(Except clauses 4, 11, 14 and 23, schedule 2, and any new clauses or new schedules relating to the termination of pregnancy by registered medical practitioners) - Clause 29
Human Fertilisation and Embryology Bill [Lords]

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

Before we broke this morning I was responding to the amendment tabled by the hon. Member for Oxford, West and Abingdon about offences under the Human Fertilisation and Embryology Act 1990 and the Bill.

The 1990 Act makes it clear, as I said this morning, that it is an offence to store gametes, or to create, use or store an embryo, without a licence. The Bill introduces further offences relating to the creation without a licence of human admixed embryos, to come alongside the provisions that already exist. Those offences apply whether or not a person intended to create an embryo or human admixed embryo. In addition, it is expected that any person working in the field will know the rules under the Act when they apply, and when a licence is needed. The point that the hon. Gentleman has raised in relation to his amendment is about things that happen accidentally or without being planned, because of the nature of division before fertilisation. I shall answer his specific points.

It is my view, and that of the Government, that the clear set of rules that has been set out is appropriate. That is because we are dealing with one of the most sensitive areas, which Parliament has deemed it appropriate to regulate. I appreciate—the hon. Gentleman quoted from the letter that I circulated to the Committee—that there are occasions when an embryo could be created when that was not the intention. An example would be the accidental creation that the hon. Gentleman referred to this morning.

Amendment No. 173 would add a new defence to the 1990 Act for a person charged with an offence of creating, storing or using an embryo or admixed embryo,  or storing gametes, without a licence. It would allow a defendant to raise the defence that at the material time they believed that what they were doing was not something to which the Act applied. As I said this morning, it is not acceptable in this complex area for the law to include a caveat to the effect that, despite the fact that incredibly knowledgeable people are engaged in highly complex activities, the test should be what was or was not in the mind of the researcher as to whether the creation was accidental.

I reiterate what I said this morning: there is no defence in the 1990 Act, and for a prosecution to be brought under that Act some safeguards or additional points need to be borne in mind. The Crown Prosecution Service must first obtain the consent of the Director of Public Prosecutions to proceed. That is not a common proceeding for criminal offences. It is reserved for offences in relation to which weighing the discretionary factors relevant to the decision whether to prosecute is likely to be a sensitive and difficult task. That makes it desirable for the CPS to obtain prior approval for a prosecution. If an offence were committed under the 1990 Act, the facts of the case would be looked at carefully and in detail before any proceedings were brought. That is necessary in such a complex area.

The hon. Member for Oxford, West and Abingdon quoted from the letter that I circulated to members of the Committee last week. Where there is any doubt about particular research projects, it would always be wise to talk to the HFEA about whether a licence was required. Indeed, there is currently a licensed project in connection with the research that we are discussing, which indicates that such projects are covered by the current definitions, so no further clarity is required.

I would, however, go further. The amendment says that, although the individual creates an embryo, they do not think that the Act applies to them. However, we have talked about the responsible person and the circumstances under which a licence would be granted or revoked, and the obligations are quite clear: the emphasis is on the researcher to understand and comply with the law.

Clearly, a researcher storing eggs will know that they could divide and thus create an embryo. Such people are at the forefront of their science and need to be aware not only that such things can happen, but of the consequences. Equally, they should know that the 1990 Act regulates their activities. It is therefore incredibly difficult to see how the defence in the amendment could work, given that it is based on what each researcher will know, instead of taking a clear line from the Bill, with the caveats that I have outlined regarding when a prosecution might proceed. This is not a new issue, and there is no indication that we should move away from the current arrangements.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

Even despite the caveats, it is clear from what the Minister is saying and from her letter—at least she is being clear—that anyone who cultures eggs in vitro will have to get a licence because the eggs might divide. I wanted to confirm that there is no escape from that and that things that did not previously require a licence will now require one for safety.

There is a further problem, because storing gametes is a licensable activity. Where, in terms of the development of the germ line cell, does the gamete start? If work is  being done to generate IV-derived gametes, researchers will require a licence because an early-stage IV-derived gamete, even if it is just a germ cell at an early stage—a stem cell—will be covered. If the Minister can make that clear, there will at least be clarity.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

No, I am not making that clear. The hon. Gentleman seeks to get me to make a general rule in a highly complex area of science. I have made myself quite clear. I am not taking responsibility for the scientific judgments and the understanding of those involved in such research. The clear indication that I am giving is that an embryo developing spontaneously from an egg is a rare occurrence—that is what I said in my letter, and it is true. Whether a researcher working on eggs would require a licence would depend on the specific project. For example, if a project used donated frozen eggs to analyse their components at a molecular level, the eggs would not necessarily be cultured, so there would be no chance of the parthenote developing. It is therefore not the case that every researcher working on eggs would need a licence from the HFEA. However, it is the researcher’s responsibility to be fully acquainted with the arrangements in the Act and to ensure that he or she complies with them.

This is a highly complex area. The steps to prosecution do not follow the normal criminal prosecution route—if I can put it that way—as there must be consent from the Director of Public Prosecutions, which is not common. The hon. Member for Oxford, West and Abingdon argues that there should be a general rule, licensed or not. The Government are trying to travel a narrow line by regulating where appropriate, but not allowing a caveat whereby some research might deem itself not to be covered by the Act and the offence. The responsibility goes squarely back to the researchers, the purpose of their research and the circumstances under which a licence should be acquired. If they have any doubts, they should refer them to the HFEA. That is the right place to put it.

