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Select Committee on Science and Technology Fifth Report

4 The HFEA and the current regulatory framework

Current applications to the HFEA

61. On 7 November 2006 the HFEA received two separate applications for licences to allow researchers from King's College London and Newcastle University to transfer human genetic material from human somatic cells into animal ova (eggs) from which the main source of genetic material had been previously removed.[133] Within this Report, we refer to such creations as 'cytoplasmic hybrid embryos'. In this chapter we focus on whether or not these research proposals should be assessed for licensing by the HFEA and whether HFEA has acted appropriately in its management of these applications in respect of its current role and remit. The timetable for the steps taken by the HFEA in relation to these applications is set out below for ease of reference.

Table 3: Timescale of events with respect to when and whom HFEA consulted in its decision-making process regarding whether or not the creation of human-animal chimera or hybrid embryos, and specifically cytoplasmic hybrid embryos, falls within its remit.

Date Action Conclusions and notes

November 2005 HFEA responds to Government consultation on the HFE Act The HFEA states that creation of human-animal chimera and hybrid embryos for research purposes should be permitted[134]

Early 2006 Scientists state that they may wish to create cytoplasmic hybrid embryos[135]

26 April 2006 HFEA Scientific and Clinical Advances Group (SCAG) asked to consider whether cytoplasmic hybrid embryos would fall within HFEA remit SCAG forms the general opinion that cytoplasmic hybrid embryos should be classified as human embryos[136]

17 May 2006 HFEA Ethics and Law Committee (ELC) asked to consider whether cytoplasmic hybrid embryos would fall within HFEA remit ELC agrees that embryo containing human nuclear DNA and mitochondria of animal origin should be regarded as an 'embryo' for the purposes of the 1990 Act[137]

6 July 2006 HFEA receives legal opinion on whether cytoplasmic hybrid embryos should be regarded as 'human' for the purposes of the HFE Act and whether such creations would be prohibited or licensable under the Act The legal opinions provided by HFEA are confidential but summarised within the evidence published alongside this report[138]

7 November 2006 HFEA receives applications from researchers at King's College London and Newcastle University for licences to create cytoplasmic hybrid embryos for research purposes

30 November 2006 HFEA Horizon Scanning Expert Panel sought for advice on whether cytoplasmic hybrid embryos would fall within HFEA remit Those who responded agreed that this type of hybrid embryo would contain a complete human genome[139]

5 January 2007 HFEA receives revisited legal opinion on whether cytoplasmic hybrid embryos should be regarded as 'human' for the purposes of the HFE Act and whether such creations would be prohibited or licensable under the Act The legal opinions provided by HFEA are confidential but summarised within the evidence published alongside this report[140]

10 January 2007 Summary of advice and opinions presented to Authority

11 January 2007 HFEA releases statement indicating that the creation of cytoplasmic hybrid embryos potentially falls within its remit to regulate and licence

The role of the HFEA in regulating research

62. The HFEA is responsible for licensing research within the scope of the HFE Act and, if it is accepted that an application for research falls within HFEA remit, such an application must go to the HFEA Licence Committee for consideration. The HFEA has faced difficulties in the regulation of research, and the interpretation of the HFE Act has been at the centre of a number of legal challenges in recent years.[141] Cases against the HFEA include that brought by Bruno Quintavalle, a campaigner for the Pro-life Alliance, where it was argued that organisms created by cell nuclear replacement did not fall within the definition of 'embryo' in the HFE Act.[142] The Quintavalle challenge was successful in the High Court but failed on appeal before both the Court of Appeal and the House of Lords. According to the Law Lords, the HFEA has regulatory jurisdiction over human embryos, irrespective of whether such embryos are produced by fertilisation or by a process involving cell nuclear transfer. This ruling, though, does not explicitly settle the question of whether a human-animal chimera or a hybrid embryo would fall within the HFEA remit. Reflecting the lack of legal certainty on this particular matter, the HFEA has stated that it considers the law in this area to be "far from explicit".[143]

DO THESE APPLICATIONS FALL WITHIN HFEA REMIT?

