who worry about a slippery slope and over-permissive legislation regarding genetic alteration that there may be scope to narrow things somewhat?
Dawn Primarolo: To answer the point about redefining or adding, which was raised by the hon. Member for Southport: no. It is simply incorrect to assert that they can be redefined by secondary legislation.
The hon. Member for Oxford, West and Abingdon is theoretically correct, and if he can think of a better way of doing that, that is fine. However, nobody has so far managed to do soincluding him, during pre-legislative scrutiny.
The Government have stated clearly that there should be a prohibition of genetic modification such as the Bill provides, so it is, frankly, dangerous for the hon. Gentleman to move into the sphere of what might theoretically be possible, even though it is prohibited, because he undermines the principles in the Bill to which he is committed.
I think we have had a very interesting debate. This is a very difficult areathere are not many simple areas in the Billbut I hope that the thoroughness of the consultation and the extensive contributions that have been made to the process satisfy members of the Committee that the Bill is as accurate and as well crafted as possible, and that there is therefore no reason not to proceed with the arrangements in the clause. When the hon. Member for Boston and Skegness replies, I sincerely hope that he will consider withdrawing his amendment, at least to allow further reflection, rather than pressing it to a Division.
Dr. Harris: I thank the Minister for responding to my point. I appreciate it when she addresses a point that I raise. I accept that there is a risk of being over-prescriptive for fear of something that is theoretically possible. She knows that I want to see something that allows Parliament to have confidence in regulation, but that is not over-regulatory as far as scientists, researchers and clinicians are concerned. I want something that allows this country to be seen as a properly regulated, ethical place in which to do research, but a place that allows research to go on.
I confess that I did not spot this issue in the pre-legislative scrutiny period. I do not find it easy to acknowledge that it was pointed out to me by Human Genetics Alert, an organisation that, I think, gets it wrong a lot of the time and interprets incorrectly some of the proposals that we are addressing. The Minister has accepted that there is a point here. I have not thought about what the drafting would be, but I think that she has given an invitation to others to look at whether there can be drafting that makes it very clear that we are not envisaging the alteration of nuclear DNA. She mentioned that the Bill provides for a ban on the alteration of nuclear DNA, which is found in proposed new section 3ZA(4), which states:
An embryo is a permitted embryo if...no nuclear or mitochondrial DNA of any cell of the embryo has been altered.
That situation is altered, as far as mitochondrial DNA is concerned, under subsection (5), or at least that is the intention. In other words, the ban that rightly exists on nuclear DNA alteration is in the same terms as the ban on mitochondrial DNA alteration, which subsection (5) overturns subject to regulations.
Although I am reassuredthe Minister knows I am reassuredof the Governments intention on the existing ban, other people may consider that this provision does allow regulations to make provision on that. While I accept the Ministers sincerity, and indeed
Dawn Primarolo: Does the hon. Gentleman accept that it is absolutely the Governments intention to ban this? I understand the point that he is making. Although I am utterly convinced that this work has been done, I will do all I can in this process as the Ministerincluding reflecting on the point he has madeto ensure that what I am saying is absolutely correct and there are no lacunae or any way that the situation could be undermined.
Dr. Harris: I absolutely accept the Ministers position and that she does not envisage any alteration to nuclear DNA being permitted under regulations. I also said that I agreed with her judgment that no other Government would permit this. Such interventions show her to be the thoughtful and helpful Minister who she is. It is extremely valuable that she has given us the opportunity to think further about whether action might be necessaryI accept that she does not say that it is necessary to do somethingand, if it is judged necessary, whether it can be done without being over-restrictive.
|©Parliamentary copyright 2008||Prepared 4 June 2008|