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Regulating IVF and embryo research: Balancing clarity with flexibility

19 July 2007
By James Lawford Davies
Bevan Brittan LLP and Lecturer in Law and Medicine at the Institute for Human Genetics, University of Newcastle
Appeared in BioNews 412
I will miss the UK's Human Fertilisation and Embryology (HFE) 1990 Act when it is gone. I am no great supporter of our regulatory model and the 1990 Act is flawed and idiosyncratic. However, if you are going to regulate IVF and embryo research, ours is a reasonably solid regulatory framework to adopt and, although it may not always have seemed so during the last 16 years, its approach to regulation is relatively straightforward. It uses a broad, simplistic working definition of 'embryos' and offers a compromise on their use: you can create them, use them, and destroy them - but only with permission and under supervision.  

The supervisor in this case is of course the Human Fertilisation and Embryology Authority, the HFEA. It is partly because of their conduct in licensing treatment and research under the 1990 Act that we see a notable shift away from the simplicity of the 1990 Act in the style and content of the draft Human Tissue and Embryos Bill currently being scrutinised in Parliament.

A clear example of this shift is apparent in relation to PGD. The 1990 Act does not specifically address the testing and selection of embryos, but litigation has helped clarify that it does fall within the HFEA's remit and can be licensed. However, the HFEA faced widespread criticism for agreeing to license PGD for tissue typing (to allow couples to give birth to 'saviour siblings', who can donate tissue-matched cord blood stem cells to sick children) - not because the outcome was ethically unacceptable, but because such an important decision was being made by the HFEA without recourse to Parliament or the wider public. It was therefore unsurprising that the consultation document on the review of the 1990 Act stated that 'the Government believes that there is a general desire for the law to be clearer on this matter, and hence for Parliament to define some limits or criteria that apply to testing of embryos'. The draft Bill therefore includes a list of specific criteria and restrictions for PGD, tissue typing and sex selection.

Does this provide clarity? In the short term, yes. Whether one agrees or disagrees with the provisions, they provide a degree of certainty about what is licensable by the HFEA. However, detailed statutory provisions of this kind are a mixed blessing. In my view, the 1990 Act survived all of its legal challenges because it was phrased in general terms which allowed new technologies to be accommodated (albeit sometimes rather tenuously). The more prescriptive the primary legislation, the less flexibility there is to accommodate future developments and the greater the opportunity for legal challenge in the longer term.

This is not the only area where we see a change in the approach of the legislation when compared to that of the 1990 Act. Whilst the Act is largely general in its terms, the draft Bill addresses a number of particular treatments and research techniques - mainly those which have attracted controversy or debate during recent months. For example, a new category of embryo, the 'inter-species embryo' is created, and the potential benefits of mitochondrial disease research are recognised through provisions which allow for the creation of embryos using healthy mitochondria in the future. However, both techniques are subject to an important qualification: they will require the Government pass further legislation before they can be used. These regulation-making powers are common tools in statutory drafting but the powers may never in fact be applied.

There are other areas in which even a regulation-making power has been deemed unacceptable. The draft Bill prohibits certain specific techniques such as social sex selection and the use of artificial gamete. In its consultation document on the review of the 1990 Act, the Government stated that 'the development of artificial gametes...would, in theory, enable the alleviation of infertility problems for persons in certain circumstances, such as where a man is unable to produce his own sperm'. This indeed is the focus of ongoing research at my own University, yet the consultation goes on to recommend that the use of any such gametes be prohibited. It further states that 'The Government has considered whether such a ban on the use of artificial gametes should be capable of being removed through secondary legislation (that is by a regulation-making power)...The Government has decided, on balance, not to recommend such a power, proposing instead that this would be a matter requiring primary legislation'. No further reasons for this decision are given.

Like the Harry Potter books, the HFEA's Code of Practice gets longer with each new edition. The clinical and scientific judgment of those working in assisted reproduction and related research is increasingly controlled and restricted through such guidance, and now we see draft legislation which promises to turn much of what used to be in the Code into law. I am not attracted to this shift towards a greater level of detail and specificity which is apparent in the draft Bill. In addition to the diminished flexibility and risk of challenge, it also signals a move away from the already limited discretion and independence of the Authority's licensing function - in the context of a Bill which does plenty more to dilute the expertise of the Authority and transfer power to the Executive. Likewise, if we are going to adhere to this model of licensing and regulation, why restrict the application of techniques through the use of regulation-making hurdles and prohibitions? If the HFEA is capable of granting treatment and research licences for the wide range of existing techniques, surely it is also capable of determining applications for hybrid and mitochondrial disease research, or the use of artificial gametes in the future.

SOURCES & REFERENCES
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