Human Fertilisation and Embryology Bill [Lords]
The Chairman: With this it will be convenient to discuss amendment No. 29, in schedule 3, page 60, line 36,after storage, insert , embryo testing.
Mark Simmonds: Under the 1990 Act, consent must, quite correctly, specify the purposes for which any gametes or embryos are used. The Bill enhances that provision so that in addition to being able to consent to the use of embryos for treatment or research, a person may also specify that an embryo can be used in the training of embryologists. Again, that is quite correct and I welcome it. It is right that those undergoing treatment are able to choose what, if anything, extra embryos are used for. Some people who donate embryos may prefer them to be used for the treatment of other infertile couples, while others may not like the prospect of their embryos being used by other people and would prefer them to be used for research or training.
Training is essential and vital, and these challenging procedures must be completed accurately. Without scientists who are well trained in research and IVF techniques, success rates for IVF will inevitably be lower and research could become less fruitful.
The amendment would put embryo testing, which is not in the Bill, on the list of embryological techniques. It would be helpful if the Minister clarified why embryo testing is omitted, although other categories are included. This is particularly important in pre-implementation genetic diagnosis, or PGD, which is set to increase as more illnesses and diseases are found to have a gene marker. Skills and experiences of embryo testing will become even more important. The amendment would put that in the Bill, so that that people who may choose to use their extra embryos and give consent would understand the full range of techniques covered by the phrase embryological techniques. Amendment No. 29 is a consequential amendment.
Dr. Harris: I am pleased to speak to the amendment, because it relates to a provision that was not originally included, but which I and many other people had felt for a long time should have been. The history is that there was always a feeling that there was an omission in the original legislation, because it did not provide for consent to the use of embryos for training purposes.
It was always difficult for clinics to know how new people could learn embryological techniques, because although training is an integral part of what any scientific laboratory or clinic does, it cannot always be said to be a necessary part of treatment or an integral or necessary part of research. There was always a fudge, and clinics and laboratories were always concerned that they might be found to be acting outside the law, and that it would be difficult to find enough people trained in difficult techniques.
My noble Friend Baroness Tonge proposed a form of words like that which has now been adopted, but unfortunately a peer, or peers, intervened to assert that it was not necessary, and some momentum developed around that idea. The Minister, whom I thought was about to accept the amendment in principle, said that she would reflect on it. However, everything was put right on Report and the Government returned with the provision that is now paragraph 4(2) of schedule 3.
Is the hon. Member for Boston and Skegness making the case that some people who give consent for embryos to be used might agree specifically to their use in training people for general IVF work, but not for PGD, because of the sensitivities about that? I think he is making that case, and arguing that therefore the consent needs to specify it. I would be interested to hear whether the Minister thinks that it is a matter for primary legislation, because merely separating out embryo testing in paragraph 4(2) does not provide that the consent form will be that detailed.
The key question, regardless of the fate of the amendment, is what the detail of the consent forms will be, and whether the Government intend to tell the HFEA that its code of practice must make it clear that consent forms must in turn make it clear, in terms, that PGD requires specific consent.
I do not see a problem with that, because I recognise that there may be those who have concerns about training people to do something that they think is unethical on personal grounds, even though they accept the destruction of embryos. That would not be a problem, because I think that the consent form is already relatively detailed. I would be grateful if the Minister confirmed that the issue may well be dealt with just in terms of how the consent is obtained, rather than by making detailed specifications in primary legislation, although our debate and the point that the hon. Member for Boston and Skegness is making will certainly draw the attention of the HFEA to the issue.
Dawn Primarolo: Schedule 2 introduces the provisions that allow embryos to be used for the purposes of training persons in embryological techniques, including embryo biopsy and embryo storage. There are consequential provisions in schedule 3, relating to consent to the use of embryos for this purpose. We might, I think, come on to a discussion of that, so perhaps it is sensible to answer one of the questions that has been posed in that context.
A provision to allow training is necessary because it is appropriate for embryologists to practise certain techniques before carrying them out in treatmentfor example, embryo biopsy, in which cells are removed from the embryo to be tested for genes that result in serious medical conditions. There is no specific provision to allow embryologists to train in that technique. The Bill will rectify that to allow training for embryo biopsy.
Following discussion in another place, as the hon. Member for Oxford, West and Abingdon said, the training provision was widened to include not only embryo biopsy, but techniques involved in embryo storage, such as vitrification and other embryological techniques. The Bill states that training purposes can include
embryo biopsy, embryo storage or other embryological techniques.
Amendments Nos. 27 and 29 would amend the consent provisions in relation to training of embryologists to list embryo testing specifically as one of the purposes for which consent can be given in relation to embryos being used in training.
The embryological technique primarily associated with embryo testing is embryo biopsy. The Bill already allows for other embryo testing techniques, including some
As the two specific techniques listed are the only examples and there is another catch-all purpose, which will allow other embryo testing techniques, I do not feel that amendment would add anything to the provisions. Perhaps the hon. Member for Boston and Skegness can tell us exactly what is missing. The two specific techniques and the catch-all purpose cover all the techniques that he wishes to identify, so I take it that he has tabled the amendments to probe and to satisfy himself on this important issue. I therefore hope that he will not press them to a Division.
