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We have set out in the Bill a framework of regulation for human admixed embryos, which is equally as robust as that in place for human embryos at present. There will be an absolute time limit banning the keeping of embryos beyond 14 days’ development and an absolute prohibition upon the implantation of a human admixed embryo in a woman or an animal.
Amendments Nos. 9 and 41 seek to change the criteria by which the HFEA considers applications for a research licence. Such research will be permissible only with a licence from the HFEA, and only in circumstances in which the HFEA deems the research necessary or desirable for one of the statutory purposes, and the creation of embryos is necessary. In making such decisions the HFEA will be required to take into account other avenues of research available which may achieve the same end, according to the criteria already imposed in the legislation.
The HFEA has for nearly two decades licensed embryo research. In that time it has, through the provisions of the 1990 Act, been given the flexibility to form and utilise its own tests on whether the use of embryos is necessary in each licence application. The extra criteria which this amendment seeks to impose on the HFEA do not need to appear in the legislation. The authority already considers each of the new criteria stated, as part of its interpretation of the test of necessity.
In addition, the requirement that research should already have been successfully attempted using animal embryos is appropriate in some, but not all, cases. Any application to undertake embryo research should have a firm evidence base upon which the detail of the
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Animal research is clearly vital for better achieving success in human embryo research. However, research using human embryos must not be strictly limited to being undertaken only in cases where animal models have shown success. The authority has effectively made decisions on the necessity of using human embryos in research, and will always look to animal-based evidence in deciding whether a research project application is valid. It should retain the flexibility, however, to be able to license research in those cases where evidence from animal embryo experimentation is not available or not relevant.
Regarding the requirement in the amendments that the research should be likely to produce satisfactory results, I should point out that this approach is undertaken by the authority through the peer review process for each research licence application, as highlighted by the noble and right reverend Lord, Lord Harries.
Lastly, as regards the requirement that the research cannot be satisfactorily achieved by means other than through embryo research, adult stem cell research, embryonic stem cell research, and reprogrammed stem cell research each hold out promise to the sufferers of many wide-ranging diseases and medical conditions, as we heard. The sufferers of these diseases should not have valid avenues of research, such as embryonic stem cell research, limited because of the possibility that a treatment may be developed in the future by other means. Until diseases such as these, and many others, have a clear treatment available it is only right that we allow all avenues of research to proceed—I stress under regulation—in the hope of cures being developed as soon as possible.
A rigid framework of criteria set out in legislation would seriously limit the research which the HFEA can license, which would surely be a great loss to those suffering from serious medical conditions, who are hoping that cell-based therapies will be developed and used within their lifetime.
As regards the point made by the noble Lord, Lord Patten, on the appointment of HFEA members, a wide range of criteria is used to determine the type of members appointed. These take into account the skills and expertise that the HFEA requires at that particular time. It would obviously be difficult for someone to be appointed to the HFEA who, for example, fundamentally disagreed with IVF.
I invite the noble Baroness to withdraw the amendment.
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Baroness Williams of Crosby: My Lords, I listened very carefully to what the noble Lord, Lord Darzi, said. It was clear from the first part of his remarks that he understood exactly the purpose of the amendment. I refer that to the noble Lord, Lord Patel, but I think that the amendment’s purpose is pretty clear; namely, that the preference should lie with other than embryonic stem cell research if—I repeat this—it is evident that other forms of research would be equally efficacious for the purposes for which the research was originally demanded.
It is also the case in the example given by the Minister of people with serious degenerative or other diseases who are waiting for a cure. I fully understand and sympathise with that view. The further argument is that, until now, those cures have largely come from adult stem cells, rather than from embryonic stem cells, and that we are trying to correct a bias in the system. The noble Lord, Lord Patel, pointed out that when one looks at the pattern of grants given by the HFEA since 1990, decisions in the earlier stages largely—indeed, almost entirely—favoured embryonic stem cell research over other research. It is now true that, largely on the basis of its results, adult stem cell research has become much more substantial and accounts for nearly half the financing made available. That is a considerable change in recent years and reflects the fact that the scientific community now recognises the potential of adult stem cell research.
The main point of this amendment was the one referred to by the noble and learned Lord, Lord Mackay of Clashfern. That is, if we are all agreed that the HFEA effectively works in a way that reflects what my amendment asks for—though I do not think it has built into it quite this element of special preference for non-embryonic forms of research—it is reasonable to say that that should be clearly in the Bill. The noble Baroness, Lady Knight, made the same point. It is a way of saying to the public that we take their concerns seriously, that the HFEA takes them seriously and that those concerns will be taken into account by a House of Lords that reflects, to some extent, public concerns. At the moment, as the noble Lord, Lord Alton, said, the public have very little awareness of the criteria that the HFEA employs. It works largely in private. It is not widely understood what concerns people have, and how far those concerns are reflected. Therefore I propose not to ask for the opinion of the House now, because I take very seriously the remarks of the noble and learned Lord, Lord Mackay of Clashfern. I will go back and look at sub-paragraph (b). I will see whether it should be redrafted in the way that he suggests. But I will bring back this amendment at Third Reading, with whatever correction is needed to address the point made by the noble and learned Lord, because many of us believe that this would be a very useful addition to the Bill. I beg leave to withdraw this amendment.
