The HFE Act 2008 - an end or a beginning?

1 October 2009 marked the second and major phase of the coming into force of the amendments to the Human Fertilisation and Embryology (HFE) Act 1990 (1) made by the HFE Act 2008 (2). The first phase, in April 2009, concerned parenthood provisions and the third and final phase (expected April 2010), will affect parental orders in surrogacy arrangements. Even from a legal perspective it is unfortunate and rather baffling that these changes have been brought about by amending the original legislation rather than by repeal and re-enactment. The result is that one lengthy and, in places, difficult to follow statute has now to be read in conjunction with another and, indeed, the 2008 Act is arguably more complex still. Coupled with the extended period for introducing parts of the new legislation, the risk of misunderstandings and a failure to appreciate the current legal position would seem to be increased by this legislative approach.

It may be useful to refer to the Department of Health (DH)'s document which sets out how the legislation will read once all of the amendments made by the 2008 Act are in force, although this document is not itself a legally binding instrument and serves an illustrative purpose only (3). Furthermore, it must be remembered that it does not take into account the differing timescale for the implementation of the amendments.

Examples of increased complexity can be seen with the new Act's extended re-definitions of even apparently basic concepts like human 'embryo' and 'gametes'. These are intended to take account of actual and imagined scientific developments that could be used to create material with realisable reproductive potential. The renewed attempt to provide anticipatory regulation is at least in part the legacy of the Quintavalle case in 2003, which saw the House of Lords interpret the 1990 Act so that it could be taken as covering human embryos created by CNR, the technique pioneered with the creation of Dolly the sheep (4). Although one method of producing a clone was expressly prohibited by the Act, this particular method was not, as it was not then imagined, nor did the resulting cloned embryos appear to fall within the Act's definition of an embryo. This might have been thought to leave these embryos effectively unregulated and a challenge was brought against the Human Fertilisation and Embryology Authority (HFEA) on this basis. The court was not prepared to accept that Parliament could have intended this conclusion, although the statutory interpretation used to reach this decision may, perhaps charitably, be described as ingenious.

The tension between providing sufficiently detailed regulation to ensure certainty over what it covers and employing such narrow definitions that they are outstripped by technical advances remains in the new legislation. It is interesting to note the increase in the number of provisions that contain express permission to make Regulations, which could hasten any legislative response to future developments. In respect of reproductive cloning, the 2008 Act follows the stance taken by the Human Reproductive Cloning Act 2001 (5), which it repeals. It states that only 'permitted' embryos and gametes may be used for fertility treatment, essentially those whose source are female ovaries and male testes and which have not been genetically modified. Even so, the possibility of some alteration (for example, to treat mitochondrial) disorders is contemplated, although not yet lawful. The wording of the legislation also prohibits any attempt to use in fertility treatment the multitude of additional types of embryos that can now be legally created from human and animal sources, broadly referred to as human admixed embryos. Despite considerable controversy over mixing human and animal material in this way, the prospect of gains in knowledge and the development of applications for treatment of illness and injury finally won the day in Parliament, although quite how significant this will turn out to be in practice remains a matter for speculation.

The need for lengthy and complicated provisions is also apparent in other aspects of the 2008 amendments, such as the important issue of the determination of legal parenthood. Although there is a clear attempt to equalise the position of same-sex couples with heterosexual couples, complete equality remains elusive. Female couples can now both be legal parents, as long as one carries the child and the other is either her legal partner under the Civil Partnership Act 2004 or they both agree before treatment, in the terms of the amended HFEA 1990, that she will be a legal parent. From 1 September 2009, both female parent's names can be included on the birth certificate.

