Human Fertilisation and Embryology Bill [Lords]
Dawn Primarolo: I thought that I had made it clear during a previous debate that the Government see training as an integral part of research. We do not see the necessity for a licence for training only and we do not permit that.
With regard to the point made by the hon. Member for Boston and Skegness, I am not aware that there has ever been an issue about unsigned consents, so I cannot specifically reassure him on that point. I suppose that it
Mark Simmonds: If that is the caseI am sure that the Minister is correctit gives rise to a question about the necessity of adding a signature to a system that is working perfectly well already.
Dawn Primarolo: I am sure that the hon. Gentleman would accept that if a signature were made explicit, most of us would sign consent automatically. However, I cannot tell him whether we have ever had a consent that has not been signed. The point is to make it explicit. However, in this matter, we would all ensure that we signed it, particularly bearing in mind that that could have implications for future research. As my right hon. Friend the Member for Coatbridge, Chryston and Bellshill said, there might be areas of research to which we would not want to consent. I will return to the matter, but I am unable at the moment to give the hon. Gentleman specific details at the moment.
Dr. Harris: I raised six points. The Minister has said that the first one arose due to a misunderstanding of intention and I shall look at what she has said. I accept that she has dealt with the second and third points in respect of training matters.
I asked whether the Minister could give an explanation on the provisions on lavage, and the hon. Member for Boston and Skegness, who can speak for himself, indicated that he was also interested in that answer. I have also raised substantivelytwicethe threshold for the patient being likely to regain capacity in respect of amended paragraph 10 of schedule 3 to the 1990 Act. I would be grateful if the Minister could respond to those two issues only, having had her amusing fun with my asking questions about the schedule.
Dawn Primarolo: I have answered the hon. Gentlemans questions specifically with regard to consent and to that point. I put all his points together by explaining how they interact in the schedule. If the hon. Gentleman is still dissatisfied after reading Hansard, I will be more than happy to correspond with him and make sure that the letters are circulated to every member of the Committee. I am not trying to avoid answering his questions, but if he wants complex answers about the interaction of a whole range of things with which he can be satisfied, he could always give me notice. That would ensure that I understood before he said it, as well as when he said it, exactly what was his intention so that I would not misinterpret it.
The hon. Member for Boston and Skegness raised a point about the amendment to paragraph 4 of schedule 3 to the 1990 Act concerning whether people who are physically incapacitated can withdraw consent. Yes, they can. Provision is made in paragraph 3 of schedule 3 to the Bill, which amends paragraph 1 of schedule 3 to the 1990 Act. I hope that he will be able to reflect on that after the Committee, and if he is still not satisfied, I would, of course, be happy to come back to him.
Dr. Harris: The record will show that I made no criticism of the Minister either in my opening remarks
I am grateful to the Minister for explaining the position with regard to testing, which was not immediately apparent to me in respect of human admixed embryos. More importantly, she explained that under this regime, training was very clearly going to be permitted on human admixed embryos and that it was part and parcel of the research licence. I am not the only person who has expressed concerns about thispeople working in the field want clarificationso I am grateful to her for that.
I did not think, however, that it was unreasonable to ask for an explanation of paragraph 10 of the schedule. The explanatory notes merely say:
Paragraph 7 of Schedule 3 to the 1990 Act is amended by paragraph 10 of Schedule 3 to the Bill to prohibit the use of an embryo taken from a woman to create an embryo in vitro or to create a human admixed embryo in vitro.
I merely asked whether this was just tidying up, or whether there had been a problem or a concern expressed and what was the mischief that this was seeking to amend.
Dawn Primarolo: And I did answer the hon. Gentlemans point. I say again that this relates to the question of consent that is in the 1990 Act regarding women and lavage. Paragraph 10 simply makes it clear that that has not been superseded. It makes it clear that the embryo taken from the woman is tied up with questions of consent, in general or specifically. It cannot be used to create a human admixed embryo, so the consent on that issue in the 1990 Act is linked to this schedule. That is the answer that I gave him.
