Key changes in the regulation of assisted reproduction introduced by the Human Fertilisation and Embryology Act 2008

The Human Fertilisation and Embryology Act 2008 revised and amended the Human Fertilisation and Embryology Act 1990 and introduced some new provisions relating to assisted reproduction. In some respects it closed perceived loopholes in the original 1990 Act, and it also updated the law in the light of changing views on issues such as whether same-sex couples should be recognized as the legal parents of children conceived by assisted reproduction. While, in some ways, the 1990 Act had stood the test of time well, ‘there were a number of new scientific advances, including the birth of Dolly the sheep, the isolation of the first embryonic stem cell line and the possibility of creating animal/human hybrid embryos’ that made a new Act in this area necessary. ¹ In this eighth Five-Minute Focus on Law we set out and explain some of the key changes that the 2008 Act has made to the original 1990 Act. Before this, it is worth briefly explaining what the Human Fertilisation and Embryology Acts regulate.

The remit of the Human Fertilisation and Embryology Acts

These Acts are designed to regulate assisted reproduction services and the use of gametes and embryos for both reproduction and research. Even though the majority of the Warnock Committee (the body set-up by the government in 1982 to consider the legal and ethical issues raised by this developing area and chaired by the moral philosopher Baroness Warnock) agreed that gametes and embryos were not to be considered legal persons, they also agreed that their status as potential legal persons made them worthy of respect. ² It was thus appropriate to regulate their use in order to ensure that they were afforded this respect. Assisted reproduction services and the use of gametes and embryos are regulated, under the Acts, by the Human Fertilisation and Embryology Authority (HFEA). The HFEA is the key to the regulatory structure introduced by the original 1990 Act as it is responsible for enforcing and keeping the practical implementation of the Act as up-to-date as possible within the confines of the wording of the legislation. It also oversees the statutorily required Code of Practice, which is meant to be the living and breathing embodiment of the Act. ³ The Code aids in the practical application of the Act, as well as allowing for minor updates if specific problems or issues are identified. Furthermore, the HFEA must grant a licence before any clinic can use human gametes and embryos for any reason. This licence will be revoked if the clinic does not conform to the rules laid out in the Acts and the Code of Practice. This system not only enables clinics to be ‘policed’ but also allows the HFEA, through the Code, to retain a level of flexibility which is essential in this area where both biotechnology and public opinion continually evolve, develop and change.

Nevertheless, particularly given the fast-paced nature of the area being regulated, it was inevitable that at some point the 1990 Act would need to be formally reviewed and revised. The Codes of Practice coped well with changes in the field, but it became clear that the original legislation was in danger of becoming unfit for purpose as biotechnology advanced and society's views on assisted reproductive services changed. The 2008 Act attempts to address these points, and the Department of Health has set out the six key changes introduced by this Act which we consider here as follows:

The regulation of all human embryos outside the body whatever the process used in their creation;

The regulation of ‘human-admixed’ embryos created from a combination of human and non-human animal genetic material for research;

A prohibition on sex selection for non-medical reasons;

The recognition of same-sex couples as the legal parents of children conceived through the use of donated sperm, eggs or embryos;

The retention of the duty to take account of the welfare of the child in providing fertility treatment but replacing the reference to ‘the need for a father’ with ‘the need for supportive parenting’;

The removal of some of the restrictions on the use of HFEA-collected data to help enable follow-up research on infertility treatment. ⁴

