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I hope that the Minister will give a good response and that the House, if asked to vote, will come clearly down against genetic modification, which I am sure everyone in the House is against. The argument is about how best to be against it. If amendment No. 49, tabled by the hon. Member for Southport, is pushed to a Division, I will support it. However, I hope that my more
comprehensive amendment is taken seriously and seen as a way of helping the Government, who, I am sad to say, have listened but not acted as some of us would have wished. They have not been comprehensive in clarifying their views on human genetic modification.
Mr. David Burrowes (Enfield, Southgate) (Con): It is a pleasure to follow the hon. Members for Southport (Dr. Pugh) and for Stroud (Mr. Drew), and I support their amendments. Many of us opposed in principle the prospect of human admixed embryos, but we had a vote on that principle and the House decided to go ahead with it. Many also opposed the practical results proposed by the Government; indeed, during discussion of the programme motion today, the Minister again alluded to the prospect of treatment for Alzheimer’s disease and other debilitating conditions. Many of us applaud that fine motivation, but are concerned that the Government are marching us up to a false summit. Many of us sought to oppose the move because we felt that there were ready alternatives that are producing therapeutic treatments and offer great prospects of further cures to such debilitating illnesses.
I wish to speak to amendment No. 47, tabled in my name and those of other right hon. and hon. Members. It is not a wrecking amendment; it does not seek to oppose the principle of human admixed embryos, as we have to accept the previous will of the House. Nevertheless, there will obviously be a fundamental vote on Third Reading. Our amendment seeks to do something important: plug a gap that has exercised the minds of many. The Minister has mentioned that there have been 80 hours of deliberation and many of those have been taken up in discussion of whether the definitions of human admixed embryos in the Bill are adequate. Amendment No. 47 is significant, and I will want to press it to a Division.
On Third Reading in the other place, the noble Lord Darzi raised the issue of definition. He said:
“My Lords, the issue of defining human admixed embryos has long vexed all those who have tried to tackle it. It was probably the topic that the Joint Committee of both Houses that scrutinised the draft Bill spent most time considering.”
Like other hon. Members here, eighteen months ago I was a member of that ably chaired Joint Committee. We sought to be as constructive as possible to assist the Government to come to an appropriate definition. The House of Lords Science and Technology Committee also undertook an inquiry specifically into the issue of definitions, which is a matter that has led us down many different paths. Indeed, I pay tribute to the noble Lord Mackay, who gave particular consideration to the issue, both in the Joint Committee and in the other place, with Ministers and others, to try to help us come to a definition.
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As a lawyer, I would perhaps tend to look to definitions as an important part of any Bill. It is therefore quite right that we should begin our considerations this afternoon with the issue of definition. If we cannot get the definitions right, that does not hold out much hope for the Bill’s practical application. Notwithstanding all the results that we want to achieve, it should concern us all in the House if we cannot get the definition right. I therefore
hope that my amendment No. 47 will attract widespread support from those who, despite being vehemently for or against human admixed embryos in principle, whatever I say, are concerned that the definitions in the Bill should be comprehensive.
The noble Lord Darzi said on Third Reading:
“We are now facing what we hope will be the final steps in this journey.”
Those final steps led to an essentially catch-all definition, which he described in that debate in terms of clause 4, which includes a
“regulation-making power to extend the definition of human admixed embryos if necessary.”
“It has been included to ensure that if someone comes up with the type of human-animal embryo at the human end of the spectrum that is not captured by the definition, there is a power to extend the definition to catch it. This is a future-proofing mechanism.”
It is for this House to try to ensure to the best of our ability that we get the definitions right, so that they are fully comprehensive and so that everyone out there—the scientists and the public—is clear about what we mean by human admixed embryos. We should not simply devolve the issue to future delegation or a future-proofing mechanism. That is not satisfactory.
The gap in the current definitions needs to be addressed properly. My amendment No. 47 seeks to do that. The gap is crucial—it is the gap in the law between the Bill and the Animals (Scientific Procedures) Act 1986. The amendment standing in my name addresses that gap, by adding another type of chimeric embryo to the definition of “human admixed embryo” in clause 4, which would otherwise remain unregulated.