63. The HFE Act makes provision for the creation, storage and use of human embryos. Under the HFE Act, provisions are limited to the use of exclusively human embryos, with a single exception for the hamster test. Whether or not the creation of cytoplasmic hybrid embryos falls under the HFE Act has been questioned since when the HFE Act was approved, the requirement for human-animal chimera or hybrid embryos in research had not been anticipated.[144] Mr Mark Bale from the Department of Health told us, in specific relation to the creation of cytoplasmic hybrid embryos, that "this certainly was not a technique that was envisaged when the White Paper that preceded the Act was put together".[145] We also heard from Caroline Flint MP, the Minister of State for Public Health, that the Act could not determine whether or not use of human-animal chimera or hybrid embryos should be allowed in research because "it was not something that was part of that discussion".[146] Consequently, the HFEA has consistently called for Parliament to decide on this issue, starting in July 2002 when the then Chief Executive of the HFEA, Maureen Dalziel said that "new, clearer legislation is desperately needed that takes into account the massive scientific advances that have taken place since the last Act was drafted and is less open to misinterpretation".[147] More recently, in response to the Department of Health 2005 consultation on the review of the HFE Act, the Authority recommended that "hybrids and chimeras are defined in the new Act".[148]

64. Whilst accepting that the HFE Act is not clear in this area, the HFEA has recognised the "very clear responsibility" it has in acting under current law and that, should a decision be reached that these applications fall within its regulatory remit, they must be assessed accordingly.[149] It is important to recognise that the HFEA was created to take difficult decisions in areas where the precise meaning of the law was unclear and, as the Minister explained, "the regulator has been given certain powers to make judgments outside of what the legislation provides for within the spirit of the legislation".[150] Past experience indicates a greater willingness on the part of the HFEA to fulfil this role than it perhaps displayed on this occasion. For example, the BioIndustry Association argued that:

151

We agree with HFEA that the wider issue of whether human-animal chimera or hybrid embryos should be allowed for research should be decided by Parliament. However, it is the role of HFEA to make judgements in areas considered within the spirit of the HFE Act where its legal advice indicates that it is reasonable to do so. Not to do so undermines the effectiveness of an independent regulator.

65. For the HFEA to determine whether applications for the creation of cytoplasmic hybrid embryos should be put forward for licence consideration, a "key question" for the Authority was whether hybrid embryos fall within its jurisdiction under the 1990 Act. The HFEA stated that:

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The current legal basis for definition of an embryo derives from the HFE Act which states that 'embryo' means "a live human embryo where fertilisation is complete and references to an embryo include an egg in the process of fertilisation".[153] With respect to whether or not cytoplasmic hybrid embryos should be regarded as "human embryos", we were told in written evidence by HFEA that:

154

We discuss below the two aspects of (a) whether or not cytoplasmic hybrid embryos contain a full human genome and (b) the appropriateness of using viability as a criterion to determine fit within HFEA remit.

Do cytoplasmic hybrid embryos contain a full human genome?

66. Alerted to expected applications for the creation of human-animal chimera or hybrid embryos, in April and May 2006 the HFEA requested that its Scientific and Clinical Advances Group (SCAG) and Ethics and Law Committee (ELC) consider whether or not cytoplasmic hybrid embryos could be deemed 'human', suggesting that "anything which has a complete human genome should be classed as human".[155]

67. Since cytoplasmic hybrid embryos consist of primarily human genetic material from the nucleus of a human somatic cell, many experts consider such creations to contain a 'full human genome'. For example, in evidence submitted to this inquiry we have heard from the Biosciences Federation (BSF), representing experts in the biological sciences, that "the only nuclear DNA [in a cytoplasmic hybrid embryo] would be derived from the inserted human nuclei" and thus "all cells in the developing embryo would have the same human DNA".[156] However, we have also received evidence to suggest that there would not only be nuclear DNA present but also mitochondrial DNA, as discussed previously in paragraph 57. When questioned about the potential impact of mitochondrial DNA on cytoplasmic hybrid embryos, Dr Lyle Armstrong of Newcastle University argued that:

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Professor Austin Smith of Cambridge University agreed, saying that "you have only a small component, which is the mitochondrial component".[158]

