Clause 29

Human Fertilisation and Embryology Bill [Lords] – in a Public Bill Committee at 12:45 pm on 10 June 2008.

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Offences under the 1990 Act

Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

I beg to move amendment No. 173, in clause 29, page 33, line 20, at end insert—

‘(10B) It is a defence for a person (“the defendant”) charged with an offence of doing anything which, under section 3(1) or (1A), 4(1)(a) or 4A(2), cannot be done other than in pursuance of a licence, to prove that at the material time the defendant believed on reasonable grounds that what they did was not something to which the Act applied.’.

This amendment, which deals with a potential new defence under the clause, is a probing one that tries to clarify what will happen in the new situation. The problem is caused by the new definition of an embryo, which clearly has been decided already during the procedure and has been debated in this Committee. It is now accepted that that issue will not be re-opened, and that an embryo is as defined at the beginning of the Bill, in clause 1. It must be recognised that that is a new definition that, from enactment, will capture issues that are not currently captured, and which are therefore not subject to regulation and do not require licences. As a consequence, the criminal law will be brought into new areas.

That creates a new problem: due to the nature of science, it is not entirely clear when something might be defined as an embryo under the Bill. We touched on that problem when we debated the clause in question, and following an exchange that I had with the Minister, it was covered in a letter that was sent to you, Mr. Hood, your co-Chairman and members of the Committee. That letter makes it clear that there is, as far as researchers are concerned, a particular problem.

I shall set out briefly the problem that might require defence. I draw attention to the fact that it was first raised in the House of Lords, following representations made in a briefing to all relevant peers by the Academy of Medical Sciences, the Medical Research Council, the Law Society, the Wellcome Trust and the Association of Medical Research Charities. That briefing set out the problem in relation to the amendment, which I have re-tabled to try to take the debate on. The briefing states:

“Embryos are broadly defined under the Bill to include ‘an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo’. Gametes are also broadly defined to include germ line cells at any stage of maturity. Our understanding”— that is, the scientists’ or science’s understanding—

“of the processes by which eggs develop into embryos and cells develop into germ line cells is incomplete. It is therefore possible that a researcher could store or carry out research on cells that are not currently known to be or destined to become germ line cells, or could carry out research on eggs that are (unknown to current science) capable of resulting in an embryo.”

The argument—the thrust of the amendment—is that it should be a defence for a researcher if they can prove that they reasonably believed that what they stored or were creating was not a gamete, embryo or interspecies embryo as defined in the Bill. Of course, the researcher would have to cease their activity, seek a licence or destroy the material as soon as it became reasonably clear that that was necessary.

There is an analogous defence in the Human Tissue Act 2004, which the Minister in the other place mentioned in the debate on the amendment. She said:

“The noble Lord, Lord Patel, said that the Human Tissue Act had a similar defence and asked why it was not appropriate for the Human Fertilisation and Embryology Bill also to have a similar defence. Although this is a defence under the Human Tissue Act, the activities that require a licence under the Human Fertilisation and Embryology Act 1990 relate to the handling of human embryos and gametes, and the sensitivity of these activities means that it is imperative that scientists are aware of whether their activities require a licence under the Act.”—[Official Report, House of Lords, 28 January 2008; Vol. 698, c. 469.]

That is true, but I do not believe that it answers my point. We are not talking about a defence based on ignorance of the law, and it is unfortunate that that did not come across clearly in the Lords debate. Unquestionably, researchers in the field know what the law is and that an embryo that is created—that outcome is likely or at least possible—predictably and reasonably comes under the Act. This is about the uncertainty of the law, not the science.

Clearly, such a defence was felt necessary for inclusion in the 2004 Act, which also dealt with sensitive matters. It therefore seems reasonable to include a similar, if narrower, defence in the Bill if we accept that there is a problem.

