A Bill to reform the law of assisted reproduction and embryo research is going through Parliament. The Human Fertilisation & Embryology Bill will amend the 1990 Act of the same name. There are serious implications for new treatments and for research. However, such a controversial subject means we cannot be sure of the outcome of the debate. A key element of the Bill concerns embryos that combine human and animal material.

Law and attitudes often struggle to keep up with scientific and medical advance. Never more so than in the fields of reproductive and regenerative medicine. After Louise Brown’s birth in 1978, a government committee proposed a regulatory framework to deal with such matters. Lady Warnock, who chaired the committee, described its purpose as being to protect society from “its real and very proper fear of a rudderless voyage into unknown and threatening seas”. The 1990 Act adopted the Warnock proposals. It built a regulatory framework for the creation of human embryos for use in fertility treatment, the use of embryos in research and the use of donated sperm, eggs and embryos. It also established a regulator to oversee it: the Human Fertilisation and Embryology Authority (“HFEA”). The Act and its Authority became landmarks of medicine and research. However, while generous decisions of the higher courts helped them to deal with scientific and medical advances, they soon began to lag behind the laboratory and clinic.

This first became apparent in 1997, when the unveiling of Dolly the sheep opened up the possibility of human cloning. The gap increased a year later, when James Thomson isolated stem cells from human embryos. It has continued to widen. As new diagnostic and therapeutic promises appear, so do new ethical dilemmas: embryo screening, sex selection, saviour siblings. Attitudes have shifted in the wider world, too. The right to a father now vies with the rights of same sex couples to be parents.

Reform has followed on the heels of such developments. In 2001, it was declared illegal to place an embryo in a woman unless it had been produced by fertilisation; intended as a ban on human cloning. At the same time, however, opportunities for embryo research were significantly extended. Three years later, donors lost their anonymity. European legislation also began to work its way into the Act and now features prominently in the HFEA’s Code of Practice.

Reform

In January 2004, the Department of Health announced a review of the 1990 Act. Four years on, Parliament is debating amendments. The Human Fertilisation & Embryology Bill might have been purpose-built for dispute. Its main elements include:

  • ensuring that the creation of all human embryos outside the body is subject to regulation, irrespective of the process of creation;
  • banning sex-selection of children on non-medical grounds;
  • removing “the need for a father” while continuing to respect “the welfare of the child”;
  • recognising same-sex couples as legal parents of children conceived through the use of donated sperm, eggs or embryos;
  • altering restrictions on HFEA-collected data to facilitate follow-up research; and
  • enlarging the scope for legitimate embryo research, including the regulation of embryos which combine human and animal genetic material.

The last of these has proved especially contentious.

Chimeras

Human/animal embryos are important for many areas of research. For example, “chimeras” provide valuable tools for the study of many human diseases and the drugs that might treat them. It is already permissible, subject to the Animal (Scientific Procedures) Act 1986, to create animals containing human cells. It is not, after all, a matter of human fertilisation or embryology to allow human cells to develop within a mouse embryo. A chimera created “the other way round”, – by allowing animal cells to develop within a human embryo, – would not, however, fall under the 1986 Act. On the other hand, it would only fall under the Human Fertilisation & Embryology1990 by stretching the meaning of that Act. Although the House of Lords permitted this in the Bruno Quintavalle case, the use of animal cells is pushing at the envelope.

Stem Cells

A striking example of an animal/human mix arose in 2003. A Shanghai team reported that embryos could be created by replacing the nucleus of an animal egg with that of an adult human cell. Although such “cytoplasmic hybrids” are only viable for about a week, this is long enough for stem cells to be extracted. The only DNA provided by the egg derives from its mitochondria, comprising less than 0.1% of the total. It has nothing to do with development and is practically the same as human mitochondrial DNA anyway.

If this appears somewhat unnecessary, you have to bear in mind the importance of research into stem cells and regenerative medicine, a field in which the UK is a world leader. Human embryonic stem cells are in extremely short supply. To get them, you need embryos. To get embryos, you need eggs. To get eggs, you need women. Because of the risk to health and fecundity, most women will only agree to donate their eggs for research while undergoing fertility treatment. Cytoplasmic hybrids offer the prospect of increasing the supply of stem cells, promoting research and, ultimately, of alleviating the misery of human diseases.

The course of debate has been anything but plain sailing. Indeed, the government originally proposed to ban such research, while the HFEA had to seek legal advice as to whether it had power to grant licences for the creation of cytoplasmic hybrids. It took the report of a galvanised House of Commons Select Committee on Science and Technology and a thorough public consultation by the HFEA to include human/animal embryos in the Bill.

A significant moment in the animal/human debate was reached on the afternoon of 15 January 2008. An amendment moved by Lord Alton, that would have prevented the licensed keeping and use of “human admixed embryos”, was defeated by 268 votes to 96. Two days later, the HFEA Licensing Committee reported that licences had now been granted to create cytoplasmic hybrids.

Existing Holdings

At the time of writing, the House of Lords has adjourned its considerations. Important work remains to be concluded, however, before the Bill is sent to the Commons. Among these is an amendment, moved by Lord Naren Patel of Dunkeld, Chairman of the UK Stem Cell Network Steering Committee, in connection with existing holdings of stem cells. The concern is that the Bill’s proposed consent requirements are too high. They would require explicit consent from people whose cells are used for the creation or storage of embryos (whether human or admixed).

Lord Patel and his many supporters from across the research community fully endorse the policy of consent as regards future donations. They also agree that it would be wrong to use existing cell holdings where it is clear that the donor would not have wished his or her cells to be used in a particular way. However, in many cases, lawfully-obtained cells, cell lines and tissues are irreversibly anonymised. Their donors are often untraceable and could not have anticipated the specific use of their donations at the time of donation. Researchers and patients are therefore concerned that the government’s proposed restriction would seriously impede UK stem cell research, by denying access to vital cell and tissue resources that have been collected over many years. In a letter to The Times on January 21st, a list of the country’s most senior stem cell and biomedical scientists, headed by the 2007 Nobel Laureate Sir Martin Evans, urged the government to accept Lord Patel’s amendment, noting that it had previously called for the UK to be a world leader in stem cell science, and drawing attention to an inconsistency with the provisions as regards “existing holdings” under the Human Tissue Act 2004.

Next Steps

While the debate goes on, the science has moved forward even faster and could take the argument in new directions. During the House of Lords debate, for example, Shinya Yamanaka and James Thomson independently announced that they had induced the creation of pluripotent stem cells without recourse to embryos; by using ordinary skin cells. This had an immediate effect upon the debate, Lord Alton proposing that embryos should only be licensed for research if no other means were available. Such developments underline the importance of researchers, clinicians, lawyers and patient groups continuing to inform the legislative process and checking the effect of the Bill against the unexpected. As if to illustrate the point, Samuel Wood announced that he had cloned human embryos from his own skin cells a day after peers voted on human admixed embryos.