The regulation of all human embryos outside the body

This change is a direct result of the science developing in a way that was not envisaged towards the end of the 1980s, and so the regulatory structure of the original 1990 Act was not able to accommodate these advances. For example, the birth of Dolly the sheep in 1997 via cell nuclear replacement (CNR) was a problem for the original 1990 Act which defined an embryo as ‘a live human embryo where fertilisation is complete’. ⁵ As CNR does not involve fertilization, an embryo created by this process would not fall within the legal definition of an ‘embryo’ under the original 1990 Act, and it and its ‘creators’ would thus be outside of the regulatory ambit of the Act. Indeed, a High Court decision in 2002 confirmed that embryos cloned via CNR were outside of the regulatory remit of the 1990 Act and the HFEA, ⁶ but this decision was subsequently repealed by the Court of Appeal ⁷ and the House of Lords agreed. ⁸ Nevertheless, the legal confusion led to fears that doctors/scientists would come to England and exploit the apparent legal lacuna, so the Human Reproductive Cloning Act 2001 was passed as emergency legislation to make human reproductive cloning illegal and punishable by up to 10 years imprisonment.

In order to pre-empt possible future scientific advances, the 2008 Act has changed the definition of embryo and removed all reference to fertilization. Under section 1(1)(a) of the amended 1990 Act an ‘embryo means a live human embryo and does not include a human admixed embryo.’ The change not only brings embryos created by CNR under the auspices of the 1990 Act but also it defines embryo as widely as possible so that it includes any human embryo – however it is made – in order to try to ensure that such a loophole does not present itself in the future. The purpose and effect of the change is to:

[maintain] the status quo, but with a greater degree of future-proofing, and thereby reducing the potential for legal challenge. The aim of this policy is to ensure active monitoring and regulation of the creation and use of embryos, and therefore must have all human embryos clearly within its purview. ⁹

Additionally, the new section 1(6) of the amended 1990 Act states that if the Secretary of State is of the opinion that developments demand it, the regulations may be changed to include new definitions of ‘embryo’, ‘egg’, ‘sperm’ or 'gametes’, and ‘includes things specified in the regulations which would not otherwise fall within the definition’. The idea is to further future-proof these definitions. CNR demonstrated that in a scientifically advancing field legislation may become redundant, so these provisions of the amended 1990 Act now ensure that if a human embryo is created artificially, it will be regulated either under existing provisions or by the new provisions in section 1(6) which allow the Secretary of State to modify the definitions in order to make this the case.

Regulating human admixed embryos

Following the birth of Dolly the sheep, researchers were able to create ‘admixed’ human and non-human animal hybrid embryos by CNR using denucleated non-human animal eggs and human nuclear DNA. These admixed embryos are used for research purposes, and non-human animal eggs are used because of the limited supply of human eggs (as few women donate their eggs for research). In 2003 the House of Lords held that embryos created by CNR could come under the 1990 Act as parliament would not have intended them not to be regulated, ⁸ and the HFEA subsequently decided that it was also able to licence the creation and use of human admixed embryos under the original 1990 Act. In some respects this was a pragmatic decision because otherwise these embryos would have been unregulated as they would not fall within the regulatory scheme relating to non-human animals since they would not be defined as non-human animals. ¹⁰ Thus, ‘if not covered by the 1990 Act, scientists could mix animal and human material in this way in their garden sheds, if they so wished, and then do whatever they liked to them’. ¹⁰

The HFEA's decision that it could regulate admixed human embryos was about to be legally challenged when the 2008 Act introduced its amendments to the original 1990 Act, which clarified the legal situation. ¹¹ The new section 4A of the 1990 Act brings admixed human embryos and non-human gametes within the ambit of the Act, and section 4A(6) defines a human admixed embryo as:

an embryo created by replacing the nucleus of an animal egg or of an animal cell, or two animal pronuclei, with –

two human pronuclei,

one nucleus of a human gamete or of any other human cell, or

one human gamete or other human cell,

any other embryo created by using –

human gametes and animal gametes, or

one human pronucleus and one animal pronucleus,

a human embryo that has been altered by the introduction of any sequence of nuclear or mitochondrial DNA of an animal into one or more cells of the embryo,

a human embryo that has been altered by the introduction of one or more animal cells, or

any embryo not falling within paragraphs (a) to (d) which contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal (‘animal DNA’) but in which the animal DNA is not predominant.

