At the time of writing, the Human Fertilisation and Embryology Bill 2007 was just about to start its passage through the House of Commons in the UK. Unless there are any unforeseen delays, Royal Assent is likely in July 2008, probably a few days before the 30th birthday of the very first child, Louise Brown, born as a result of IVF. The Act is expected to come into force in 2009.
Initially, the government had intended to merge the Human Fertilisation and Embryology Authority (HFEA) with the newly set up Human Tissue Authority to form the Regulatory Authority for Tissues and Embryos. Following sustained opposition from, perhaps most importantly, clinicians themselves, the government announced in October 2007 that the proposal to move to the Regulatory Authority for Tissues and Embryos would be shelved and the HFEA and the Human Tissue Authority would retain their separate identities.
In a sense, the reform process that had initially been intended to set up a new regulatory body and make some amendments to the rules governing assisted conception and embryo research, was derailed rather late in the day, and so the Bill lost its focus in merging two existing regulatory bodies, however, it retained its status as an amending statute. Much of the current law will therefore remain intact, although there are a number of interesting changes and clarifications. During its passage through the Lords and in the press coverage that has surrounded the Bill, it has become evident that some parts of the Bill are much more controversial and newsworthy than others.
It is noteworthy that the Bill does not significantly alter the regulatory framework, suggesting that the 1990 Act has, in fact, stood the test of time rather well. Of course, the nature of clinical practice in the field of assisted conception and in research on human embryos has changed dramatically in the past 18 years; stem cell research, for example, was unheard of in 1990. Nevertheless, the legislation has proved sufficiently flexible to enable a number of previously unforeseen developments, such as cell nuclear replacement (this was the technique used to create Dolly the sheep) and cytoplasmic hybrid embryos to be licensed for research purposes. On a number of occasions, the judiciary has confirmed that the Parliament’s intention in passing the 1990 Act was to give the HFEA considerable discretion to respond appropriately to new developments.
Therefore, if much of the regulatory architecture remains intact, what changes are introduced by the new Bill?
Some parts of the new Bill do no more than clarify that the HFEA has the power to license practices that were not previously specifically spelled out on the face of the legislation. Under the previous legislation, the question of whether the HFEA had the power to license creation of embryos by cell nuclear replacement was ultimately decided by the House of Lords, which concluded that the determining criteria for embryos to be covered by the Act was that they were live and human, rather than that they had to have been created in a particular way. The Bill rectifies wording in the 1990 Act, and explicitly sets out that embryos created by methods other than fertilization fall within the scope of regulation.
In addition, the Bill specifically permits the creation, under licence, of what are now referred to as ‘human admixed embryos’ that is, cytoplasmic hybrids created using denucleated animal eggs and human nuclear DNA. The HFEA had already determined that licensing the creation of cytoplasmic hybrid embryos lay within its statutory powers in September 2007, following an intensive public consultation exercise. Since such embryos contain a full nuclear human genome, it was determined that they too were both live and human, and hence covered by regulation. Just as with cell nuclear replacement, the Bill explicitly permits their creation, under licence, subject to a number of statutory conditions. However, this provision has proved to be especially controversial. After much debate, the House of Lords voted in favor of the creation of human admixed embryos. In the House of Commons, following sustained pressure from Catholic bishops, among others, Gordon Brown relented and Labour MPs will now have a free vote on this part of the Bill.
The Bill will specifically allow artificial gametes to be created for research purposes. There has been some debate over whether the prohibition on their use in treatment should be subject to regulation-making powers, which would enable this ban to be removed more quickly if it became evident that the use of artificial gametes in treatment would be safe and appropriate.
All of the limits that already apply to other sorts of embryo research, such as the 14-day time limit and the need to prove that the use and/or creation of embryos is necessary and performed to further certain statutory purposes, will apply to all these newly specified types of research.
The 1990 Act did not mention the circumstances in which preimplantation genetic diagnosis (PGD) is legitimate, and this gap has been remedied in the new Bill. While additional clarity is to be welcomed, there can be dangers in putting a great deal of detail on the face of a statute. When the rules governing PGD are – as they have been until now – contained in the HFEA’s Code of Practice, they can be updated to accommodate new issues or developments much more easily than if they are contained in primary legislation.
Under the Bill, PGD may be requested by couples where there is a significant risk that the child would have or develop a serious disability, illness or other serious condition. This does not confine PGD to the detection of conditions that would be present from birth, so later onset conditions (such as Huntington’s disease) could be covered. The chance that the child will develop this condition does not have to be 100%, provided that it amounts to a ‘significant risk’, thus allowing testing for certain lower penetrance genes, such as BRCA1 and -2.
