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It would be highly desirable for the rest of the spectrum to be looked at from the point of view of appropriate regulation. I do not think that the 1986 Act, which, after all, is a little elderly, is adequate to deal with the kind of considerations involved when less than 50 per cent human material is introduced into animals. Many people to whom I have spoken or who have spoken to me about the Bill did not know that such an end of the spectrum existed and has existed in practical terms for some time. The Government would do well to consider whether a different form of control or regulation is required at the other end of the spectrum.
Perhaps because I had some part in framing this definition, I think it is entirely satisfactory. The use of the word predominant, a word we hit on in the discussions to which the noble Lord, Lord Darzi, has referred with the eminent scientists who were willing to talk to us about it, is a general word which covers the whole period of an embryo's existence. Therefore, you look at whether the animal DNA is to predominate. If it does, it leaves this definition and, if not, it stays within it.
My view is that the amendment proposed by my noble friend Lord Howe is not necessary. However, we discussed it before and it is important to raise it now so that the precise scope of the word predominate might be discussed at this stage which might help in any future matter which may arise in court or in some other way. I thank the Minister very much for what he has said. I certainly support government Amendment No. 3 and I say that Amendment No. 3A tabled by my noble friend is not necessary, although I believe this discussion is necessary.
Lord Walton of Detchant: My Lords, I, too, congratulate the Government on Amendment No. 3, which is a very worthy attempt to deal with the issues which were so cogently argued by the noble and learned Lord, Lord Mackay, when this matter was last before the House. I am sufficiently attracted by certain features of the amendment now proposed by the noble Earl, Lord Howe, but at the same time I agree very much with the noble and learned Lord, Lord Mackay, that it does not seem to be necessary.
Amendment No. 3 as it stands is the outcome of detailed discussions between the noble and learned Lord, Lord Mackay, the Academy of Medical Sciences and the Government and deals with a fifth category of admixed embryo. It relies on an alternative regulation-making power in new Section 4A to amend the five categories to catch any other entities. The only problem is that it still is not totally and completely inclusive in one respect: the Amendment No. 3 approach is not entirely clear in that it does not specify precisely how an embryo is to be treated where the proportion of animal DNA varies such that it may predominate at some point but not at another. I hope that the noble Lord, Lord Darzi, will deal with that in his reply.
One example of thatI have received a two-page briefing from Professor Robin Lovell-Badgeis the issue of tetraploid complementation and diploid complementation, but I do not understand those sufficiently to be able to impose the details on your Lordships' House. Therefore, I leave that matter in the worthy hands of the noble Lord, Lord Darzi. I hope that he can deal with the issue as to why, in some respects, this amendment, which is very satisfactory in many ways, is not totally complete and must be kept under review by the Government in the future.
Lord Patel: My Lords, I thank the Government for tabling this amendment. I supported the amendment tabled by the noble and learned Lord, Lord Mackay of Clashfern, in Committee and I support this government amendment. I have some sympathy with the amendment tabled by the noble Earl, Lord Howe. We discussed
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To confuse the matter further, all the evidence from animal studies suggests that for tetraploid complementation, mentioned by my noble friend Lord Walton of Detchant, to happen the two species have to be very close. For example, tetraploid complementation will work in sheep and goat embryonic cells, but not in those of mice or rats. For it to work in humans, therefore, it will have to be a closely related species such as a chimpanzee. The transfer of an embryo into an animal will require a Home Office licence and that will not be permitted. If such an entity were created at some point, not too far along in the development of the embryo, it would grow faster than the embryonic tissues, so it is important to know at what point we are talking about. If, for example, it was in a human, I believeI might be wrongthat could occur at what we call gastrulation. I think the Minister understands what I mean. In humans it would be about 14 days when organs are beginning to be defined. However, for the purposes of this Bill and the research, embryos will not be allowed to be experimented on beyond 14 days and for the purposes of obtaining stem cells, we are talking about four to six days.
The amendment tabled by the noble Earl, Lord Howe, has some issues to be discussed but they may not be directly applicable to this Bill. The fact that the Government in the Commons retained a regulation-making power in new Section 4A(10) which allows existing categories to be amended, may mean that, in future, if necessary, we could discuss this again.
Lord Darzi of Denham: My Lords, the amendment tabled by the noble Earl, Lord Howe, would extend the new admixed category where the animal DNA does not predominate to include embryos where the animal DNA would not ultimately predominate. I shall try to explain that. I can appreciate why the noble Earl may think this is necessary, but I can assure him that the provisions in the Bill already address this situation.