Once within the scope of the Act, human admixed embryos can only be used by those who have a licence from the HFEA, and it is illegal to implant non-human gametes, embryos or human admixed embryos into a woman (section 4A[1]), or to keep a human admixed embryo beyond either the primitive streak or 14 days’ development from when the embryo is created (section 4A[3]). The provisions introduced into the 1990 Act by the 2008 Act ensure that human admixed embryos are under regulatory control. Again, there is a specific subsection allowing the Secretary of State to introduce changes to the regulations if s/he deems it necessary (section 4A[13]) in order to replicate the future-proofing envisioned with the definition of embryo discussed above, and to ensure that all admixed human embryos are regulated by the amended 1990 Act.

Banning sex selection for non-medical reasons

The circumstances in which preimplantation genetic diagnosis (PGD) could be used were not set out in the original 1990 Act but were contained within the HFEA's Code of Practice. The prohibition on sex selection for non-medical reasons had existed in the Code since its third edition in 1995, ¹² and the amendments introduced into the 1990 Act by the 2008 Act simply put into statute and formalized this prohibition. Thus, two new paragraphs of Schedule 2 of the 1990 Act explicitly state the medical reasons for which testing for the sex of an embryo may take place (paragraph 1ZA), and declare that other than for these reasons a clinic providing treatment ‘cannot authorize any practice designed to secure that any resulting child will be of one sex rather than the other’ (paragraph 1ZB(1)). This therefore also includes other methods, such as sperm sorting. These amendments do not practically change anything but give statutory force to a longstanding policy, and it is now a criminal offence punishable by two years imprisonment, a fine or both, to perform PGD without a licence or outside the terms of a licence (section 41(2) amended 1990 Act).

Recognizing same-sex couples as the child's legal parents

Under the original 1990 Act, same-sex couples who sought assisted reproductive treatment together encountered difficulties in being registered as the legal parents of any resulting child. With regard to the legal mother, the 2008 Act reaffirms that the legal mother of a child is the woman who carries and gives birth to that child (section 33(1); previously section 27 original 1990 Act). For fathers, their status as legal parent will depend on whether they are married to the woman who gives birth (sections 35 and 38 2008 Act). If they are not, then under section 37 of the 2008 Act if both parties agree a man can be registered as the legal father of a child resulting from reproductive treatment even if he has no genetic connection to that child. These provisions do not substantially change the nature and effect of the provisions contained in section 28 of the original 1990 Act; rather, they clarify some of the issues raised by the wording contained within that section.

The 2008 Act does, however, introduce significant changes in relation to same-sex couples. Under the 1990 Act if a lesbian couple sought treatment with donated sperm, the partner of the woman who carried the child was not entitled to be registered as the legal parent of any child subsequently born. The 2008 Act has changed this so that, under section 42, if a female couple are civil partners then the woman who is not the legal mother will now be a legal parent of the child, though not a second ‘mother’. If the couple is not registered civil partners then, under section 44, the female partner of the woman who gives birth will still be a legal parent provided they sought treatment together knowing and consenting to the intended results, just as it is for heterosexual couples. These sections thus widen the definition of a legal family to include lesbian couples, but also mean that a man can be recognized as a child's legal father even though he has neither a genetic connection with that child nor is in an intimate relationship with the mother. So, a mother's platonic male friend could be so registered as long as both parties agree that he is to be named the father of the child. Given this, it is surprising that these changes have not received more attention, particularly in the media.