The science behind the creation of such embryos is complex—one would perhaps need a hot towel on one’s head to understand it fully—but it is important not to be blinded by that complexity, because the concept is very simple. Indeed, the noble Lord Darzi put the issue in its proper context, again on Third Reading, saying that the Government’s intention was for the Bill to ensure that the Human Fertilisation and Embryology Authority
“regulates human-animal embryos at the human end of the spectrum.”— [ Official Report, House of Lords, 4 February 2008; Vol. 698, c. 853- 4.]
That is the context that my amendment No. 47 seeks to address.
That principle was reinforced in Committee on 19 May by proposed new section 4A (6)(e) to the 1990 Act, which captures any embryo outside the other definitions of a human admixed embryo in subsection (6) that
“contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal...but in which the animal DNA is not predominant.”
Hon. Members need to ask themselves today whether that provides sufficient clarity or whether there are any circumstances that would lead to a lack of regulation of a key area of research.
Mr. William Cash (Stone) (Con):
Does my hon. Friend agree that, despite the Prime Minister writing in an article in The Observer on 8 May that the Government were bringing forward clear legislation, that is precisely what they have not done? My hon. Friend is manfully dealing with the complexity of the issue, as have other
members of the Public Bill Committee, but they have been completely swept along by a vast labyrinth of complexity, which will render most of the legislation impossible for anybody to understand.
Mr. Burrowes: Certainly the issues are complex and certainly there has been a desire at an early stage for clarity. Whether we have all been swept along by that complexity is perhaps for others to judge. There is certainly a need for clarity, however, particularly in the definitions.
I would like to give some examples of where that lack of clarity poses potential dangers that need to be dealt with. As the Minister will no doubt remind me when she responds, the Government’s intention in adding a catch-all category to the definition of human admixed embryos in the Bill was, as she explained on a previous occasion, to provide
“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.”— [ Official Report, 18 May 2008; Vol. 476, c. 59.]
That is the test that we have to hold that catch-all category up to. Does it provide further clarity? Does it ensure that all new forms of embryos that we are aware of are captured? The Government’s approach was that the human end of the spectrum referred to any embryo containing both animal and human DNA, where the human DNA was more than 50 per cent. of the total, and that all such embryos should and would be regulated under the Bill.
The Joint Committee, of which I was a member, considered the matter and reported on it. The issue exercised our minds; indeed, letters were written to the Department of Health and the Home Office, given their twin responsibilities. In our conclusions, in paragraph 163, on page 47 of the report, we said:
“The second issue centres on the human-animal boundary and which entities should be regulated as human embryos and which should be regulated under the Animals (Scientific Procedures) Act 1986. We have received a lot of evidence suggesting that there is no principle, as such, which underpins the Government’s choice of 50 per cent. 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 per cent. rule intended to be embodied in subsection (e)”,
as it was then—it has since been amended—
“is essentially an arbitrary attempt to draw a line between what qualifies as human and what as animal.”
There can perhaps be few more important issues than what qualifies as human and what as animal.
The Joint Committee continued, in paragraph 164:
“We heard evidence arguing that the issue as to what proportion of the entity is human and what proportion is animal is not clear-cut.”
To pick up on the intervention that my hon. Friend the Member for Stone (Mr. Cash) made, the issue is a complex one that has exercised the minds of great experts. The Joint Committee continued:
“For example, Professor Martin Bobrow, Chair of the Academy of Medical Sciences”—
reference has already been made to that august body—
“working party on interspecies embryos, told us that what makes an entity human rather than animal is not easily measured in DNA terms, although, if a line in the sand had to be drawn, he saw no reason why it should not be drawn at 50 per cent.”
“Professor Sir Richard Gardner, Edward Penley Abraham Research Professor of the Royal Society in the University of Oxford, raised the more technical issue of what the 50 per cent. actually refers to—for example, when calculating the relative quantities of mitochondrial DNA (which may come from a cow egg) against quantities of nuclear DNA (which may come from a human skin cell), different answers would result according to whether you measured the mass or the number of genes.”
Those are the experts who say that the issue exercised their minds.