I should set out the circumstances in which such a defence could be required. Again, I am grateful to the Newcastle scientists for meeting me last night to provide me with more specific information. They said that several centres in the UK—the problem is not rare—are carrying out in vitro research on human eggs with the approval of a research ethics committee but not under an HFE licence, which is unnecessary because regulations under the HFEA exempt such research unless the eggs are fertilised or stimulated specifically to develop into an embryo. Lord Patel pointed that out in the Lords debate, and Mary Herbert, who is an expert in meiosis at the North East England Stem Cell Institute, has confirmed that although it is rare, the division of an egg cannot be ruled out because it may occur spontaneously and unexpectedly. There is no intention to create an embryo, but it is possible that any cultured egg may divide parthenogenetically; very occasionally—this is the point—the cell may continue to divide to a two-cell stage with a full set of chromosomes.

It is the view of those scientists and the Government that such an entity would be covered by the definition in clause 1. Therefore, an offence would in theory have been committed if such a thing occurs in an unlicensed laboratory. Will all research on eggs in vitro require a licence to avoid the problem? Are we unravelling the whole point of the regulations made under the 1990 Act shortly after it was passed that allowed gamete research to continue without a licence, as it does?

It is important to give one example of the work specifically concerning the investigation of the meiosis process, because it is ongoing. Meiosis is the division of chromosomes in the egg immediately before fertilisation, so that the number of chromosomes is reduced by half. Errors occurring during meiosis result in miscarriage and cause congenital abnormalities such as Down’s syndrome. The studies involve measuring proteins and other molecular signals within an egg as it undergoes meiosis. Research on how to store the eggs of young women to preserve their fertility before chemotherapy is another example.

In our exchange, which I shall not repeat, the Minister said that either embryos should be licensed or that the eggs that this might happen to should be destroyed, but her letter was clear. It is important that we recognise what it said. The Government’s letter to the Committee said that

“eggs can spontaneously activate and begin to divide without having been fertilised...It is highly unlikely that a human parthenote could implant and/or develop into a baby. However they do divide for several days in vitro allowing some research to be carried out on them.”

That would be research under a licence, because it would involve a parthenogenetic embryo. However:

“As well as occurring spontaneously, it is possible to stimulate parthenogenesis by exposing eggs to a specific chemical or by stimulating them with an electric shock.”

Again, that would require a licence under the Bill, which is fair enough, because one anticipates that that sort of thing will continue. The letter said that such embryos would be covered by the definition, and went on to say:

“As far as we understand, there are very few research projects involving human eggs which do not involve fertilisation of the eggs. The majority of research on eggs would involve creating an embryo, and therefore would require a license from the HFEA. However, we accept that where there was non-licensed research on eggs being carried out, there is a possibility that an egg may spontaneously begin to divide.

The Human Fertilisation and Embryology Act 1990 states that you cannot bring about the creation of an embryo in vitro without a license from the HFEA. Therefore, if a researcher were concerned that this might not be the case, they would need to obtain a license. The Bill does not change this position.”

I do not seek to argue with the letter; I am just setting it out to save time. The Bill changes the position. There was some doubt before, but now it is clear that spontaneous parthenogenesis, because it involves the creation of an embryo, albeit not deliberately, would require a licence. Is it the Department’s advice and the HFEA’s likely advice that anyone culturing eggs in vitro, even if there is no intention of stimulating them or creating embryos, will require a licence?

If that is the case, certainty is needed about it, or researchers may believe that even if it is not their intention, the research ethics committee does not feel that it is a possibility and they do not publish anything about parthenogenetic embryos, they may still be liable for a criminal offence. Although they may be able to “not have a problem”, as it were, now that the matter has been raised in the House of Lords and here, it is important to be absolutely clear for those researchers and to realise that there will be more research licences—and, pursuant to previous debates, more income for the HFEA—and an increase in regulation. I look forward to the Minister’s response.

Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

I find it somewhat difficult to accept that although the very best scientists in the world, at the forefront of this science, know exactly what to do in order to progress that science, the hon. Gentleman seeks none the less to move an amendment to give them the defence that they did not know that they were doing something that the legislation applied to. We need to be very clear, and being very clear about what the offence is means that the scientists concerned must know the exact parameters within which they are working. There should not be an ambiguous judgment to be made about what a particular scientist may or may not have known at the point when they breached the legislation. There is no defence in the 1990 Act—

It being One o’clock, The Chairman adjourned the Committee without Question put, pursuant to the Standing Order.

Adjourned till this day at Four o’clock.