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No human admixed embryo that has been created may be implanted into a woman or an animal, or be cultured for more than 14 days or after the appearance of the primitive streak. Equally, any research done using human embryos must satisfy the HFEA that it
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is necessary or desirable for one of the statutory purposes. This research is about giving scientists the ability, within clear boundaries—which have been discussed in the House before, particularly in 1990—within which to advance technologies that could help in the development of treatments for devastating degenerative conditions, in continuing research into male infertility and in learning more about what makes embryonic stem cells so different from any other cell.

The use of animal eggs will provide a valuable resource to embryo research scientists, giving them the ability to perfect the techniques that could one day help to develop our understanding of diseases and to speed up the development of their cures. My right hon. Friend the Member for Manchester, Gorton (Sir Gerald Kaufman) made a very eloquent speech earlier. I make no apology to the Committee for saying that we cannot promise that this research will definitely lead to those treatments; it is an aspiration that it could do so, if it is permitted, along with the rest of the research that is being carried out.

Amendments Nos. 1, 2, 41 and 42 would prohibit the creation of all forms of human admixed embryos for any purpose, including cytoplasmic hybrid embryos. A major barrier to continuing embryonic stem-cell research is the lack of human eggs for use in research, as they can be obtained only through the stimulation of a woman’s ovaries. That procedure is not without risk, and the best eggs are quite rightly used in treatment. Researchers have been looking for a solution to the shortage, and they believe that they have found one in the form of animal eggs, which are widely available and believed to be as useful in the creation of embryos as human eggs. If successful, they could advance embryonic stem-cell research by many years.

The hon. Member for Boston and Skegness (Mark Simmonds), in speaking to amendments Nos. 10 and 11, sought to prohibit embryos created from the mixing of human and animal gametes—the so-called true hybrids. I must admit that I was not clear about the ethical principle that the hon. Gentleman was drawing on. In fairness to him, however, let me say that that was also reflected in the way the Government proceeded in their consideration of the matter. The hon. Gentleman asked for an explanation.

The Government took into account the arguments of the joint pre-legislative scrutiny Committee—a Committee of this House and the other place—which saw no clear reason to preclude such activity within the regulatory controls of the Human Fertility and Embryology Authority. Any project to create true hybrids would need to satisfy the research licensing criteria that the work is necessary or desirable for a statutory research purpose and that the use of the embryos is necessary. The hon. Member for Harrogate and Knaresborough (Mr. Willis), who chaired the Joint Committee, said on Second Reading that

which we already have—

The Government agreed with that conclusion.

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The Academy of Medical Sciences, the Royal Society, the Wellcome Trust and the Medical Research Council have written to say that true hybrids offer significant potential for research to improve our understanding of infertility, sperm function and stem-cell development—and must not be prohibited. Given that the hon. Member for Boston and Skegness could not set out a clear reason for this particular deletion, I urge the House to resist his amendment.

Mr. Edward Vaizey (Wantage) (Con): For the benefit of those of us who are close to supporting what is in the Bill, will the right hon. Lady help us on one specific point? Given that she has acknowledged that the Government were persuaded by the pre-legislative scrutiny Committee, what were the Government’s concerns about true hybrids before its report was published? Clearly, the Government had drawn a distinction before that report persuaded them otherwise.

Dawn Primarolo: I was not the appropriate Minister at the time, but I shall attempt to summarise the position. I think that we were concerned about some of the issues raised by the hon. Member for Boston and Skegness. In searching around to put the argument clearly on an ethical basis that drew the lines in logic and science, the Government had to admit—I hope that the hon. Gentleman will do the same tonight—that we were simply wrong in our original decision. There was no such line to be drawn.

Robert Key: I would like to help the right hon. Lady, as I was a member of the Joint Committee. The real problem was that the scientists could not fathom the definitions laid down by the Department in the draft Bill; they successfully challenged them as being completely unworkable. A number of distinguished scientists, including Lord Winston, said that they simply did not understand what the Government were trying to say.

Dawn Primarolo: I am eternally grateful that the whole Government and Ministers in the Department of Health were able, through this process, to listen, learn and come to the correct decision. I sincerely hope that the Committee will do the same this evening and reject the amendment. Clearly, the public consultation, the drafting of the Bill, pre-scrutiny by a Committee of both Houses and then a full debate in the other place have demonstrated that the decision is now in the right place.

Mark Simmonds: Does the Minister accept that there is a difference between an embryonic cell that is a 50:50 hybrid and one that is 99 per cent. human?

Dawn Primarolo: What I am saying is that we are trying to be clear about what should be regulated and when it falls within the remit of the HFEA. I defy the hon. Gentleman to tell me the principle whereby we could define his proposition in law.

Amendment No. 3 would prohibit the hamster test that was clearly allowed under the 1990 Act.

Mark Simmonds: Will the Minister give way?