If it were considered that an embryo was to be created in which the human DNA would ultimatelypredominate, an application for an admixed research licence would have to be made to the HFEA at the outset. This is because a licence is required to bring about the creation of a human admixed embryo. If a researcher was intending to create an embryo that would at some stage be predominantly human, for however short that time might be, they would need a licence to do so.
The noble Lord, Lord Walton, also referred to tetraploid complementation where the cells of an early animal embryo are altered so that they contain twice the usual complement of DNA. These cells could give rise only to extra-embryonic tissuefor example, a placentaand any human cells placed within it could give rise to the embryo proper. It would be an admixed embryo for the purposes of the new catch-all category that the Bill is adding to the definition of human admixed embryo at Clause 4.
The amendment tabled by the noble Earl, Lord Howe, adds a regulation-making power to the categories of human admixed embryos to enable the definition to be extended. That was the position the Bill was in when it was last considered by your Lordships' House. We listened to persuasive arguments at that time that such a provision was too open, and we therefore replaced it with a category proposed by the noble and learned Lord, Lord Mackay of Clashfern, of any other embryo containing animal and human DNA where the animal DNA does not predominate. In the case of an embryo in which the brain might be predominantly animal, it is worth reminding ourselves what we mean by predominant. We refer not only to the percentage of the DNA but also to its location and functionality. If that entity had a human brain, that could clearly have a predominant function so, by definition, it would be at the human end of the spectrum of human admixed embryos and would require an HFEA licence.
Earl Howe: My Lords, that was a very helpful reply, and I am grateful to noble Lords who spoke in this short debate. As the Minister will appreciate, my worry was that it did not seem to me to be totally clear from the wording of the Commons amendment that embryos that would alter their composition to contain predominantly human DNA post-14 days would all be captured. The Minister reassured us that the word predominate will cover all scenarios, but my problem is that the word predominate relates to an embryo, rather than a foetus, which is the term that would relate to the embryo at a later stage of its development where the proportion of animal and human DNA changes during development. A mid or late gestation foetus would definitely not be classified as an embryo. My amendment, which is inserted at the end of the government amendment, retains all the careful wording that my noble and learned friend helped to develop and clarifies that no matter how late in the potential development of the organism, which could be as late as the point of birth, if the human DNA ultimately predominated, it would be included as a human admixed embryo and thus would not be allowed to develop to that stage. After listening to the Ministers reply, I am not totally secure that he has covered that point because of the use of the word embryo rather than foetus.
I listened with care to his helpful answer on the second part of my amendment. He clarified that the amendment covers not only the percentage of DNA, but also the functionality of the tissue. I had not appreciated that, and I do not think I could have been expected to from a bald reading of the wording of the amendment. It is valuable that that will go down in Hansard to be read. Unless the Minister wants to come back to me on the point I made about embryo as opposed to foetus, which is a significant point, I will bow to his reassurance.
Baroness Thornton: My Lords, I do not think this is an appropriate point at which to reopen the debate. The only remark that might be called for is one from my noble friend, if he chooses to speak. We are at the end.
Lord Elton: My Lords, I think I am in order in using this opportunity to suggest to my noble friend that he might elicit from the Minister a clarification of a little sentence he put in that could be quite important. He said that predominance would not depend upon percentage only but also on location or function. Could my noble friend ask the Minister whether that means that if the cells concerned relate to the brain, which is the example he gave, although they are less than 50 per cent, they still predominate?
(a) omit the and at the end of paragraph (a), and
(b) at the end of paragraph (b) insert , and
(c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application..
During passage of the Bill through this House, debate took place on the use of embryonic stem cells, derived under a research licence, in therapeutic applications. The Government subsequently wrote to all Peers involved in those discussions setting out how, in the Governments view, embryonic stem cells derived under an HFEA research licence could be used in therapeutic applications.
These amendments were made in the light of that debate to ensure that research centres deriving embryonic stem cells, where those stem cells are intended for therapeutic use, are required to abide by the quality and safety standards set out in the European Union tissue and cells directive in relation to the stem cells and the embryos from which they are derived.
The directive lays down standards of quality and safety for human tissues and cells intended for human application, including gametes and embryos. The relevant requirements already apply to embryos used in reproductive treatment as a result of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. Stem cells derived from embryos are also regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. It is important that these standards are also applied to the embryos that are used to derive stem cells to be used in human application to ensure the necessary levels of quality and safety of any tissue to be used in treatment.
