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People have asked whether this is the same as germ-line gene therapy, a term used for modifying a gene in the nuclear genome at the beginning of development. It is not germ-line therapy, because mitochondrial genomes are not being modified; they are simply being replaced. It is true that, once normal mitochondria are in place, subsequent generations will have normal mitochondria, too, which is hardly a bad thing. This is a crucial piece of evidence, which is of inestimable value to many women and many families where this group of mitochondrial diseases has been present—I have seen many such in my professional life. We cannot miss this opportunity.
Lord Brennan: I share your Lordships’ sense of trepidation as I begin my remarks, but we must assuage it with the success of my recovery, which was due to the assistance given to me in this House by many noble friends, including the noble Lords, Lord Patel, Lord Walton and Lord Turnberg, by its staff—Stella Devadason gave me the earliest treatment—but in particular by the noble Lord, Lord Darzi. Decisive action is what we demand from Ministers. His life-saving skill came to my rescue at the moment of my greatest need. In the non-parliamentary sense, he will ever be my noble friend.
When I came to in the moments afterwards, I looked up and thought to myself, “Can this be paradise—still in the House of Lords, surrounded by a halo of Anglican bishops?”. Well, perhaps it is a kind of paradise after all. I thank all in this House for their wonderful messages of support, which fortified me in my recovery and convinced me that this is a place full of feelings of friendship and a sense of solidarity, which I value greatly. I thank God for the opportunity to return to the love of my family and to continue to serve in this House.
Now to Amendment No. 3. In 2001, this House thought it appropriate to pass a statute for the sole purpose of banning human reproductive cloning. It was a one-clause statute passed unanimously by both Houses. This Bill seeks to repeal that Act but to continue the prohibition. I have tabled Amendment No. 3 to seek clarification from the Government. I am sure that they do not wish there to be human reproductive cloning, as does none of us. The question that arises is whether the wording of Clause 3 is sufficient and whether it deals with the questions that the noble Lord, Lord Alton, raised.
I shall not continue my speech.
Earl Howe: I shall comment briefly on Amendment No. 5 in the name of the noble Lord, Lord Patel. It is with some trepidation that I venture to part company with the noble Lord in relation to this amendment, but nevertheless I must do so.
As the noble Lord said, there may come a time when eggs and sperm can be created from stem cells. I understand that work is already going on to try to do this. If that work should succeed, it could be of huge benefit to a person who cannot produce mature eggs or sperm but would like to have a child who is
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The noble Lord would doubtless say that he does not propose to make artificial gametes legal for treatment purposes and that he merely proposes an order-making power to do so. The problem for me with an order-making power, especially one expressed in terms as broad as in this amendment, is that it does not afford Parliament enough control over an idea that, if put before us, would be bound to give rise to controversy. The potential degree of controversy could be very great, for the reasons that I have given. Therefore I believe that such matters are more appropriately left to primary legislation. The Bill is right to prohibit the use of artificial gametes for treatment purposes.
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Baroness Tonge: I speak with some trepidation and amusement: likening this place to paradise was a pleasant thought in many ways, but this afternoon it actually feels more like purgatory as we plough through the gametes, stem lines and embryos—the terminology that has been introduced in the Bill. At least I did the second MBBS examination in embryology and should have some understanding of these terms, but for the majority of noble Lords it is purgatory trying to make sense of them.
Another thought occurred to me. If WS Gilbert were still alive I wonder what he would make of the cells, gametes and the stem lines. The argument about terminology becomes almost comical in its complexity. That is why I support what the noble Lord, Lord Patel, has proposed in many of the amendments. We need to clarify what we are talking about.
In my Second Reading speech, I said that I dislike the use of the word “embryo” to describe cell lines that were created from various sources. “Embryo” is a very emotive term and should not have been used in the Bill to describe the sort of interspecies and other embryos that are to be created. The general public think in terms of little babies with thumbs in their mouths pictured in utero, but that is not what we mean in the terms of the Bill. We cannot emphasise strongly enough that we are talking only about destroying 14 day-old cell lines, not embryos.
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The noble Lord, Lord Patel, made the distinction between cells, gametes and germ cell lines. That is a useful distinction. Germ cell lines are not gametes and we must make that clear. If we are going to use any language at all, let us use the scientific language in embryology textbooks that we all understand. Let us not muddle things.