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Dawn Primarolo: No, I will not. Other Members want to speak and I am trying to make some progress. I have been absolutely candid with the House on this matter.

The usefulness of the hamster test was mentioned in the evidence given to the Committee in 2007, which cited the value of using hamster eggs over and above other assessments of male fertility. In recent correspondence to the Department, Professor Lynn Fraser made a clear argument for the continuation of this work, citing the use of hamster eggs as the best option for testing treatments designed to increase the ability of human sperm to fertilise an egg. Such research is valuable in trying to find ways to overcome male infertility. Prohibiting its use and the use of this technique seems completely unjustified, especially as this prohibition would be a step backwards from the position enshrined in the 1990 Act.

My hon. Friend the Member for Stroud (Mr. Drew) tabled amendment No. 44, which deals with embryos. The Bill allows for the alteration of the genetic structure of embryos for research purposes only. It prohibits the transfer of such embryos to a woman. That is underpinned by an international consensus that prohibits such practice and the Bill also reinforces the point.

Government amendments Nos. 33 to 39 amend the definition of human admixed embryos. The Bill uses the term “human admixed embryo” as an umbrella term for four types of embryo containing human and animal genetic material ranging from those that are—in simple terms, as the hon. Member for Boston and Skegness says—99 per cent. genetically human through to those that are 50 per cent. genetically human. The amendments are a response to the debate in the other place, where clarification of the definitions was sought. The Government amendments add a catch-all category to the definition of human admixed embryos in the Bill, providing further clarity of the scope of the term. In addition to the four precise scientific definitions already in the Bill, that will ensure that all new forms of embryos that may be developed that contain both human and animal DNA will, where the animal DNA does not predominate, fall within the regulation.

The Bill and these provisions are about ensuring that the wishes of this House for this area of research, as set down in 1990, are respected so that regulation can be carried out by the HFEA. The Government amendments improve the Bill, but I sincerely hope that hon. Members will reject all the other amendments and support both the Government and this clause.

Mr. Burrowes: I begin by making a point that I would have liked to raise by intervening on the Minister earlier. It concerns Government amendment No. 34. The problem of definition has been an issue for this House and the other place. Some have sought to define what is human, what is animal and then what is a human admixed embryo. In other provisions, the Government have sought to do that by way of illustrative examples. When dealing with legislation that needs to be applied by regulations—no doubt it will be challenged in due course by lawyers and others—it is important that the House at least leave the Bill in a state of clarity and with clear definitions so
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that we know what we are dealing with, although that is extremely complex. The Joint Committee, on which I sat, challenged the Government’s previous position. It is still an issue of concern. In the other place, Lord Mackay of Clashfern introduced an amendment to provide some clarity of definition about what is human, what is animal and what is a mixture of the two.

6 pm

Government amendment No. 34 attempts to provide clarity on the issue of defining what might be subject to regulation. The question, though, for the Minister, which perhaps highlights the problems that we have over definition is, where Government amendment No. 34 would capture that embryo which is created by what is called tetraploid complementation. Those embryos are normally created by adding embryonic stem cells to an animal embryo that has been altered to have double the number of chromosomes—that is, it is a tetraploid. The embryonic stem cells form the foetus while the tetraploid embryo forms the placenta.

In the Joint Committee, I questioned Professor Lovell-Badge, who replied:

The reality is that this science is a moveable feast—moving towards human and animal. That causes profound concern, not least in the area of tetraploid complementation, which at present might be subject to Home Office regulations in animal legislation, rather than regulation under such a Bill. I invite the Minister to respond on that point and say whether consideration might be given to dealing with that area of research—not leaving it to regulation, but ensuring that it is dealt with by primary means.

Moving to the general positions in the Bill, I support the amendment tabled by my hon. Friend the Member for Gainsborough (Mr. Leigh). Concerns have been expressed and we often hear the refrain, “All avenues must be kept open.” However, when one looks through the Bill, one sees that all avenues are not left open. The Government would wish us to close off various avenues in various arenas. Today, tomorrow and during consideration by the Public Bill Committee, there will be debate on certain avenues that have been cut off, not least those concerning sex selection.

The House is charged with the duty of building an ethical framework that can properly lead to good science, but my position and that of hon. Friends and hon. Members who have spoken is based on good science but also good ethics. The framework must be built that is sound, lasts for a considerable time and deals with future developments, but is based solidly on ethics and a firm belief in and respect for human life and the dignity of human life, which the House needs to send out and establish clearly in the Bill.

There is perhaps no greater duty on the House than ensuring that we are clear about that. It cannot be left to chance. It cannot be left to whim. It cannot be left to saying to scientists, “Let’s give it a chance and see how far it goes.” It is important that we ensure that we properly respect those principles of human life, certainly when we are dealing with human admixed
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embryos, and it is incumbent on us to achieve a Bill that has not only clarity of definition, but clarity of ethics.

