Cradle of legislation

March 14, 1997

Amid speculation that human cloning may be only two years away, Ruth Deech considers whether further research should be banned.

Britain leads the world in regulating in-vitro fertilisation treatment and research. We already have a statutory framework in place but this may now need some amendment to encompass the most recent scientific advances in cloning - perhaps, in the future, human beings - in order to meet public concern.

All the work of the Human Fertilisation Embryology Authority, of which I am the chair, is informed by ethical standards, both those specified in the 1990 Human Fertilisation and Embryology Act and those applied by its members. The authority controls attempts at human cloning in the United Kingdom; animal cloning is regulated by the Home Office. Not only are we primarily concerned with the physical and mental welfare of the potential child, we believe that the regulation of fertility and allied research should respect the special status of the embryo and the dignity of the human being. We are opposed to the intentional production of genetically identical individuals.

As our stand in the Diane Blood case showed, (the authority refused to permit Mrs Blood to be inseminated with her dead husband's sperm without his consent), we would not wish any person to be regarded as a convenience, or as a bank of spare parts or genetic tissue. For ethical reasons we have already prohibited sex selection and the use in treatment of foetal ovarian tissue. Under the present statutory regulations we would not permit cloning of people.

In our view there is no need to rush into new legislation, because human cloning is at least two years away. This gives time for reflection to achieve control over experiments that affront human individuality while possibly permitting, project by project, work that might benefit mankind. Alternatively, Parliament might decide that nothing will safeguard the public except a broad statutory ban on every possible form of cloning.

The 1984 Warnock report, which laid the foundation for our regulatory system, anticipated the possibility of cloning. Section 3(3)(d) of the 1990 HFE Act prohibits cloning of human embryos by nuclear replacement of embryos, ie, replacing the nucleus of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo.

Section 3(1)(b) of the Act requires that the use of any embryo can only be carried out with a licence from the authority, which announced in 1994 that it would not grant licences that used embryo splitting to develop cloning for fertility treatment. The technique used at Edinburgh's Roslin Institute to produce Dolly, the cloned sheep, was different, however. It involved the use of an unfertilised, enucleated egg to receive the nucleus of another cell, not an embryo as stated in s.3(3)(d).

An embryo is defined as a "live human embryo where fertilisation is complete''. This definition needs clarification as to whether it covers embryos produced asexually as well as those that are the product of fertilisation.

If the definition of an embryo in the Act is amended by Parliament to ensure that it covers asexual cloning, then the Secretary of State has powers under the Act to prohibit awarding a licence for keeping an embryo produced by cloning. The Roslin technique is still covered by the Act despite the use of an enucleated egg in treatment, because a donor egg is used in this process and the use of a donor egg always requires a licence from the HFEA.

Any attempt to use cloning at a fertility clinic is controlled by the HFEA's code of practice, which states that "eggs or sperm which have been subjected to procedures which carry a . . . risk of harm to their developmental potential, and embryos created from them, should not be used for treatment.''

A further safeguard is the Act's provision that a woman shall not be given fertility treatment unless account has been taken of the welfare of any child born as a result (including the need of that child for a father). Cloning is a process where there may be no fathers and where other difficult issues concerning family relationships would have to be resolved.

The 1990 Act also deals with licences issued by the authority for research on embryos. The only purposes for which licences may be issued are for promoting advances in the treatment of infertility; increasing knowledge about the causes of congenital disease and the causes of miscarriages; developing more effective methods of contraception or methods for detecting gene or chromosome abnormalities in embryos before implantation. Offences under the Act are punishable, in some cases by two years' imprisonment.

There is one weakness in the system of protection outlined above. It stems from our membership of the European Union. The authority may permit the export of gametes or embryos in circumstances that may include breaches of the Act. In deciding whether to grant such permission, the authority has to have regard to the right of every European citizen under the European Treaty to obtain medical services in another European state.

This right was given unusually strong emphasis in the Diane Blood case by the Court of Appeal (Mrs Blood was eventually given permission to use her husband's sperm in fertility treatment abroad) and can now only be outweighed by the formulation of overriding public policy considerations. Hence it might be difficult for the authority legally to refuse to allow export of an incipient clone from a British laboratory to a European one, and all the more so if the medical circumstances involved a mother or baby whose cause was taken up by the media.

Of course, the authority has no control over what happens abroad, and given the mobility of scientists, cloning might well occur regardless of the strictest UK statutory controls. There are no Europe-wide laws covering fertilisation or cloning. It would be ideal if there were an agreed international policy on cloning.

Parliament has to decide whether there should be an outright ban on the creation, use and storage of embryos created by asexual means and the production of genetically identical individuals. This would avoid the doubts that may exist about the current wording of the Act.

On the other hand Parliament might wish only to broaden definitions, whereby it would still be possible to licence certain projects, so that any therapeutic benefits of the new technique were not totally excluded. A total ban might inhibit research into a number of crippling inherited illnesses, such as some forms of encephalomyopathy, cardiovascular disease and type II diabetes.

Thoughtful consideration of the scientific breakthrough at Roslin might lead to the conclusion that there should be an adaptation of existing regulation rather than the imposition of an outright ban on further research.

Ruth Deech is chair of the HFEA and principal of St Anne's College Oxford.

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