I have one or two other points. I am extremely distressed by the apparent opposition to the use of cytoplasmic hybrids. Mitochondria are understood by some people to be the same as a nucleus—containing genetic material in the same way as the nucleus of a cell. They do not. I happen to think that mitochondria are one of the most exciting things that people are researching at the moment, because they go all the way back to where life emerged out of a combination of chemicals. Some people say that mitochondria were bacteria engulfed by a primitive cell many billions of years ago. That is something of a digression, but mitochondria are the energy givers to the cell. They are not the same as the nucleus. If you put a nucleus from whatever sort of cell into a cell that has had the nucleus removed and just use the wonderful things that the mitochondria can do, that is not cloning. Nor is it anything more than we do in the laboratory when we use a substrate to grow things: the cytoplasm and the mitochondria are that substrate. We should get that clear and stop being too emotive on the subject. That is why I support the amendments tabled by the noble Lord, Lord Walton, who I can see is as enthusiastic about mitochondria as I am.
I have one thing to say in response to the remarks of the noble Lord, Lord Elton. Many people say that adoption is the answer to infertility: women should not have abortions but should allow the child to be adopted. Women are not baby factories, nor should they be regarded as such to enable other women to adopt. It is very unfair to expect them to see themselves in that light. Therefore, I do not think that adoption is an answer to infertility and we should never regard it as such.
I wish to speak to Amendment No. 12 in the name of my noble friend Lady Barker, who cannot be here until later because she is attending a funeral. Amendment No. 12 proposes to delete subsection (6)(b) of new Section 4A, which appears to prevent the use of germ cell lines and nuclei in the creation of cybrids under subsection (5)(b)(ii) and (iii) in new Section 4A, when, in fact, such germ-line cells may have the most suitable nuclei to transfer because of their usefulness in repairing DNA. We believe that the bar on this process is wholly contained in the spurious subsection (6)(b) of new Section 4A and is not a consequence of the broad definition of “gamete” dealt with previously, or indeed at lines 13 or 18 on page 5, which Amendments Nos. 17 and 18, in the name of the noble Lord, Lord Patel, address. We cannot see why the Government seek to prevent this. Furthermore, subsection (6) of new Section 4A runs the risk of leaving the use of gametes and germ-line cells in interspecies nuclear transfer outside the Act. Why would the Government want to do this? Perhaps the Minister will tell us. Therefore, we would like subsection (6)(b) of new Section 4A to be deleted, as that would correct this anomaly.
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Baroness Royall of Blaisdon: This has been an excellent and hugely well informed debate and I am sure that it will be the first of many in Committee. Before I respond to the various amendments I should make it clear to the noble Lord, Lord Alton, in response to his question about the conscience clause, that Section 38 of the 1990 Act continues to apply and is not affected by the Bill.
The first clause in the Bill amends Section 1 of the 1990 Act. This section is key to many other provisions in the Bill, and indeed the remit of the HFEA, as it contains the meanings of key terms, including embryo, gamete, sperm and eggs. While we are often clear about what these terms mean from a biological point of view, definitions may be capable of being interpreted quite differently within the context of legislation. For this reason definitions are vital and we must have legal clarity: we are legislators.
On Amendment No. 1, moved by the noble Lord, Lord Patel, the meaning of the term “egg” in the Bill was drafted to include cells of the female germ line at any stage of maturity. It should be noted that the wording of this provision followed the precedent of a provision in the 1990 Act, as amended by the Criminal Justice and Public Order Act 1994. It was drafted in this way to ensure that any egg precursor cell would be subject to all the same provisions in the Bill and the 1990 Act as an egg itself.
