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Human Fertilisation and Embryology Bill [HL]

Volume 696: debated on Monday 3 December 2007

My Lords, I beg to move that the House do now resolve itself into Committee on this Bill.

Moved accordingly, and, on Question, Motion agreed to.

House in Committee accordingly.

[The LORD SPEAKER in the Chair.]

Clause 1 [Meaning of “embryo” and “gamete”]:

1: Clause 1, page 2, line 5, leave out from second “eggs” to “but” in line 6

The noble Lord said: I shall speak also to Amendments Nos. 2, 10, 11, 13 to 15, 17, 18 and 52. The purpose of these amendments relates to the Bill’s extension of the definition of “gametes” under the 1990 Act to include germ-line cells at any stage of maturity. It is not clear to me why this is necessary or desirable. The extended definition is out of line with the ordinary scientific meaning of the term. Biologically, a diploid germ cell, with a full complement of 46 chromosomes, needs to undergo DNA replication before the DNA divides to become a haploid gamete, with 23 chromosomes. Gametes are germ lines that have at least initiated meiosis—the process of halving the number of chromosomes to create a haploid cell. Therefore, the definition under the Bill extends “gametes” to cover germ lines in the early stage of development which have not reached the stage of becoming gametes. This creates considerable confusion, but with no obvious rationale for treating early-stage germ-line cells in the same way as gametes. Extending the definition of gametes brings immature germ cells under the remit of the Bill and presumably out of the Human Tissue Act. Why is that required?

The first two amendments would remove the extension to early germ cells from the definition of gametes, reverting to the terminology used in the current Human Fertilisation and Embryology Act and Human Tissue Act. That is in keeping with the scientific understanding of the term and keeps those two Acts in line in this respect.

The next seven amendments are consequential, ensuring consistency of approach in the definitions of, and division between, gametes and other cellular tissue. The changes to the definition of gametes and the consequential amendments to the interpretation of cells in new Section 4A(6) will affect the interpretation of the definition of interspecies embryo in new Section 4A(5); for example, some creations such as cytoplasmic hybrids, created by replacing the nucleus of an animal egg with the nucleus of a human germ cell, will now be covered under paragraph (b) of the definition rather than paragraph (a). However, I do not believe that the changes will alter the scope; rather, in my view they will enable a more natural reading of that definition. That covers Amendments Nos. 10, 11, 13 to 15, 17 and 18.

Finally, I turn to Amendment No. 5, which is also in my name. The background to this amendment is that eggs are naturally formed in the ovary and sperm in the testes. Developments in stem cell biology indicate that it is possible to make sperm from embryonic or other stem cells. These are being called artificial gametes, and early studies in mice confirm the reproductive potential of these cells. They are thus seen as a potential cure for some forms of infertility; for example, in cases where the testes no longer function as a result of cancer treatment or where sperm production is defective. Although it may be several years before the use of artificial gametes in clinical trials can be initiated, it is most likely that this will happen within the next five to 10 years. The Bill must take account of this likely development, and I am told that the UK is now leading the international field in this respect.

The 1990 Act makes no mention of artificial gametes but, in the 2005 consultation on the review of the Act, the Government state:

“The Government believes that the potential use of artificial gametes raises safety issues and that some uses may also raise ethical concerns. Therefore the Government proposes that the use of artificial gametes in assisted reproduction treatment should not be permitted but that the HFE Act should contain a regulation-making power giving Parliament more flexibility to allow the use of artificial gametes in future should it wish to do so”.

However, in the White Paper, the Government proposed a ban on the use of artificial gametes—a view which they stated was well supported by the responses received to their consultation. As it stands, the Bill prohibits the use or treatment of gametes other than those that originate from the ovary or testes.

The Government also considered introducing a regulation-making power to permit the future use of gametes. The White Paper stated:

“The Government has decided, on balance, not to recommend such a power, proposing instead that this would be a matter requiring primary legislation”.

The problem is that the Bill does not permit the use of gametes which do not originate from testes or ovaries for the purpose of creating a permitted embryo under a treatment licence from the HFEA. Furthermore, there is no regulation-making power in the Bill to enable such treatment to be permitted in the future as there is, for example, for the use of mitochondrial transplant embryos, which we shall discuss later under the amendment of my noble friend Lord Walton of Detchant. Several leading researchers are already working in this area in the United Kingdom. In fact, the United Kingdom has managed to recruit scientists from overseas because of our legislative support. If we do not allow that to continue, research in this area will stop.

The following consequences will flow from the current position under the Bill. UK researchers are pursuing research projects to develop treatments for infertility which will become illegal in primary legislation and require further primary legislation to permit them in the future. That could have inevitable consequences such as difficulty in obtaining funding for such research and consequences for the future of clinical trials and for infertile patients who wish to have their own children.

It must also be remembered that artificial gametes could be derived from bone marrow stem cells, other adult stem cells or adult cells in which pluripotency has been induced. Therefore, it does not refer only to embryonic stem cells. That makes the potential use in therapy even less controversial, especially in the case of derivation from adult stem cells where no genes are inserted to reprogram the nucleus.

If such treatment were not banned—and this is important—several safeguards remain. First, the use of such gametes for fertility treatment would require a licence. Secondly, the HFEA has powers to ensure that the procedure used for the creation and use of embryos for fertility treatment takes account of the welfare of any child that may result. The Bill thus requires that safety issues are the priority consideration of any treatment license application that would use artificial gametes for fertility purposes. If regulation-making powers were included in the Bill, as the noble Lord, Lord Walton, suggests, additional oversight by Parliament would be available.

I do not suggest that a therapeutic application of this technology is imminent, but it is likely to emerge at some point in the foreseeable future. A clinical trial may be proposed and Parliament needs to be in a position to permit the HFEA to license at that point—hence my amendments. These amendments, on which the noble Lord, Lord Winston, may wish to comment, are supported by those who work in the clinical infertility area, such as the British Fertility Society and the British Medical Association.

I turn to Amendments Nos. 51 and 53. The Bill as introduced uses the term “human cell” throughout Schedule 3 but does not fully clarify its meaning in that context. This creates ambiguity as to its scope, and as to the meaning of the phrases in which it is used in the schedule, including “a person’s human cells” and “a person providing human cells”. It is unclear to me whether the term refers to cells from an individual, in line with the approach taken in the Human Tissue Act 2004, or to cells artificially created in vitro; that is, cell lines. By extension, it is unclear whether references to “a person’s human cells” are to cells from the body of a person or cells, such as cell lines, that may be personal property and are owned by the person who generated them in vitro.

In my view, clarification of that definition is pivotal to the consent provision in Schedule 3. Cell lines created in vitro are currently outside the scope of the 1990 Act. They are also outside the scope of the Human Tissue Act 2004. This approach is entirely logical and sensible. If the consent requirements of the 1990 Act were extended by the Bill to cell lines, vast stores of valuable cell lines currently held in public, charitable and commercial collections of cell lines would become unusable for the purposes set out in Schedule 3, contrary to the interests of patients and public. The approach adopted to cell lines to date has significant support and we see no reason to change it. I presume that that is not the Government’s intention.

The amendment would make it clear that a “human cell” in Schedule 3 is a cell from the body of a person and that references to a person in the phrase “a person’s human cells” are to the person from whose body the cell has come. The amendment also makes it clear that the requirements of Schedule 3 do not apply to cell lines generated in vitro from human cells.

Briefly, on the other amendments in this group, I support the amendment of my noble friend Lord Walton and Amendment No. 5, which would clearly define a permitted egg, sperm and embryo. I shall reserve my comments on Amendment No. 2A, tabled by my noble friend Lord Alton. I beg to move.

Somewhat surprisingly, it may be appropriate to speak now to Amendment No. 2A, which has been tabled in the names of the noble Lord, Lord Alton, and myself. The noble Lord, Lord Patel, has lucidly illustrated to your Lordships the intimate relationship between the use of language and the activities of researchers; that is what the Bill is concerned with.

The noble Lord, Lord Patel, has three sub-groups within this group. In the first he refers to a series of provisions that, possibly unintentionally, affect the research procedures that may be embarked on, and in the second he refers to developments that can be expected to take place in five to 10 years, a period in which the Bill is expected to continue, as an Act of Parliament, to provide for the contingency of those developments. It must be clear to all of us that, in the next 10 years, many unforeseen developments will arrive in this fast-moving field of research. It is undoubtedly with that in mind that the Bill’s drafters included Clause 1(5) to give the Secretary of State the power to intervene to change the meanings of terms which are already understood to be defined in the Bill as your Lordships have it. That is in fact a power to change, possibly dramatically, the effect of the Act of Parliament that we have in mind should be put on the statute book.

It is appropriate to raise that point now in order to ask Members of the Committee to have at the back of their minds throughout the discussion of this group, and every time a question of a definition or change of definition arises, the question whether that definition or change would fall under the provisions of Clause 1(5). If it would, one would have to think carefully whether some politician—not necessarily a member of a Government, let alone this one—shall be given the power to decide what shall be the effect in the years to come of what your Lordships are doing today and in the next three Committee sittings. I would submit that that is a power that we should not surrender. The reason that the Bill has attracted so much public interest and filled your Lordships’ in-trays with petitions is that it closely affects the emotions as well as the genes not only of ourselves but of future generations.

If your Lordships prove sympathetic to this idea, it may well be that we should come forward on Report with an alternative means of providing for changes in the interpretation of parts of the Bill. I do not think that that should be left to the discretion of one elected or appointed member of a Government and a group of advisers who are unknown to all of us. I ask noble Lords to bear that in mind in the next hour and a half.

I rise briefly to support the amendment tabled by the noble Lord, Lord Patel. I declare an interest as an employee of Imperial College London, working in the Institute of Developmental and Reproductive Biology and as a director of a spin-out company which is involved in the modification of gamete cells.

I draw your Lordships’ attention to the prevalence of the kind of infertility that the noble Lord, Lord Patel, is addressing. It is now extremely common to see young women who cannot produce egg cells for one reason or another. Indeed, I think I have seen it written somewhere that it is now the fifth most common cause of anovulatory infertility—which is rising in a population that is tending to gain skills, get better education and leave child-bearing a little later. By the age of 40 a very large number of women have run out of eggs in their ovary and cannot conceive naturally, although they would be in a perfect position to have children were an egg to be available. As we know, the donation of eggs, which is dealt with elsewhere in the Bill, is a very fraught subject and not acceptable to all infertile couples. People would quite reasonably prefer to have their own genetic material, as I mentioned at Second Reading.

In the case of the male, testicular failure—the failure of germ cells to mature to produce sperm—is extremely common. It can occur as a result of many factors, some of which are unknown. A few factors are genetic, and some are due to injury. As we get better at treating diseases such as Hodgkin’s disease and cancer, we are also increasingly finding men with maturation arrest; that is, when the testicle is no longer producing sperm. These issues are extremely common and cause great distress to patients. They are important clinical issues. At present the only alternative available to these people is a donated gamete, a solution which all noble Lords agree is not ideal. Although we accept it within the legislation, it is, broadly speaking, much better if people can have their own genetic child.

As the noble Lord, Lord Patel, said, there is growing evidence of a research ability to produce gametes that are likely to be entirely viable in mice and other mammals, and it is very likely that this technology could be applied also to humans. Indeed, there have been suggestions that we can now develop viable animal embryos from gametes that have been matured from germ cells in viva. It would seem extremely cruel, in a Bill designed to help infertile couples, if that technology were prevented and that research was not allowed to continue in humans in Britain. The noble Lord, Lord Patel, is right to suggest that there are many issues in the clinical use of such matured gametes. We need to do a huge amount of investigation to make certain that the chromosomes, the genes, the development and the cell biology of these cells are normal before such an embryo is put back into the uterus. There are very few countries where this kind of research is possible, and it would be shocking if, in the process of passing the Bill, it was unwittingly prevented in a country that is most able to do it. It is essential that this research continues.

There is another issue. There are situations where we use primary germ cells and other cells without the intention of doing in vitro fertilisation or any infertility treatment. In my own laboratory we are trying to modify the male stem cells of pigs. We are doing it so that we will eventually, we hope, be able to transplant pig organs into the human safely without the pigs’ cell-surface proteins being recognised by the human system. As Members of the Committee will appreciate, a large number of people need heart transplants or other organ transplantation. This technology, which is the focus of the spin-out company to which I referred, is one example of where we could prevent such recognition.

If we can develop this technology in the pig, important issues surrounding use of the same kind of technology in humans will arise—not to modify humans but to understand the science of germ-cell development, so that in future we might be able, for example, to treat male infertility much better by encouraging primary germ cells to go through better maturation to arrive at gametes. The problem with the Government’s proposed legislation is that research into human tissue would be difficult and would need a licence. I do not think that a licence should be required because there is no intention to produce a pregnancy, simply an intention to understand the cell biology. Any use of these gametes would thereafter of course be subject to law—as they should be—under the Government’s proposals.

There is a risk of unwitting restriction which could prevent and inhibit research that is quite properly required and is not threatening. I do not believe that any member of the public, even those with fairly strong religious convictions, would see this as a problem. The issue is not much more than one affecting the use of human tissue. I therefore hope that the Government will look favourably on the amendments tabled by the noble Lord, Lord Patel.

My comments on the amendment will be brief. The future makes it possible to create eggs or sperm from stem cells. These are known as in vitro-derived or artificial gametes. I prefer to use the term “gametes”. Those cells, artificial sperm or artificial eggs derived from stem cells may make it possible for individuals not able to produce mature eggs or sperm to have a child. That is a prospect for the future which should be supported. For that reason I strongly support the amendment.

It would be surprising if Members of the Committee were not dazzled by the scientific acumen of noble Lords such as the noble Lord, Lord Winston, and my noble friends Lord Walton and Lord Patel. The noble Lord, Lord Elton, put the matter well; I have no difficulties with some of what my noble friend Lord Patel said earlier, and I believe that there is scope for common ground on the use of adult stem cells, a matter he alluded to. Nevertheless, issues have been raised in some of noble Lords’ remarks, and indeed in the remarks on mitochondria, which no doubt we will come to later when my noble friend Lord Walton of Detchant speaks to his Amendment No. 4 in the group.

We are being asked to do different things. The amendment of my noble friend Lord Walton asks us to remove all regulation and to allow what he would like to do to proceed in a wholly unregulated way. On the other hand, my noble friend Lord Patel suggests a form of regulation. I suggest in my Amendment No. 2A that we should reserve to Parliament the right to decide on these complex and sometimes controversial issues.

The amendments in the group deal not only with the questions already alluded to but with reproductive cloning, mitochondrial DNA, and immature human and animal gametes, expanding their use into interspecies embryos. That is a phenomenally wide group of issues to consider in one group of amendments. It is also a phenomenally complex group of issues for any lay person to deal with.

We are having a rather back-to-front debate very late in our proceedings. Probably tomorrow or perhaps next week, we come to Amendments Nos. 66 and 67, tabled by the noble Lord, Lord Brennan, which urge on us the creation of a national bioethics committee that is outside Parliament and capable of giving informed opinion to Members of both Houses before decisions such as this are taken. In many ways, I wish we could have had that debate at the head of our consideration of the Bill in Committee.

My noble friend Lord Walton seeks in Amendment No. 4 to remove the need for regulation. The practical effect would be to allow licence holders to modify an egg or embryo for mitochondrial reasons without further regulatory requirement. If that were to permit reproductive cloning to prevent the transmission of mitochondrial disease without having to go through the affirmative procedure, we would have entered a brave new world without so much as a parliamentary grunt. Many of us who admire scientists and science nevertheless believe that Parliament has a right and a duty to insist that good science and good ethics march hand in hand. I doubt that I am alone in wearying of the political mantra, “We will follow the science”. Parliament’s job is surely to inform itself; arrive at wise and just judgments; and to lead, not to follow. We should be deeply suspicious of any attempt to remove regulation and simply place that power in the hands of the Secretary of State, however esteemed they may be.

To sleep-walk into provisions that might have irreversible effects, and to do so in the absence of a legislative, ethical and regulatory framework, would be a dereliction of our duty. So, too, would the failure to close a route to reproductive cloning. As we are seduced and subverted by the dazzle of these various proposals, I am reminded of CS Lewis’s prophetic polemic, The Abolition of Man, published in 1943, and of his futuristic work, That Hideous Strength, published in 1945. He foresaw what he described as technological brutalism, just as Huxley foresaw a world populated from vast hatcheries and peopled with entities with intelligences ranging from alpha to epsilon. Even before Lewis and Huxley, in 1896, HG Wells published The Island of Dr Moreau. Dr Moreau, who specialised in creating animal-human hybrids, says:

“I went on with this research just the way it led me … I have never troubled about the ethics of the matter”.

He was not subject to regulation.

Instructively, Lord Feverstone, the creator of the National Institute for Coordinated Experiments in That Hideous Strength and a fictional Member of your Lordships’ House, says that his aim is:

“Quite simple and obvious things, at first—sterilization of the unfit, liquidation of backward races … selective breeding”.

Ultimately, he will create:

“A new type of man”.

All this was futuristic, speculative writing, but it is fast becoming reality because of the extremely permissive flexibility of provisions in Bills such as this. It is clear that the desire of the scientific lobby, to which my noble friend Lord Patel referred earlier, and evidenced in arguments for deregulation, is that the Bill embrace all future technological developments without wasting time coming back to Parliament for approval. Even when specific restrictions are stated in the Bill, they are usually accompanied by provisions to permit further change, with a minimum of scrutiny or accountability. I hope that when the Minister replies, he will reiterate that the provision of the conscience clause in the 1990 Act will continue to apply, thus protecting those scientists who do not wish to be corralled into work that in other European jurisdictions would carry a prison sentence.