The Bill also explicitly permits preimplantation tissue typing, in order to select a child who would be a good tissue match for an older sibling whose condition must be life threatening or serious. Normally, the intention would be to use blood from the baby’s umbilical cord, but there might be cases in which bone marrow donation might subsequently take place (subject, of course, to the ordinary law governing the treatment of children, which makes the child’s welfare the paramount consideration). The Bill was amended in the House of Lords to provide that there must be no intention to take a solid organ later in the child’s life.
Again, consistent with current HFEA policy, sex selection for social reasons is specifically outlawed on the face of the Bill.
There has been some controversy over the Bill’s provision that embryos or persons known to have a genetic abnormality must not be ‘preferred’ to embryos or persons without an abnormality. This provision was intended to prevent people positively selecting for a disability, such as congenital deafness. The deaf community has been especially critical of this provision, and the ‘message’ it sends to deaf people. It is also possible to think of a scenario in which a couple who need a sperm or egg donor might prefer to use a family member who happens to be deaf. Given the shortages of both sperm and eggs, particularly from some minority ethnic groups, a deaf sibling or friend may be the only available donor. If the couple who wish to use a (deaf) known donor could be said to be preferring a donor with a disability, this would not be allowed under the Bill.
In the House of Lords, there was a great deal of debate over the government’s proposal to remove the need to take account of the child’s ‘need for a father’ before offering assisted conception services. This provision is currently part of the 1990 Act’s ‘welfare principle’, under which clinicians must take account of the future child’s welfare before assisting a couple to conceive. Since same sex couples and single people have been able to adopt for many years, and gay couples can acquire the same rights as married people as a result of the Civil Partnerships Act, many had assumed that removal of this clause would unproblematically bring this piece of legislation into line with other laws. Moreover, given that discrimination on the grounds of sexual orientation in the exercise of one’s convention rights (such as the right to family life and the right to marry and found a family) is prohibited, this statutory provision, which implies that single or lesbian parents should be at a disadvantage in accessing assisted conception services, is arguably inconsistent with the Human Rights Act, as well as equality legislation. Nevertheless, in the House of Lords, many peers argued that to remove the requirement to consider the child’s ‘need for a father’ was tantamount to impugning the value of fathers in modern family life. In the interests of compromise, a new clause was inserted under which clinicians will have to take account of the child’s ‘need for supportive parenting’.
Interestingly, in other respects, the Bill does provide for some equalization of the treatment of same sex couples. In the case of a lesbian couple having treatment in a licensed clinic, it will be possible for the woman who does not give birth to be recognized as the child’s second female parent.
One area in which there has not been as much change as some would have hoped was in relation to confidentiality. The 1990 Act contains especially draconian and punitive confidentiality provisions. While protecting patient confidentiality is undoubtedly extremely important, this is true throughout the health sector and some would argue that assisted-conception treatment should not be subject to special treatment. When the 1990 Act was passed, IVF was still in its infancy and it was thought that there might be some stigma attached to having received fertility treatment. IVF is now a routine medical procedure and so the need for extra secrecy is not necessarily warranted, particularly given the consequences of these strict confidentiality provisions.
One thing that has been prohibited under the current law is linking the HFEA’s database with those from, for example, disease registries in order to conduct epidemiological research into the possibility of any links between fertility treatment and health problems later in life. Second, some doctors have been concerned that it might be difficult for a doctor treating an unconscious woman in an accident and emergency department to gain access to notes that might reveal which fertility drugs she had been taking and therefore be relevant to decisions regarding how to treat her.
While there have been some changes to these rules, it will, for example, be easier for researchers to gain access to information that the HFEA holds in order to conduct important research on health outcomes, the government has argued that European law prevents the equalization of confidentiality under the Act with confidentiality in other health settings.
In conclusion, the new Bill undoubtedly clarifies and updates much of the law governing assisted conception and embryo research. If it reaches the statute books in its present form, there will be some important changes, but in many respects, the current structure of regulation in this area will remain intact. Some people have argued for more radical changes. For example, while both embryo research and IVF were novel and controversial techniques in 1990, this is no longer the case and while the public may still want stringent rules to cover research on human embryos, IVF is now a fairly common way to conceive and some would argue a separate regulatory regime is unwarranted. On the other hand, the storage and use of human embryos is a matter of great sensitivity and treatment with donated sperm and eggs raises a number of important issues, not least the importance of maintaining an accurate and secure register of information.
The UK’s regulatory regime in this area – the first of its type – has been widely copied throughout the world. It has enabled clear statutory prohibitions to coexist with a degree of flexibility, which is generally believed to have worked well and which will, in large part, be reproduced when the Human Fertilisation and Embryology Act 2008 comes into force.
Financial & competing interests disclosure
E Jackson is a Member of the Human Fertilisation and Embryology Authority. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.