(The following is an extended rationale of our Case against the HFEA. We are arguing for fair play.)

The HFEA (Authority) was created to “carry out regulation with the purpose of maintaining ‘respect for human life at all stages’.” However, the Authority’s 18-year history of granting research licences demonstrates a disproportionate concern for the interests of scientists and a singular lack of objective consideration for the special status of the human embryo.

According to the 1990 Act, the Authority should evaluate a licence application to determine whether the proposed research is “necessary and desirable.” In 18 years, the Authority has determined that nearly 200 research projects satisfy this standard. Over this period, while several applications have been amended and later approved, no research application has ever been completely rejected.

In addition to generously facilitating the granting of licences, the 1990 Act further protects the interests of scientists by creating an appeals process for researchers to challenge any limitations that might be imposed on their research by the HFEA. Only three researchers have ever needed to appeal under this process.

Parliament recently concluded its debates on an updated version of the 1990 Act, aimed to prepare the Authority for the scientific and ethical questions of the future. However, the Authority had already made its decision on the most controversial aspects of the new bill. For example, their licensing committee had already twice authorised animal/human hybrid embryo research in 2007. Even as the House of Commons was debating the merits of such research, the Authority granted a third licence for such embryos to be created.

The 2008 Act purports to supersede the Human Reproduction Cloning Act of 2001. However, the Authority essentially anticipated overruling the Cloning Act when in 2004 it granted a licence for research on mitochondrial DNA, a process which involves the cloning process and and is clearly designed as a future treatment. So-called ‘saviour-sibling’ treatments, also focus of the new HFE Act, have been licensed ever more liberally by the Authority for years. Such research or treatment is always approved as “necessary and desirable” and the rights of the embryo as incorporated in the Act never outweigh the scientific imperative.

These are but a few examples, but enough to make one seriously question whether it is Parliament or the Authority who is the centre of decision-making power.

It is erroneously assumed that the Authority is a neutral group of people, capable of making purely objective assessment of the issues of “necessity and desirability”. This is a big mistake. Analysis of the nature of the membership of the Authority confirms the inevitability of the liberal position it invariably endorses. The composition of the Authority is not democratically representative. It currently comprises 24 members plus the new Chair, Prof Lisa Jardine, who is considered to be the most liberal ever appointed to this position. Some 13 members are involved either academically or personally as patient representatives in IVF related fields, and there is a lawyer, philosopher and churchman who are also known for their liberal approach. Five other members are involved more specifically with science, and the final three represent the world of media or finance. There is no evidence of any of the 25 members ever opposing embryo research. Nor has anybody opposed to embryo research ever been invited to sit on the Authority, even though they have applied.

In light of its clear position on embryo research, a legal test which asks only whether the Authority is “satisfied” that such research is “necessary and desirable”, with no innate control mechanism representing alternative view points, is unlikely to inhibit them from granting controversial licenses. Furthermore, under the current system, there is no effective means to challenge the Authority once these licences are granted, apart from prohibitively expensive legal action. There is absolutely no democratic vehicle currently available for defending the position of the embryo. It was for this reason that the Accountability Amendment was tabled during the recent passage of the HFE Act. It would have provided a genuine mechanism to defend the special status of the human embryo. It could be described as a ‘fair play amendment’, and it is lamentable that this amendment was not called and that fair play has not been achieved.

More than any other amendment before Parliament at the time it could have contributed to genuine democracy in this arena. Rather than waiting for the HFEA to grant a licence and then challenging the research through the judicial process, those interested in protecting the special status of the embryo would have been able to use an appeals process to challenge a proposed licence, similar to the appeals process already in place for scientists. On such an occasion the arguments of necessity could have been fairly explored.

It is unfortunate that the Accountability Amendment was not called, and that still no restrictions have been placed on the HFEA in its assessment of licences involving destruction of the human embryo.

The only recourse left is once again the Courts. It is time for fair play and democracy to take their proper roles in the assessment of research on the human embryo.