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Human Fertilisation and Embryology Bill [HL]

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.