Human Fertilisation and Embryology Bill [Lords]

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Dawn Primarolo: The issue that the hon. Gentleman raises is not a new problem with regard to the interpretation of the regulations. Clearly, an embryo outside the body is subject to regulation. However, he touches on a practical issue for researchers and regulatory authorities regarding of the purpose of research. I said that when an egg is developing into an embryo, either a licence would be needed, or the egg would need to be destroyed. That is the position.
In answer to the hon. Gentleman’s second question, that matter was carefully considered. At every point, the struggle—if I may put it like that—in drafting legislation is to come up with definitions that clearly define regulation and therefore make the legality of the regulation work. The Government settled where they did on that basis. During the debates on the Floor of the House we found, as I am sure we will find time and time again as the Bill progresses, that there were very fine judgments and difficulties when going from biological definitions and trying to permit scientific development and then putting that into legislation so that it is capable of regulation.
Dr. Harris: I am grateful to the Minister for addressing those points, and I beg the forgiveness of the hon. Member for Boston and Skegness for responding to the Minister’s comments before he finishes the debate. On the second point, the Minister is clearly saying that all options were considered and that this one was decided on for good reasons. One must accept that at this stage. I was interested to hear that the practical issue for researchers working on eggs could be dealt with in one of two ways. First, she said that that could be licensed. Obviously that would be possible, although it would be a burden if the intention of the research was not to produce an embryo or something capable of resulting in an embryo.
The Minister’s other option was that the egg would be destroyed. Perhaps she cannot give me more detail now, but if she could clarify what she means by that in a letter, I would be grateful. Is she saying that if this was unlicensed work, but the researcher noticed that an egg was dividing on its own, as long as that egg was destroyed, there would be no question of the researcher having to get a retrospective licence or being prosecuted? That would be a significant reassurance for researchers, some of whom have contacted me to raise their concerns. I ask her to confirm that now, or to offer useful clarification in a letter to me and other members of the Committee.
Mark Simmonds: As I said at the beginning, these are probing amendments. I thank the Minister for her thorough and detailed response and her clear answers both to the amendments and to the comments made by the hon. Member for Oxford, West and Abingdon. It was never the intention of the amendment to remove research on single-cell embryos from the law. We were looking for greater clarity, not a loss of clarity. Of course, I accept the prohibitions that are set out and detailed in this part of the Bill. I also accept the challenges that the Minister highlighted of translating biological definitions into legislative drafting and structure. It is always a challenging journey to do that, and that will be a common theme as we go through the Committee stage. It is a challenging juxtaposition to get those two things right. With those comments, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
The Chairman: Those who have served on Committees under my chairmanship before know that I take a fairly relaxed view of stand part debates and breadth of discussion. It is often helpful for the Committee to have a broad-ranging debate on a first set of amendments as it tends to set the discussion in context. However, I am not prepared to permit two stand part debates, one at the beginning and one at the end. Inevitably, in this context, with a fairly narrowly drawn clause, we have already had a fairly broad debate so I suspect that I may be minded to consider that a stand-part debate is not necessary. It is only fair that I should tell the Committee that now.
Clause 1 ordered to stand part of the Bill.

