Clause 1

Human Fertilisation and Embryology Bill [Lords] – in a Public Bill Committee at 10:30 am on 3rd June 2008.

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Meaning of “embryo” and “gamete”

Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

I beg to move amendment No. 16, in clause 1, page 1, line 10, after second ‘embryo’, insert ‘where fertilisation is complete’.

Photo of Roger Gale Roger Gale Conservative, North Thanet

With this it will be convenient to discuss the following amendments:

No. 17, in clause 1, page 1, line 14, at end insert—

‘(c) for this purpose fertilisation is not complete until the appearance of a two cell zygote.’.

No. 18, in clause 1, page 2, line 5, leave out from second ‘eggs’ to ‘but’ in line 6.

No. 19, in clause 1, page 2, line 10, leave out from second ‘sperm’ to ‘and’ in line 11.

No. 20, in clause 1, page 2, line 12, leave out ‘be read accordingly’ and insert ‘live human gametes’.

Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

Clause 1 concerns the meaning of “embryo” and “gamete”. I have tabled the amendments—I acknowledge that they are probing amendments—as an attempt to extract from the Government the logic behind the changes to the 1990 Act and to determine whether this is merely to do with scientific advancement, or whether there is something more fundamental behind the changes proposed. The amendments would bring the wording of the provisions back in line with that in the 1990 Act, which essentially says that there is not a true embryo unless the embryo has been fertilised. The amendments would make the definition clearer than what is proposed in the Bill.

Before I run through the differences between the amendments, I would ask the Minister about the fact that changes due to scientific advancement—for example, clone embryos and licensed hybrids, which are based on the court judgement that was made—are allowed under the wording of the 1990 Act. If those have been allowed under the wording of the 1990 Act, why is there a necessity to change that Act in the way proposed in the Bill?

Amendment No. 17 addresses the fact that there is no definition of fertilisation anywhere else in the Bill. It would be helpful to understand why that is the case.

Photo of Ian Gibson Ian Gibson Labour, Norwich North

I dread making this intervention, but whenever I see the word “zygote”, I always think that it is a single cell. I do not want to get into arguments meaning that a later process is rolled out of order because of some “Oxford English Dictionary” definition. Would the hon. Gentleman like to say where the two-cell zygote comes from? Two cells are never a zygote; one cell is a zygote. The hon. Gentleman was once a zygote; that was when he was a single cell with everything else to do in terms of multiplying and so on.

Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

As indeed was the hon. Gentleman. That was why I said that these were probing amendments. I am attempting to draw from the Government exactly why these changes to the 1990 Act have been put in the Bill. I do not think that there is a definition of fertilisation elsewhere in the Bill, so it would be helpful if the Minister would establish why that was the case.

With amendment No. 18, we want to understand about the

“cells of the female germ lines at any stage of maturity”.

There is no definition of “eggs”, which include the cells of the female germ line. Amendment No. 19 relates to “sperm”, which includes

“cells of the male germ line at any stage of maturity”,

and, again, there is no definition of that in this part of the Bill.

Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills 10:45 am, 3rd June 2008

I declare an interest as a member of the British Medical Association medical ethics committee, although I will not seek to speak about the Bill in  Parliament on behalf of the BMA or the ethics committee, except where stated.

The group of probing amendments is useful because it gives the Government the opportunity to clarify why they have chosen such a formula for the definitions. I would note, however, that they are clearly probing amendments, because without the deletion of the proposed new subsection (1)(b) in subsection (2), one would still include an egg that was in the process of fertilisation in the definition of “embryo”.

My understanding is that there has always been some doubt about whether an egg in the process of fertilisation would be covered by the 1990 Act. The provisions would put it beyond doubt that it would. The alternative would be that an embryo was not created until the process of fertilisation was complete. I would be grateful if the Government could explain, for reasons of clarity, why they have gone for the suggestion that an egg

“in the process of fertilisation or...undergoing any other process capable of resulting in an embryo” is the chosen option.

My concern with the Government’s formulation is that some work is being done on eggs. Eggs are extremely fascinating cells from a scientific point of view, and a lot of insights into fertility and basic biology are made by studying eggs. It is quite possible that, during the study of eggs, an egg might spontaneously divide through the process of parthenogenesis. Although the resulting entity does not develop much further, it is a dividing egg. For example, activating an egg either by the application of some compounds, or by providing an electric charge, can result in parthenogenesis. I would be grateful if the Minister could clarify whether such an egg undergoing parthenogenetic division—without the addition of sperm and in its haploid state—would still be an embryo for that purpose.