It may be very unfashionable to say this, but there are tens of thousands of desperately unhappy children who are orphans and who would desperately love to be in a loving home. Adoption has gone out of favour, and I noticed in a reply to a Parliamentary Question which I tabled recently that, in the whole of last year, only 165 babies were available in this country for adoption. Of course couples who wish to prevent the transmission of disease to their children should, as the noble Lord, Lord Winston, has said, be given every support possible if they want to adopt an orphaned child, instead of going to extraordinary lengths and using cell nuclear replacement procedures to create children who may turn out to have some other unexpected disorder resulting from the very artificial procedure used to create the embryo.

Adoption would also be better than creating three genetic parents. At Second Reading my noble friend Lord Walton said that to be able to prevent the transmission of mitochondrial disease:

“One can take a donor ovum from which you have removed the nucleus and put the nucleus into that donor ovum, which has normal mitochondria in the cytoplasm, and then allow that to be fertilised by the partner’s sperm, thus allowing these women to have normal children”.—[Official Report, 19/11/07; col. 709.]

This means that you can carry out a technique to insert the nucleus of an egg from the woman with mitochondrial disease into the egg of an egg donor who has healthy mitochondria where the nucleus of that egg has been removed, and that would be followed by IVF.

If we simply insert an adult somatic cell from the woman with unhealthy mitochondria into the enucleated egg instead of inserting the nucleus from her egg, would that not be reproductive cloning after activation instead of IVF? What precisely in the Bill would prevent this, as permitted eggs and embryos are allowed to have alterations in their mitochondrial and nuclear genes if it is for the treatment of mitochondrial disease, and do not have to have been created by fertilisation as new Section 3ZA(5) can override the prohibitions in new Section 3ZA(2) and (4) which would otherwise have prohibited implanting embryos created by altering DNA and embryos that had not been created by fertilisation?

Paragraph 2(3) of Schedule 2 on page 54 also specifies that licences can be given where the nuclear and mitochondrial DNA of embryos to be implanted has been altered for the purpose of mitochondrial disease. These eggs and embryos are also specifically permitted to have material from two women according to new Section 35A on page 30. All this would seem again to permit reproductive cloning as one of several possible ways to prevent transmission of mitochondrial disease.

With the Bill as it stands in new Section 3ZA(5), both this and the procedure suggested by the noble Lord, Lord Walton, would be subject only to affirmative resolution. However, if the noble Lord’s Amendment No. 4 is approved, then neither procedure would be required to go through Parliament for affirmation. This means that reproductive cloning would be legal as one method to prevent transmission of mitochondrial disease without ever having come back to Parliament. We must not allow this law of unintended consequences to happen.

I agree with the noble Lord, Lord Alton, in showing concern about the groupings in the Bill. I feel the groupings are far too wide. For example, in the first grouping, it may appear as though the amendments have a great deal in common but, in reality, there are basic differences which lead to various different outcomes. Unless it is properly understood, we are in danger of passing the Bill to the House of Commons without proper scrutiny of the possible—or, indeed, probable—unintended consequences to which the noble Lord, Lord Alton, has referred. After all, the danger of any new legislation is unintended consequences, and we have had a long history of looking at this over the years.

As has already been said, the science involved is dazzling, and for a lay person to get involved in this might seem like utter stupidity. On the other hand, there are underlying issues in the Bill to which I referred at Second Reading. The Bill concerns an enormous number of people who have no idea of the basic science. When we hear people stating that the great public out there have no problem with the issues, of course they have no problem because they do not understand the issues. When you are asked a question about something which you do not understand and you just say, “Oh yes” or whatever, that really is a problem. I am deeply concerned about this.

We are now determined that we are going to be so leading edge in this area, where there is no guarantee of therapeutic success. In case noble Lords are not aware of the issues that were raised at Second Reading—I have not read them—I repeat that over a period of some 17 years there have been attempts to undertake this type of research and, during that period, there have been no positive results, whereas we have more than 70 proven therapeutic treatments directly attributed to the ethical adult stem cell research.

I shall address Amendment No. 1, in the name of the noble Lord, Lord Patel, in particular. Will the Minister—or indeed the noble Lord himself, if he wishes to come back—give me some satisfaction on some of the issues the amendment raises? Does it necessarily mean that no licence under Clause 4(1)(a) will any longer be needed to store or use immature eggs? Will no consent be required any more under Schedule 3 for the use of immature eggs? Immature eggs derived from adult ovarian tissue could be used without consent for cloning experimentation and so on. Immature foetal eggs derived from abortion could be stored and used without any need for a licence, while no restrictions would exist any longer on the use of immature eggs derived from born persons for treatment purposes. A licence-free environment in which immature eggs could be used for experimentation without any control is, I suggest, not the right way to go.

As it appears that we are now discussing this whole group of amendments, it is appropriate that I should comment on my Amendment No. 4, which was referred to in detail by my noble friend Lord Alton. The purpose of the amendment is quite simple: to remove the need for research on the prevention of mitochondrial disease to be subject to regulations made by both Houses of Parliament, simply leaving the responsibility for licensing such research with the Human Fertilisation and Embryology Authority. I shall come to that in just a moment.

I remind your Lordships that mitochondrial disorders are a cruel class of inherited disease— life-threatening conditions coupled with great unpredictability about how future children will be affected. They can include fatal liver failure, stroke-like episodes, mental retardation with intractable epilepsy, muscle weakness, diabetes and deafness. All cells in the body contain between 1,000 and 10,000 mitochondria in the cytoplasm that surrounds the nucleus. They are tiny energy-producing structures, or organelles, vital to cell function. If they malfunction, organs will eventually fail.

Because there are no mitochondria in sperm but only in the ovum cytoplasm, when mutations occur in the mitochondrial genes, causing these devastating diseases, those mutations are transmitted by the female who has those genes to all her children of either sex. They are therefore inherited only from the mother. Mitochondria carry only a very small number of human genes—just over 0.1 per cent. It is in those genes that the mutations may occur.

The Human Fertilisation and Embryology Act 1990 permits laboratory research into human cytoplasmic transplantation. Such a research licence was granted by the Human Fertilisation and Embryology Authority to a team at Newcastle University in 2005, and the laboratory studies are ongoing. The team is working on animal studies in which it is carrying out the procedure, to which I referred in detail at Second Reading, of taking an ovum, removing the nucleus from it and transplanting the nucleus from another ovum into it so that that nucleus will contain 99.5 per cent of the DNA of the donor nucleus but will also contain the normal cytoplasm.

The proposal that we are discussing now is the next step—when safety has been assured and when all the evidence, scientific and otherwise, has accumulated to make it clear to the Human Fertilisation and Embryology Authority that this is a practical possibility—which is to be able to take an ovum from a women carrying these devastating mitochondrial abnormalities in her cytoplasm, take the nucleus containing 99.5 per cent of her DNA and transplant it into a donor ovum from which the nucleus has been removed but which has normal cytoplasm.

The decision to allow that to happen is hinted at in the Bill, which allows regulations to be introduced in the future in respect of the clinical application of the current animal research to prevent the transmission of mitochondrial disease. This amber signal is welcome, but is it not just introducing yet another stage of bureaucracy in allowing the research to proceed? The decision to introduce this technique as a clinical treatment must be based on whether researchers can produce convincing evidence of safety and efficacy. The decision to grant a licence for such new clinical treatment involving embryos and gametes ordinarily rests with the HFEA. Similarly, there is a strong case for the HFEA to be allowed to determine whether to license cytoplasmic transplantation in human subjects. It will be ideally placed to assess the safety and efficacy of each case and to incorporate detailed scrutiny by members of the scientific community with appropriate expertise. There is a need for such research to progress to therapeutic application for the prevention of such serious, life-threatening diseases.

The idea that the resulting child has three parents is nonsense. The DNA in mitochondria carries no information that defines any human attributes whatever, so it cannot be parental in any way either. On this reasoning, one might well claim that people with a kidney transplant have four parents; indeed, that is a stronger claim, as the kidney carries nuclear DNA from the donor and not just cytoplasmic DNA.

This treatment is not the same as reproductive cloning, which describes the situation where any baby created would be genetically identical to a donor through the transferring of a nucleus from that donor into an egg from which its own nuclear DNA had been removed. Reproductive cloning is, and must remain, illegal in the UK. However, in mitochondrial disease treatment, there is in effect the exact opposite: a transfer of a cytoplasm and, with it, normal mitochondria from the donor.

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.

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.

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 genetically related to them. In theory, that technique could obviate altogether the need for donor sperm and eggs, which many of us would surely welcome. However, if such a technique were to be developed, it would open up all sorts of other possibilities, which we have really not begun to think about. It could mean that the stem cells of a man could be used to create a female ovum and the stem cells of a woman could be developed into male sperm. I use that notion as only one example of what might become possible. It would enable a woman to become a child’s genetic father and a man to become a child’s genetic mother. Some may feel perfectly relaxed about that idea—the noble Lord, Lord Patel, may be one of them. However, I would be amazed if parliamentarians in general did not regard it as an idea that needed considerable thought and deliberation before we could contemplate making it legal.

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.

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.

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.

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 the 1990 Act. It removes the words, “including cells of the female germ line at any stage of maturity”. That has the effect of altering the meaning of “egg” in the Bill to live human eggs but does not include eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo.

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—

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?

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.

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 would be that it would no longer be clear whether cells of the female and male germ line at any stage of maturity would be gametes for the purpose of these provisions.

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.

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?

I understand the reservation and, perhaps, fears expressed by the noble Lord, but the fact that matters would be discussed by Parliament through the affirmative resolution procedure is the best way that we have found to date. But of course we would be open to discuss this with the noble Lord if he believes that there are better ways forward. I look forward to discussing these matters with him after Committee stage.

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 an offence. However, the Government remain firmly committed to a ban on reproductive cloning. In this Bill, the provisions have the same effect as the 2001 Act—that is, to prevent anything other than an embryo created by fertilisation of a natural egg with a natural sperm being placed in a woman. Therefore, the 2001 Act is suppressed but it is still an offence to carry out reproductive cloning.

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.

I turn to Amendment No. 4, tabled by the noble Lord, Lord Walton, who spoke passionately about this issue at Second Reading and this afternoon. As discussed in relation to earlier amendments in this group, Clause 3 introduces the concept of permitted embryos, sperm and eggs. The Bill prohibits placing in a woman any embryo, gametes, eggs or sperm other than permitted embryos or gametes. This essentially prevents placing in a woman anything other than an embryo created by the fertilisation of a naturally occurring egg with a naturally occurring sperm, so, although the legislation covers a much wider spectrum of embryos created through various techniques, only those created through fertilisation can be used to create new life.

Clause 3 inserts new Section 3ZA into the 1990 Act to define permitted embryos and gametes. For gametes, this means an egg produced or extracted from the ovaries of a woman or sperm produced or extracted from the testes of a man with unaltered nuclear or mitochondrial DNA. For embryos, this means an embryo created by the fertilisation of a permitted egg with the 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.

The noble Lord, Lord Walton, referred to the research group in Newcastle which is trying to find ways to prevent the transmission of mitochondrial disease conditions. If that research develops into a safe and effective treatment, the Bill has a provision that will allow Parliament, through regulations, to amend the legislation so that embryos and eggs created to avoid the transmission of those conditions can be placed in a woman. That regulation-making power, therefore, provides for an egg or an embryo to be brought within the definition of a permitted egg or embryo if it has had applied to it, in prescribed circumstances, a prescribed process designed to prevent the transmission of mitochondrial disease.

Clause 3(5), inserting new Section 3ZA(5) into the 1990 Act, is a very specific regulation-making power which would enable such eggs or embryos to be placed in a woman under a treatment licence. Amendment No. 4 moves the provision from secondary legislation and places it in the Bill. The provision was left to secondary legislation not because we believe that the issues relating to mitochondrial disease are, as the noble Lord, Lord Alton, says, to do with technological brutalism, nor because we want to introduce a further layer of bureaucracy, but because we believe that data on safety and efficiency of this technique are not yet available and, therefore, it would seem premature to provide for this technique to be licensed in the Bill.

The technique also raises important ethical considerations because it covers the creation of an embryo using three separate genetic contributions. Although we recognise that this research is significant and has the potential to alter significantly the reproductive options for those people who suffer from serious mitochondrial diseases, we feel, at this time, when the safety and efficacy of the technique has yet to be demonstrated, that this provision is most appropriate in secondary legislation with an opportunity for debate in both Houses.

Amendment No. 5, tabled by the noble Lord, Lord Patel, raises another important matter. The amendment introduces a regulation-making power which would allow the definition of permitted eggs and sperm to be expanded to eggs and sperm that have been derived from a prescribed process to treat infertility. That relates to research to help those people who are unable to produce gametes naturally to have children that are genetically related to them. It is also possible that in some circumstances that technology could be used for the purpose of enabling same-sex couples to have children who are genetically related to both parents.

I note what the noble Lord, Lord Patel, has said about researchers working in this specific area and what the noble Lords, Lord Winston and Lord Wilson, have said. We believe that this research is not yet at a stage when it can be translated into infertility treatments, but Amendment No. 5 provides for the expanded definition of permitted embryos to include artificial gametes to be introduced by secondary legislation. The Bill allows for research into artificial gametes to be carried out but the use of artificial gametes is not permitted in treatment. I understand the arguments that have been put forward from a scientific perspective, but I believe that the amendment raises wider ethical questions, as the noble Earl, Lord Howe, said. Therefore, on balance, the Government have decided that such a significant and potentially wide-ranging development should be subject to full parliamentary debate and consultation as and when further data on these techniques are available.

Amendments Nos. 51 and 53 seek to permit the use of cell lines, a tool commonly used in research for the creation of embryos in the laboratory by means of therapeutic cloning without specific consent to this activity. The cell lines may be cultured for many years; some cells found in cell lines were originally donated decades ago. The cells would have been taken from a donor with the person's consent, but that person would be unlikely to have imagined, particularly if the cells were donated many years ago, that they could or would be used for the creation of cloned embryos.

Every person has the right to decide whether their cells may be used in the creation of an embryo, and for what purposes that embryo may be used. That was the main reason for the consent regime found in the 1990 Act and the reason behind the proposed changes to the consent requirements found in the Bill today. These changes have been introduced to ensure that a person’s consent is always obtained before the use of their cells or gametes in embryo research. Schedule 3 to the Bill preserves the system of consent under the 1990 Act that makes changes to reflect the fact that human embryos can now be created in more ways than simply mixing human gametes. Additional consent requirements are introduced to ensure that informed consent is obtained before any human material can be used to create an embryo and for the subsequent use and storage of such embryos. These provisions ensure that the same safeguards provided in the 1990 Act for consents relating to embryos are applied to all types of embryo creation.

I understand that these cell lines will provide a reliable resource of cells for the creation of cloned embryos, particularly following the advent of cytoplasmic hybrid embryo research, which gives a plentiful supply of animal eggs. I am not convinced that the other use of cells for which proper consent is in place is not just as easy and abundant.

The noble Lord, Lord Patel, asked whether “cell” included cell lines. Yes, we have proposed that the definition of “human cell” that may be used to create a human embryo should include cell lines. The general principle is that consent should be obtained for the creation of embryos. As the Bill stands, this includes where cell lines are used.

This huge group of amendments covers some important—

I could not quite follow the Minister there. Is she saying that it is proposed that this shall be the definition, or that it is the definition? If the latter, where is it? If the former, when will it be?

We have proposed that the definition of “human cell” should include cell lines. I would therefore imagine that “cell” equalling “cell lines” is within the Bill, but I will come back to the noble Lord with clarification on this issue shortly.

In the mean time, the group of amendments covers some important matters which define to what entities and biological material the controls in the Bill apply, and what some of these controls should be. The Government are prepared to reconsider the details of the relevant provisions, and will continue their dialogue with stakeholders on these matters—and, of course, with all noble Lords present today. I thank all noble Lords for their vital contributions on these matters and ask the noble Lord, Lord Patel, to withdraw his amendment.

I am still unclear about the response to Amendments Nos. 1 and 2 of the noble Lord, Lord Patel. Surely where it says,

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

that is already adequately covered by existing regulations through local and central ethical committees. It therefore hardly needs an extra piece of legislation through the Human Fertilisation and Embryology Authority. It is important that we understand that human tissues are already seriously regulated, as they should be, by the Government.

It would be nonsense. For example, if you take the issue of the germ cell tumour, which occurs both in the ovary and the testes, we would not actually be able to do research on those tumours in that there is no suggestion that one is going to produce a pregnancy or try to treat infertility. But this research is important, and might be curtailed. That is an example of where the Government need to think about this phrase, as raised by my friend the noble Lord, Lord Patel. Can the noble Baroness respond to my concern?

I note the deep concern expressed by noble Lords. The Government are seeking only to ensure that there is legal clarity. There is currently no legal clarity in the definitions mentioned. However, the Government are very willing to discuss these matters further, and I suggest that after Committee stage we have an in-depth conversation about them before Report.

I shall be happy to do that, particularly about the final point the Minister made about cells. I was very precise in what I said about human cells. I think there has been a misinterpretation. I hope the Minister did not mean that cell lines will be excluded because that would mean that all cell lines, including cancer cell lines, would come under regulations. That cannot be the Government’s intention.

It may be of interest to recollect that the Joint Committee that examined the draft Bill was faced with these extensions to the definitions. The noble Lord, Lord Winston, was a member of that committee and knows much more about this than I do, but I think that the committee felt that basic science work might be affected by these definitions and that that sort of work would not necessarily involve the creation of embryos or the kinds of ethical considerations that surround that concept. The HFEA is set up primarily to deal with the special ethical considerations that arise from the creation and use of embryos. As I recollect, the committee recommended that the authority should have the power to exempt from the requirements of a licence activities in respect of which a licence was applied for but which in the view of the authority did not involve the ethics of embryos. It may be worth while seeing whether it is possible to revive that idea. It might well deal with at least some of the problems. It does not deal with them all—it does not deal with the problem raised by the noble Lord, Lord Walton of Detchant—but it deals with some of the problems raised by the noble Lords, Lord Patel and Lord Winston.