Amendment, by leave, withdrawn.
Lord Darzi of Denham moved Amendments Nos. 11 to 15:
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On Question, amendments agreed to.
Lord Darzi of Denham moved Amendment No. 16:
“(a) an embryo created by replacing the nucleus of an animal egg or of an animal cell, or two animal pronuclei, with—(i) two human pronuclei,(ii) one nucleus of a human gamete or of any other human cell, or(iii) one human gamete or other human cell,(b) any other embryo created by using—(i) human gametes and animal gametes, or(ii) one human pronucleus and one animal pronucleus,”The noble Lord said: My Lords, the Bill seeks to bring within legislation certain types of part-human, part-animal embryos, which in the Bill are referred to as “interspecies embryos”. It is now intended that these will be called “human admixed embryos”. The definition of “human admixed embryos” found in new Section 4A(5), as introduced by Clause 4, breaks down into four components, representing the four methods of creating a human admixed embryo.
New Section 4A(5)(a) represents those embryos created by the fertilisation of a human egg with an animal sperm, or an animal egg with a human sperm—or other techniques that create the same type of embryo. These are commonly referred to as “true hybrid embryos”. New Section 4A(5)(b) represents embryos created by cell nuclear replacement—a technique used in cloning, which combines human cells and animal eggs. They are commonly referred to as “cytoplasmic hybrid embryos” or “cybrids”. New Section 4A(5)(c) represents embryos created by genetically modifying the cells of a human embryo using animal DNA. These are commonly referred to as “transgenic human embryos”. Finally, new Section 4A(5)(d) represents embryos created by attaching one or more animal cells to a human embryo. These are commonly referred to as “human-animal chimera embryos”.
On the introduction of the Bill to the House, it was brought to our attention that the definition of “cytoplasmic hybrid embryos” in new Section 4A(5)(b) contained a loophole. As drafted, the category expressly excluded the use of human cells of the female and male germ line, which can be used to create cytoplasmic hybrid embryos. Germ cells are the cells of the body that lead to the formation of gametes and the gametes themselves. Amendments Nos. 19 and 20 therefore remove this express exclusion. In addition, to ensure that it is clear that germ line cells are covered, new Section 4A(5)(b) is amended to include the use of human gametes. Gametes are defined as including cells of the female or male germ line. These amendments ensure that cybrids created using any human cell types will be caught under the Bill.
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Much of the debate regarding the human admixed embryos has centred on getting the correct definitions. This amendment ensures that the Bill will bring all the necessary entities within the regulation of the HFEA. I invite noble Lords to accept the amendment. I beg to move.
Lord Patel: My Lords, I support this amendment—but then I would, wouldn’t I, because I raised this issue in Committee? I welcome the amendment because it addresses the main practical issue relating to the definitions of “gametes” and “germ cells” and removes the only cause for concern that the definition would adversely affect research.
On Question, amendment agreed to.
Lord Mackay of Clashfern moved Amendment No. 17:
“(e) such other embryo, not falling within subsections (a) to (d), which contains the DNA of a human and the DNA of an animal, in which the DNA of an animal does not predominate throughout the period of its keeping or use.”The noble and learned Lord said: My Lords, Amendments Nos. 17 and 18 are intended to complete the definition of “admixed human embryo”. In new Section 4A(5) of the Bill, paragraph (e) refers to,
Most of us would agree that this is a not particularly felicitous way of looking forward to some scientific development yet to occur which might show some other way of producing an admixed human embryo. The other point is that it is not at all clear in summarising the character of paragraphs (a) to (d). “Such other thing” is really not a particularly good gathering up of what went before. When this Bill was originally presented in draft to the Joint Committee, the Government had a paragraph that was intended to be a catch-all provision. It specified the proportion of animal and human material that would be required to constitute what was then described as an “interspecies embryo” and is now more accurately described as an “admixed human embryo”. That paragraph did not have any percentage at all to start with. The percentage was added in ink, which suggested it was a slight afterthought, and the scientists who gave evidence found it impossible to understand, because the percentage depends on what you are measuring and the effect depends on more than mere proportion. The Joint Committee was anxious to produce a definition that would clarify the issue and also tie the whole paragraph together. We made a suggestion in the report that was taken up by the Government but apparently they failed to produce any improvement, and it was ultimately given up in favour of “such other thing”.
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Following the Committee stage, the noble Lord, Lord Patel, kindly arranged for us to meet some of the leaders of the scientific community to see whether we could produce an effective definition that would “catch all” and that would also be illustrative of the point that we are regulating not all interspecies embryos, but
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The amendment would be an immediate answer to the question asked by my noble friend Lord Tebbit on Amendment No. 1. We say in the amendment that the human end of the spectrum of interspecies embryos ends where the amount of animal material predominates in the embryo. That means that roughly the 50 per cent or equal category would be caught as a human embryo and would have the regulation and protection of the human embryo, leaving the embryos in which animal material predominates to be regulated, if at all, by the Animals (Scientific Procedures) Act.