Dr. Harris: If that is the case, I am grateful to the Minister for reiterating that and I will go away and study that.
Finally, I have raised three times now the position of a patient likely to regain capacity and whether we have the correct threshold. I do not think that this is a question of interaction or of how the consent arrangements fall. There is a specific provision. I wish to ask whether there will be patients in certain conditions in which it will be very difficult to judge whether likely is the right test. I think that that will create problems, and it struck me that it might be possible, before the Bill completes its passage, to provide clarity on that.
Question put and agreed to.
Schedule 3, as amended, agreed to.
Schedule inserted in the 1990 Act as Schedule 3ZA
Question proposed, That the schedule be the Fourth schedule to the Bill.
Mark Simmonds: I have one or two questions for the Minister about counselling and the circumstances in which it should be offered. I certainly do not believe that counselling should be mandatory, but it should be offered and it should be effective. It is important that counselling is provided by skilled professionals who are experienced in such matters, so I have some questions.
Do counsellors working in this field have specialised training or expertise, or are they counsellors in other
Dawn Primarolo: On the question of the fee, the cost of counselling is covered in the cost of the treatment servicesit is all wrapped up. On the question of who sets the guidelines, a code of practice is set as guidance for clinics on how to offer counselling. The code states specifically that patients need to be aware of the offer, that it needs to be routine, that it should include written information and that it should give the names of qualified counsellors in the area, who may also have wider qualifications. The counsellors role needs to be explained, as well as when they are available and how to access the service. Obviously, there should be no pressure to accept counselling, but sufficient time should be given to consider the offer.
I am afraid that I do not know the answer to the hon. Gentlemans question about the division of counsellors roles, so I will have to write to him. The HFEA sets the code of practice, counselling is included within the cost of treatment, and counsellors need to be specialised. I will respond to his last point as soon as I can.
Question put and agreed to.
Schedule 4 agreed to.
Conditions of storage licences
Mark Simmonds: I beg to move amendment No. 5, in clause 15, page 11, line 47, leave out ten and insert seven.
The Chairman: With this it will be convenient to discuss amendment No. 34, in clause 15, page 12, line 3, leave out ten and insert seven.
Mark Simmonds: Amendment No. 34 is a consequential amendment to amendment No. 5, so I shall concentrate on the latter. It is, I acknowledge, a further probing amendment, which relates to how long gametes and embryos can be kept in storage. At the moment, embryos can be kept for five years, and then for five years beyond that, if the couple chooses. Will the Minister put on record what evidence exists that embryos and gametes are of sufficient quality after and up to 10 years? For how long afterwards does she believe that embryos can be kept in storage without deteriorating, if there is indeed evidence to support that?
Is the Minister concerned that removing the five-year break will result in fewer couples giving their embryos for research as they will not necessarily be reminded of the possibility after the five years? As the 1990 Act
I think that a recent case forms the basis of an amendment that has been tabled by the hon. Member for Oxford, West and Abingdon. A young girl, because of treatment she has received, will not be able to have children later on in life. However, she is of such a young age that even if her mother donates an egg for her now, after the 10-year period has elapsed, she will still not be old enough to have a child. Regulations might allow that situation to be changed as scientific techniques develop and, again, it could be amended by new clause 2, which was tabled by the hon. Gentleman.
Dawn Primarolo: I recognise that limits on the storage of gametes and embryos can cause some concern. The length of storage needs to ensure fairness, while also taking into account the safety of freezing. I believe that the statutory 10-year period for gametes, with extended storage for medical reasons, remains appropriate. I also consider that the same limits should be applied to embryos. Therefore, the Bill brings storage limits into line with each other.