I am grateful for that intervention from the noble and learned Lord, Lord Mackay. It is important that we have further discussions about definitions, perhaps along the same lines as in the Joint Committee. I look forward to discussing these issues further.

I respect the views expressed by my noble friend Lord Alton, the noble Lords, Lord Elton and Lord Brennan, and the noble Baroness, Lady O’Cathain. The noble Lord, Lord Brennan, is not in his place, but I hope he is well. I am not trying to dazzle noble Lords with science. My scientific knowledge cannot dazzle anyone, as my children regularly remind me. Scientists merely wish to inform so that parliamentarians can make better regulations. The purpose of my amendment is to clarify definitions in scientific terms so that we can decide what should be regulated, what should be allowed and what should be made illegal. That is the sole purpose of the changes of definition that I suggest.

I welcome the support of noble Lords for my amendments. The purpose of my amendment relating to artificial gametes is to treat those who are infertile. I made a point of referring to patients such as those treated with cancer therapies whose germ line cells are destroyed. I accept the concern of the noble Earl, Lord Howe, but we are not talking about using male somatic cells to produce female germ cells or vice versa, but about infertile couples using male somatic cells, adult cells or induced pluripotent cells to produce male sperm or vice versa for female eggs. I would not be at all “relaxed”, to use the words of the noble Earl, Lord Howe, if the case was as he suggests.

As far as concerns the amendment of my noble friend Lord Walton, we have to recognise that mitochondrial diseases are serious. People who suffer from such a disease inherit it through the female line. Mitochondria are not germ cells. The embryo created will be the fusion of a male sperm, the father, and the female egg, the mother. The DNA material that would not belong to them would be the mitochondrial material. It is therefore not cloning in the correct sense of the word “cloning”, unless you wish to abuse that term scientifically. I would not wish to do that. So I do not accept that that is cloning, and I support the noble Lord, Lord Walton, in what he is trying to promote.

As regards unintended consequences, my Amendments Nos. 10 and 11 were put forward to remove germ-line cells from the definitions. Otherwise germ-line cells would have fallen outside the regulations and could have been used for cloning purposes. I tabled the amendments for precisely that reason—to avoid unintended consequences if the Bill is not amended.

I hear what noble Lords have said and I hear what the Minister has said. I shall read very carefully what she has said, particularly about definitions. I welcome her offer to meet to sort out these definitions. For the mean time, I beg leave to withdraw my amendment.

Amendment, by leave withdrawn.

[Amendments Nos. 2 and 2A not moved.]

Clause 1 agreed to.

Clause 2 agreed to.

Clause 3 [Prohibitions in connection with embryos]:

[Amendment No. 3 not moved.]

4: Clause 3, page 3, leave out line 24

The noble Lord said: I appreciate that the issue of mitochondrial disease is an extremely complex piece of science. I hope that the opportunity to come back to this issue may arise at a later stage.

[Amendment No. 4 not moved.]

[Amendment No. 5 not moved.]

Clause 3 agreed to.

Clause 4 [Prohibitions in connection with genetic material not of human origin]:

As the noble Lord, Lord Alton, will also be speaking to Amendment No. 6A, I should draw the Committee’s attention to an error in the Marshalled List. It says “leave out from ‘authorise’ to the end of line 19”; it should say “to end of line 18”.

6: Clause 4, page 4, leave out line 11

The noble Lord said: I am grateful for that clarification. It saves me having to make it later. In moving Amendment No. 6, I shall speak also to Amendments Nos. 6A, 16, 28, 42, 43, 45, 47, 48, 65A and 65B, which are grouped together. I am sure that the Committee will bear with me as I try to speak to this large group of amendments.

The cumulative effect of the amendments will be to ban the creation of interspecies embryos. I welcome Amendments Nos. 19, 20 and 61 in the name of the noble Earl, Lord Howe, which have been grouped with my amendments. Amendments Nos. 19 and 20 would prevent tetraploid complementation, giving rise to a substantially human foetus.

My apologies. They are not ungrouped on the list that I have been given. I am grateful for that clarification, and I will come to those amendments in due course.

Following the BSE crisis, and after the saga of genetic crops, the Science and Technology Committee of your Lordships’ House said that,

“many are deeply uneasy about the huge opportunities presented by areas of science including biotechnology and information technology, which seem to be advancing far ahead of their awareness and assent. In turn, public unease, mistrust and outright hostility are breeding a climate of deep anxiety among scientists themselves ... Science’s relationship with United Kingdom society is under strain”.

Do we seriously believe that the creation of animal-human hybrid embryos, about which there is deep unease, will heal that fractured relationship? The main argument for using hybrids is for medical cures. Interspecies cloning is particularly in highlight in this regard. However, the Japanese procedure, which was referred to at Second Reading, to produce cells that resemble embryonic stem cells directly from skin, producing multipotent stem cells that were identical immunologically to the patient without using an embryo, was recently found to work with human cells by two groups, as several noble Lords mentioned in our debate on 19 November. That is a major advance. The two groups were led by Professor Yamanaka in Japan and by Professor James Thomson in America, who originally isolated human embryonic stem cells.

My noble friend Lord Patel spoke powerfully against the Japanese procedure in that debate. He questioned the ability of the production of embryonic stem cells directly from skin, and pointed to some of the issues that might arise. He emphasised that the mouse produced from these cells had tumours, owing to a particular gene that had been inserted to induce the cells to become multipotent. I am delighted to be able to tell your Lordships’ House that the same research group published a further article on 30 November in Nature Biotechnology in which it described research in which it did not use that gene and none of the mice developed tumours. The cells are likely to be much more biologically relevant than cells produced by interspecies cloning, as cloning produces numerous biological flaws and carrying out interspecies cloning would simply magnify those problems. On 30 November, The Daily Telegraph reported:

“Now the Japanese team led by Prof Shinya Yamanaka and colleagues at Kyoto University show in the journal Nature Biotechnology how to convert adult human skin cells into cells that resemble embryonic stem cells without using the tumour-causing gene”.

These genes will be an immune match to the patient, so pursuing this avenue of research would negate the need to pursue therapeutic cloning and interspecies cloning.

What is the precise purpose of what we are being asked to approve, should the amendments not be made to the Bill? What did scientists speaking to the Joint Committee say on being asked their views on so-called true hybrids? Dr Lovell-Badge said:

“I cannot think of a good experiment to do now but I am sure someone will think of a good experiment”.

Professor Bobrow said that,

“we are also not aware of any pressing scientific reasons at the moment for creating such entities, but who knows what tomorrow might bring?”.

Professor Smith said:

“At the present time, we have not been able to identify such a particular reason”—

to make true hybrids—

“but that does not mean that they do not already exist and that there are not people already in the scientific community who would have appropriate grounds or that they would come along in the future”.

This is not exactly overwhelming, compelling evidence that true hybrids are urgently required for medical use. Furthermore, the Chief Medical Officer, Sir Liam Donaldson, said in his evidence to the Joint Committee on the draft Bill on 6 June that,

“there was no clear scientific argument as to why you would want to do it, and, secondly, a feeling that this would be a step too far as far as the public are concerned. I think we do have a responsibility to ensure that we take the public with us in the other important areas of research that we want to do, and do not lose their confidence by moving forward with something which is much further out, as far as acceptability is concerned, and where the scientific arguments for wanting to do it are not particularly strong or convincing, or even existent”.

I know that many of those who voted for embryonic cloning in 2001, and who will vote for animal-human hybrids, did so out of a genuine humanitarian desire to help those who suffer from disabling diseases. I do not believe that anything divides us in this House in our determination to try to do that, but were those beliefs well founded?

It may be instructive to note the subsequent widely reported comments of the noble Lord, Lord Winston, in 2005. He said:

“I think it is unlikely that embryonic stem cells are likely to be useful in healthcare for a long time ... I was concerned that parliamentarians—particularly in the House of Commons—have been convinced that it was just a matter of a few years before we would be able to transplant stem cells and cure a lot of neurological disorders, like Alzheimer’s disease, for which I think it is going to be a hugely difficult problem and probably completely insoluble by stem cells”.

To pretend that the creation of hybrid embryos from animal eggs will offer a desperate patient with motor neurone disease their only hope of a cure, as was prominently asserted earlier this year, is perpetrating yet another piece of fiction which does no service to the seriously ill.

Perhaps now would be a good time to pause and similarly ask what the creation of interspecies embryos might realistically promise. In his speech on Second Reading, my noble friend Lord Walton of Detchant inform us that,

“the new technique of cloning using the interspecies embryo”,

would not require suppression of the immune response. Indeed, he went on to say:

“Now, if one can use animal cells to produce the type of capsule or framework in which the nucleus from that cell can be implanted, stem cells derived from that cell will be immunologically compatible with the host into whom the subsequent stem cells will be implanted. That overcomes the difficulties arising as a result of some use of other cells such as the adult stem cells to which the noble Lord, Lord Alton, referred”.—[Official Report, 19/11/07; cols. 708-09.]

In due course, I know that the Committee will greatly appreciate it if my noble friend would be willing to explain how it is that cells containing proteins from a distantly related species would not provoke an immune response, yet stem cells taken only from the same individual supposedly would. In expounding such views, I also trust that my noble friend will explain fully how one can be so sure about the developmental potential of such a cloned interspecies entity, especially without implanting it in a womb or crossing the 14-day limit.

In our debate in January 2001, my noble friend was sceptical about progress using adult stem cells, stating that progress would take many years of fundamental research. In his speech on Second Reading, my noble friend also commended an article by Julian Savulescu on the purported benefits of attempts at human cloning with eggs of distantly related species. I hope my noble friend will take the opportunity to dissociate himself from Professor Savulescu’s previously expressed views in favour of reproductive cloning or the harvesting of tissue from cloned foetuses.

Meanwhile, Her Majesty’s Government seem decidedly confused regarding whether the potential use of a technique known as tetraploid complementation would fall under the remit of the Human Fertilisation and Embryology Act if human embryonic stem cells were injected into a tetraploid embryo of another species. Tetraploid embryo complementation is already a well established technique for deriving mature mice entirely from mouse embryonic stem cells in which the cells of a tetraploid mouse embryo give rise to extra embryonic tissue, such as placenta, while the mouse’s embryonic stem cells contribute directly to the developing foetus.

The Minister has stated that the reference to,

“such other things as may be specified in regulations”,

as proposed to be inserted under Clause 4(2) of the Bill has the scope to cover any predominantly or substantially human organism that conceivably may be created by injecting human embryonic stem cells into an embryo of another species into which the animal cells primarily produce extra embryonic tissue.

I invite the Committee to contrast those remarks with those of the noble Baroness, Lady Royall of Blaisdon, and with those previously made by the noble Lord, Lord Hunt of Kings Heath. He stated that an animal embryo altered for an experimental or other scientific purpose by the introduction of one or more human cells will be governed by the provisions of the Animals (Scientific Procedures) Act 1986 once it reached the half-way point of gestation or incubation. That was given to me in a Written Answer on 28 June 2007. Subsequently, the noble Baroness, Lady Royall of Blaisdon, stated that if the cells that make up an embryo contain at least a haploid set of human chromosomes and at least one sequence of animal DNA, including a tetraploid complement of animal chromosomes, then it will be regulated as an interspecies embryo, but the regulation of animal embryos that contain single or multiple human cells is not within the scope of the Bill. That was given in a Written Answer on 12 July 2007.

Under which legislation would an embryo fall if it contained a significant proportion of human embryonic stem cells, which obviously themselves contain at least a haploid set of human chromosomes that have been injected into a tetraploid primate embryo? The evident confusion displayed by the contrasting answers from Her Majesty’s Government on this potential issue have not inspired much more confidence in the ability to regulate such research than the extensive indecision of the Human Fertilisation and Embryology Authority regarding whether it could regulate the so-called “cybrid” embryos. Such confusion may be especially disconcerting in the light of Dr Stephen Minger’s comments to the Joint Committee on the Human Tissue and Embryos (Draft) Bill that it may be only a few years before someone will want to,

“take human embryonic stem cells and put them into a primate blastocyst and take that blastocyst to mid-gestation or maybe to birth or maybe to ten years of age”.

So much, then, for the 14-day limit as applied to interspecies embryos.

In 1990, in opposing the first Human Fertilisation and Embryology Bill, I quoted in another place scientific opinion that doubted the scientific worth, let alone the ethics, of human embryo experimentation. I quoted an intervention from a debate in your Lordships’ House by my noble friend Lord Walton, whom I respect enormously although we disagree fundamentally on this issue. I seem to have been arguing with him now for the past 20 years. He had been asked what significant cures or advances in treatment had been achieved. He replied,

“I agree that as yet there are none”.—[Official Report, 8/2/90; col. 958.]

In 2001 when I divided your Lordships’ House, when close to 1 million human embryos had been destroyed, I asked the same question. No one could point to a single cure, yet we then authorised the cloning of human embryos. Seven years later we are now being asked to permit the creation of interspecies embryos. Although some 2 million human embryos have now been destroyed or experimented upon, the answer to the question remains the same. Cures—around 80 are now documented—are coming through adult stem cells, not through interspecies manipulation.

We should be clear-sighted. We should think wisely about what we are being asked to authorise. Having done so, we should reject these proposals as a step too far. I beg to move.

I was not able to speak at Second Reading, so it is appropriate at this stage to declare an interest as a member of the Human Fertilisation and Embryology Authority, which is relevant to all stages of the Bill.

I have three points to make in response to the noble Lord, Lord Alton. First, in his first intervention today, he held before us a spectre of science that he termed “brutalism”. He set out a rather frightening future of the kind of world that might come about through science. We are always right to be wary, but there is another view of science: that it is a great blessing, that we are meant to use our minds in order to interact with natural processes to bring about human health and healing. He used the word “artificial”, and people sometimes say “unnatural”, but it is natural for us to use our minds in order to enhance human welfare and well-being.

The second point concerns this set of amendments. I presume that what is really being referred to is cytoplasmic hybrids. There is a case for looking separately at so-called “true” hybrids because, as the noble Lord rightly said, there is not a great deal of scientific pressure at the moment to do research on true hybrids, but there is a lot of such pressure to do research on cytoplasmic hybrids. The reason is clear: there is a great shortage of human eggs. If it were possible to do this research using animal eggs, there would be a virtually unlimited supply. I remind your Lordships that we are talking about research that is essential for the future.

Thirdly, the noble Lord mentioned the new research from Japan that might make it possible to produce pluripotent stem cells without destroying embryos, which is very exciting and promising. But when applications for licences for research come before the HFEA, one of the first questions it asks, if research on embryos is proposed, is whether it is possible to do the research other than by using embryos. In the future, therefore, if this new research line looks possible, the HFEA will quite rightly have to say to the research team, “Is it really necessary for you to use embryos?”.

The use of cytoplasmic hybrids is a very promising line of future research. Your Lordships’ House should approve it and make it possible.

I apologise for taking more of your Lordships’ time. The noble Lord is quite right: I said at Second Reading that Yamanaka had used in his work in Japan vectors which subsequently produced tumours in mice. He is right also that only last week—in fact, just a few days ago—there was an article in Nature Biotechnology headed:

“Generation of induced pluripotent stem cells without Myc from mouse and human fibroblasts”.

That meant that there will not be tumorogenicity of the same degree, but I shall come back to that in a minute, because the story is not quite as glorious as the noble Lord just made out. He was quite right, though, that science is moving fast in this area and may be promising.

There is no doubt that this recent publication, related to induced pluripotency in adult cells, is a scientific advance that most scientists working in stem cell science would not have expected to come with the speed with which it has. It heralds tremendous promise for achieving every stem cell scientist’s holy grail—the noble Lord, Lord Alton, will remember that I mentioned it—of being able to reprogramme an adult cell to a pluripotent cell and differentiate it in the cell types that they need to treat the diseases. That is what every scientist is chasing. It is not that they wish to do embryonic stem cell research for amusement or any other purpose; it is solely for the purpose of looking for treatments.

I return to the main point of the amendment, which relates to two issues: interspecies embryos, and embryos created for cell nuclear-transfer technology. Perhaps I may read a document that I received from Sir Martin Evans, this year’s winner of the Nobel Prize in Physiology or Medicine. He is the man who identified embryonic stem cells decades ago and showed that it was possible to obtain cells with normal chromosomes from early blastocysts. In a recent publication, Jamie Thomson, in Wisconsin, first identified chromosomally normal stem cells from human embryos and early blastocysts. Sir Martin states:

“At the moment, and for the foreseeable immediate future, neither induced pluripotent stem cells nor adult stem cells will suffice for either research or development of stem cell-based therapeutic approaches. It should be pointed out that, presently, the induced pluripotent cells all have integrated within them factors”.

Those factors are viral factors. In the original article by Yamanaka, there were four factors. One of them was an oncogene called Myc, which subsequently induced tumours in the mice. Their oncogene is now removed. What if scientists removed that and used other vectors to induce pluripotency? Yamanaka said that he had induced in his experiments 20 factors in every cell. That means that the chance of a cell subsequently derived not having any of these factors in it would be one in 10 million. We do not know at this stage what results that may produce.

The Bill defines four types of interspecies embryo and prohibits creation and use of these except under licence. At present, the main research focus for the use of those entities would be the use of cytoplasmic hybrids, as the noble Lord said—and I agree with him. Scientists currently wish to use only cytoplasmic hybrids to do the experiments, and not others. The Bill also allows for further regulations to be made by the Secretary of State to include other as yet unforeseen and therefore indefinable entities in the remit of the legislation.