The welfare of the child: replacing the ‘need for a father’ with ‘supportive parenting’

Section 13(5) of the original 1990 Act stipulated that before providing treatment, clinics must consider the welfare of any resulting child, ‘including the need for a father’. This provision reflected the Warnock Committee's view that assisted conception services should be directed towards married heterosexual couples rather than lesbian couples or single women. ¹³ This requirement was controversial at the time and has been much debated and criticized since, ¹⁴ and the 2008 Act has replaced the words ‘need for a father’ with ‘supportive parenting’ in section 13(5) of the amended 1990 Act. The impact of this change is, as yet, unclear as the HFEA's Code of Practice had long emphasized that clinics should be non-discriminatory. For example, the first edition of the Code stated that women were entitled to a ‘fair and unprejudiced assessment’ ¹⁵ and that ‘their commitment and that of their husband (or partner) if any to having and bringing up a child’ should also be considered. ¹⁶ By the third edition, clinics were already being asked to consider the parents’ ‘ability to provide a stable and supportive environment’. ¹⁷ This change is thus similar to that regarding non-medical sex selection, in that it places on a statutory footing a longstanding provision from the HFEA's Code of Practice. As such, it demonstrates the important role the Code has had in keeping the Act relevant. Nevertheless, amending the 1990 Act in this way is symbolically important as it signifies an acknowledgement and recognition that there is more than one way to raise a child that does not adversely affect its welfare.

Using HFEA-collected data in follow-up research

The confidentiality provisions in the original 1990 Act prevented researchers from using the information collected by the HFEA from licensed clinics about the treatments provided in order to, for example, conduct long-term studies on the health effects of in vitro fertilization. Section 33D of the amended 1990 Act now allows the Secretary of State to introduce regulations which allow ‘protected information’ collected by the HFEA to be used for the ‘purposes of medical research’ where this ‘is necessary or expedient in the public interest or in the interests of improving patient care’. ‘Protected’ information means confidential information and for this reason there are limits to its use. For example, under section 33D(5) disclosure of any information that may identify an individual may not be authorized if it is ‘reasonably practicable’ to obtain that information otherwise ‘having regard to the cost and technology available for achieving that purpose’. Similarly, regulations cannot authorize processing protected information in a way that is inconsistent with the Data Protection Act 1998 (section 33D(6)). These changes acknowledge the need for and importance of research to help improve the quality of reproductive treatments on offer by, for example, tracing and studying those who have accessed them, and to draw evidence-based conclusions. It attempts to balance the need to conduct research into this ever-changing field with a desire to protect the dignity and rights of those seeking access to reproductive services.

Conclusion

That the 1990 Act stood largely unchanged for nearly 20 years is a testament to those who drafted that legislation, given the nature of the subject it regulated. Indeed, the regulatory structure has not been altered by the 2008 Act; rather, the aim of the 2008 Act is for that structure to encompass all assisted reproductive treatments, techniques and research involving gametes and embryos. The six main changes introduced by the 2008 Act recognize that scientific progress and societal values and opinions have moved forward, while the relevant legislation was fixed. The changes noted here seek to ensure that no assisted reproductive techniques escape regulation, and to update the law to take into account how these techniques had been practically used by, for example, changing the requirements relating to the welfare of the child and the rules regarding legal parents. Although the change to section 13(5) received the most media coverage, it is likely to have only a minimal impact on practice as it merely formalizes what had long been set out in the HFEA's Code of Practice. The change regarding legal parentage may well have the widest-ranging effect, practically and socially, because it signifies a formal change in the definition of a family and, along with the amended section 13(5), affects the families which might be helped to exist via the use of assisted reproductive technologies. In our view, these are very welcome developments which ‘continue the UK's tradition of fairly liberal but nonetheless rigorous regulation of assisted conception services’. ¹⁸ However, we note with some concern proposals to merge the HFEA with the Human Tissue Authority, and hope that if it does go ahead the regulatory structures that have served so well are not diluted or diminished. ¹⁹

Summary points

Under the 1990 Act as amended by the 2008 Act:

All human embryos, however created, are now regulated;

Human admixed embryos are regulated;

It is illegal to select the sex of an embryo for non-medical reasons;

The need for supportive parenting should be considered when clinics address the welfare of any child who could be born following assisted reproductive treatment;

Under the 2008 Act:

A female partner can, in certain circumstances, be recognized as the legal parent of a child born following assisted reproductive treatment;

Confidential information collected by the HFEA can be used for follow-up research on infertility treatment.