Dr. Harris: If the hon. Member for Boston and Skegness does not mind my intervening again, I interpret the point of his amendment to be identifying whether people will have an opportunity to consent to the specific purpose of training for PGD. He may be reassured by schedule 3(2) of the 1990 Act, which says that a consent
may specify conditions subject to which the embryo may be so used.
That allows the HFEA, for example, to tell clinics in its guidance or code of practice that patients should be given the opportunity to specify conditions. I have not seen the consent form for that area and, as training has been specifically identified, new consent forms will have to be arranged, but the hon. Gentleman may wish to probe the Minister further on her understanding of the question.
The provision is may specify, not must, which I think is appropriate, but I urge those considering such matters to listen to the concerns raised by the hon. Gentleman, which I share. There must be the ability for consents to be specific in this area, even though only a very small proportion of people giving consent will want to volunteer a specific exclusion. However, they must have that right; it is only right and proper that they do.
I hope that those remarks are helpful to the hon. Gentleman, and that the Minister might consider coming back on the particular issue of the consent form at a later date.
Mark Simmonds: I thank the hon. Gentleman for his contribution on the amendments, which has been helpful and, as always, detailed.
The purpose of tabling the amendments was to raise the importance of these issues with the HFEA, particularly with regard to the point about the specificity of consent, which the hon. Gentleman re-emphasised. The Minister has, as always, been very clear, yet she seemed to be arguing on the one hand that embryo testing is a separate area, while on the other arguing that it is a subset of other areas in the Bill.
Clearly, this is a probing amendment and the importance of the issue has been put on the record by me and by the hon. Gentleman. The HFEA needs to clarify the fact that it will be possible to be specific.
Dawn Primarolo: I am happy to correct a point that I made early in my remarks: there are consequential provisions to schedule 3 relating to consent for the use
Mark Simmonds: I understand that. The Ministers intervention has helped to clarify the fact that the consent form can specify, in detail, subsets of consent that are not in the Billif I have correctly understood what she said. Someone will therefore be able to consent for their gametes or embryos to be used just for embryo testing. If that is the case, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
This is a probing amendment. I fully support the consent that must be at the heart of the Bill, and it is right that people should know and understand what they are consenting to and the purposes for which their gametes are used. We must ensure, however, that this necessary cornerstone of the Bill is not over-bureaucratic, hindering potential research. Not only may it be difficult to keep track of what each individual has consented to, but there could be a problem if a cell line has been developed from a persons gametes and is ready for use in clinical trials but the donor has not consented to that particular use. This could result in the work being wasted and having to be repeated.
When researchers start a project, they may specify the terms of reference to which donors consent, but, as we all know, science and research develop. Will consent have to be regained for research outside the original terms of the consent, and will researchers have to go back to the original donor for additional consent as science moves on?
Dawn Primarolo: The Bill requires consent from any person whose cells or gametes are used to create a human admixed embryo. Consent is also required for the subsequent use of any embryos created.
The amendment would remove the provision that requires the consent to be linked to a research project and that enables a person to specify conditions subject to which their embryo can be used. The purpose of that provision is to mirror the consent provisions for human embryos, which enable a donor to place limits on how any embryo created using their genetic material can be used.
The provisions also allow a person to place conditions on the consent, such as specifying that their cells may be used only for projects of a specific naturefor example, research on motor neurone disease.
Accepting the amendment would mean that each person could give only a general written consent before the cells or gametes may be used for any research project involving admixed embryos, without the individual necessarily being fully informed. I say to the hon. Member for Boston and Skegness that the intentionI
It is not the intention that we create a broad general consent, and it should not be possible for that to happen. We are quite clear about what we are doing. If the hon. Gentleman feels that we are being unnecessarily restrictivewe do not think that we areI am happy to hear further points on the matter. I would certainly want to satisfy myself that there is a mirror here, and I would go away and ensure in discussions with parliamentary counsel that that is clear. We are not seeking to put different bureaucratic arrangements in place; we are seeking to ensure that the procedures are the same as for embryos. I hope that that clarifies the point for him.
Dr. Harris: I wanted to wait until the Minister explained the point of this subsection before making a contribution. The treatment of human admixed embryos seems to be different from that of general embryos. In respect of the use of embryos generally, the illustrative text says:
A consent... must specify one... of the following purposes...
(c) use for the purposes of any project of research,
and may specify conditions subject to which the embryo may be so used.
In the case of an admixed embryo, it states that the consent
must specify use for the purposes of a project
not any project of researchand then goes on to say
may specify conditions.
There is a difference, and if the Minister is saying that she will look to see whether it is right that there is a reason for that, I welcome it. I am not sure that I can see that.
Dawn Primarolo: Yes, that is precisely my point. We want the same as we have elsewhere. We want a person to be able to give broad consent if they choose, but if they want to specify a conditionto go back to our previous debatethat should also be open to them.
This is a question of the drafting of the Bill, rather than of the Governments intention. In my view, the Governments intention is to continue to hold the position as we do for embryosthat a person can give broad consent if they choose, or specify conditions if they choose. That is what this measure is supposed to provide.
I understand absolutely the point that the hon. Member for Oxford, West and Abingdon is rightly making, which is that we need to ensure that a project has the same meaning, so that the wording does not put in more. I have told the Committee that my officials are having discussions with parliamentary counsel to ensure that that is what the wording delivers. I assure hon. Members that that is the intention, but if for some reason the wording does not do that, we will need to come back to the Committee. However, that is the clear intention and our understanding.
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