Stem cell research is one of the most exciting areas of 21st century science, as has been said many times. I have said before that if last century was the century of the physical sciences, it looks as if this century may be the century of the biological sciences. If it produces the same degree of advances as the physical sciences produced last century, our lives will be changed—and certainly, the lives of those with debilitating diseases will be changed. As we all know, the UK has an international reputation as a leader in stem cell science.

Somatic cell nuclear replacement technique may prove a reliable method of generating human embryonic stem cells, with particular properties that are not readily available using donated supernumerary embryos. SCNT, as somatic cell nuclear transfer is often referred to, has three specific aims: to create disease-specific stem cell lines that can be used to model disease processes and open up new opportunities for developing therapies; to generate stem cell lines with particular genetic backgrounds to be used in drug development assays; and to create patient-specific stem lines for therapeutic use, which would avoid rejection by the recipient immune system, because they are either created using a patient’s donor cell nucleus or selected to be immunocompatible.

SCNT techniques have proved effective in numerous animal species. Just two weeks ago there was success in achieving SCNT in monkeys, which suggests that current technical barriers might be surmountable. Nevertheless, many eggs will be required to develop SCNT techniques to derive human stem cells, and the problem with SCNT is the low availability of human oocytes, which is limited by the prior needs of patients undergoing infertility treatment and the invasiveness of the donor procedure. It may therefore be more acceptable to use animal rather than human eggs, since they could be used to generate cytoplasmic hybrid embryos for the derivation of embryonic stem cell lines of essentially human nature. At the time when these cells are harvested from the blastocysts, most of the genetic material is human to the extent of 99.9 per cent or more. Some say that if you harvest it early enough it would be virtually 100 per cent, because more of the animal material from the mitochondria is transmitted later in the blastocysts. Animal eggs are readily available from abattoirs.

Proposed research on interspecies embryos in the United Kingdom would involve taking the somatic cell from an adult with a degenerative condition and placing the nucleus in a nucleated animal egg to create stem cell lines to use as diseased models to study pathogenesis and test therapies. Currently, SCNT-derived cells could not be used therapeutically, and no one has the intention to do so, given the exposure to material of animal origin. I say “currently” because we do not know whether it will be possible in science in due course to remove all the animal material. In the United States it is likely that within two years the original embryonic stem cell lines created by James Thomson will be used, with FDA approval which has already been given. Those stem cell lines had rabbit feeder cells; by using a scientific technique, those feeder cells have been removed. The FDA has accepted that technique and allowed permission for those cells to be used for therapy for the first stage of the trial.

Generation of cytoplasmic hybrid embryos using readily available animal eggs would also provide invaluable experience in SCNT technology, thereby increasing technical efficiency and expertise so that a much smaller number of human eggs would subsequently be needed to generate “patient-specific” stem cells that could be used for clinical treatment. The information and technique would also be relevant in research looking at deriving stem cells by programming adult somatic stem cells. In that respect, I also have to say to my noble friend Lord Alton that a technique of reprogramming adult cells to become pluripotent cells used the technique developed by using embryonic stem cells. Without learning from embryonic stem cells, that particular technique would not have been possible as we had to know which vectors were needed to induce pluripotency. My noble friend may challenge that and we will have an interesting discussion if he does.

Recent advances in the methods of direct reprogramming of human somatic cells without the use of oocytes or early embryos, from the Thompson and the Yamanaka groups in the US and Japan, are exciting and welcome. However, that work is at a very preliminary stage and the current technology involves engineering the cells in a way that raises a number of safety issues that will need further refinement before the use of iPS cells in the clinic can be contemplated. To give one example: adult cells have a problem with what we call telomere, or the ageing process. If these cells are used for therapy there will always be a problem because of the loss of telomeres when inserted for treatment. They may produce cancers in the patients treated because of the limited senescence of these cells.

Not enough is known about any particular route to generating stem cells to be sure of predicting which approach will bear fruit, and all avenues of research should be left open. Discoveries in all types of stem cell research inform the field and have the potential to accelerate the delivery of safe and effective stem cell therapies. Indeed, the leading stem cell centres in the UK and overseas contain groups that are working with both embryonic and adult stem cells, and no doubt iPS cell technology will be incorporated in the very near future. In fact, scientists in the UK have already started using the iPS technology following the two reports.

Regulating the creation of interspecies embryos for research under the strict regulatory regime of the Human Fertilisation and Embryology Act will ensure that it is undertaken in a responsible and appropriate manner, subject to rigorous transparent review. Such work will undoubtedly progress in other countries and it would be preferable for the UK to conduct research in its tightly regulated environment rather than rely on results from countries where the same standards may not apply.

The Bill clearly prohibits placing an interspecies embryo in a woman. Furthermore, interspecies embryos cannot be kept after the earliest of the following: the appearance of the primitive streak, or the end of a period of 14 days beginning with the day on which the process of creating the interspecies embryo began. The regulation is firm enough to stop that happening.

There are other issues related to induced pluripotent cells derived from adult cells because of the state of senescence that I have already mentioned. Even if they are made safe for transplantation cell therapy, iPS cells may be useful in patients of a certain age only before their inherited state of senescence turns the cells cancerous. What do we do for the teenager who suffers spinal cord injury in a motorcycle accident? The answer still has to be that ES cells retain real potential in that situation.

One can assess whether induced pluripotent cells have the same behavioural potential as embryonic pluripotent stem cells by comparing them with the gold standard of embryonic pluripotent stem cells. My plea is that at this stage we should allow research on all types of stem cells: adult stem cells, cord blood stem cells, cord stem cells, bone marrow stem cells, embryonic stem cells, induced pluripotent cells and even menstrual blood stem cells.

The noble Lord, Lord Patel, made a very strong argument as to why the amendments of the noble Lord, Lord Alton, should not be accepted. I also served on the joint scrutiny committee and I am a former member of the Human Fertilisation and Embryology Authority. I want to add one point to everything that has been said. When we talked about the nature of interspecies embryos, we said how difficult it was to collect human eggs. This point has been well made but another point must be taken very seriously. If we are to continue with interspecies embryo research—I absolutely agree with those who say that we should and must—we must also recognise that there is a risk posed to women from overstimulation of their ovaries. It is not a great risk but it is a risk.

Adopting the technology of using animal eggs and human sperm to give us material on which we can do this research, which has the potential to be so very useful, is in my view preferable to encouraging more women to have their ovaries stimulated than need to do so for treatment purposes. We should look not only at the potential for the alleviation of suffering that this area of research might bring, but at trying to prevent suffering that could result if too much overstimulation of women’s ovaries should occur other than for treatment. We should take that point very seriously.

I add to what the noble Baroness, Lady Neuberger, said, because it is a relevant point which has not been made in this debate hitherto. Indeed, one could argue that the stimulation of the ovary under any circumstances may produce abnormal eggs. There is growing evidence that the lesser the stimulation, the better the quality of the egg and the better the chance of the embryo implanting and being viable. Within the next three to five years more and more in vitro fertilisation programmes may not involve stimulating the ovary. I believe that this method of stimulation, which is used worldwide, is obsolete. That will make eggs more difficult to obtain because researchers and clinicians should be working with only one or two eggs. Therefore, there will be a growing need for eggs elsewhere.

I should spell out the statistics involved with the current methods. If during stimulation you get 10 follicles, on average you will get nine or 10 eggs. From those, on average about six will fertilise, of which, on average, two or three will produce an embryo. Even then, those embryos will not necessarily be viable. Something happens during this process which is not entirely counterproductive, and we do not understand why. That is why an alternative method would be extremely useful. It is not reasonable to expect women to give up eggs during their in vitro fertilisation programme when they know that it is uncertain which egg will become the embryo which will produce the pregnancy they so desperately desire. For that reason as well it is essential to focus on the needs of these IVF patients.

I support the noble Lord, Lord Alton, in Amendment No. 6. As he said, the creation of interspecies embryos is a step too far. The noble and right reverend Lord, Lord Harries of Pentregarth, encouraged us to pursue research, but most countries have not formed specific legislation to cover the creation of human-animal hybrids for research. Many countries in Europe already prohibit the creation of human embryos for research, in line with the European Convention on Human Rights and Biomedicine. That means that we are already out of line with Europe. Surely we need to align ourselves with European thinking rather than the more permissive countries such as China, Japan and South Korea?

I will mention the results of two recent pieces of public research on this issue. The Joint Committee had an online survey in June 2007 with 153 responses, and only one person suggested that the regulatory authority should license interspecies research. Secondly, in July 2007 a public opinion poll was conducted with 2,073 people, and only 7 per cent said that they knew a lot about using human embryos in research and 9 per cent had never heard of it. That suggests that not a great deal is generally known about the subject among the general public. The summary of responses to the scientific consultation gave the general view of organisations that there is currently no reason why scientists would want to create human transgenic embryos, true hybrids or human chimera embryos.

The lack of human eggs should not be used as a justification for embarking on this unethical research. All avenues of research should not be open; only ethical avenues should be pursued. The Joint Committee recognised that the Bill lacked an ethical framework. The Bill would allow for the unnecessary licensing of these hybrids.

The initial reaction to such matters is often referred to as the “yuck factor”. Should we not rely on that basic human response to show that this research is both ethically and morally concerning and is indeed wrong? It removes any respect for human dignity and it crosses the human-animal species barrier. No consideration seems to have been given to biosecurity issues in relation to interspecies viruses. Are those who are experts in stem cell embryology also experts in such issues? It has been suggested that animal eggs from abattoir material could be used, but in any event that research is repugnant; it should be prohibited rather than allowed. I urge noble Lords to ban such scientific experiments; we need to retrace our steps to align ourselves with European countries rather than embark on even more unethical research.

In his extremely comprehensive and detailed speech, my noble friend Lord Patel has covered virtually all the points that I wish to make. In passing, I was privileged today to give lunch to Dr Stanley Prusiner, Nobel Prize winner in medicine and physiology, from San Francisco. He is a most distinguished neuroscientist, although his Nobel Prize was awarded for work on prions as a cause of Creutzfeldt-Jakob disease and bovine spongiform encephalopathy. Nevertheless, he has been taking a careful interest in the progress of these debates in the House of Lords, and he made it absolutely clear that in his view issues that are being considered today in relation to the Bill are, for various reasons, not being pursued as effectively as they might be in the United States. I say in passing to the noble Baroness, Lady O’Cathain, that for more than 20 years scientists have been inserting human genes into animals to create animal models of human disease. A significant proportion of the budgets of the National Institutes of Health in the United States and the UK’s Medical Research Council goes into this research, but it is licensed by the Animal Procedures Committee and does not fall within the ambit of the HFEA.

To return to the points made by my noble friend Lord Alton, let me say at once that although it is absolutely right that no cure for a human disease has yet been achieved by the use of stem cells, a great deal of research has been done in using stem cells to treat animal models of disease, with as yet some significant and quite encouraging results. This type of research is measured in years, not months and days. For example, in my field of research—muscular dystrophy—it has been shown that muscle stem cells, some created from adult stem cells by manipulation and other techniques, have been injected into muscle and have replicated and produced a certain amount of repair. The problem is how to get those stem cells into every muscle in the human body. That is an enormous challenge for scientists. But there are encouraging signs of benefits arising from such work.

My noble friend Lord Alton is absolutely right that adult stem cells, cord blood stem cells and embryonic stem cells have considerable potential. Nevertheless, adult stem cells, although they are valuable, are adult and therefore more mature and are much more difficult to manipulate into producing long lines of cells comparable to those that can be produced from embryos. Even cord blood cells are nine months more mature than those obtained from the embryo, and are rather more difficult to manipulate.

The point that I made at Second Reading is important. These stem cells, derived from donors of whatever kind, to be injected for treatment purposes into human beings after full consideration of all the ethical consequences and of licence under the HFEA, are not immunologically compatible with the individual into whom they are injected. Not to make too strong a point, made also by the noble Lord, Lord Patel, as I said at Second Reading, if you are performing a cybrid, where you take a rabbit cell and use simply the membrane and cytoplasm to form the actual skeleton into which you insert the cell of the skin of the human being suffering from an illness which is going to be treated by the stem cells derived from that technique, those cells are immunologically compatible because the tiny amount of DNA in the cytoplasm will not affect that situation. The cell lines could be of enormous value. I believe that to have cybrids as part of the Bill is crucial for the future management and treatment of human disease.

The point made by my noble friend Lord Patel on the work in Japan and the United States on the use of adult skin cells to create lines of stem cells is right—they are no longer using the oncogene that produced the tumours. However, if you look at this week’s British Medical Journal, you will see that Ian Wilmut, who created Dolly the sheep, is outspoken in saying that while work on the use of these cells must continue, that does not mean that we should not at the same time continue work on cybrids and embryonic stem cells. That work must go on in parallel with this new work on adult skin cells. The problem with adult skin cells, even if you do not use an oncogene, is that you have to introduce genes into those cells to make them replicate and develop in the way that we would wish. To carry that out requires a virus to carry the genes into the cell. That virus is not without potential hazard.

The work is important and must continue, but it is not the answer and does not outdo the need for cybrids and embryonic stem cells for research and, I hope, treatment.

I served on the Joint Committee with the noble Baroness, Lady Neuberger, and the noble Lord, Lord Winston, and others. I am a lay man, not a scientist and did almost no science at all at school, but I had to balance the arguments. We had evidence from some of the most distinguished scientists in the country; on Amendment No. 8 I shall refer to one or two of them. We had evidence also from a number of people who share the views of the noble Lord, Lord Alton, and who expressed themselves extremely firmly and eloquently. I am sure that my colleagues on the Joint Committee listened to them with great care. However, I think that, having listened to the scientists, particularly on the Benches opposite, the Committee will have some sympathy with why I broadly came to the conclusion—a conclusion reached by the Joint Committee—that the Government are right and that this research really does have to continue. We are talking entirely about research at this stage; we are not talking about in vitro fertilisation and that sort of thing, which we shall come to later.

My wife and I discuss these things and I described to her our experience of hearing the group who are opposed to interspecies, and indeed other, work. She said exactly what the noble and right reverend Lord, Lord Harries of Pentregarth, said: we have been given brains with which to advance human knowledge and improve the condition of the human race. That is what this is really about and I find myself very much persuaded by that argument. I discounted some of the arguments that we heard from the group at our forum as being almost beyond credibility, but some very powerful arguments were advanced as to why this should not be allowed, and they strike a chord with a large number of our people, as I think they will with many noble Lords.

As I said, ultimately a balance has to be struck, and one has to ask whether the benefit is likely to be worth what one sees as the possible risks. I heard all the evidence—I think that I was almost the only member of the Joint Committee to be present for pretty well the whole time—and I came to the conclusion that the benefits were there. I shall not begin to repeat some of the arguments that we heard as time would not allow and the Committee would not forgive me, but they came from some very distinguished scientists representing the Royal Society, the Medical Research Council, the Wellcome Trust, the Academy of Medical Sciences and so on. These people have spent their lives in this work and I trust them. Therefore, I think that we are right to back them, and I hope that the Committee will not support the amendments put forward by the noble Lord, Lord Alton.

I should like to speak to Amendment No. 61, which I tabled very much as a follow-up to a point I raised at Second Reading in relation to interspecies embryos. The point is simply that we currently lack an ethical or moral compass for decision-making in relation to this type of entity—a compass of the kind that the noble Baroness, Lady Warnock, gave us in the 1980s and which subsequently formed the framework for the 1990 Act. I find the absence of such a framework in this context extremely unsatisfactory.

Some fundamental ethical questions present themselves. Is the ethical status of an entity which is 99 per cent human on an equal footing with the status of something that is 50 per cent human? Are there particular ethical issues that need to be borne in mind when decisions are taken about the creation and use of a true hybrid embryo, as distinct from the creation and use of a cytoplasmic hybrid embryo? If there is a sensitivity about the use of completely human embryos, as the noble Baroness, Lady Warnock, said there should be, is the sensitivity associated with the use of hybrid embryos the same or is it greater or smaller? Indeed, does the special ethical status of the human embryo extend also to embryos that are less than 100 per cent human? None of these questions admits of answers that are immediate or straightforward.

The Government’s own position on the subject of true hybrid embryos has already shifted. That may be seen by some as good but, viewed in another light, it is rather worrying because it indicates that Ministers had few ethical or practical pointers to guide them in the first instance. When the Chief Medical Officer gave evidence to the Joint Committee on the subject of true hybrids—that is, hybrids created using human gametes and the gametes of an animal—he was asked to clarify the ethical distinction between a cytoplasmic hybrid and a true hybrid. He said this about the true hybrid:

“The process involved and the resulting entity is very different in character to the first. I am surprised that you cannot see that. I think the outside world would see a big distinction”.

Nevertheless, the Joint Committee could not see the distinction and concluded that there was no valid reason to exclude certain categories of interspecies embryo from the scope of the licensing arrangements while including others.

If we attempt to look for answers to some of the ethical questions about interspecies embryos, there is one aspect that I do not think has yet been mentioned. Noble Lords will remember that arising out of the special ethical status of the human embryo, which the noble Baroness, Lady Warnock, helpfully defined, has emerged an understanding about research projects involving such embryos. The understanding has been that, wherever possible, embryos used for research should be those left over from IVF treatment which would otherwise be destroyed. The utilitarian approach says that, even though these are human embryos with special ethical status, it is ethically justifiable to use them in research as a means to an end, rather than to destroy them, so long as the end potentially conduces to the public good in the way that the law allows. If one looks at the statistics for research projects approved by the HFEA, the vast majority have involved embryos that have originally been created for treatment purposes but have not, in the event, been needed. Research projects for which embryos have been expressly created from gametes have been comparatively few in number. One reason for this surely has to be the greater ethical sensitivity associated with the deliberate creation of a human life form expressly for the purposes of research.