Cells of the germ line develop in stages. For example, eggs start life as a primordial germ cell, then become a primary oocyte, a secondary oocyte and, ultimately, a definitive oocyte or egg. The Bill ensures, for example, that to store ovarian tissue containing cells of the female germ line, such as immature eggs for future use in treatment, a storage licence would be required in addition to the consent of the woman whose cells were being stored. In new Section 3ZA of the 1990 Act, as inserted by Clause 3, permitted eggs are defined. It is prohibited to place anything other than a permitted egg, sperm or embryo into a woman. Another reason for having a definition of “egg” that would include immature cells of a female germ line is to ensure that use of in vitro maturation within the context of assisted conception treatment is regulated, as would be the possible future use of in vitro growth of gametes for treatment. These techniques involve taking cells of the female germ line from the ovaries, which will clearly be eggs under the definition in the Bill, and maturing them in vitro. If the reference to “egg” did not include immature cells, there would be uncertainty that the cells removed and matured would have been an egg in legal terms. Importantly from the point of view of researchers in particular, unless eggs, including with the wider definition, are to be used for HFEA-licensed research, currently no licence for storage would be required. That is because the Human Fertilisation and Embryology (Special Exemptions) Regulations 1991 exempt gametes from requiring a storage licence if, for example, they are intended for the purpose of research on gametes alone without the creation of an embryo.
Amendment No. 1, as part of the group of amendments with similar effects, amends the definition of “eggs” in proposed new Section 1(4) of
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Amendment No. 1 removes certainty from the Bill as to the type of human cells that will be regulated as eggs. For example, it would no longer be clear that immature cells of the female germ line would be covered by this definition. Amendment No. 1 would also have the effect of casting doubt on the meaning of “egg” in this context. The effect would be that, because some immature egg cells would not fall clearly within the definition of an egg, they may not be able to be implanted in a woman. For example, if an ovarian tissue was stored for a cancer patient who then required IVF, it might not be possible to use immature cells of the female germ line with the ovarian tissue for the purpose of creating an embryo in her treatment, as the egg used to create the embryo may not be considered to be a permitted egg.
In response to the questions asked by the noble Baroness, Lady O’Cathain, if Amendment No. 1 were agreed to, a licence would not be required to store immature gametes for research or treatment, and it would be unclear whether consent would be required to create embryos. Amendment No. 2 has a similar effect—
Baroness O'Cathain: What is the process here? I referred to the fact that the grouping is so wide and that these are not all similar amendments. I only spoke against Amendment No. 1, but I want to speak against other amendments too. Is the noble Baroness going to speak on Amendment No. 2 and the rest of us do not have any chance to speak?
The Deputy Chairman of Committees (Lord Tordoff): It is not proper for me to intervene, but this is Committee stage and, as I understand it, there is no restriction on Members of your Lordships’ House intervening at any stage.
Baroness Royall of Blaisdon: I am very grateful to the Deputy Chairman for that intervention. I intend to respond now to all the amendments in the group, unless noble Lords wish me to do otherwise. I acknowledge that the group is extensive, but no other noble Lords stood up to speak, so I thought that no one else wanted to speak to the amendments in this group. I am sure that will not preclude further discussion, should noble Lords so wish.
Amendment No. 2 has a similar effect to Amendment No. 1 and was also tabled by the noble Lord, Lord Patel. It amends the definition of “sperm” in proposed new Section 1(4) in the 1990 Act. It removes the words, “including cells of the male germ line at any stage of maturity”. Amendment No. 52 also relates to definitions of gametes. It replaces the words, “cells of the female line or male germ line” with, “gametes” in proposed new Section 16(1)(a) of Schedule 3 to the 1990 Act as inserted by paragraph 14 of Schedule 3 to the Bill. The effect
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Amendment No. 17 amends the definition of eggs for the purpose of new Section 4A of the 1990 Act, inserted by Clause 4, which relates to inter-species embryos. The current definition of eggs under new Section 4A(12)(a) expressly includes cells as female germ line at any stage of maturity.
Amendments Nos. 10 and 11, tabled by the noble Lord, Lord Patel, amend the meaning of animal cells in the definition section relating to interspecies embryos. The effect of Amendment No. 10 would be that the meaning of animal cells applied not just to subsection (5)(b), but to other places in subsection (5) where animal cells were mentioned. Amendment No. 11 adds the words “other than gametes” to new Section 4A(6)(a). This means that references to animal cells and the definitions of interspecies embryos under new Section 4A(5) do not include gametes.
The overall effect of Amendments Nos. 13 and 15 is that the reference to human cells in the context of interspecies embryos expressly include cells of the germ line. The effect of Amendments Nos. 14 and 15 is that the reference to human cells in paragraph (b) would expressly include cells of the germ line.
The effect of Amendment No. 12, tabled by the noble Baroness, Lady Barker, is that human cells are not defined in relation to new Section 4A(5) and it is, therefore, open to argument as to whether cells of the female or male germ line would be covered by the reference to human cells in the definition of cytoplasmic hybrids under Section 4A(5)(b).
