Is the Human Fertilisation and Embryology Authority fit for purpose?

In the early 1980s many people both inside and outside Parliament were seeking to prohibit experimentation on human embryos. In response, the government convened a committee of enquiry, aiming to circumvent the possibility of a ban. The Warnock Report duly concluded that 'the embryo of the human species should be afforded some protection in law'. The committee was in favour of research involving the destruction of human embryos but 'because of the special status that we accord to the human embryo, such research must be subject to stringent controls and monitoring'.

There are a number of ethical concerns raised by assisted reproductive technologies, but the status of the human embryo was the prominent single issue in the debates that shaped the 1990 Human Fertilisation and Embryology Act. Similarly, when the 1990 Act came to be revised, this was still the primary rationale for regulation - 'The special status of the embryo means regulation of both research and treatment continues to be appropriate and desirable. In addition, we recognise that regulation of IVF treatment provides assurance and protection to patients'. The phrase 'in addition' is telling. The primary purpose of the HFEA (Human Fertilisation and Embryology Authority) is to maintain respect and protection for the human embryo.

Some witnesses to the House of Lords Select Committee on Stem Cell Research in 2001 argued that 'it was hypocritical to profess respect for something you were going to destroy'. This indeed had become the position of Baroness Mary Warnock, 'I regret that in the original report that led up to the 1990 legislation we used words such as 'respect for the embryo'. That seems to me to lead to certain absurdities. You cannot respectfully pour something down the sink, which is the fate of the embryo after it has been used for research'.

In response, the House of Lords Committee emphasised the respect shown to embryos by ensuring that 'research on embryos is carried out only if there is no alternative available and it is necessary or desirable to achieve one of the permitted purposes'. Nevertheless, the Secretary of State for Health admitted in 2008 that the HFEA had only once refused a research licence and this had subsequently been granted on appeal. This extraordinary record of never ultimately refusing a licence is difficult to reconcile with the idea that 'stringent controls' are operating. The Secretary of State explained this phenomenon on the basis that 'the HFEA works closely with research teams on the development of the project'. However, this very proximity raises the further concern that the HFEA is insufficiently independent from the interests it regulates. It hardly inspires confidence.

The Warnock Report recommended that 'if the public is to have confidence that this is an independent body, which is not to be unduly influenced by sectional interests, its membership must be wide-ranging'. However, rather than seeking a membership that includes a diverse range of views, it seems that the HFEA has systematically excluded those who wish to protect the embryo more effectively, as Dr Evan Harris MP acknowledges. This has produced a committee with an ethos of encouraging novel developments as far as this can be done while placating the public. It is for this reason that its public consultations are so skewed in favour of its own prior agenda. Rather than seek to protect the human embryo, the HFEA has consistently sought to facilitate further experimentation. It is not just an ineffectual guard dog, but a fox supposedly guarding a chicken coop.

Baroness Ruth Deech has lamented that 'in all such amalgamations history tells us that very often you go back to ground zero'. However, in the case of the HFEA ground zero is where we need to get back to. A regulator should not be making such significant political and ethical decisions or pursuing its own agenda. It has neither the democratic mandate nor the ethical expertise to do so. The whole notion of ethical expertise is admittedly problematic. Nevertheless, some things can be done to improve ethical discussion, for example, by encouraging transparency, democratic accountability, and mechanisms for inclusion of religious and moral diversity.

If the HFEA is to be axed then there needs to be alternative and effective forms of protection for the human embryo out of respect for its special status. This is what the HFEA was supposed to be for. The demise of the HFEA also makes the case more pressing for some kind of national bioethics committee with inclusive membership to advise on the ethics of new developments, but not itself to create policy. However, the first order of business is to acknowledge that the HFEA is not fit for purpose.