Following on from that, the point that has not been made about the provisions for interspecies embryos is that, of necessity, they envisage the creation of embryos expressly for research. These embryos are clearly not left over from anything else; they have to be manufactured. That basic point should not be ignored for the purposes of the ethical framework, and that is why I suggested in my amendment two things. First, we need a set of principles that should inform all decisions relating to any research application involving interspecies embryos. Secondly, those principles should require the regulator to consider a number of factors, over and above those normally considered, before a licence for the creation of an interspecies embryo is issued. These are that the research project in question should be designed to fill an important gap in scientific knowledge—important in the sense of its potential benefit to man—that there should be a reasonable chance that the project will be successful in achieving its aims; and, lastly, that there should be no practicable alternative to the creation and use of an interspecies embryo. For a bona fide project, those additional hurdles should not present a difficulty, but they, or something like them, are I think essential if the sensitivities relating to interspecies embryos are to be paid any sort of respect.

I hope that the Minister will agree to reflect on these issues between now and Report and that we can move towards a more considered position in relation to the ethical underpinning of these provisions.

It may surprise the noble Earl to hear that I have some sympathy with his amendment. I do not think that the scientists will find it too onerous so long as the wording is modified so that it does not appear too draconian. Paragraph (b) of proposed new subsection (3B) in the amendment refers to,

“the desirability of establishing. as far as may be reasonably practicable in all the circumstances, the likelihood of the research in question yielding a useful result”.

I could not think of embarking on a research project if I did not believe that it might produce a useful result. If the regulator was not too draconian about enforcing that provision, I would have some sympathy with that point.

I should like to comment on the misfortune of the grouping which means that with this amendment we are not discussing Amendments Nos. 66 and 67, sadly, in the absence of the noble Lord, Lord Brennan, whom we all wish well. It seems to me that on Report we shall have an important debate about the setting up of an ethical framework. It is a great pity that we could not do that before—have the framework first and the debate afterwards. However, that is how the powers that be have ordained it.

For the sake of clarity perhaps I may respond to the noble Earl from the standpoint of the HFEA. At the moment, the HFEA works with a very clear ethical and legal framework, which was originated by the noble Baroness, Lady Warnock, and enshrined in the 1990 Act. We have to work strictly within that. Therefore, when we are considering applications to carry out research on cytoplasmic hybrids, that ethical and legal framework is very much in place. Some of the principles that the noble Lord lays down in the amendment already have to be taken into account when a licence committee is considering research applications. However, I think that he raises some very good questions in relation to so-called true hybrids. I am not sure that we have given serious ethical consideration to that aspect of this clause.

In principle, I support the amendment of the noble Earl, Lord Howe. This takes us back to other legislation that we have been debating in recent months in this House; for instance, under the Mental Health Bill we were also asking for a very clear set of principles. The noble and right reverend Lord, Lord Harries of Pentregarth, has made a very strong case for the Human Fertilisation and Embryology Authority already operating under an ethical framework, but I am sure that the noble Earl is right in wanting to take it further, particularly at this stage. I believe that we should, as the House is gradually doing, ask for a clear set of ethical principles against which we judge a whole lot of decisions. It seems to me that generally we have accepted the spirit of that.

There are several avenues of research that scientists are exploring or wish to explore in the hope of better understanding the causes and the treatment of disease. One such avenue of research involves the creation, the keeping and the use of embryos containing both human and animal material. Both the Science and Technology Committee in the other place and the Joint Committee which undertook the scrutiny of the draft Bill have concluded that legislation should be extended to enable research involving such embryos, subject to strict regulations.

A broad spectrum of embryos can be created which contain both human and animal components. The Bill sets out a framework of regulation for interspecies embryos. Interspecies embryos are defined in the Bill in Clause 4 and are those embryos created using human and animal components where the resulting embryo is towards the human end of the spectrum. Two parliamentary committees have examined this topic in much detail and the scientific community has also engaged with the Government in stressing how important it is to undertake research in this area. Having listened to the arguments presented here, we have set out in this Bill a framework for regulation, the same as is already in place for embryo research using human embryos. We have also heard the limitations and the dangers to donors of eggs, as highlighted by the noble Baroness, Lady Neuberger, and by my noble friend Lord Winston. We need to open up this area of research to scientists in the hope of developing knowledge about disease, of discovering new ways of treating and perhaps even of curing serious disease and medical conditions affecting the quality of life of countless people worldwide.

I turn to Amendments Nos. 6, 6A and 43. The noble Lord, Lord Alton, has tabled a number of amendments, the combined effect of which is an absolute prohibition on research involving interspecies embryos, as defined in Clause 4 of the Bill, including the prohibition of the use of hamster eggs in testing of human sperm fertility, a test which can be licensed under the 1990 Act. Such embryo research since 1990 has been limited so that it is permissible only under licence from the HFEA. Research involving interspecies embryos will also have such boundaries. As with all human embryo research, a licence from the HFEA will always be required for the creation, the keeping and the use of interspecies embryos as well as for the hamster test. There is an absolute prohibition on placing interspecies embryos in a woman or in an animal. In addition, no licence may authorise the culture of interspecies embryos beyond 14 days or the time at which primitive streaks appear, whichever occurs first. Any interspecies embryo must be destroyed once the limit is reached. As the noble Lord, Lord Patel, suggested, research involving interspecies embryos could provide us with better understanding of human embryos and embryonic stem cells. With appropriate limitation in place, I believe that that research should be licensable under the regulatory remit of the HFEA, just as the research which Professor Wilmot intends to undertake now into reprogramming of human somatic cells would not be possible without prior research using embryonic stem cells. Research using interspecies embryos may one day provide more clues to the mechanics of human cells and lead to a better understanding of the nature of disease and provide effective treatments.

I turn to the comment of the noble Lord, Lord Alton, about tetraploid complementation, to which he referred as covered by the Bill to the extent that they will not be permitted embryos and therefore could not be implanted in a woman. The Secretary of State also has the power under the Animals (Scientific Procedures) Act 1986 to prevent them being implanted in an animal. Clause 4 contains the power to extend the definition of interspecies embryos to cover any further embryos that combine human and animal material, should the need arise.

Perhaps I may turn to the yuck factor mentioned by the noble Baroness, Lady O'Cathain. I agree that there is an important need to distinguish between the legitimate concerns and the discomfort arising merely from unfamiliarity, a point highlighted very strongly by the noble Lord, Lord Jenkin. Two moral claims have been highlighted as forming part of the yuck factor: the response of the horror of the idea of playing God and the transgression of a fundamental taboo. In some way, the claims are associated with the issues of naturalness; for example, scientists are wrong to attempt to manipulate nature in this way because such manipulation is unnatural. Not only is it very difficult to specify, as highlighted in the very powerful document published by the Academy of Medical Sciences, what “unnatural” means, but it is not clear why unnaturalness should be bad. IVF is an unnatural process; vaccination is an unnatural process; but those scientific advances have created modern medicine as we know it today.

Amendments Nos. 9 and 16, tabled by the noble Lord, Lord Alton, alter the proposed ability, through regulation, to change and to extend the definitions of interspecies embryos, as inserted by Clause 4(2). The amendments set a limit on the regulation-making power, such that any new types of interspecies embryo, once included in the Act, would be prohibited from being created. The regulation-making power would provide the future flexibility we need to ensure that the law keeps pace with any technological developments in the creation of part-human, part-animal embryos.

A power is also provided in new paragraph 3(5) of Schedule 2 to the 1990 Act, inserted by paragraph 6 of Schedule 2 to the Bill, to permit the HFEA to grant a licence to create, keep and use any form of interspecies embryos. Under new paragraph 3(8), the Secretary of State can further limit the scope of what can be licensed by the HFEA in relation to any new entities. The choice as to whether and how these powers should be exercised would be a decision for Parliament as well, as the regulations are subject to the affirmative procedure. This means that the decision on whether to devolve discretion to the HFEA to permit the creation, use and keeping of any form of interspecies embryo not already listed in the Bill can, and rightly should, be made at that time.

Amendment No. 28 would remove from the HFEA the ability to license a procedure commonly referred to as the hamster test, which involves the penetration of a hamster egg by human sperm to assess the fertility or normality of those sperms. The resulting product must be destroyed by the two-cell stage. This test has been performed by many clinics since it was permitted under the 1990 Act, and is a valuable method of assessment without the need to create a human embryo.

Can the Minister tell us when an application for a licence to use a hamster test was last lodged with the HFEA?

Although I agree that, in recent times, the use of intercytoplasmic sperm injection has reduced the need for this type of assessment in clinics, it is still useful methodology by which a sperm’s ability to penetrate an egg can be properly assessed without the use of human eggs. I am not aware of the exact number of applications, but would be more than happy to put that in writing. It is important, however, that those working in the treatment of infertility maintain the ability to carry out this test if they so wish.

Amendment No. 42 removes from the Bill the HFEA’s ability to license the storage of interspecies embryos created for research. I have made clear our intentions to permit the creation and use of interspecies embryos in research. This paragraph gives the HFEA the ability to permit the storage of interspecies embryos, which is important for researchers carrying out their day-to-day activity, and vital in creating a complete framework in the regulation for research involving interspecies embryos.

On Amendment No. 45, before the HFEA may license research using human embryos under the 1990 Act it must make a judgment that the use of embryos in that specific project of research is necessary. The Bill proposes to expand this test to research projects involving interspecies embryos, and rightly so. Interspecies embryos should not be used for research lightly or without necessity, so amendments to the 1990 Act made by the Bill must stay in place. I therefore invite the noble Lord, Lord Alton, not to move that amendment.

The power provided in new paragraph 3(5) to permit the HFEA to grant research licences to create, keep and use new forms of interspecies embryo is valuable in ensuring that the Act can remain robust following developments in science and technology. This licensing ability of the HFEA regarding these new forms of embryo may, however, be limited by the Secretary of State when any regulation is made. However, power can further limit the scope of what can be licensed by the HFEA regarding these types of embryos. Amendment No. 47 would remove the power proposed for the Secretary of State to limit the licensing by the HFEA of research involving new forms of interspecies embryo. This power is important, as it allows limits to be placed on what can be licensed if any new forms of interspecies embryos are defined in the future. Parliament’s agreement would, however, be necessary as the regulations are subject to affirmative resolution, as I mentioned earlier. This power gives the opportunity to place tougher restrictions, if necessary, on the use of any interspecies embryos appropriate to their qualities and characteristics. This is particularly important if their use could be both scientifically beneficial for one purpose and detrimental for another.

On Amendment No. 48, the inclusion of interspecies research in new paragraph 3(9) of Schedule 2 to the 1990 Act ensures that the HFEA, when licensing interspecies embryo research, has the ability to make suitable restrictions on the terms of licence. The HFEA has had the ability to do this in relation to embryo research licences since 1990, and it is right that this power is extended to enable the HFEA to provide similar restriction on interspecies embryo research should it need to.

On Amendment No. 61, tabled by the noble Earl, Lord Howe, we have proposed the same level of regulation and control on the use of interspecies embryos and research throughout the Bill as we have on the regulation and control of human embryos. The principles of the 1990 Act have worked well, where the often difficult decisions regarding appropriate licensing of embryo research are made by the specialist regulator, the HFEA. The importance of embryo research for the public good, the likelihood of the research in question yielding a useful result and the respect for how necessary the use of interspecies embryos is in that research are all measures by which its necessity can be judged. We have proposed that the use of human or interspecies embryos in research must always satisfy the criterion necessary for that research project, as highlighted by the noble Earl, Lord Howe, and that the decision on the necessity must be made by the specialist regulator, which has access to all the available scientific data and the information required to make sound decisions on each licence application.

In addition, as set out in the 1990 Act and the 2002 research purposes regulations, the research must also be necessary or desirable for a number of specific areas of research, such as the understanding or treatment of disease. The licensing principles are the same today as they were in 1990, and the HFEA has done an excellent job of licensing research since then. I see no reason to treat the licensing of interspecies embryo research any differently from how we have treated licensing of human embryo research in the past. I invite the noble Lord, Lord Alton, to withdraw his amendment.

I wish to clarify one point, which I hope will be helpful. In the hamster test, raised by the noble Lord, Lord Alton, the slight difference is that while the moral principle is the same, the use of the hamster test is clinical; it is not strictly a research procedure. That is why there will be no licences for it; it is something that clinics would declare during a routine inspection by the Human Fertilisation and Embryology Authority, and it would not necessarily be subject to a licence application.

I am very grateful to all Members of your Lordships' House who have participated in this debate. There is a fundamental disagreement between us—the noble Lord, Lord Winston, alluded to that a moment ago—and I do not suppose that we will be persuaded by the arguments today, any more than we were persuaded in 2001 or in 1990. Those who believe, as I do, in the special status of the human embryo—as my noble friend Lady Warnock put it in her report, those who believe that it is the beginning of human life—will find it deeply repellent to argue that, even up until 14 days, it should be permissible to create interspecies embryos. There is a fundamental difference between us; there can be no doubt about that. I am sure that on Report, we will want to divide to test the opinion of the House on that question.

The noble Lord, Lord Darzi, told us that the regulatory authority that has regulated these things since 1990, the Human Fertilisation and Embryology Authority, will be able to regulate the use of animal-human hybrids. I hope that it does a better job than it has thus far. When we come to a later group of amendments about the nature of the regulatory authority, with the permission of your Lordships, I will certainly have a lot more to say on that subject.

My noble and right reverend friend Lord Harries of Pentregarth debated with me and my noble friend Lord Winston in 1998 in the Grand Committee Room of another place, at a meeting organised by the Science and Technology Committee. We disagreed then about the advantages of carrying out therapeutic cloning. The noble and right reverend Lord said then that it would—I use his exact phrase—“be illicit” to use human embryos if alternatives exist. That has come out in the amendment tabled by the noble Earl, which is in some respect a paving amendment for the next group of amendments concerning the so-called Hunt test—the words that the Minister used in 2000 that if alternatives exist, it would not be right to use human embryos.

As an undercurrent to the debate in the Committee today, we have throughout been arguing whether those alternatives exist here and now. I cannot help thinking that when people come to read the Official Report of today's debate, many of them will wonder why we had this debate about what may well be just a footnote in history. My noble friend Lord Patel is right to say that huge advances are being made. He said that science is moving on at a dramatic pace and that those advances appear to be taking place mainly through the use of adult stem cells. My noble friend has claimed that there would eventually be a problem of cancer with induced pluripotent stem cells from Japan, despite the announcement made on Friday last. I hope that he would acknowledge that all human embryonic stem cells caused a specific type of tumour—indeed, that is how embryonic stem cell scientists find out whether they have isolated true embryonic stem cells.

My noble friend is quite right but, just to be accurate, I think that he meant to say “adult cells”, not “adult stem cells”. It is adult cells that are being reprogrammed. He is quite right: we do not know that induced pluripotent stem cells that are embryonic-like stem cells will not behave in the same way.

There is no difference between my noble friend and me on that point. Where there would be a difference is if we turn, for instance, to the use that stem cells can be put to. He may recall that just a few months ago, I hosted a meeting in the Moses Room and invited Professor Carlos Lima. He had been featured in a BBC television programme called “Miracle Cell”. Interestingly, Professor Lima has said absolutely that he will never use an embryonic stem cell. My noble friend specifically mentioned spinal cord injuries. Professor Lima has been able to use olfactory cells from the nose in the spine. More than 100 patients have now been able to walk using crutches and aids. They are off their backs and no longer comatose. That is extraordinarily exciting. There can be agreement among all parts of your Lordships' House that where good science and good ethics march hand in hand, we should all get behind it. I interviewed Professor Lima when he was here and published that exchange in the House Magazine, in case any of your Lordships want to read more about that.

My noble friend Lord Walton referred to Professor Ian Wilmut. It is true that in 2001 it was Professor Wilmut who was demanding that we should allow therapeutic cloning to take place in this country, so that he would be able to continue with the kind of developments that had led to the cloning of Dolly the sheep. As we all know, Professor Wilmut has now abandoned those techniques because he does not believe that that is where the future lies. Although I am delighted to listen to what Professor Wilmut has to say through my noble friend, it has to be said that the advice that he gave your Lordships' House in 2001 about what he needed to do and what we needed to do to enable that progress has not turned out to be correct.

The noble Baroness, Lady Neuberger, was right to say that we should guard against the unnecessary stimulation of ovaries. I hope that I will have her support when we get to Amendment No. 62, which attempts to deal with that very question.

We are divided. I very much doubt that anything said in Committee today will change your Lordships’ minds. Nevertheless, as other noble Lords have said—the noble Lord, Lord Jenkin of Roding, in particular—outside this place, there is huge public consternation among people who feel that we are going in an unnecessary direction.

The noble Lord said that there was concern outside and that that concern had been expressed to the Joint Committee by distinguished people. He said that he did not agree with it, but that that concern was often well articulated and represented a perfectly reasonable point of view.

When we get to Report, I intend to test the opinion of your Lordships' House but, for today, I am willing not to press the amendments. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 6A not moved.]

7: Clause 4, page 4, line 18, at end insert—

“( ) A licence cannot be issued unless the criterion set out in paragraph 3(b) of Schedule 2 to this Act is satisfied.”

The noble Lord said: In moving Amendment No. 7 and speaking to the amendments grouped with it, Amendments Nos. 44 and 46, I point out that the amendment should read—I have mentioned this to the Public Bill Office—“3(6)”, not “3(b)”. That is a minor point, because this is only a consequential amendment; the real issue is contained in Amendments Nos. 44 and 46.