However, male couples necessarily require the involvement of a woman to carry a child for them, and she remains the child's legal mother. If treatment is conducted at a licensed clinic, the HFEA's 8th Code of Practice currently states that if an intended father has provided sperm for a surrogacy arrangement, he will need to be registered as a donor and hence cannot be the legal father (6). Rather bizarrely, under the agreed parenthood provisions, it appears that the donor man's male partner could potentially be the legal father. Assuming that the woman is neither married nor in a Civil Partnership, the second man would be an intending parent of a child created using donor sperm, thus being able to acquire legal parenthood that his partner, the biological father, would be denied. Previously the child would have been legally fatherless. The surrogate mother will only lose her parental status if the child is adopted or a parental order is made, although the provisions for same-sex couples to apply for a parental order will not be available until April 2010. They will allow both men to be registered as the parents in the Parental Order Register. However if the second man were already a legal parent, it would seem that adoption would be the only available route for the biological father to acquire legal parenthood.

Applications for parental orders remain subject to conditions, including the child being biologically related to one of the couple seeking an order and residing with them. Although the same would be true in any surrogacy arrangement, regardless of the sexes of the commissioning couple, the legal status given to the woman who bears the child is evidently likely to impact more upon male couples than female ones. The final phase of implementation of the 2008 Act will also allow unmarried heterosexual couples to apply for parental orders, but not single people.

Changes to the welfare of the child provision in the Act, now requiring treatment providers to take into account the 'need of a child for supportive parenting' instead of the 'need of a child for a father', may also be interpreted as a shift in approach to same sex couples, particularly female ones. In addition it may lessen the perceived potential for refusing treatment to single women - and possibly men, although the same caveat applies here that the mother's parental status would need to be removed by adoption procedures if a man is to be in law a single parent. For some, this will represent a success in removing unjustifiable and outdated prejudices when considering who should receive treatment; for others it will be seen as a signal that a second parent, and specifically a male parent, is increasingly regarded as an optional extra to the detriment of child development and welfare. However, there will also be those who will feel that the changes do not go far enough and agree with the House of Commons Science and Technology Committee, which considered that the welfare provision discriminates against the infertile and is of questionable practical value in protecting children (7). Instead it placed great importance upon the autonomy of the prospective parents and recommended overriding their wishes only when treatment would put a child at risk of unpreventable and significant harm. While this approach is to some extent reflected in the latest HFEA Code of Practice, the retention of a specific need to consider 'supportive parenting' may be viewed as going beyond this minimum threshold.

Welfare of the child considerations also appear to have loomed large in respect of one of the most controversial areas of the HFE Act 2008, that concerning pre-implantation genetic testing and screening of embryos, which now requires a specific licence. In addition, it is a condition of a treatment licence that embryos that have abnormalities of a kind set out in the Act are not to be preferred to embryos not known to have such an abnormality. Although this part of the Act does not completely prevent the use of embryos with abnormalities, it does if there is an embryo available for transfer without them and even if there is not, there remains the fallback position of the general welfare provision that could prevent implantation. The relevant abnormalities are described as being where there is a significant risk that a person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition. Deciding whether an abnormality fits within this description is expected to continue to provoke fierce debate, along with the broader question of whether it is necessary or appropriate to limit prospective parents' decision-making in this way.

In reviewing the new regulatory regime, it is important to remember that much still rests upon the judgement of treatment providers and the interpretation of the legislation made by the HFEA. Given the evident and increasing willingness of patients, professionals and special interest groups to challenge decisions made under the HFE Act 1990, attempts to test the limits of the legislation and its application seem extremely likely. The implementation of the HFE Act 2008 may thus be seen as the start of its real examination, rather than its end.

1) The Human Fertilisation and Embryology Act 1990

2) The Human Fertilisation and Embryology Act 2008

3) The Department of Health, The Human Fertilisation and Embryology Act 1990: An Illustrative text

4) R (on the application of Quintavalle) v Secretary of State for Health [2003] UKHL 13

5) The Human Reproductive Cloning Act 2001

6) Human Fertilisation and Embryology Authority, 8^th Code of Practice, 1 October 2009

7) House of Commons Science and Technology Committee (March 2005) 'Human Reproductive Technologies and the Law', 5th Report of Session 2004-05, HC 7-1