Clause 2

Meaning of “nuclear DNA”
Question proposed, That the clause stand part of the Bill.
Mark Simmonds: I just have a brief question for the Minister about the definition of nuclear DNA. Why does the clause not include a definition of mitochondrial DNA, which is obviously different from nuclear DNA?
Dawn Primarolo: The clause specifically deals only with nuclear DNA, and it was required only to ensure that the new definition in section 2 of the 1990 Act actually clarified the term “nuclear” to include the pronucleus of an embryo. That was specifically what we were trying to do here. We did not go on to define “mitochondrial” for the same reason that I gave the hon. Gentleman with regard to the definition of fertilisation in terms of where it was anchored in 1990. There is an accepted standard biological term in the case of “fertilisation”, as there also is in the case of “mitochondrial” and therefore it was considered not to be necessary.
Mr. Gary Streeter (South-West Devon) (Con): The Minister says that the Bill deals only with nuclear DNA, but proposed new section 3ZA(2) and (3) refer to “nuclear or mitochondrial DNA.” Surely that would warrant a definition.
Dawn Primarolo: The answer that I just gave to the hon. Member for Boston and Skegness was that we did not define “fertilisation” because it was not necessary to have a definition, since there was a clear biological meaning for HFEA to interpret. The same is true of “mitochondrial.” What was necessary was to clarify DNA to include the pronucleus, and that is why clause 2 is here. The biological definition of “mitochondrial” stands in the same way as that of “fertilisation”.
Mark Simmonds: I am intrigued by this because later on in the Bill we are going to be discussing allowing mitochondrial DNA to be implanted to stop mitochondrial disease, but prohibiting nuclear DNA from being manipulated to stop nuclear DNA diseases being transferred. There is a distinct difference between the two kinds of DNA, depending on where they are located within the cell. That is why I am intrigued as to why there is no distinct definition between the two.
Dawn Primarolo: And the answer I am giving is that, where a definition is contentious, where it is challenged, as it was between “nuclear” and “pronuclear”, it is necessary to define. Where it is not, as with “fertilisation” and “mitochondrial”, it is not necessary because the biological terms stand. It is not that the Bill is silent on this: it is anchored by the clear understanding.
Robert Key (Salisbury) (Con): What a pleasure it is to serve under your chairmanship, Mr. Gale. Clause 2 of the Bill refers at the end of the first line to
“the definition of ‘non-medical fertility services’”
in section 2(1) of the 1990 Act, but the 1990 Act does not mention “non-medical fertility services”. It is rather important, since we are dealing with definitions right at the start of the process, that we are absolutely sure what is meant by the term “non-medical fertility services”—the phrase is in quotes in the Bill. I am not at all sure at the moment.
11.15 am
Dawn Primarolo: I shall make sure that the hon. Gentleman and the members of the Committee have a full definition of what that means, to ensure that they understand the position. I have a feeling that it will come up later, when we discuss the European Union tissue directive. I am trying not to jump ahead of myself in the Bill.
Dr. Harris: The Government, with the draft Bill, helpfully provided the 1990 Act as amended by the regulations—I think that they were the European tissue directive regulations. The regulations inserted the reference to “non-medical fertility services”. Those services would be
“any services that are provided, in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services.”
The European directive required us to widen the scope of some of our regulations to include that. I commend that document, because it gives the 1990 Act not only as amended by the draft Bill, but also as amended by the directive.
Robert Key: On a point of order, Mr. Gale. It seems appropriate for that document to be made available to the Committee, if the Bill as we have it does not take account of that.
The Chairman: The hon. Gentleman pre-empts the announcement that I was about to make. That document will be made available. I apologise that it is not here. Why I apologise, I am not sure. I do not think that it is my responsibility, but we will make sure that it is made available.
Dawn Primarolo: It is this document.
Mike Penning (Hemel Hempstead) (Con): Where is it?
Dawn Primarolo: It was circulated with the Bill. If it is not in the room as well—
The Chairman: Order. For clarification, we will ensure that that document, whether or not it has been circulated, is made available in the room in time for this afternoon’s sitting. Everyone happy?
Mark Simmonds: May I say one final thing on clause 2? I am trying to draw information. Unusually, I am not particularly happy with the Minister’s response. I understand about the broader definition. As I said before, that will be one of the main challenges and themes running through the Bill. However, there are distinct differences between mitochondrial DNA, nuclear and pro-nuclear DNA. I think it would be sensible if the relevant individuals went back and gave some thought to whether that distinction needs to be made clear in the Bill.
Question put and agreed to.
Clause 2 ordered to stand part of the Bill.