I turn to Amendment No. 2A. The noble Lord, Lord Elton, is absolutely right to say that definitions are important. The amendment would remove from the Bill the provision allowing through affirmative regulation the extension of the definition of the human embryo if the need arose following developments in science and medicine, which by their nature cannot be predicted at this time. The regulation-making power in Clause 1(5) allows us to ensure that the 1990 Act will always be up to date with current developments in science and technology. While I understand the noble Lord’s misgivings, this power is incredibly important in ensuring a continued proper regulation in this complex area of science.
Lord Elton: Before the noble Baroness leaves that important point, does she accept that there may be grounds for thinking that there are better ways of securing the modernisation of this legislation, year by year, than entrusting it to the Secretary of State, albeit with an affirmative order-making power, which would involve parliamentary process? Does she understand that for some of us this is not an entirely appropriate process?
Baroness Royall of Blaisdon: I understand the reservation and, perhaps, fears expressed by the noble Lord, but the fact that matters would be discussed
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I turn now to Amendment No. 3 of the noble Lord, Lord Brennan, who I trust is well. It is a delight to see him back in the House. The Bill introduces a wider definition of a human embryo in order to include embryos created in ways other than by fertilisation—for example, by adding genetic material to an egg. New Section 3(2) of the 1990, as inserted by Clause 3, ensures that only permitted embryos, eggs and sperm can be placed in a woman. New Section 3ZA provides definitions of what will be permitted and has the effect that only embryos produced by fertilisation of a natural egg with a natural sperm and natural gametes can be placed in a woman. Removing subsection (5), as proposed by Amendment No. 3, would remove that definition. Amendment No. 3 removes subsections (5) and (6) from page 3. This has two principal effects. First, it removes new Section 3ZA, which defines a permitted egg, sperm and embryo for the purposes of the 1990 Act and, secondly, it removes the provision that repeals the Human Reproductive Cloning Act 2001. New Section 3ZA defines a permitted gamete as an egg produced or extracted from the ovary of a woman or sperm produced or extracted from the testes of a man with unaltered nuclear or mitochondrial DNA. A permitted embryo is defined as an embryo created by the fertilisation of a permitted egg by permitted sperm where no nuclear or mitochondrial DNA of any cell of the embryo has been altered and where no additional cells have been added to the embryo. This new subsection also has a provision that will allow Parliament, through regulations, to amend the legislation so that embryos created to avoid the transmission of mitochondrial disease can be replaced in a woman. This regulation-making power would also be removed from the Bill by the amendment tabled by the noble Lord, Lord Walton. I shall return to mitochondrial issues when I respond to that amendment.
If the definition of a permitted egg, sperm and embryo in subsection (5) were removed, it would not be clear in the legislation which embryos and gametes could be placed in a woman. That would mean that, for treatment purposes, we would have to rely on a general definition of embryos and gametes similar to that in the 1990 Act. This definition resulted in the Human Reproductive Cloning Act 2001 to prevent embryos created in ways other than by fertilisation to be placed in a woman. The approach under the Bill is to specify precisely what entities can be placed in a woman rather than to list those that cannot, as under the 2001 Act. We believe that this approach gives greater certainty and ensures that only the types of embryos and gametes that Parliament intended could ever be placed in a woman.
The Human Reproductive Cloning Act 2001 is repealed by the Bill, but the purpose of this amendment is to remove the provision in the Bill that has that effect. The 2001 Act states that anyone placing in a woman a human embryo that has been created otherwise than by fertilisation will be guilty of
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The definitions of embryos and gametes in the Bill are drafted to capture a wide range of things that may be created under a research licence. However, we consider it appropriate to separate out embryos and gametes that can be created and used for important research from those that will be used to create a human being. The definition in new Section 3ZA(5) of the Bill clarifies which embryos, eggs and sperm can be placed in a woman, and we think that this clear separation is vital.
The noble Lord, Lord Alton, asked whether it would be reproductive cloning if a somatic cell were used in mitochondrial donation. As I said, the Government remain committed to a ban on human reproductive cloning, and the intention of the regulation-making power in new subsection (5) is to use techniques involving fertilisation to prevent the transmission of serious mitochondrial disease, not the use of somatic cells.
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