I return to an issue that I raised on Second Reading: what I then dubbed the Hunt test, which I hope will be incorporated into the granting of all licences. In the debate in your Lordships' House in 2001, the then Minister, the noble Lord, Lord Hunt, said that,

“the 1990 Act already provides the answer to the question of what happens if and when research into adult cells overtakes research using embryos: embryonic research would have to stop because the use of embryos would no longer be necessary for that research”.—[Official Report, 22/1/01; col. 120.]

In another place, the Minister said in debate that the HFEA,

“must satisfy itself that there is no other way of doing the research, avoiding embryo use”.—[Official Report, Commons, 19/12/00; col. 214.]

That point was alluded to by my noble and right reverend friend Lord Harries of Pentregarth in our previous debate.

Accordingly, I propose Amendments Nos. 44 and 46 to ensure that licences may be granted only when applicants can prove that no alternative is available and to encourage the best substantiated scientific research. They will also bring the Human Fertilisation and Embryology Act in line with paragraph 8(3) of the International Society for Stem Cell Research guidelines for human embryonic stem cell research, which states:

“The project proposal should include a discussion of alternative methods, and provide a rationale for employing the requested human materials, the proposed methodology and for performing the experiments in a human rather than an animal model system”.

Although the noble Lord, Lord Darzi, has tried to offer assurances that current legislation and regulation are in accordance with the International Society for Stem Cell Research and the World Medical Association’s Declaration of Helsinki, I remain to be convinced that all is necessarily as it should be. Paragraph 11 of the Declaration of Helsinki states:

“Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation”.

Can any Member of the Committee demonstrate how the shifting rationale underlying currently licensed human cloning research fits those criteria? By way of example, initially, Licence R0152 was stated to be for the treatment of diabetes, then for no particular disease, then again for the study of diabetes and now, apparently, for general transplantation purposes.

In a Written Answer, the noble Lord, Lord Triesman, asserted that somatic cell nuclear transfer,

“is considered to hold great promise for the development of patient-specific stem cell therapies, which may overcome the problems of immune rejection that would otherwise prove a barrier to the use of transplanted stem cells”.—[Official Report, 12/11/07; col. WA 2.]

At present, there is understandable excitement about whether direct reprogramming of human skin cells might ultimately achieve the same goal, and particularly about the work of Professor Yamanaka in Japan. In June 2007, three publications heralded the successful creation of embryonic-like cells from adult stem cells. Within the past month, no fewer than three further publications have shown that the same approach is feasible in directly reprogramming human cells. It remains to be seen how much work might lead to specific therapies, but there are grounds for optimism as well as caution. By contrast, I was surprised to discover that no similar supporting references were provided in a reply to a subsequent Question for Written Answer in which I asked,

“which empirical studies in either humans or other species have conclusively demonstrated the benefits of human somatic cell nuclear transfer with regard to therapies that overcome the problems of immune rejection with patient-specific embryonic stem cells”.—[Official Report, 26/11/07; col. WA 98.]

This question is especially pertinent when the research in question is now diverting £760,000 of public funding so that women might be persuaded to provide around 700 precious eggs that otherwise might be used for their own fertility treatment. If such research with human subjects requires financial inducements and the underlying rationale may not be unequivocally supported by scientific literature and prior animal experimentation, how does it accord with international standards? This is especially curious in the light of oral evidence given to the House of Commons Science and Technology Committee by the chief executive of the Medical Research Council on 5 February 2007, which was published as House of Commons Paper HC 272-I. He expressed doubt about support for the use of human oocytes for somatic nuclear transfer due to the virtually zero success rate. Given the alternatives pursued in other countries, with which some of our leading scientists now hope to catch up, it seems fair to ask what could conceivably be accomplished with human cloning that could not possibly be achieved by other approaches. Perhaps the Minister will enlighten us and will say which other countries permit interspecies human embryos.

Forbes magazine, which is hardly interested in ethical objections, recommends that investors do not do what the British Government have done. It says that only dumb public money is going into embryonic stem cells. As yet, there are no therapies anywhere in the world that use embryonic stem cells. It is striking that a 2005 editorial in Nature Biotechnology, a magazine that was referred to during our earlier proceedings, says:

“Meanwhile forward steps continue to be made in the field of adult stem cell therapy. One estimate is that there are currently over 80 therapies and around 300 clinical trials under way using such cells”.

I know that in 2001—

I was not able to be here during the week when the Bill had its Second Reading, and this is my first intervention. I am very glad to have the opportunity to intervene, and I am grateful to the noble Lord for giving way. I have just come relatively hot-foot, by my standards, from the City of London where opinion seems to be exactly as the noble Lord sets out. At the moment, only the dumbest of dumb money is putting its resources behind such experimentation. The markets—I have chosen my moment carefully, because the noble Baroness, Lady Thatcher, is not present—are not always right. I recognise that they can get it wrong, but at the moment they do not feel it is very sensible to put what is, alas, a diminishing amount of liquidity behind this research.

I am grateful to the noble Lord, Lord Patten, for his intervention. He brings to our debates great expertise about the movements of attitudes in the City. I hope that at later stages he will be able to talk more about some of the economic as well as the ethical and scientific arguments.

No commercial money went into the development of in vitro fertilisation, one of the technologies that have led to more than 1 million babies being produced. Unfortunately for Robert Edwards and Patrick Steptoe, they worked without any such investment. They could not get investment.

I am grateful to the noble Lord for that intervention. There is a huge amount of altruism involved in these debates, and there is also vested interest. At Second Reading, the noble Lord, Lord Winston, rightly drew our attention to some of the charlatans who operate in this area.

As soon as laboratories were required to provide more justification for their requests to use animals in vivisection, repetitive duplication and the number of animals used were radically reduced. Is it so unreasonable to demand at least the same for human embryos? Can the Government truly say that it was necessary to destroy or experiment on 2 million human embryos? Even if they no longer believe that the human embryo has special status—perhaps the Minister will say whether they do—surely it should be necessary to demonstrate that no alternative exists. Amendments Nos. 44 and 46 would do that. I beg to move.

I find it difficult to understand what the noble Lord, Lord Alton, is saying. I have huge sympathy with his moral purpose, but I cannot agree with it because in vitro fertilisation at present results in large numbers of human embryos being wasted. They are literally thrown away. If they are not to be used for the treatment of infertile couples, the only alternative for them is to be used in research that might further that process in future. That is axiomatic.

Listening to the noble Lord, I am reminded that in my own laboratory a remarkable experiment has been done by one of my colleagues, Ellen Poon. She is one of my post-doctoral research workers and has been working on genes that direct differentiation in completely surprising fashions. Her work would not have arisen without the use of embryonic material, under licence, of course. Most of the embryos that she has been using are defunct. They would not be regarded as being suitable for transfer on the grounds of their morphological appearance. Under the microscope they look completely dead or inactive and are not undergoing cell growth. We are about to publish a paper. We have not yet got it approved by a journal, but I think it will be accepted because it is a good piece of experimental work by her—my contribution was minimal. When we take cells from these embryos, we can get stem cells that express in quite a surprising way exactly the genes that are wanted. Basic research does not necessarily arrive at foregone conclusions. One does not know where the exciting things may develop. If Ellen is right—and I have watched her work very carefully—using effectively non-viable embryos surprisingly might give rise to stem cells. This kind of amendment would prevent that, which would be a pity.

This amendment would not prevent that. The noble Lord and I disagree about whether human embryos should be used, but this amendment says, “Let us take the Hunt test at its word”. If the noble Lord were able to put the case he has just been putting to the regulatory authority, despite the dislike of the regulations he expressed at Second Reading, presumably under the Hunt test formula if no other way could be found to use it, he would be given permission to go ahead with that work.

Whether one uses for this research embryos that look non-viable or embryos that look much more viable and are possibly capable of producing a foetus if implanted in the mother, one concern is that such embryos would be wasted. They would be thrown away. That is a difficult argument to ignore.

My professional friend the noble Lord, Lord Winston, speaks with much more experience than I. I speak only with some second-hand knowledge. The noble Lord, Lord Alton, tries to promote in all these amendments his wish that—and he truly believes in it: I respect that—the only form of stem cell research we should allow is that based on adult stem cells, or, now, pluripotent stem cells derived from adult cells.

I accept that both these lines seem enormously promising. What I do not accept is that any other form of stem cell research, including particularly embryonic stem cell, does not seem to have much future. The noble Lord may well be right, but just now he has to accept that the fundamental research is done on embryonic stem cells. I repeat: these are chromosomally normal cells present in early blastocysts that have the capacity to differentiate in all 257 types of human cells. None of the other cells has the same pluripotency.

We have to wait to see whether induced pluripotent cells will have the same capacity. Whether they will and whether they behave the same way as embryonic stem cells will have to be compared with embryonic stem cells. Research on all types of stem cells at this stage is therefore important. We should not turn off any avenues of research in that respect.

I refer to the noble Lord’s Amendment No. 46. In paragraph (b) he proposes that much of the interspecies embryo research could not be done solely in animal models. The whole purpose of interspecies embryo work is to be able to develop disease because many diseases are specific to humans; they do not occur in animals. The point of much of the research is to create disease-specific stem cell lines that reflect the human specific gene mutations and abnormal functioning involved in the disease.

I may be able to accept paragraph (c) but I will have to discuss it further. Paragraph (d) states that,

“the research method proposed is most likely to produce satisfactory results”.

That is too high a standard for any research project. Not just in biological science but in any kind of science it would be unusual to have this degree of confidence in likely results in any research. That is the nature of research.

While I am on my feet, I say to the noble Lord that while we can get very excited about induced pluripotent cells, we must remember that what we are saying is that, as my noble friend Lord Walton said, inserting viral vectors into the cells makes them differentiate and become pluripotent cells which carry these vectors with them. As I said earlier, even Yamanaka in his paper says that they had at least 20 insertions per cell. If you work out the mathematics, that means for a cell not to have an insertion would require 10 million cells. To get that is a tall task.

Furthermore, perhaps I may say to the noble Lord that to be able to understand that these cells are truly pluripotent in the same way that embryonic stem cells are, he or any scientist would have to take them down to a blastocyst stage. That blastocyst is an embryo in every respect, and, if implanted, would be a clone of where the adult cell came from. Therefore, it too might need regulating.

I am not sure where the noble Lord, Lord Alton, gets his figure of 2 million embryos, if I remember correctly what he said. For the sake of clarity and for the information of the Committee, when a research licence committee looks at a research licence application, the application has to say roughly how many embryos will be used. It may be 100, 200 or whatever. But I do not see how the noble Lord gets this figure of 2 million embryos. It may also reassure the noble Lord that paragraph (b) of Amendment No. 46 already has to be considered in all research licence applications. They have to show that appropriate work on animals has been done before saying it is now an appropriate stage to move to try to do something in relation to humans.

The criterion in paragraph (c), as we have said before, already has to be considered. As the noble Lord, Lord Patel, and I think the noble Lord, Lord Winston, said in relation to paragraph (d), you cannot predict exactly a research outcome. The whole point about research is that you are testing something. You may not get out what you are expecting and hoping to get out. That result might still be useful to future scientific work.

It may assist the Committee to learn that a briefing I received this morning from the HFEA gave me the figures for the number of embryos donated to research by patients in the course of treatment between 1990 and 2005. The total I have in front of me is 82,955.

Since 1990 the HFEA has issued licences for the creation and the use of embryos in research. These licences have been issued only where the authority believes that the use of embryos is necessary. That is a requirement of the Act, a requirement which would be kept through the provision in the Bill.

The noble Lord, Lord Alton, suggested a further three criteria of which the HFEA must be satisfied before it licenses embryo or interspecies embryo research. The first is the requirement that research should already have been successfully attempted using animal models. In order for the use of embryos to be necessary, the research should have a firm base on which the project is founded. This could be data from animal embryo research or data from research conducted through other means.

Human physiology and genetics are close enough to some animals for them to provide good models on which to test research methodologies. However, the differences which are present can mean that research which works well in an animal model does not work in humans. This principle can also work in the other direction, and we may fail to get satisfactory results in animal research where clear successes occur in humans. Animal research is vital to a better understanding of embryology and stem cell biology, but research using human embryos must not be limited to being undertaken only in cases where animal models have shown success. The authority will make decisions on the necessity of the use of human or interspecies embryos in research projects.

Secondly, there is the requirement that research cannot be satisfactorily achieved by means other than through embryo research. Among the many aims of research on embryos and, in the future, interspecies embryos, one particular aim is to benefit the development of disease models and treatments primarily through the use of stem cells. Human stem cells can be obtained from many sources, as highlighted by the noble Lord, Lord Alton, including from stem cells, from cells sourced from the adult body, from embryos, from umbilical cord blood and, in recent developments, by the manipulation of normal human cells, so-called cell programming.

Each of these lines of research holds out a promise to the sufferers of many wide-ranging diseases and medical conditions. We should not limit ourselves regarding the avenues in which research should be undertaken in the hope of cures. Embryo research, for example, provided vital pieces of the puzzle which allowed researchers to begin exploring how to perform cell reprogramming. I agree with the noble Lord, Lord Patel, that limiting embryo research only to goals which cannot be reached by other means is not appropriate if we are to succeed in curing many presently incurable diseases. All avenues of research that have the aim of achieving the same goal should be allowed to flourish in the hope one day of making better the lives of those suffering today.

Finally, the point was made that the research undertaken should be the research most likely to produce satisfactory results. This is in part already the approach of the authority through the peer-review process of the research licensing application. Nor should we forget the peer-review process of funding for the project. Available evidence will be examined to assess the validity of research through a depth of evidence, and can equally be good justification for following an avenue of research.

Not all research is successful. In fact, researchers in almost every field of science undertake significant research to yield only a few positive results. The results, however, are significant. A specialist regulator is in place to assess the necessity of each embryo research project, and legislation has set out which scientific goals are suitable for embryo research. Such goals include the treatment of disease. This system has worked well in the past, and is the best arrangement that we can hope for to permit embryo and interspecies embryo research while ensuring that the special status of the embryo is upheld. I invite the noble Lord to withdraw his amendment.

I am grateful to everyone who has participated in the debate this evening. I shall return to this issue on Report, because it is a fundamental question. I draw noble Lords’ attention to paragraph (c) in my Amendment No. 46, which says,

“that the research specified in the licence cannot be achieved satisfactorily by any other reasonably practicable method not entailing the use of embryos or inter-species embryos”.

That is the crux of the debate. If it is possible for my noble friends Lord Patel and Lord Walton, or the noble Lord, Lord Winston, to demonstrate satisfactorily to the Human Fertilisation and Embryology Authority that alternatives exist, they could proceed under the terms of the amendment.

The noble Lord, Lord Patel, reminded us of something that he said earlier when he questioned the work of Professor Yamanaka and the need for 20 vectors to expedite that work. However, compared with the more than 200 attempts that Professor Wilmut had to make to clone Dolly the sheep, that seems to be rather better and more effective. I said earlier that we should exercise caution as well as optimism. Importantly, extraordinary alternatives are emerging that do not need to use human embryos. This creates some middle ground in the debate, and I am sorry that more Members of the Committee have not attempted to stand on that middle ground.

I was struck by a comment by Professor Neil Scolding, who is professor of neuroscience at the University of Bristol at Frenchay Hospital, when he gave evidence to the Joint Committee and was asked what he thought was driving this determination to have interspecies embryos and to create more human embryos. I dispute the figure given by the Human Fertilisation and Embryology Authority. The figures that I have been using have been based on replies that I have been given in your Lordships’ House about the numbers of embryos that have been destroyed or experimented on. That is the point—not the figure given by the noble Earl, which in turn was given to him by the Human Fertilisation and Embryology Authority. Professor Scolding’s point was that mere curiosity is driving the debate, and we need to give some attention to it. If mere scientific curiosity, admirable though that may be, is really what is driving the debate, surely we have a duty to say that other factors must be held in account.

I was surprised to hear the noble Lord, Lord Patel, say that producing satisfactory results, which this amendment would require, is too high a hurdle. In the world in which I work and live, one is expected to give some evidence that the line of inquiry pursued, certainly where public resources are being used, should have to have some reasonable outcome in order to justify continuing with it. I shall return to this issue, but I have two other points to make before I conclude.

My noble friend Lord Walton of Detchant said that there would be no immunological reaction if the cells were transplanted into the patient. I refer him to an article in Methods in Enzymology, volume 260, in which it was discovered that mitochondria can cause an immune reaction. Would not the animal mitochondria that would be present in these cells therefore be likely to cause an even greater immune reaction? The noble Lord, Lord Winston, intervened on the issue of the hamster test and said, if I understood him correctly, that you do not need a licence for the hamster test if it is for treatment rather than for research. I do not understand this, and I hope that the Minister will—

I am not a biologist, but I am given to understand that if you have a sybarite embryo from which you create generations of stem cells that are subsequently reprogrammed, even if the nuclei have been inserted into an animal cell such as a rabbit cell, mitochondria are very fragile organelles, and it is likely that as those cell lines matured, the nuclei would continue to present their DNA in those cells but the mitochondrial genome would probably disappear. That is my understanding. I cannot prove it, but I believe that that is right.

My noble friend may well be right, and if he is not a biologist I am certainly in no position to be able to say conclusively that he is right or wrong. However, I refer him to the paper by VM Dabhi and KF Lindahl, published in 1995 in Methods in Enzymology, volume 260, and entitled “Mitochondrial DNA-encoded histocompatibility antigens”. It is precisely because there is difference between scientists that I passionately believe that regulatory authorities need to hear these arguments so that people better qualified than me can assess what is true and what is not.