To have a general rule means that we are in great danger of opening up areas of research that we intended to be regulated, but which are not regulated as we cannot get the legislation in line with all the objectives. This is a good, balanced and fair position to be in. It is not a new issue. It has worked over the period since the 1990 Act, and I see no reason why it should not work further. I do not suppose that I have convinced the hon. Member for Oxford, West and Abingdon with those comments, as he may hold very strong views on the matter, but I hope that at least he can clearly see the Government’s reasoning behind remaining at this position.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

I can see clearly what the Minister is saying. I said that this was a probing amendment and I was not wedded to it. I do not have strong views about the amendment, and a defence is not the ideal way to deal with this. However, it is necessary for the Committee to be certain about what is going to happen. I never spoke about “every researcher working with eggs”—which is what the Minister said—because obviously, if eggs are frozen, they are not in culture and they are not going to divide. I spoke about “every researcher who is dealing with eggs in culture”. Considering the situation, including this debate and what has been said in the Minister’s letter, it appears that those researchers will  have to get a licence. I do not believe that that was the previous position—I know that it was not. There will be more licences, and regulation will extend. If regulation must extend as a by-product of a wider definition for other reasons then so be it, but it is important that researchers understand that.

Some researchers have a view on the matter. Those at Newcastle told me that it would be a disappointment to researchers that the spectre—as they put it—of the need to get a licence was going to hang over anyone working with eggs where the purpose did not involve fertilisation and so forth. At least now there is clarity about the Government’s position on that. The HFEA will have to work quickly before and after enactment, to ensure that everyone is clear.

One other area is not absolutely clear. The Minister has finished her contribution so I am not necessarily expecting a reply, but I would like her, and those reading the proceedings, to reflect on this. An egg is defined as a cell of the

“female germ line at any stage of maturity”.

If one has an embryonic stem cell that is pluripotent, at what point does that become an early stage bone marrow or germ line stem cell? It is pluripotent; in theory, from that embryonic stem cell, a cell from that line could be differentiated into a germ line cell—that is the point of them. There is therefore another question about at what stage people who are researching solely on stem cell lines—separate from the embryo work that another group may be doing—may themselves need a licence. The entity that they are working with may be heading with differentiation towards a germ line cell, and it may be considered to be captured. The storage of such cells is a licensable activity.

The point that I was making in tabling the amendment was that the breadth of regulation might well have increased, but it is not a question of scientists not knowing either the law or what they are doing. I was a little surprised by the Minister and do not think that she was serious when she said that I was arguing that senior scientists did not know what they were doing. The way science works means that it sometimes surprises people, and many discoveries are made through surprising and serendipitous findings, so no scientist is able to say in a protocol that something definitely will or will not happen. That is the nature and excitement of research. Clearly, any scientist working in this field has a responsibility to know and accept the law. When it is likely that an embryo, or something that could possibly be defined as an embryo, will be created, they will have to get a licence.

I do not want it to be left in anyone’s mind that scientists do not understand the law or are seeking to avoid it. It is just that there will now be extra regulation. If the Minister could reflect on the question about embryonic stem cells and when they become germ line cells at any stage of development, it might be useful to clarify that, because the HFEA will certainly have to.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

Does the hon. Gentleman accept that discretionary factors are already in place that can be considered before a decision is taken on whether to prosecute, and that those discretionary factors are intended  to deal precisely with some of the issues that he has identified? He has not made a case for why that is not enough; he simply reasserted that a licence is needed for everything. I clearly stated the conditions under which we would expect them to consider whether a licence was necessary.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

I apologise to the Minister for not dealing with that, although it was my intention to. They clearly have a choice: they can get a licence or rely on the fact that there would be discretion in prosecution. I am sure that that discretion would be used wisely, but many people do not like the idea that, although there can be an investigation, there could be a decision later in that process not to prosecute. We saw that during the debates in the House on religious hatred.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

The hon. Gentleman started his contribution on the amendment wanting to cover scientists who inadvertently went outside the licences. It was not that they set about going outside the licence. He referred to that just a minute ago as the wonder of science, and I have told him that that is covered. Is he now saying that he wants them to have the absolute right to do certain research outside the licence? That is a slightly different proposition.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

I do not think that it is a different proposition. If it is likely that an embryo will be created, either as the intention of research or as a foreseeable consequence, clearly they should get a licence, and I think that that now applies to eggs in culture. An alternative, to avoid the need to get a licence, would be for there to be a clear defence to cover those circumstances in which, in full knowledge of the law, research artefacts that are not the purpose of the study, are not being described and will not last long, might emerge. That would make the whole question of investigation and prosecution much less likely. That would actually add an extra safeguard with regard to the decision to prosecute, because prosecutors will not prosecute if there is a defence that could be prevailed upon. So that would give researchers more confidence that they are not going outside their licence. It would be wrong for them to go outside their licence, and that is not what I am saying. It would be something that is not obviously licensable and could be done without a licence because it has nothing to do with embryos, but if something that could be described as an embryo in this wide definition is produced as a research artefact, they will be reassured and not scared off the idea of doing the research.

I do not think that it is satisfactory to rely on the DPP discretion, although I understand what the Minister says about that, just as it is not satisfactory to rely on an Attorney-General’s discretion, although it is better than nothing. Researchers will have to get a licence. I do not think that scientists will run the risk of not having one and having complaints made against them. However, that is for them to judge.

The Government have made their position clear on the question of eggs in culture. I repeat that there is a further issue about stem cells, but that probably needs greater reflection. I was not planning to put the matter to a vote, so I beg to ask leave to withdraw the amendment.