I draw attention to the evidence given to the Committee by Professor Robin Lovell-Badge in response to my question, which was:
“In terms of definitions and in terms of inter-species embryos would you want there to be a definition to cover animal chimeras starting with an animal embryo and a set of human cells, whether that should come into the ambit of an inter-species embryo, tetraploid complementation processes and the like”—
we will come to that definition—
“whether that should be subject to the Bill?”
“Again, you have got yourself right into a difficult position again because it is very hard to come up with any strict definition saying this is 50 per cent. human and 50 per cent. animal, therefore it falls into this category rather than this one, because things change as well. You may start off with an embryo which is 20 per cent. human and end up with something which is 60 per cent. human or vice versa.”
The challenge from the Minister to provide further clarity of the scope of the definition of what is animal, what is human and what should be subject to regulation is surely put to the test by the very nature of the subject. We must ask ourselves a serious question about clause 4—whether it contains the definitions needed for the public to understand, for us to understand and for the scientists to work with.
The subject of amendment No. 47 is the case of embryos created by a process called tetraploid complementation. If the results were to be the same in experimentation with human-animal embryos as they are with mice, the potential exists for the embryos to end up completely or almost completely human. In tetraploid complementation, pluripotent stem cells are combined with an embryo that has been altered in such a way that the cells in the embryo have double the number of chromosomes. The cells are then tetraploid and develop into an extra-embryonic tissue such as placenta, while the pluripotent stem cells develop into the foetus. However, this specific class of embryos would not fall within the ambit of the Bill. That is the issue that my amendment seeks to address.
Mr. John Gummer (Suffolk, Coastal) (Con): My hon. Friend has been demonstrating how complex these questions are. Is it not true that one has a simple question to ask as well—that is, what would the general public, on whichever side they happen to be, expect us to do in trying to deal with these questions? Would they not expect us to make sure that the examples that my hon. Friend has given came within the ambit of the legislation and did not fall outside? That is how they would understand, as well as they could, the very detailed arguments that he puts forward.
Mr. Burrowes: I am grateful to my right hon. Friend. That is the least the public would expect of us. They may or may not agree with the principles and the practical results, but at the very least they would expect the Bill to cover researched examples of animal-human embryos. It is important that we do not leave that to a foolproof clause regulating future embryo research.
In tetraploid complementation, pluripotent stem cells are combined with an embryo that has been altered in such a way that the terms of Bill would not properly apply. Under the Animals (Scientific Procedures) Act 1986 those embryos could be legally implanted into an animal and taken up to mid-gestation without requiring a Home Office licence for the research project—it is this part of the process that causes concern and is not subject to proper regulation—other than an implementation licence, which is an unrelated animal welfare issue.
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That goes against the principles behind clause 4 as described by the noble Lord Darzi in the other place. Those principles are also reflected in the new sub-paragraph (e) which is intended, as the Minister said, to capture all hybrid embryos in which human DNA is predominant. The embryos that I am describing would be similar to the type of chimeric embryos described in section 4A(6)(d) of the 1990 Act. They would be, as defined in the Bill, a mixture of human and animal cells, rather than transgenic embryos or cloned embryos. However, they would remain outside regulation, and I shall spend a few minutes explaining why they would fall outside the ambit of the Bill.
First, the chimeric embryos referred to in section 4A(6)(d) are human embryos to which animal cells are added. However, the chimeric embryos in the example that I am putting forward would be animal embryos to which human cells were added. As confirmed by Lord Hunt of Kings Heath in a written answer on 25 June 2007, they would not be captured by sub-paragraph (d). Lord Hunt stated:
“Chimera embryos created by the addition of human cells to an animal embryo are not within the regulatory framework set out in the draft Bill. These chimeras, made using animal embryos, are regulated under the Animals (Scientific Procedures) Act 1986 at such time as they become a protected animal under that Act. Any embryos not considered to be a protected animal do not come within the Animals (Scientific Procedures) Act.”— [ Official Report, House of Lords, 25 June 2007; Vol. 693, c. WA101.]
The second reason why there is a need for amendment No. 47 is that the chimeric embryos that I am describing would not be captured by new sub-paragraph (e), as embryos created by tetraploid complementation would start as predominantly animal, with very little human DNA contribution. They may develop to have predominantly human DNA only after the first 14 days of development. In the examples that the eminent experts discussed in the Joint Committee, the human or animal definitions could not easily be applied.
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