If that is the case, it means for researchers something that was raised in the House of Lords regarding a potential offence. Any researcher working on eggs without a licence from the Human Fertilisation and Embryology Authority, as they are permitted to do under regulations passed almost immediately after the 1990 Act, would run the risk of finding that they had created something defined under the Bill as an embryo if a parthenogenetically dividing egg—after just one division—was considered to be one. Without a licence, researchers would be committing an offence, albeit inadvertently and with no intention of creating an embryo, and although something had been created that clearly could not develop beyond its initial division, because it had only half the chromosomes. No one is suggesting that a parthenogenetically dividing egg in vitro could develop significantly far.

The worry is that if one creates an accidental “embryo”—under the definition proposed—one finds that one is liable to prosecution, or that one would need a licence for all work in case an embryo was created. That would defeat the purpose of much of the appropriate deregulation that was created after the 1990 Act to allow gametes to be studied in isolation without a process of fertilisation or cloning—clearly that would require a licence. I would be grateful if the Minister could offer any reassurance or provide her understanding about whether people currently working  in egg research without a licence for embryos would have to go through the expensive and over-regulatory process of having to get a licence.

I am not sure whether the hon. Member for Norwich, North has a good point about amendment No. 17, but as I say, it is a probing amendment. My other point is about amendments Nos. 18 and 19. The question of whether the Government were being helpful or unhelpful by defining eggs as

“including cells of the female germ line at any stage of maturity” was explored thoroughly in the Lords. I came to the view, which was shared by people from the science community, that the formulation given by the Government was helpful for a number of reasons, but mainly because if that was not in the definition of eggs, the permitted eggs and permitted sperm approach taken in clause 3 would not, without major amendment, allow in vitro maturation of gametes to be used in the creation of embryos. Sometimes, particularly with young children whose fertility is being preserved prior to chemotherapy, a biopsy would be taken of spermatogonal or ovarian tissue, and gametes would hopefully be derived from those gonadal stem cells in vitro. They would not be stem cell derived gametes; they would be gonadally derived. Without specifying that, it is extremely difficult to construct legislation that allows such a thing. I was reassured by debates in the Lords that the Government are doing the right thing with this definition, although there were a number of concerns. I hope that the Government will confirm that their approach is right.

Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

The drafting and the consultation about updating the legislation worked from the 1990 Act. During the passage through Parliament of the Bill that became that Act, the point at which the regulation of a human embryo should begin was discussed extensively. As a result, the Act provides that it should begin at the initiation of the process of fertilisation, rather than at the point at which the embryo reaches two cells.

To answer the point raised by the hon. Member for Boston and Skegness about the definition of fertilisation, the 1990 Act did not seek to define fertilisation. It was felt that that was a common term used in biology and that the HFEA should make a decision about the term and what it meant within legislation. As he pointed out in his opening remarks on the probing amendments, that Act has stood us in good stead and works. That is a specific answer. We sought to ensure that we were maintaining the position by keeping the wording that an embryo includes

“an egg that is in the process of fertilisation”.

The Science and Technology Committee stated in its 2005 report “Human Reproductive Technologies and the Law” that the definition of an embryo should be changed to begin only at the two-cell stage. That was based on concerns that research might be restricted into the treatment of mitochondrial diseases. Those concerns have been met in the Bill, first through the definition of “embryo”, as it now includes any human embryo created by any process, not just fertilisation, and, secondly, by removing the prohibition on the genetic modification of an embryo for research. Mitochondrial disease research has already been licensed by the HFEA and the changes in the Bill bring  further clarification on that matter. That answers the point with regard to legal cases.

We seek to put the position beyond doubt by ensuring that it is reflected in legislation, rather than dealt with by reference to a court judgment. I appreciate that these are probing amendments, but they would reverse the position outlined in the 1990 Act, so that, for the purposes of the legislation, an embryo would not come into existence until the two-cell stage—the point at which the nucleus of an embryo fully forms for the first time. They would, in effect, remove single-cell embryos from regulation, meaning that the creation, keeping, storage and use of single-cell embryos would fall outside the law.

Research on single-cell embryos could then be undertaken without a licence, provided the cell did not divide, and it has clearly been the view of Parliament that we cannot allow the creation, keeping, storage and use of single-cell embryos to fall outside the law. These embryos should be regulated in the same way as embryos at the two-cell stage or later. The Government’s position is therefore that the existing principle, which remains unchanged since it was formed in 1990, should be upheld.