The Government would wish us to be a world leader in this area of stem-cell research. We can all extol the virtues of stem-cell research and regenerative medicine. Indeed, last week in Paris there was a conference to promote responsible regenerative medicine. We could all sign up to that and to cures that come as a result of it. The context of the conference was cord blood stem-cell research. We have already heard from hon. Friends and hon. Members about the developments in relation to cord blood source, which have led and are leading us beyond the normal route of blood immune deficiency to the regeneration of nerves, bone, cartilage, tendon, vessel tissue and beyond. That is an exciting area, but sadly this country is lagging way behind in the league table for collecting cord blood. I understand that we are 13th, and we should do much more in those areas.

It is important that we consider the context of stem-cell research, although we should not concentrate on just that. We should consider the clinical trials throughout the world. There are 1,987 in relation to adult stem-cell research and 106 on cord blood. There are none on embryonic stem-cell research. That is a significant context, but it should not necessarily be given undue weight when one is considering the context of the Bill.

The human admixed embryo provisions seek to take us to a new level of the human embryo stem-cell project. We perhaps need to throw some water on the high expectations for embryo stem-cell research. We should take note and be cautious in relation to the fact that embryo stem-cell lines do not work in mature tissues. That is the problem that many scientists are seeking to fix. Embryo stem-cell lines develop tissues. There are fundamental engineering problems. Once embryo stem-cell lines are differentiated, the concern is that what is involved will stop being a stem cell and lose its “stemness”. It has difficulty turning into a tissue type.

The concern, though, is that we do not simply deal with the problems of embryo stem-cell research; the issue is human hybrid embryos and whether there are alternatives. In the development of embryo stem-cell research, one has to focus on cloned human embryos. Those are particularly difficult to create. They are very inefficient and defective. There is difficulty that leads to abnormality. When one looks at the research, one sees that there are problems. The problems develop when dealing with the structure of cloned human animal embryos.

The concern goes beyond risk of infection, immune logical reactions and the tumours that develop. The development of cloned human animal embryos represents taking another leap. That is the focus of the Bill, which will establish that we must move into the area of cytoplasmic hybrids. Taking the scientist’s view, one struggles to see how one could get to the point of curing diseases, which is what we all want.

The Government put it forward—one has to take them at their word—that cytoplasmic hybrids are essential for groundbreaking research and that they will produce those medical cures for genetic neurodegenerative diseases, but if one goes back a stage to cloned human
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embryos the reality is that they cannot properly be used for therapies for genetic diseases. The genetic flaw would remain in the tissue, as the genes would come from a person with a disease.

If one took a leap towards cloned animal human embryos it would be even worse, as they would contain the genetic flaws and the additional genetic and epigenetic flaws because of the way they are created. The human genome would have been reprogrammed with reprogramming factors from the animal egg, and there would be a degree of mismatch between relevant human and animal material. There would also be the risk of the creation of new diseases. As I mentioned earlier, there may be the risk of immune rejection, as mitochondria have proteins that can cause an immune reaction. Some animal mitochondrial proteins would be present in the cells, and they might cause an even stronger immune reaction than human mitochondria.

Looking back, the concern is that embryonic stem cells have caused dangerous tumours. That led to the withholding of the US Food and Drug Administration licence for clinical trials of embryonic stem cells to go ahead. But it is far too dangerous medically to attempt to use embryo stem-cell lines for therapies. Looking to take that a stage further in terms of human animal cloned embryos, it would be even less safe to use them for therapies.

In the other place, noble Lords said that cloned human animal embryos would be used for transplant. That certainly is not the case, and I was grateful that Dr. Stephen Minger, speaking to the Associate Parliamentary Health Group on 23 April, made it clear that they could not be used for transplant.

The Government say that we need cybrids because they will help to inform people about genetic diseases when used with specific cell lines from patients with such diseases. However, we need to consider ethical alternatives. Much has been said about the investigation of motor neurone disease. The hon. Member for Montgomeryshire (Lembit Öpik) has said that we need to find the avenue for progress, but what is that avenue?

The Government seek to be a world leader. Since they presented the Bill there has been rapid progress in other areas of alternative stem-cell research, not least in the area of induced pluripotent cells. On Second Reading we heard mention of Professor Wilmut, creator of Dolly the sheep. He had planned to create disease-specific cell lines using so-called cybrids to investigate motor neurone disease, but abandoned that approach very publicly a few months ago, stating that reprogrammed adult cells—induced pluripotent stem cells—showed much more potential. That was another avenue for research. He intends to make motor-neurone-disease-specific cell lines using IPS cells.

Lembit Öpik: There is room for both, surely. Professor Chris Shaw is not guaranteeing that this is the right way forward, but says that it would be unwise to abandon it. I recognise that there are ethical considerations for many Members, but does the hon. Gentleman not accept that, from a scientific perspective, it makes sense to pursue parallel paths in the knowledge that one of them might provide the solution to motor neurone disease? That would save 1,600 lives a year in the United Kingdom alone.

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