Human Fertilisation and Embryology Bill [Lords]

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Mark Simmonds: 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.
Dr. Ian Gibson (Norwich, North) (Lab): 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.
Mark Simmonds: 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.
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Dr. Harris: 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.
Dawn Primarolo: 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.
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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.
Dr. Harris: 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”.
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