The definitions of “egg” and “sperm” in clause 1 are of equal importance to the Bill and to the HFEA, because terms such as “gamete”, “sperm” and “egg” are vital in setting out the authority’s regulatory remit. While we are often clear about what these terms mean from a biological point of view, definitions can be interpreted differently in the context of legislation. These definitions are designed to set out an effective remit for the authority, clearly indicating what biological material it regulates. How are we to make sure that biological definitions can be interpreted through a regulatory framework? That has always been the challenge. It was the challenge faced by the Committee that considered the 1990 Bill, and, as the hon. Gentleman rightly said, the resulting Act has stood us in good stead.

The definitions of the terms “gamete”, “sperm” and “egg” were drafted to include cells of the germ line at any stage of maturity, and it should be noted that the wording of this provision follows the precedent of section 3A of the 1990 Act, which was inserted by the Criminal Justice and Public Order Act 1994 and ensured that female germ line cells taken from an embryo or foetus could not be used in treatment.

The Bill is drafted to include germ line cells to ensure that the storage and use of ovarian tissue containing immature egg cells to create embryos is regulated by the HFEA and that, following maturation in the laboratory, any egg produced can be used in treatment. It also sets out a prohibition on placing anything other than a permitted egg, sperm or embryo into a woman, and so it is important that the definition of “gamete” includes immature cells of the female germ line. This ensures that the use of in vitro maturation within the context of assisted conception treatment is regulated and permitted. I am sure the hon. Gentleman understands that this is particularly important for women who are undergoing chemotherapy or radiotherapy and will lose their future fertility. Freezing mature eggs is difficult and often unsuccessful, whereas freezing ovarian tissue containing immature eggs is much more reliable.

The legislation that deals with these difficult and complex areas needs to be as clear as possible to ensure that the legality of complex reproductive medicine is equally clear. The clause as it stands ensures clarity around the regulation and use of single human embryos and immature eggs and sperm, making it clear that single-cell embryos fall within the authority’s remit and that immature gametes may be matured in the laboratory and used in treatment.

If the amendments were made, clarity would be lost and single-cell embryos would fall outside regulation. The law would, at best, become uncertain and, at worst, prohibit the use of immature eggs and sperm in reproductive therapies. In trying to address what were the difficult challenges in 1990, the Government have listened very closely to the evidence presented and to debates about the Bill in another place. We have proposed the wording as it stands. I assure the hon. Gentleman that the Government seek to continue to regulate and enforce according to the principles of the 1990 Act, which I know that he and many of his hon. Friends support. I hope that he accepts that his probing amendment has secured comments on the record for clarity and that he will withdraw it at as suitable time.

Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills 11:00 am, 3rd June 2008

I would be grateful if the Minister would address herself to the point that I raised about her expectations of the impact of the new wording on people who are researching eggs, but not putting them through a process of cloning or fertilisation. In their research, an egg may start to divide as a consequence of manipulation that is done for perfectly legitimate scientific reasons—not as the deliberate end point of the research, but just as a happenstance. The 1990 Act stated:

“embryo means a live human embryo where fertilisation is complete, and...references to an embryo include an egg in the process of fertilisation”.

I understand that. It has been transferred to the Bill, but the new Bill also states that

“references to an embryo include an egg” not just in the process of fertilisation, but

“undergoing any other process capable of resulting in an embryo.”

The Government had the option of stating that references to an embryo would include an egg that had undergone any other process capable of resulting in an embryo and, indeed, of considering a one-cell embryo to be an embryo, thus avoiding the worry about the distinction between one-cell and two-cell embryos. I accept the Minister’s view that one-cell embryos have to be included in regulation, but the wording “has undergone” would enable research that does not intend to produce an embryo to continue without a licence when it is looking at the properties of an egg. I wonder whether the Government considered using the wording, “has undergone any other process resulting in an embryo”, rather than

“is undergoing any other process capable of resulting in an embryo”.

The definition used is going to make things wider. At the moment, there is no defence for people researching eggs when there might be division. What is the  Minister’s response to the point I raised originally? Secondly, did she consider the slightly narrower definition that, I think, would still tick all the boxes that she quite rightly feels ought to be ticked to ensure that regulation is accurate?

Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

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.

Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

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.

Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

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.

Photo of Roger Gale Roger Gale Conservative, North Thanet

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.