As I said earlier, it is not absolutely clear that it regulates embryos, but it regulates what you can do with animal embryos after six months, and it regulates putting into animals materials of any kind that might cause them harm or pain. There is an element of regulation there, but there is no actual regulation of a non-animal embryo in the Animals (Scientific Procedures) Act, so far as I can see in my study of it. That is not an essential point. The essential point about the amendment is that it clarifies what we mean and what the Government mean by “human admixed embryo”. It is therefore an element in clarification of the scope of the Bill as a whole and replaces the inaccurate description that was in the Bill originally and which has now been replaced by the Government in this House. I beg to move.
Lord Patel: My Lords, I am very pleased to add my name to the amendment, which I strongly support. I would not attempt to try to make it clear in legal terms what the noble and learned Lord has in his usual way made absolutely clear. The amendment captures the important factor in such a decision as to whether an embryo will need to be accorded the same status as a human embryo or should be treated as an animal embryo.
It has been widely discussed in the scientific community and it is supported by all the eminent stem cell scientists. As the noble and learned Lord said, the use of “predominate” moves away from simplistic counting of the proportion of DNA and allows a more qualitative assessment to be made. It refers to the whole period of use, not in the expectation that this could be checked constantly but in recognition of the fact that the relative amount of DNA may alter with time when animal and human materials combine. That must be considered in any new construct.
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Lord Jenkin of Roding: My Lords, my noble and learned friend Lord Mackay has really got his teeth into this one. He did so in the Joint Committee, he did so in the Committee of this House and he has done so again tonight. The question of how you can wrap up a definition in a way that includes everything that you want to include but excludes the things that you do not want to include has proved very difficult. My noble and learned friend drew on the word “predominate”, which apparently emerged from scientific discussion of how to do this. My difficulty comes after reading the evidence that we heard in the Joint Committee from Dr Robin Lovell-Badge. He made the point:
“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 with an embryo which is 20 per cent human and end up with something which is 60 per cent human or vice versa”.
Because the licence has to come at the beginning of the process, before the research is done, how do you decide whether you are going to be dealing with an entity that requires a licence? It may be only 20 per cent human, but by the time you are finished it may end up being 70 per cent or 80 per cent human. I am not sure that we have solved that problem, but I warmly congratulate my noble and learned friend on what is obviously an extremely brave try.
Lord Darzi of Denham: My Lords, first, I thank the noble and learned Lord, Lord Mackay, for his tremendous interest in this area and for his intellectual rigour in identifying a proper definition. However, the amendment seeks to replace the regulatory-making power under proposed new Section 4A(5)(e) of the 1990 Act as inserted by Clause 4, which would permit regulations to extend the list of interspecies embryos and replace it with a provision aiming to capture all forms of embryos that are predominantly human in their genetic make-up.
As we have heard, there is always a difficulty in adopting a broad definition that leaves scope for interpretation, particularly in cases such as this one. The Government, working with professional bodies such as the academy, the Royal Society, the Medical Research Council and the Wellcome Trust, endeavoured to put together a catch-all definition that would ensure that, should a new form of human admixed embryo come to light, there would be the scope for it to come within HFEA regulation.
However, a definition attempting to cover different entities such as chimera, hybrids and transgenic embryos, where such a definition is easily interpretable by scientists in the HFEA and which is also practically sound, has proven elusive. The Bill therefore includes a regulation-making power to extend the list of human admixed embryo at proposed new Section 4A(5)(e). The amendments introduce a more limited provision to ensure that any embryo will be regulated if it contains both animal and human DNA and throughout the period of its keeping and use of the animal DNA does not predominate. The practical application of this definition may leave both the regulator and scientist in difficulties.
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The definition seeks to ensure clarity, but we do not believe that it achieves it. For example, if on any day of its gestation the embryo is considered to be more human than animal in terms of predominance of DNA, it falls under the regulatory remit of the authority; but would it not fall under its remit beforehand? Does this mean that the scientists can culture it before that point without a licence or would they need one because it would break through the 50 per cent barrier on a different day or if a scientist destroyed it at 10 days, when at the 11th day, it would, if it had been kept, become predominantly human?
The definition also refers to the predominance of DNA, including nuclear and mitochondria. In some cases, the predominance of DNA would shift throughout the keeping of an embryo. When assessing an embryo on day 13 that contains hundreds of cells—some of which may be human, some animal, some hidden and some even hybrid—it would be difficult for the researcher to make a sensible estimation of the proportion of DNA which is human and the proportion which is animal. Let us not forget that the functionality of that small content also might be different. Does this researcher have to estimate the number of mitochondria found in each cell and how this affects the balance? Does the researcher count the number of genes or the physical quantity of DNA? We also know that not all DNA is functional. In fact, large portions of human and animal genomes, according to our current understanding, have no functional role in the development. However, as we all know, our understanding in this area is far from complete.
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