Clause 3

Prohibitions in connection with embryos
Mark Simmonds: I beg to move amendment No. 1, in clause 3, page 3, line 7, at the end insert
‘except when the egg has in prescribed circumstances undergone a prescribed process designed to prevent the transmission of serious or life-threatening mitochondrial diseases.’.
The Chairman: With this it will be convenient to discuss the following amendments: No. 2, in clause 3, page 3, leave out lines 19 to 24.
No. 33, in schedule 4, page 67, line 8, after ‘gametes’, insert ‘including the mitochondria,’.
Mark Simmonds: Clause 3 deals with prohibitions in connection with embryos. Amendment No. 1 relates to the transfer of some serious and life-threatening diseases through the mitochondrial part of the cell—the outside part, surrounding the nucleus—which can be translated through generations. I am supportive of mitochondrial research, which could make a significant contribution to eradicating—certainly reducing the incidence of—some serious diseases that are passed on through the generations. The amendment would place a reference to mitochondrial transplant in the Bill, rather than in a regulation-making power. Such a serious area of medical research clearly throws up, as other parts of the Bill do, important moral and ethical issues, which Parliament needs to debate thoroughly.
You may or may not be aware, Mr. Gale, that there are no mitochondria in sperm. Scientists are working to remove the nucleus of a cell of a woman with a mitochondrial disease, place the cytoplasm of a healthy woman’s egg in there, and then fertilise it. Once normal mitochondria are established, future generations will also have normal mitochondria. The controversial part of this is that the resulting child will have 99.5 per cent. of the mother’s genetic material, 100 per cent. of the father’s genetic material and clearly 0.5 per cent. from a third party, although the DNA in the mitochondria—this is the part that I think is very significant—carries no information that defines any human attributes.
Indeed, Professor Turnbull at Newcastle university has carried out under licence a process whereby an ovum from a woman with a mitochondrial disease has been fertilised by her partner’s sperm. As soon as the first cell is formed, it contains two pronuclei, one from the woman and one from the partner, containing 100 per cent. of his DNA and 99.95 per cent. of hers. However, at the moment, the licence from the HFEA does not allow this embryo to be implanted in the woman. I think that this needs to be changed in the actual Bill rather than through regulation-making powers.
Amendment No. 2 removes the regulation-making power, which would be superfluous if the reference was included in the Bill.
Amendment No. 33 is a consequential amendment that, if mitochondria donation is permitted under amendment No. 1, ensures that consent is received from a person whose mitochondria are used in treatment. Mitochondria are tiny parts of the gamete, so it is important that the Bill refers not just to whole gametes but also to parts of gametes, and it is absolutely important that consent remains a fundamental cornerstone of the Bill and this particular part of the Bill.
Robert Key: I think I am right in saying that I am the only Back-Bench member of this Committee who is a veteran of the 1990 Standing Committee—although I am delighted to acknowledge the Minister as another veteran of that Bill. The amendment raises issues that are absolutely fundamental to this Bill. I entirely support what my hon. Friend has been saying about this specific issue. However, it raises the more fundamental issue of the purpose of the legislation and the process by which we need to consider it.
In the 1990 Act, we tried to set out the broad framework and established the HFEA as the body of specialists charged with carrying out the wishes of Parliament. That was one reason why the HFEA was never designed to be made up of people who were, on the one hand, very pro-science and pro the processes involved, and on the other hand, deeply philosophically and ethically opposed to it. That was not the function of the HFEA.
Since I, along with the pre-legislative joint Committee, recommended this procedure, I would prefer to see this particular clause stand as it is, and certainly not see it removed. That does not devalue what my hon. Friend the Member for Boston and Skegness has said. He is absolutely right. However, it does mean that we should not tinker with the fundamental principle that it is for Parliament to set the broad parameters and for the regulatory authority to decide the detail.
Dr. John Pugh (Southport) (LD): The business end of this group of amendments relates to subsection (5), which is related in turn to subsection (6), which repeals a section of the Human Reproductive Cloning Act 2001—which, I believe, is repealed in full elsewhere in this piece of legislation. There are some anxieties about doing that, but there is a desirable goal to be achieved, namely, preventing the transmission of serious mitochondrial disease. I support attempts to achieve that. The problem is that there are many ways to do it.
Pre-screening is one way with which we are familiar. However, if we look at nuclear transfer, which appears to be the object of the regulations mentioned in the Bill, there are different ways in which that may be done. There is the simple case of transferring one person’s egg into another person’s cytoplasm. There is also the transferring of a fertilised embryo into the cytoplasm of a third person. That creates some concerns. Lord Walton announced in the House of Lords that researchers at Newcastle university had found successful ways of doing that, and he pointed it out as something else that was new and which could be authorised by the legislation and subsequent regulations.
It is an inescapable fact that some mitochondrial diseases are not a product of diseased mitochondria per se, but have an origin in the nucleus of the cell itself. That is an indisputable scientific fact, and I do not think there is any argument about it. It would follow from that, necessarily, that regulations are therefore capable of prescribing in this particular case manipulation of the nucleus of human cells or some form of connected engineering. The Minister can contradict me on that, but it seems to me a fairly transparent reading of the legislation as it stands before us. It does not seem to be the case—particularly as we have not repealed the Human Reproductive Cloning Act 2001—that there is a loophole whereby cloning can also be authorised.
There are genuine ethical concerns here. I am concerned that this is, in a sense, carte blanche. It is an opportunity for a number of things to happen, some of which we will be comfortable with, and some of which we will not. Lord Walton, in the House of Lords, said that he thought this probably was encompassed by the legislation. However, in a less than complimentary article in Nature, Dr. Chinnery, who conducted the research to which Lord Walton referred, said:
“I wouldn't feel comfortable doing it [in patients] now for a number of reasons ... There are a number of scientific, legal and ethical issues—we've got to engage in a debate to ensure that society feels this is the right thing for us to do.”
Who is going to engage in the debate? It seems to me that if we leave the clause as it stands, the debate is only going to be had in the HFEA and nowhere else.
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