I am concerned that there is quite a statistical gap between the figure given by the noble Lord of the number of embryos destroyed, which was around 2 million, and the figure suggested by my noble friend Lord Howe on the Front Bench on information provided to him by the authority, which was about 80,000. I know that the Minister has been listening most carefully to this debate, and it occurred to me that the noble Lord might wish to ask him if we could have the facts and figures by the time we next debate this issue. I understand that they have come out in Parliamentary Answers given by the Minister’s predecessors to the noble Lord, Lord Alton.

I understand that procedurally I have to give way to someone else before they can intervene. I am very happy to give way to the noble Lord, Lord Winston, and to my noble and right reverend friend after that.

That is a curious piece of procedure. I think that the noble Lord, Lord Alton, was pointing out that a large number of embryos have been destroyed. He argues that the figure is possibly 2 million. I cannot contradict that. The noble Earl, Lord Howe, pointed out that 83,000 registered embryos have been used for research. However, in vitro fertilisation, as I pointed out, destroys a large number of embryos that cannot be used for fertility treatment. Sadly, they are not researched. It would be helpful if they were. I think it would be ethically justified—ethically a good thing—if we encouraged more research, but that is my personal opinion.

I am grateful to the noble Lord, because that demonstrates that both figures are in the world of reality, although it is clear that what the HFEA is saying is entirely different from what I had already said to the Committee. I think that my noble and right reverend friend wanted to intervene, but in his absence perhaps the noble Lord, Lord Patel, will.

I stand merely to comment on the statement made by my noble friend Lord Alton about mitochondria. Of course if might be possible to go further and remove the mitochondria in an interspecies embryo so that the embryo ends up being a nucleus of a somatic cell inserted into an animal egg from which the nucleus and the mitochondria are removed. You cannot of course remove the cytoplasm, because it would not divide.

I understand that point, which demonstrates again the need for a body that can properly evaluate these issues before proceeding with further experimentation and research. That is why I will argue later in our proceedings for the appointment of an amicus curiae to the Human Fertilisation and Embryology Authority, whose job it would be to speak out on behalf of the human embryo precisely as local ethics committees do in relation to animal procedures. I will also argue that we need more balanced representation on the Human Fertilisation and Embryology Authority, and, as the noble Lord, Lord Brennan, argued earlier in our proceedings, that we should establish a national bioethics committee.

Before I conclude, I return to what the noble Lord, Lord Winston, said about the hamster test. When the Minister responds, perhaps he will be able to tell us the precise position. I am told that you need a licence to use the hamster test for treatment as well as for research. Paragraph 9(1)(f) of Schedule 2 to the Human Fertilisation and Embryology Act 1990 specifies that you need a licence for both research and treatment, so I wonder whether we could have clarification on that as the debate unfolds.

At this point, I beg leave to withdraw the amendment, to which I shall return on Report.

Amendment, by leave, withdrawn.

8: Clause 4, page 4, leave out line 35

The noble and learned Lord said: The amendment seeks to delete the last provision in the present definition of interspecies embryos in the Bill. Let me rehearse briefly some of the history of this matter. When the Bill came before the Joint Committee in draft form, it had specific examples of interspecies embryos like the ones presently in the Bill, and a final provision which the department described as a “catch-all”. In other words, if you took them all together you had a complete description of what was meant by interspecies embryo.

The difficulty of that situation was that the scientific witnesses who were asked to comment on the catch-all provision found great difficulty in understanding it. I have not been able to find out exactly who thought it up—indeed I have not really inquired—but that is the way that the scientists viewed it. So it was not at all surprising, when the Government came to publish their Bill, that that provision had disappeared. We had suggested that the way to approach this matter was to look for a general definition of interspecies embryos, stating what their characteristics were and defining them in that way, rather than by a list of examples and then the difficult catch-all which was found to be impractical.

What has now happened is that the Government have not come forward with another catch-all provision but have taken refuge in a power to add to the list of things which amount to an interspecies embryo,

“such other thing as may be specified in regulations”.

Whatever you have to say about that, it is a fairly all-embracing kind of definition; the regulation-making power does not seem to be extremely restricted.

When we are talking about interspecies embryos, as many Members of the Committee were doing earlier, it is essential to know what it is we are talking about. The interspecies embryos that the Government are seeking to capture, if that is the right word, in the Bill were described by the noble Lord, Lord Darzi, in his reply at Second Reading as the

“human end of the spectrum”—[Official Report, 21/11/07; col. 867.]

I think that that was his phrase—of interspecies embryos. That immediately suggests that there is more to the spectrum than is intended to be captured by this definition—and, of course, we do not have far to go to find some examples.

I had understood, rather vaguely, that the Secretary of State for the Home Department regulated this, but, with the great help that I received from officials of the noble Lord’s department, I have examined this issue a little more fully. It seemed to me that if we could not get a catch-all provision, we could have a general provision and then extract from it what had already been given to the Secretary of State for the Home Department. That would make a perfectly reasonable type of definition also and I was anxious to see how that could be fitted into the scheme.

The answer is that it does not fit at all. The Animals (Scientific Procedures) Act 1986 proceeds by requiring licences for animal experimentation that causes distress, pain or harm to the animals that are the subject of the legislation. The embryo of an animal does not come under the protection of that legislation until it is half-way along the gestation period for that particular animal, unless it be an animal that does not have that kind of characteristic and then it is when it first qualifies for independent feeding. So it is not captured by the Home Office legislation unless and until it is of a half-gestation period and only if it is an animal embryo.

I believe that an interspecies embryo which starts off being an animal embryo and has human material inserted into it in some way or other is no longer the embryo of that animal. If that is right—and that, I think, was the hypothesis of the answer given to the Joint Committee to which the noble Lord, Lord Alton, referred—the result is that interspecies embryos are not regulated at all if they come from that end of the spectrum. They might of course attract regulation if they were to be implanted in an animal, as that would be a part of the procedure which would require a licence, but if nothing like that happens, then as far as I can see there is no regulation of these at all. I do not find that a very satisfactory situation.

The split between what I might call “the human end of the spectrum” and “the animal end of the spectrum” is rather hard to define. When the working group of the association met to consider these matters it decided that the Bill with which we are concerned should aim to capture human embryos treated with animal material, leaving out animal embryos treated with human material. That was its broad definition, and basically that is what was reflected in the draft Bill and in the Bill before us. However, it is not satisfactory. Indeed, in some ways, we are in a position rather like the one we were in before the 1990 Act became law. Everyone felt that the embryo research and in vitro fertilisation should be the subject of control and there was unanimity that some regulation was required. The only dispute was what that regulation should be. In particular, the main dispute was whether research on the embryo up to the 14-day or primitive-streak stage should be allowed.

The noble Lord, Lord Alton, and those of a like mind who have spoken in the previous debates on these ethical issued would think it right that this area of interspecies embryos should be regulated, but the question is what that regulation should be. From what I have learnt up to now—and I am always in the learning process—the kind of regulation you want at the human end partakes of an extension of the regulation of the human embryos that the HFEA was set up to supervise and carry on. But there is no corresponding control at the other end. If that is the way of the situation, it is extremely important that the definition should specify where the human part of the spectrum ends.

We have had some communication with experts in this area and my noble friend Lord Jenkin of Roding will speak about that. The parts of the scientific community that are interested in this field have seen the problem and are seeking to address it. They are better qualified than I am to provide an answer, although we tried to do so in the Joint Committee’s report. We realised that it was not perfect, but then no research is. As we have just heard, you cannot say it is perfect in advance; you can only do that once it has happened.

We did our best, but the Government felt that that was not good enough and have proposed this route instead. It is not right to leave this important area of regulation in this vague state, with a ministerial power to say what the definition really is. The noble Lord, Lord Darzi, said at Second Reading that that gave flexibility. I entirely accept that it does, but flexibility is inappropriate at the point of definition. When you want to regulate something, I submit that it is vital that the area to be regulated is clearly defined. It is about as mad to have flexibility in that area as it would be to have flexibility in a fence around an animal enclosure. Flexibility is very useful, and Ministers—myself included—have often invoked it in support of powers of various kinds, but I respectfully suggest to your Lordships that it is not appropriate when it comes to defining an area of concept and research as important as this, where there are ethical principles to be followed that are already in the 1990 Act and will be continued in the licensing of this type of interspecies embryo, should it be allowed under provisions similar to those in the Bill. I beg to move.

I must advise your Lordships that if this amendment is agreed to, I will be unable to call Amendment No. 9 because of pre-emption.

I do not need to add a great deal to what my noble and learned friend has said about the purpose for which we tabled our amendment. We did so not necessarily with a view to removing the power, but to open up the discussion about the apparent conflict between the procedures under the Bill and those under the Animals (Scientific Procedures) Act 1986. The purposes of the two bits of legislation are entirely different. Whereas we are concerned with protecting the human embryo and regulating the circumstances in which it can be used, whether for therapeutic care, therapy or research, the Home Office legislation is concerned with animal protection, animal welfare, good husbandry and so on. Of course it envisages that there may be transgenic experiments, but, as my noble and learned friend has explained, the regulation comes in only at a later stage. As the witness from the Department of Health, Mr Edward Webb, put it to us:

“You are quite right, we have produced this definition for our purposes, that is what we are here for. We are also working in conjunction with the Home Office to make sure that the two bits of legislation do butt up against each other and do not contradict each other. There may be more work to be done on that”.

I think we would all agree with that. Mr Webb highlighted a problem in response to another question from my noble and learned friend:

“Lord Mackay of Clashfern: What is the requirement so far as using embryonic material to implant into animals is concerned?

“Mr Webb: That depends on the embryo”,

and then the telling words:

“That, again, is Home Office territory rather than human fertilisation”.

Anyone who has been in government and has had to deal with the Home Office will recognise that completely. The Home Office has always had a strong instinct to defend its boundaries. That has been its culture. I suspect that the noble Lord, Lord Darzi, will find that for himself if he has to try to sort out how we will deal with this in the context of the Bill.

As my noble and learned friend has said, I have been in touch with one of our principal witnesses, Professor Martin Bobrow, who chaired the committee of the Academy of Medical Sciences and gave us valuable evidence on how the medical scientific world views this difficulty. In answer to my noble and learned friend, Professor Bobrow said:

“The idea of a single, general definition is very attractive. The problem for me in this area is that we do have this bifid system where we regulate animals and things that come from an animal in one way and things that start as human in another way. We are trying to deal with the meeting of it”.

He then went on to comment on the amendment that my noble and learned friend had put to him.

It is clear that at the moment we are in a difficult and unsatisfactory situation. My first proposition is that it is for the Government to sort this out. If the Bill says “the Secretary of State”, the convention is that that means any Secretary of State—including, of course, the Home Secretary—not just the Secretary of State for Health. That is the pattern of the legislation. It rests firmly upon the Government to find a solution to the problem, otherwise the regulators will find great difficulty, as my noble and learned friend has said, in knowing what to regulate.

Professor Bobrow, with whom I have had a long discussion today, said that the Academy of Medical Sciences has been sympathetic to a suggestion, made some while ago, that early in the new year a workshop should be convened, followed by a new working party to consider the status of animal embryos with some human admixture. That would allow widespread debate and perhaps deliver some new thoughts into the discussion about the definition of what constitutes a human embryo. That, of course, is the question. What is “human”? We are very concerned to defend humanity in this. The reason why we attach such importance to the embryo is that it is human. The profession is now going to sit and work on that. It will not be just the academy; it will be the Medical Research Council, the Wellcome Trust and, I suspect, the Royal Society. The question is: will they do it in time for Parliament to be able to amend the Bill? In other words, it may well be that a regulation-making power of the sort contained in this clause will be the only way to deal with it. However, I hope the Minister can give us an assurance that his officials will work closely with the Academy of Medical Sciences and the others in order that they may proceed in tandem and learn from each other. It is abundantly clear that this is not a problem that can be left to drift.

I have a brief question for the noble Lord, who has made a hugely important point. Given his own experience in government, which he has alluded to, if this is not resolved, what does he think should then happen with this Bill? Should it proceed in an unamended form or should it be sent back in its entirety?

It is too soon for me to express an answer on that. I intend to keep in touch with the scientists, as I have no doubt others will. If the Bill contains this regulation-making power, this may have to be the mechanism by which one can resolve it, but we are not nearly there yet.

The noble and learned Lord, Lord Mackay, raises an important issue with his amendment. I draw the attention of the Committee to one aspect of this in the research area. True stem cells, at best, are totipotent; that is, they can develop into any one of numerous cell types—in the case of the human body, it is about 220 different cell types. There are various degrees of potency. Some stem cells are pluripotent, which means that they can develop into many tissues, but not all. Some stem cells—mostly, it seems, from adult sources—have even more limited potential and can grow only into certain tissue types.

There are many ways of assessing a stem cell’s potency for further development. One can look at the genes which the cells produce and get some idea of how they are likely to progress if allowed to differentiate into different tissues. One can look at the tissues which are produced in vitro in the laboratory, to see whether one is developing nerve cells, muscle cells, heart cells and so on. However, one of the best tests—it is almost the prime test, and the one that has been most used in the literature and the most valuable—is to mix stem cells with an animal embryo, usually that of a mouse, to see what happens to the human cells during that animal’s development, which is then sacrificed either before gestation has finished or shortly afterwards.

The classic experiments have allowed it to be established that good stem cells, which one really might want to use, can be incorporated in a wide range of tissues—liver, spleen, kidney, brain, heart and so on. This is without doubt an extremely valuable test. The question is whether it would continue to be a viable possibility for experimenters in this country who look at stem cells in the future. It would seem to me very important that it does; there will be no question of producing a hybrid, which would in any case be monstrous or threatening. This apportionment and prediction of how tissues develop have been vital in the past and a key point in many of the papers published on stem cells.

The noble and learned Lord, Lord Mackay, and the noble Lord, Lord Jenkin, raise crucial points. In light of what they said, I wonder whether the Government are right to have accepted the recommendation of the Science and Technology Committee that all forms of human-animal hybrid should be brought into the Bill.

I remind your Lordships that a number of scientific research projects are banging on the door and wanting permission to use cytoplasmic hybrids for the reasons which we have discussed previously; that is, taking out the nucleus of an animal egg and replacing it with the nucleus from an adult human cell. The HFEA has received scientific and legal advice that this is a human embryo from the standpoint of the 1990 Act. It is very different from the other kinds of human-animal hybrids—the so-called true hybrids—which have all been brought together in this definition. I wonder whether a way forward might not be to ensure that the question of cytoplasmic hybrids should be in the Bill so that the House’s opinion on it can be tested. Scientists would welcome the opinion of this House and the House of Commons. The suggestion of the noble Lord, Lord Jenkin of Roding, of a workshop to look into other forms of hybrids should be pursued, because, as two other noble Lords have suggested, we have not yet had a proper moral compass on them. As far as cytoplasmic hybrids are concerned, the HFEA has received scientific and legal advice that they are human embryos from the standpoint of the 1990 Act.

Does my noble and right reverend friend believe that it is right, if the report in today’s Times is to be believed, that on 5 December—that is, later this week—the Human Fertilisation and Embryology Authority will consider whether to grant one of these licences? Does that pre-empt not only the points that have just been made so well by noble Lords, but also the debate on this Bill in your Lordships’ House?

I strongly support the amendment argued by my noble and learned friend Lord Mackay and my noble friend Lord Jenkin of Roding. I have only two, rather simple points. First, any practitioner of the ministerial arts—being a Minister is probably more of an art, sometimes black rather than white, than a scientific practice—is always wise to have as much wriggle room as possible and, in taking legislation through this place and another place, to have opt-outs, opt-ins and the ability to put things in and out by regulation. It would be helpful to know at this or some later stage of these considerations in Committee whether the noble Lord, Lord Darzi, sees the regulation-making power that he proposes as having to be debated regulation by regulation in your Lordships' House, or as being able to go through simply by ministerial fiat, as is often the case.

Secondly, although I am no expert in these medical and ethical issues, it strikes me that if the noble Lord has his way and line 35 appears on the statute book when the Bill passes into law, it would be possible for him or one of his colleagues in the Department of Health to come forward with a regulation in some future year, notwithstanding the fact that there has been an enormous amount of regulatory angst and philosophical discussion about the ethical position of this or that outside your Lordships’ House.

I have much sympathy with what noble Lords have said. My professional friend, the noble Lord, Lord Winston, spoke about the tests. The test of a stem cell’s pluripotency would apply also to induced pluripotent cells. They would have to be tested for efficacy by using that kind of test—and that is the standard test. One cannot conduct such chimera tests in humans; they have to be done in animals, using human stem cells.

I agree with my noble and right reverend friend Lord Harries of Pentregarth that what scientists are seeking is to use cytoplasmic hybrid embryos. As I said previously, the transfer of a somatic adult cell nucleus into an animal egg from which the nucleus is removed—it might even be possible to remove mitochondria, but that is a separate discussion—and removal of the stem cells from early blastocysts is 99.9 per cent, if not 100 per cent, human DNA. In that respect, as my noble and right reverend friend said, it could be regarded as a human embryo. To produce stem cell lines that carry the disease genes that occur in humans, but not in animals, is what scientists are seeking to do. These stem cells are useful in testing how these diseases developed and how to change these chromosomes by genetic manipulation. They are used also in future drug development. Avastin was developed by using such experiments, as my noble friend Lord Winston described.

I, too, feel uncomfortable about the definition in new Section 4A(5)(e), which refers to “such … thing”. That seems rather a curious definition in any legislation coming before your Lordships’ House. However, I should draw to your Lordships’ attention the views of the Wellcome Trust, the Academy of Medical Sciences, the Medical Research Council, the Royal Society of Medicine and the Association of Medical Research Charities, which support the inclusion of a definition of interspecies embryos of the two hybrids, the cytoplasmic embryos, the transgenic embryos and the rest. One thing that has been postulated, although I think that it is very far into the future, is that with the creation of such hybrid embryos—about which I feel I have a somewhat sneaking feeling of discomfort—by inserting human genes into an animal embryo you might be able to create an animal that would be a source of organs for transplant. People have been trying to use pig livers for transplant, for example, due to a shortage of organs for human transplantation. The problem with that was a viral difficulty and a major incompatibility. However, I believe that it is something that is being looked at for the future of research.