68. The HFEA's Scientific and Clinical Advances Group, which also considered the potential impact of mitochondrial DNA on cytoplasmic hybrid embryos, offered the general opinion that "this type of hybrid embryo should be classed as human".[159] The Authority's Ethics and Law Committee "agreed that an embryo containing human nuclear DNA and mitochondria of animal origin should be regarded as an 'embryo' for the purposes of the 1990 Act".[160] A third source consulted, experts at the HFEA horizon scanning meeting on 30 November 2006, reached a similar conclusion.[161] Angela McNab, Chief Executive of HFEA, summarised the evidence before the Authority on this issue by stating that "there was, from those scientists we consulted, a view that the entity or the embryo that would be produced would be likely to have the full human genome within it".[162] This decision that cytoplasmic hybrid embryos can be classed as 'human embryos' would bring them within the jurisdiction of the HFE Act. We support the decisions of the HFEA Science and Clinical Advances Group, Ethics and Law Committee and Horizon Scanning Group that an embryo containing human nuclear DNA and mitochondria of animal origin should be regarded as a human embryo for the purposes of the 1990 Act.

Embryo viability

69. However, the HFEA considered also a second facet of whether the hybrid embryos would be live human embryos with the condition that under the Act "embryos should be treated as live human embryos unless it could be clearly proved that the embryo could never be viable".[163] Angela McNab, Chief Executive of HFEA, told us that viability "is the second test in order for it to be within our scope".[164] The HFEA intends to include viability within its consultation on research in this area, discussed below.[165] This introduces greater uncertainty into the application of the Act to these embryos since it is not clear that cytoplasmic hybrid embryos are viable.[166] The HFEA told us that they "were unable to obtain a clear idea from scientists on this: there was not a consensus, from those experts we consulted, about the viability, whether or not it would be able potentially to implant and be viable".[167]

70. The reliance on viability, or the 'normal' potential to develop, of cytoplasmic hybrid embryos to determine whether such creations fall within their jurisdiction for regulation of research does not derive directly from the HFE Act but results from later attempts to define further what is meant by a 'live human embryo'. The scope of what is meant by the term 'human embryo' was discussed within the judgement of the House of Lords in the "Quintavalle case", which examined whether live human embryos created by cell nuclear replacement (CNR) fall outside the regulatory scope of the Human Fertilisation and Embryology Act 1990 and whether licensing the creation of such embryos is prohibited by the Act.[168] During this case, one of the Law Lords (Lord Millett) attempted to define further what is meant by the term 'human embryo', stating that "in the case of a human embryo, it is a live human organism containing within its cell or cells a full set of 46 chromosomes with the normal potential to develop and, if planted in a woman, to become a foetus and eventually a human being".[169] The HFEA appeared to rely on this sentence in interpreting its legal advice regarding a test of viability. However, that sentence is ambiguous as to whether implantation is a necessary component of the test of viability.

71. That scientists are unable to determine whether or not cytoplasmic hybrid embryos would be 'viable' can come as no surprise since it is surely impossible to determine whether or not an embryo is viable without first implanting it in a woman to determine whether it will develop. Since implantation of embryos created in this way is illegal, embryo viability is impossible to prove categorically and as such, this is a circular argument. In addition, we were interested to note recent scientific studies relating to the creation of blastocysts which have been genetically altered to inhibit implantation.[170] If the HFEA is to take viability as an indicator to determine whether something should be classified as a 'human embryo', then it would be interesting to establish whether embryos inactivated in this way would fall under regulation. We understand that some form of viability test will have been subject to the legal advice sought by the HFEA on this issue. Nevertheless, we have grave scientific concerns about its validity. We do not believe that it is appropriate to use viability as a mechanism for determining whether or not a creation is human, particularly since attempts to prove viability through implantation in a uterus would be unlawful. Furthermore, were the viability test to be failed, this would mean that such research would be completely unregulated, which case law has found to be unsatisfactory.

THE HFEA DECISION OF 10 JANUARY 2007

72. Having taken advice from its Committees and others on cytoplasmic hybrid embryos, the HFEA concluded on 10 January 2007 that "in the light of current scientific opinion, it believes it is probable that hybrid embryos are within its scope".[171] We support the decision of the HFEA that these sorts of research would probably fall with the remit of the HFEA to regulate and license and would not be prohibited by current legislation. Although we have received submissions from those who do not believe that this is the case, the weight of scientific and legal argument is in favour of treating these embryos as human. We accept that this decision might leave the HFEA open to legal challenge that it was acting ultra vires in considering the applications. However, given the accepted desirability for legal clarification in this area, we view legal challenge as highly likely but also potentially helpful in establishing the limits of the HFEA's remit.

