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Human Fertilisation and Embryology Bill [HL]

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 the HFEA—that is, by a body licensing individual research projects using human embryos and interspecies embryos—are brought within its remit. However, as the noble and learned Lord, Lord Mackay, pointed out, we can never be sure that new techniques will not be developed in the future or that new forms of human-animal embryos will not be developed that may also need to be regulated under the 1990 Act. Therefore, the problem of definition is an issue. 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””—" interspecies embryo— "““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. 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.