The group of important bodies to which I referred supports the inclusion of a regulation-making power in new Section 4A(5)(e) to make adjustments to the definition of interspecies embryos in light of the difficulties of defining all the types of such embryos that might be created in future. They believe that to be an important and sensible approach to future-proofing of legislation. I pass that suggestion on from these bodies as something that they have made clear in their views.

I shall speak to Amendments Nos. 19 and 20 in this group, which I have tabled for the very reason set out so well by my noble and learned friend Lord Mackay of Clashfern.

It is highly unsatisfactory that in debating a subject as sensitive and difficult as interspecies embryos we have no clear idea of what kinds of embryo are capable of falling under that heading. Like my noble and learned friend, I am distinctly uncomfortable about giving the Secretary of State a broad order-making power to widen the scope of new Section 4A, even under the affirmative procedure. It would be better to omit that provision altogether than to have the current lack of clarity about the definition, difficult as it may be to come up with such a definition.

At the same time, I am conscious that the creation of interspecies embryos is permitted, and has indeed been authorised, under the Animals (Scientific Procedures) Act 1986. As my noble friend Lord Jenkin pointed out, the thrust of that Act has little to do with embryology as such; it is about minimising suffering in animals that are used for medical research. The Act, almost by default, allows for a wide range of experimentation involving animal embryos to which human genetic material has been added. It appears also to regulate only those procedures involving so-called protected animals, which are defined in the Bill. Animals that do not fall within the scope of this definition are not subject to regulation when it comes to research. The question of when an animal embryo ceases to be an animal embryo and becomes human is equally not addressed in the Act. It leaves us as bereft of a definition of interspecies embryo as does this Bill. That cannot be satisfactory in an area of law as important as this.

I am particularly worried about the scope that there appears to be in the 1986 Act to authorise research that involves bringing hybrid creatures to maturity inside the womb of an animal, a process that this Bill would explicitly ban in relation to an interspecies embryo in any of the forms listed in new Section 4A. We have read about transgenic mice that are bred using human genetic material, including the mouse on which a human ear was made to grow. I am not condemning that kind of experiment, which may well carry the potential for enormous good, but it takes us close to an area with which most of us would, I think, feel decidedly uncomfortable if, for example, there was any question of replicating a human-like brain inside an animal. I have no idea whether that is technically possible, but the issue that should concern us is whether it is currently legal or capable of being allowed.

What is the acceptable time limit for propagating animal-human hybrid embryos in the laboratory? For hybrids that are at least 50 per cent human, this Bill says that the limit should be the earlier of 14 days or the appearance of the primitive streak. But for animal-human hybrids—that is to say, hybrids that are predominantly animal but partly human—the current law is a lot less restrictive, especially for animals that do not fall within the definition of protected animals. What are we to think about that? These are major questions on which we currently have no guidance at all.

The report of the Joint Committee said:

“There is no principle, as such, which underpins the Government's choice of 50% as a cut-off point for whether an entity is sufficiently human to merit regulation by the HFEA, or whether it is more appropriately regulated as an animal by the Home Office. The 50% rule is essentially an arbitrary attempt to draw a line between what qualifies as human and what as animal”.

That indeed is the nub of the problem and, to be frank, it does not make life any easier to be told by the Government that the definition of interspecies embryo proposed by the Joint Committee will not do because it would sweep up within it various sorts of scientific procedure currently overseen by the Home Office. The retort to that is surely that the regulatory structures ought to follow the ethical principle rather than the other way round. If it is not possible to distinguish the ethic status of something that is 99 per cent human from that of something that is 49 per cent human, we are bound to question whether the dual arrangement for research approvals makes proper sense.

The Government’s adherence to the dual arrangement would be more tenable in practice were it possible to predict in advance that an entity would be, say, 20 per cent human on the basis that it begins as 20 per cent human. But, unfortunately, as Dr Robin Lovell-Badge told the Joint Committee, things are not as neat as that, since, in his words, you may,

“start off with an entity which is 20% human and end up with something that is 60% human or vice versa”.

It seems fairly clear that if in legislation we doggedly stick to the artificial distinction between entities that are more than 50 per cent human and those that are less than 50 per cent human, yet fail to define in the legislation what we mean by interspecies embryo, there are bound to be categories of entity that do not fall to be regulated by either the 1986 Act or this Bill. We have to deal with that, and the Government and Parliament need to approve a legal architecture that would straddle all types of interspecies embryo—an architecture that rests on the foundations of ethics and science and which has clear guidelines but which allows for a sensible degree of autonomy by the regulator in taking decisions. We are nowhere near that position at the moment. I hope that the Minister will take seriously an issue about which I and my noble friends share very considerable concerns.

The amendment has serious implications for several current forms of research. As for how much of a mouse or another organism is human, when we share nearly 30 per cent of our genome with a banana, we could ask: is a banana human?

The amendment could affect a huge amount of current research funded by the MRC, for example—at least one-quarter and maybe up to one-third. Even if the work were not banned, introducing additional regulations would be a major setback for the speed at which such research could progress. The noble Earl may correct me if I am wrong, but the amendment would prohibit two extremely valuable approaches. One is the use of transgenic animals, which is currently allowable under Home Office licence and fundamental to biomedical research. Testing the pluripotency of stem cells, as the noble Lord, Lord Winston, mentioned, is critical for realising the therapeutic potential of stem cells, not only embryonic stem cells. Even more so, it will be needed for induced pluripotent stem cells.

Transgenic models are used in both basic and applied medical research. These uses include the modelling of human diseases, drug development and drug testing. The vast majority of work aimed at understanding the genetic basis of disease uses, and will continue to use, transgenic approaches. All universities and biomedical research centres, including industry, undoubtedly use this technology extensively. I will describe some of the disease areas where transgenic animals are used in MRC programmes.

The MRC funds research programmes that employ a wide range of approaches using animal models, in particular mice, to study human genetic disease as well as a variety of fundamental biological phenomena and their relevance to clinical medicine. For example, the MRC has significant investments—the Mammalian Genetics Unit and the Mary Lyon Centre, which is a central mouse facility, and the UK Mouse Genome Centre at the Harwell site. This integrated campus for mouse genetic research has excellent facilities for molecular genetics, genomics, animal breeding, mutagenesis and transgenesis. A particular focus for the MGU is the provision of mouse models for human disease by using N-ethyl-N-nitrosourea—ENU for short—mutations and more targeted approaches. Examples of these include a study of deafness and neuromuscular genes, congenital disorders caused by misregulated development such as neural tube defects, lung development and neurological behavioural and sensory disorders, including neurodegenerative disease such as motor neurone disease.

Programmes at the MRC Human Genetics Unit employ extensive use of transgenic animals—for example, gene knockout in mice to understand the causes and treatment of many diseases such as airways disease, including cystic fibrosis, understanding the causes of cancer of the large bowel through genetic and preventive strategies, dissecting the role of a multifunctional gene, WT1, in Wilms’ tumour, development of the kidney and heart, identification of genes important in brain function and neurological disorders, mouse models of human eye disorders such as Fraser's syndrome, retinal degenerative disorders such as retinitis pigmentosa, which causes blindness, identification of new genes that confer risk of human melanoma, and development after exposure to ultraviolet radiation.

The research at the MRC Functional Genetics Unit aims to integrate advanced comparative genomics, genetic model systems and cutting-edge physiological approaches to discover potential therapies for human diseases such as muscular dystrophy, motor neurone disease, ataxia, Alzheimer's disease, Rasmussen’s encephalitis and congenital myasthenia, to mention just a few.

Analogous experiments form a key part of research into HIV, hypertension and many other diseases. One of the most notable recent advances has been the creation of a mouse strain that carries an almost complete extra copy of human chromosome 21—the Down’s syndrome chromosome—designed to facilitate research into Down’s syndrome. In humans, there are two compensatory genes that are not present in animals. The only model in which to study this disease and the potential therapy is to place these two genes into an animal. Other examples include mice generated with a human immune system—so-called huMAb mice. These mice have been used to address a variety of research questions but also to generate humanised monoclonal antibodies, which are increasingly utilised to produce antibody-based drugs, such as the cancer treatment I mentioned earlier, Avastin.

In the second instance, the proposed amendment could—specifically with the words,

“one or more each human cells”—

block important research into human ES cells. Determining pluripotency—a cell’s ability to form all the body’s cell lineages, a defining feature of stem cells—is an important step in deriving ES cells. My noble friend Lord Winston mentioned that. The most effective method is, as he said, to determine their ability to participate in normal embryonic development after reintroduction into blastocyst stage mouse embryos, which are then implanted into the uterus of receptive female mice—so-called surrogate mother mice.

The creation of transgenic animals, including those incorporating human DNA, is regulated by the Home Office under the Animals (Scientific Procedures) Act 1986. An animal comes under the remit of that Act at the end point of gestation. Research involving protected animals—all vertebrates, excluding humans but including octopi—including transgenic animals, is subject to licence by the Secretary of State for the Home Office under the Animals (Scientific Procedures) Act 1986. Section 2 of the Act includes within the definition any protected animal from the midpoint of the gestation or incubation period for the relevant species.

Any such research also requires approval by a research funding agency as well as an institutional research ethics committee. There is no legislation that specifically applies to research involving non-human embryo in vitro, but the 1986 Act applies to any procedure involving a living animal—for example, the hormonal stimulation of oocyte maturation for implantation of a blastocyst as well as the production or breeding of any genetically altered animal.

All the scientific agencies—not only the MRC, but the BBSRC—are concerned about this amendment. Examples of the BBSRC’s work include the use of farm animals to generate large quantities of human protein to treat specific human diseases. This has been possible through the incorporation of human genes into fertilised sheep eggs. Examples are alpha-1-antitrypsin, with a specific promoter region so that the gene is expressed in a mammary gland. When the egg is implanted, it develops into a transgenic sheep and when the gene is expressed the protein is secreted in milk and can be harvested to be used to treat emphysema, for example. A similar approach has been adopted with the human blood-clotting factor VIII expressed in sheep's milk for haemophiliacs.

Transgenic research on mice has now become an important technological approach to study the role of deleted genes and added human genes. There are many examples that I could quote. Briefly, this amendment will affect a significant amount of current medical research funded by all research agencies. I believe that such research is already regulated through the animal regulation Act.

The noble Lord, Lord Patel, speaks as though my amendment would ban all sorts of scientific experimentation. It would do no such thing. My amendments are not designed to ban useful research and they would not do so. They are designed, as I mentioned, to focus the mind of the Government on the need to arrive at satisfactory legal definitions. While I am on my feet, let me say that I am not sure that our discussion should be subverted by the mention of bananas. It is fair to say that the banana is not a sentient animal, which is the issue at stake here.

It is the concern about any part of a cell that is at issue here. I would put it much more strongly than the noble Lord, Lord Patel. As noble Lords know, I am not given to exaggeration, but I believe that transgenic technology has been the single most important advance in human medicine in the past two decades. It was started in 1980 by Dr John Gordon in New York. I do not think that any other biological technology has been more important.

When we talk about genes it is rather important that we understand that a gene is really just a chemical. There are no such things as human genes. I am afraid that my colleague, the noble Lord, Lord Walton, talked about human genes, but essentially genes may be conserved right through evolution and one should think of them in terms of a chemical structure, not as something that is somehow innately part of life. That is a misunderstanding.

As I said on the previous amendment, the test for a cell’s potential to develop into other tissues is one that we must consider carefully. We might argue that any animals that are so produced should be destroyed before they become viable, or at least should not be allowed to breed. That might help the Committee; it might be a way of looking at that in the future. However, transgenic animals must be allowed to breed. Without that breeding process, one will not understand the basis of functional genetics, which, as I say, is such a significant advance in every field of medicine and one which is accepted in every country; even countries that are querulous about in vitro fertilisation accept this kind of animal research as being a sine qua non of good biology.

The spectrum of human animal embryo research is broad. It extends from animals created to contain one human gene through to human embryos modified to contain one animal gene. The purposes of human animal embryo research, and the limits that should be placed on it, depend on what point along that spectrum the research is undertaken.

Research at the human end of the spectrum involving human embryos, and embryos created using human eggs or human sperm or human somatic cells, warrants the regulation warranted under the 1990 Act—strict regulation and strict limits placed on the creation and use of such embryos. This is what we propose to bring about through this Bill.

Research involving protected animals, which are all vertebrates—excluding humans—and octopi, including transgenic animals, is subject to licence by the Home Secretary under the Animals (Scientific Procedures) Act 1986. Section 2 of the Act includes within the definition any protected animal from the mid-point of the gestation or incubation period for the relevant species.

There is no legislation that specifically applies to research involving non-human embryos in vitro, but the 1986 Act applies to any procedure involving a living animal, including the implantation of an embryo, as well as the creation or breeding of any genetically modified animal.

The noble and learned Lord, Lord Mackay, and the noble Lord, Lord Jenkin, have tabled an amendment that would remove the ability to update the definitions of interspecies embryos through regulations. This regulation-making power was proposed such that if new technologies are developed by which human-animal embryos can be created, where those entities warrant the level of regulation proposed in this Bill for interspecies embryos, they can be brought within the scope of regulation provided by the 1990 Act.

I believe that through the definitions provided in new Section 4A(5)(a) to (d) of the 1990 Act, as inserted by Clause 4, all the necessary categories of interspecies embryos are caught. This means that all forms of human-animal embryo, which we believe warrant the level of regulatory oversight provided by the HFEA—that is, by a body licensing individual research projects using human embryos and interspecies embryos—are brought within its remit. However, as the noble and learned Lord, Lord Mackay, pointed out, we can never be sure that new techniques will not be developed in the future or that new forms of human-animal embryos will not be developed that may also need to be regulated under the 1990 Act. Therefore, the problem of definition is an issue.

I refer to a letter sent over the weekend by Professor Bobrow of the Academy of Medical Sciences. It states:

“The Scrutiny Committee’s final report acknowledged the limitations of the proposed definition. Following publication, the Academy liaised extensively with the Department of Health, to see if we could refine the Scrutiny Committee’s definition to avoid the problems outlined above. This involved a great deal of e-mail correspondence and a meeting hosted by the Wellcome Trust on 7 August attended by representatives from the Academy, MRC, Royal Society, Wellcome Trust and Department of Health. Despite considerable efforts, we were unable to draft a satisfactory general definition of an ISE”—

interspecies embryo—

“and concluded that, even with more time, we were unlikely to reach a viable solution. We agreed that a regulation-making power, allowing the list of definitions to be expanded as necessary in the light of new research methods and findings, to be the preferable option”.

That is the scrutiny of the scientific committee. I come back to the point raised about regulation. The noble Lord, Lord Patten, asked who would regulate interspecies embryos. The regulations in question would be for the House to debate in the form of an affirmative resolution.

Amendment No. 19, tabled by the noble Earl, Lord Howe, seeks to insert new provisions into the Animals (Scientific Procedures) Act 1986 to regulate the placing in an animal of an embryo altered by the introduction of any elements derived from human cells and seeks to create an associated regulation-making power. In so far as it applies to the placing of embryos into recipient animals already protected by the Animals (Scientific Procedures) Act 1986, it adds nothing new to the existing provisions of that Act and is redundant. However, the amendment, as worded, also seeks to regulate the placing of an embryo into recipient animals other than those protected by the Animals (Scientific Procedures) Act.

The 1986 Act defines a “protected animal” as any living vertebrate, other than man and one invertebrate species, Octopus vulgaris. Unprotected animals therefore comprise man and all invertebrates other than Octopus vulgaris. This would vastly extend the reach of the Animals (Scientific Procedures) Act. As the noble Lord, Lord Patel, pointed out, the generation of transgenic animals containing human DNA has become a common technique to study both basic and applied human biology. It forms an important part of modern medical research. Any additional regulation would be an unnecessary burden in cost and time for researchers and regulators and would have little or no additional benefits for animal welfare. It would be contrary to the Government's better regulation agenda.

Amendment No. 20, tabled by the noble Earl, Lord Howe, seeks to insert new provisions into the Animals (Scientific Procedures) Act 1986 to regulate the keeping or using of animal embryos altered by the introduction of any elements derived from human cells. It also seeks to set time limits for keeping or using them. As with Amendment No. 19, in so far as it applies to keeping or using embryos of animals already protected by the Animals (Scientific Procedures) Act 1986—other than creating a requirement to restate in regulations the criteria on which the relevant licences are granted—the amendment adds nothing new to the existing provisions and protections afforded by that Act and is redundant. However, in common with Amendment No. 19, it would vastly extend the reach of the Animals (Scientific Procedures) Act to the embryos of unprotected animals; that is, to human and invertebrate embryos.

I invite noble Lords not to press the amendments. However, we may in later debates discuss some of the issues relating to definition, which I feel are important and need further debate.

I am very grateful to the Minister for his response to the amendment. I understood that the various colleges had come to the view that this was the best answer. However, it is, in a sense, recognition by authorities of the highest standing that they cannot answer the question that they themselves have proposed on regulation of an area on this spectrum. They can delineate perfectly the human end, which is all human, but they have not been able so far, with all their expertise, to define the other end. We just await the research that may produce that answer. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 9 to 18 not moved.]

Clause 4 agreed to.

[Amendments Nos. 19 and 20 not moved.]

I beg to move that the House do now resume. In doing so, I suggest that the Committee stage begin again not before 8.42 pm.

Moved accordingly, and, on Question, Motion agreed to.

House resumed.