The Warnock report proposed a 10-year period. I suppose that the hon. Gentleman is quite right about which years one picksit is arbitrary. Five years was the decision of Parliament. In the 24 years since the report was published, there has been no body of evidence to suggest that using embryos that have been frozen for 10 years endangers a mother or child. There is a possibility of changethe hon. Gentleman pointed to the regulating powerenabling an extension beyond 10 years in specific circumstances, but that is something that would need to be considered later. At this point, because we can see that there is an application to go further, it seems sensible to go for 10 years. I suppose that his guess might be as good as anyone elses. That is the reason for settling at 10 years, but allowing variation under specific circumstances and having the regulatory power in place, if it is necessary to extend it further in the future.
Mark Simmonds: I am grateful to the Minister for that explanation and for the confirmation that there are regulatory powers for changing what is in the Bill, if scientific advancement allows. In that context, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
The Chairman: With this it will be convenient to discuss new clause 2Extension of statutory storage period for treatment of blood relatives
(1) The Human Fertilisation and Embryology (Statutory Storage Period) Regulations (S.I. 1991/1540) are amended as follows.
(2) In regulation 2(1) for paragraph (2) substitute paragraphs (2) and (2A).
(3) After regulation 2(2) insert
(2A) The circumstances referred to in paragraph (1) are that the gametes were provided by a person who has given written consent for them to be used by another person
(a) who is a blood relative of the person providing the gametes,
(b) whose fertility was, in the written opinion of a registered medical practitioner, significantly impaired on the date on which the gametes were provided, and
(c) who was aged under 45 on the date on which the gametes were provided...
Dr. Harris: I wanted to draw attention to something that has already been touched upon: a problem with not only the current storage legislation, but the regulations. The Minister will be aware of the case that I am going to cite on behalf of my hon. Friend the Member for Hazel Grove (Andrew Stunell), who has been assiduously pursuing the issue for one of his constituents. He raised it on Second Reading and wrote to the Minister on 14 May to set out the problems. I thought that it would be useful to summarise the situation and to quote from that letter, with the permission of my hon. Friend.
The problem is that the regulations for storing gametes were set by the Human Fertilisation and Embryology (Statutory Storage Periods) Regulations 1991, which could, in theory, be amended under the current Bill. In this case, there is a woman whose daughter suffers from Turner syndrome. That is not life-threateninga relatively normal life can be led with treatmentbut one of its features is infertility. In this case, the mother wishes to donate her own eggs so that her daughter will be able to have children by IVF treatment in the future. The problem is that the time limit for storing gametes is set at 10 years. Regulations state that gametes must be donated before the donor reaches the age of 36, which creates a problem in this family and, presumably, others. If the mother donated before the age of 36, the 10 years would expire when her daughter was still only 18 and therefore extremely unlikely to be ready to use the eggs.
The Committee will be aware that the current regulations provide for an exception if the gametes are stored for the use of the donor. However, according to a letter received by my hon. Friend the Member for Hazel Grove from the HFEA, the reason for the 10-year limit is that it is best if clinics are not overburdened by the number of samples in storage. I accept that there is a regulatory issue, so the question is whether there could be exceptional circumstances in which samples might be permitted to be stored for longer than 10 years, for example if donated eggs are intended for another family member who is infertile, which is the case that my hon. Friend has made in a number of forums. Would new clause 2 achieve that? If not, might an amended version?
There is discretion on retrieving eggs after the age of 36. In exceptional circumstances, clinics can use eggs from women over the age of 36, but I think that everyone is awarethe Minister is, of coursethat fertility and thus the efficacy of the treatment diminishes rapidly after that point.
Even if the drafting of new clause 2 is not perfectif there are imperfections, it is through no fault of my hon. FriendI hope that its intention is clear. It states that an exception can be made when a person
has given written consent for them to be used by another person...(a) who is a blood relative of the person providing the gametes...(b) whose fertility was, in the written opinion of a registered medical practitioner, significantly impaired on the date on which the gametes were provided, and...(c) who was aged under 45 on the date on which the gametes were provided.
This is not a unique caseI am conscious of the fact that we should not legislate to provide for an individual caseand I wonder whether an amendment could be made. Obviously, we do not need primary legislation, so I would understand if the Minister said that the Government wished to consider the matter themselves and introduce their own regulations to allow for an exception.
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