Baroness Thornton: My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 8 and 9. I shall speak also to Amendments Nos. 13, 32, 33, 35, 37, 40, 56 and 95 to 103. These are minor and technical drafting amendments to provide correction, clarity and consistency. Amendments Nos. 8 and 9 are purely technical and ensure consistency with the wording of the new Section 13(6) of the 1990 Act, as inserted by Clause 14 of the Bill. The amendments replace the words the woman being treated in the new Section 13(6B)(a) and the words,
Amendment No. 13 is simply a minor drafting amendment, removing the superfluous words any of in reference to the three paragraphs of new Section 31ZD(3) in connection with the disclosure of information to donors. Amendment No. 32 makes a minor drafting correction to Clause 40. It is purely technical and changes the words in the clause to the man instead of a man, as currently drafted. I turn now to Amendments Nos. 33 and 35. In Clause 43 the woman being treated is referred to as W. Amendment
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Amendment No. 37 relates to Clause 50, which makes clear what a civil partnership is for the purpose of Clauses 35 to 47. This provision is equivalent to the provision in Clause 49 relating to marriage. The clause makes clear that a civil partnership is one which has been subsisting, unless a separation order is in force, and it includes the parties to a void civil partnership if either or both parties reasonably believed it was valid. Currently Clause 50 applies the definition to the reference to civil partnerships, but it needs to apply to any reference to civil partnerships at any time in Clauses 35 to 47. Amendment No. 37 is therefore a grammatical correction to Clause 50, which ensures that the meaning of civil partnership applies to any reference to civil partnership in Clauses 35 to 47 of the Bill.
Amendment No. 40 makes a minor amendment to Clause 55, which provides for the Secretary of State to be able to make regulations relating to enactments about adoption. Clause 55(3) lists what the enactments about adoption are. Amendment No. 40 makes a technical change to Clause 55(3) to ensure that it reads consistently with Clause 55(1) by changing enactments relating to adoption to enactments about adoption.
Amendment No. 56 is a drafting amendment to ensure consistency in situations where consent is required. This amendment is consequential to the embryo training provisions in the Bill, which allow embryologists to train using donated embryos. Provisions in the Bill ensure that before an embryo is received by any person, effective consent to the use of that embryo must be in place. Under the Bill, this consent could be to treatment, research or both. This amendment adds that consent could have been given for the use of an embryo in training. The person receiving the embryo must ensure that consent to one or more of these purposes is in place.
Amendment No. 95 corrects the amendments in Schedule 6 to the Births and Deaths Registration Act 1953 so that reference to that person is replaced with the woman concerned to reflect the definition inserted into Section 10(1B)(b)(i) of a woman concerned as a parent of a child by virtue of Clause 43 of the Bill. Amendments Nos. 98 and 99 are also technical and correct the amendment to the Registration of Births, Deaths and Marriages (Scotland) Act 1965 so that the references to other parent of the child and references to the person are replaced by the woman concerned to reflect the definition inserted into Section 18B(1) of a woman concerned as the parent of a child by virtue of Clause 43 of the Bill.
Amendments Nos. 96, 97, 101 and 102 make technical corrections to ensure that the Bill refers to the formation of a civil partnership and not the time of the civil partnership. This is because Section 1 of the Civil Partnership Act 2004 defines a civil partnership as the relationship, not the ceremony. Therefore, references to entry into marriage cannot be translated to civil partnerships. Amendment No. 100 is a drafting correction to change the reference in Section 18B(3)(b) of the
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Amendment No. 103 is a technical correction; it corrects the amendment to the Children (Northern Ireland) Order 1995 under paragraph 75 of Schedule 6 to the Bill to make an equivalent provision to the amendment to the Family Law Reform Act 1987 under paragraph 24(3) of Schedule 6 to the Bill, which makes provision for England and Wales. The amendment brings Northern Ireland provision in line with the provision for England and Wales, and ensures that both provisions read domiciled immediately. I beg to move.
(g) the disclosure is made so that no individual can be identified from the information,
(h) the disclosure is of information other than identifying donor information and is made with the consent required by section 33AB,
(ja) the disclosure-
(i) is made by a person who is satisfied that it is necessary to make the disclosure to avert an imminent danger to the health of an individual (P),
(ii) is of information falling within section 31(2)(a) which could be disclosed by virtue of paragraph (h) with P's consent or could be disclosed to P by virtue of subsection (10), and
(iii) is made in circumstances where it is not reasonably practicable to obtain P's consent,
20: Page 28, line 36, leave out treated together with another and insert who is treated together with, or gives a notice under section 37 or 44 of the Human Fertilisation and Embryology Act 2008 in respect of, another
( ) In this section identifying donor information means information enabling a person to be identified as a person whose gametes were used in accordance with consent given under paragraph 5 of Schedule 3 for the purposes of treatment services or non-medical fertility services in consequence of which an identifiable individual was, or may have been, born.
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