73. The second stage in the HFEA's decision of 10 January was less courageous. Since HFEA had reached agreement that the creation of cytoplasmic hybrid embryos falls within its remit, the Authority was obliged to put the applications received forward for licence consideration and indeed, Angela McNab, Chief Executive of the HFEA, accepted that the Authority has "a responsibility to respond and deal with applications that come to us, and so we must do that".[172] However, rather than take this line of action, the Authority made the decision to "to delay reaching a policy position and consideration by licence committee pending a full public consultation".[173]

74. It appears that the HFEA may have made the decision to delay assessment until public consultation had been held in an attempt to forestall giving rise to grounds for a legal challenge. Angela McNab told us that "if we make a decision based on shaky ground, then we would be open to challenge and we would not want to do that".[174] Ms Harrison added that the decision to delay assessment until such time when public consultation had been held was "really to do with being fair to everybody".[175] Ms Harrison explained that:

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Indeed, it can be seen from the publicly available summary that the legal advice given to HFEA indicated that "one of the classic grounds for a Judicial Review would be when a public body makes a decision by an unfair process".[177]

75. There also seems to have been an element of doubt within the HFEA about its own decision on its remit. Ms Harrison, the Chair of HFEA, told us that "part of the consultation we are trying to establish is does what is being proposed fall within our remit".[178] We do not believe that a public consultation will in any way clarify the legal questions regarding the HFEA's remit. However, we recognise that, having received legal advice that a public consultation process was necessary, it would have been irresponsible of the HFEA as a public body to discount it. It would have aided transparency and public and parliamentary debate on this subject if the HFEA's legal advice had been published.

76. There is a second purpose of the public consultation with which we have more sympathy. The Authority had decided to use this consultation to develop a broader policy in this area. Ms Harrison told us that "we do have two specific licence applications in front of us but we want to have our policy to be able to cover possible future applications that may come to us. We want to have some broad guidelines".[179] We were, however, surprised that HFEA waited until it was in receipt of the research applications from King's College London and Newcastle University for licences to allow the creation of cytoplasmic hybrid embryos to initiate this exercise. When questioned on why the HFEA waited to hold consultation in this area, rather than do so early in 2006 when suggestions that this area of research may become required were first made,[180] Angela McNab told us that "in an ideal world" horizon scanning would show a variety of areas where future applications might be expected and that "one would be developing a well formulated, well evidenced policy in advance of that happening".[181] However, Ms McNab continued, "our resources are limited and we have to make a judgment call about which of those horizon scanning issues we are going to be able to pursue, in terms of opening the full policy, and at what stage".[182] Given the near certainty of the applications and the predictable reaction to them from opponents of embryo research, we find this attitude short-sighted. We view public consultation in this area as valuable. However, we are of the opinion that this exercise should have been undertaken when the HFEA first received information to indicate that applications for licensing the creation of human-animal chimera or hybrid embryos could be expected.

Delay in assessment of the applications

77. It is clear that the delay to science caused by the HFEA decision to delay assessment may have a detrimental impact. Professor Shaw of King's College London told us "we cannot start" and "this is a really important area". He added that "if we cannot work in the field and do not have access to human eggs, I cannot see how we can go forward".[183] We also heard from Dr Armstrong of Newcastle University, who supported these claims and stated that "we cannot [currently] answer all of the questions which we would like to ask in an animal model".[184] We deprecate the delay in considering the applications. We note the HFEA's assurances that the applications will be considered in September at the end of the consultation. However, we also note that Ms Harrison told us "we are going to make a decision based on the law as it stands at the moment"[185] and that "the advance of the science, and the scientists wishing to proceed, obviously makes this an issue we have a responsibility to deal with now".[186] This does not fit easily with arguing a need for consultation on the basis of legal issues. While we agree with the HFEA that the general issues of hybrid and chimera embryos should be dealt with by Parliament, we consider that it is the role of the HFEA to deal with the applications for the creation of cytoplasmic hybrid embryos under current legislation with due speed and process.