The new Human Fertilisation and Embryology Act, which entered the statute book on 13 November, reforms the 1990 Act of the same name so as to extend the subject matter of legitimate in vitro embryo research, and the purposes for which licences may be granted by the Human Fertilisation and Embryology Authority (HFEA).
Besides conventional human embryos, it will also be possible to conduct research on "human admixed embryos"; a class which comprises:
- cytoplasmic hybrids (also known as "cybrids"), which are created by removing the nucleus of an animal egg cell and replacing it with one from a human;
- true hybrids, which are created by combining human gametes (ie, egg or sperm) with animal gametes;
- human transgenic embryos, which are created by introducing animal DNA into one or more cells of a human embryo. This encompasses both nuclear and mitochondrial DNA; and
- human animal chimeras, which are created by adding animal cells to a human embryo. A chimera is an organism comprised of cells from two or more genetically different organisms. A mouse-mouse chimera might, for example, be made by adding stem cells from a sandy-coloured mouse to the developing embryo of a black mouse. The resulting mouse is perfectly normal, but remarkable in having two genomes. In this example, the chimeric mouse might have black and sandy fur.
Licences to alter the genetic structure of cells forming part of an embryo will also become possible.
Purposes of research
The 2008 Act continues to make an important distinction between a project of research and the purpose of that project. The basic rule remains that use of embryos (or, now, human admixed embryos) must be necessary for the purposes of the proposed research project. However, because the number of legitimate purposes has been extended, the range of potential research projects has grown.
Under the 2008 Act, research may be licensed for purposes of increasing knowledge, not only of "serious disease", but also of "other serious medical conditions"; for example, neural trauma or tissue damage. Applications may also be made for the purpose of developing treatments for such conditions. For example, studies into how stem cells differentiate into particular tissue types could lead to methods for repairing and regenerating tissue lost to disease or trauma. Significantly, the HFEA may now grant licences for projects to yield knowledge which it considers to be "capable of being applied for" such purposes. These might be dubbed "enabling licences", in that they enable embryos to be used in the development of technologies, which need not be biological, relevant to laboratory or clinical research.
The new provisions will come into effect with the passage of a Commencement Order. We cannot say when this will appear, but know of no obvious reason for its delay.
The great significance of the 2008 Act is less the enlargement of the research franchise or the statutory tidying-up, but the fact that it could all have been so different. Precisely because these issues ran the gauntlet of full-on Parliamentary debate, the Act provides the highest possible support for the ethically responsible development of regenerative medicine in the United Kingdom.