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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.
7.15 pm
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
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Lord Patel: 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
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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,
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
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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.
Earl Howe: 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.
Lord Patel: I was merely giving an example.
7.30 pm
Lord Winston: 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.
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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.
Earl Howe: I would not for a minute disagree with the noble Lord in anything that he has said.
Lord Darzi of Denham: 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
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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”—
- “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.
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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.
Lord Mackay of Clashfern: 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.]
[Amendments Nos. 19 and 20 not moved.]
Baroness Royall of Blaisdon: 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.
Education: Adult Learners
7.42 pm
Baroness Sharp of Guildford asked Her Majesty’s Government why at a time when they are encouraging people to upgrade skills and continue working later in life, adult learners seeking a second qualification at an equivalent or lower level to that already held must pay full-cost fees.
The noble Baroness said: My Lords, on 7 September, the Secretary of State for the Department for Innovation, Universities and Skills wrote to the chairman of the Higher Education Funding Council for England setting out the CSR settlement for 2008-11.
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