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Baroness Blatch: I am becoming more and more attracted to the answer that the noble Lord has given to me, setting aside the issue about clinics and the regulatory framework of the HFEA.

What I now understand the noble Lord to be saying is that anybody who aids, abets, counsels or procures, as part of the process towards the placing of a cloned embryo in a woman, will be caught by the criminal terms of the Bill. All of them will be, not including the process. The answer therefore is that both of my amendments are subsumed within the Bill; that is, my first amendment in relation to collaborating in the process, and my second amendment in relation to all of the preparatory work leading to the process of placing the embryo in the woman.

I am extremely happy with that and that my amendments are subsumed in this Bill. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 7 not moved.]

Clause 1 agreed to.

Baroness Blatch moved Amendment No. 8:

In this Act, except where otherwise stated, references to an embryo include—
(a) a unicellular embryo;
(b) a totipotent embryonic stem cell; and
(c) an egg undergoing a process which will lead to the formation of an embryo."

The noble Baroness said: Amendment No. 8 is a technical amendment. The proposed paragraph (a) refers to a Xunicellular embryo"; that is, a one-cell embryo.

Amendment No. 8 will extend the definition of Xembryo" and prevent the placing of a one-cell embryo, created otherwise than by fertilisation, into a woman. It might be thought that the Bill already prevents that. But as the law now stands, that is not the case. This amendment is needed to close a serious loophole that was exposed by the ProLife Alliance in the High Court and is not dealt with by the Bill as drafted.

In court the government lawyers were forced to concede that, according to their arguments, a one-cell Xentity" created by cell nuclear replacement was not an embryo. Mr Justice Crane left open the question of whether a one-cell entity created by nuclear replacement would be an embryo from a scientific point of view. Clearly he held that it was not an embryo from a legal point of view. But scientifically he was not sure and in paragraph 49 of his judgment he held as follows:

    Xthere could be doubt whether that organism [the CNR product] was an 'embryo' prior to the two-cell stage ... It may well be that responsible researchers would treat the organism as subject to control . . . However they would not be obliged to do so".

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Unless Amendment No. 8 is accepted, the Bill will not prohibit the placing in a woman of the one-cell product of cell nuclear replacement. By accepting this amendment Parliament would extend the definition of an embryo to include the one-cell product of cell nuclear replacement and would therefore ensure that the ban covers such embryos as well.

It is a fact that a one-cell CNR entity could be placed into the fallopian tube of a woman with the potential to carry on developing. It was surprising to hear that the noble Lord, Lord Hunt, when speaking earlier today, was setting much store by the hope that the Appeal Court may solve the regulatory problems by overturning Mr Justice Crane's judgment in favour of the ProLife Alliance. In fact, the consequences of such a ruling on appeal would create its own regulatory problem; it would leave one-cell CNR entities outside the scope of this Bill.

The Government's legal team accepted that the worrying exclusion would follow from their own arguments. Therefore this is a case of heads the Government lose and tails the Government lose. No legal remedy remains for the Government's problems in this area. For that reason I regard the new paragraph (a) as absolutely necessary.

New paragraph (b), which refers to,

    Xa totipotent embryonic stem cell",

deals with another serious loophole which exists in the Bill as now drafted. It may be that the Bill does not prohibit the placing of embryonic stem cells into women. The fact is that such cells have the potential to develop as embryos. That that is so is beyond doubt. Over the past few years researchers have managed to grow mice and cows by implanting mice and cow stem cells into female mice and cows.

If Members of the Committee will be patient, I shall read the titles of some of the published papers which deal with that practice. First, Nagy A et al, Derivation of completely cell-derived mice from early-passage embryonic stem cells. That paper was published in the proceedings of the National Academy of Sciences in the United States as long ago as September 1993. Secondly, Wang ZQ et al, Generation of completely embryonic stem-cell derived mutant mice using tetraploid blastocyst injection, again published in Mechanisms of Development, in March 1997. Thirdly, Iwasaki S et al, Production of live calves derived from embryonic stem-like cells aggregated with tetraploid embryos. That paper was published in Biology of Reproduction in 2000.

If Amendment No. 8 is not passed, then cloners will be able to by-pass the parliamentary prohibition on live birth cloning by implanting embryonic stem cells into women. The stem cells could then develop as embryos inside the women.

Finally, paragraph (c) relates to,

    Xan egg undergoing a process which will lead to the formation of an embryo".

Amendment No. 8 will ensure that no non-fertilised entity which cannot yet be described as an embryo, but if left to develop will turn into an embryo, can be implanted into a woman.

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The Human Fertilisation and Embryology Act 1990 took care to ensure that even,

    Xeggs in the process of fertilisation"

which might not yet be embryos would nonetheless be treated as embryos for the purposes of the law. Section 1(1)(b) of the HFE Act provides that,

    Xreferences to an embryo include an egg in the process of fertilisation".

The amendment provides a similar extended definition to cloned embryos as already exists for fertilised embryos. Without the amendment scientists would be able to place in a woman an entity which was not yet an embryo but would, if allowed to develop, whether inside or outside a woman, turn into an embryo. I beg to move.

Lord Alton of Liverpool: I support Amendment No. 8 which the noble Baroness, Lady Blatch, has just moved. In doing so, I refer the Committee to the Human Fertilisation and Embryology Act and to the principal terms used in Part I which states:

    XIn this Act, except where otherwise stated—

    (a) embryo means a live human embryo where fertilisation is complete, and

    (b) references to an embryo include an egg in the process of fertilisation, and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote".

Embryo means a live human embryo where fertilisation is complete. Effectively, the Government's appeal before the High Court sought to render those words redundant. That clearly has to be read in conjunction with the phrase,

    Xfertilisation is not complete until the appearance of a two cell zygote".

The Government went to the High Court determined to win the point that a one-cell cell nuclear replacement entity is not an embryo. Paragraph 49 of the judgment handed down by Mr Justice Crane agreed with that. That points to a lacuna in the definition in the 1990 Act and in today's Bill. It may be that the Government do not like the amendment that has been placed before the Committee today, but their own failure to bring forward a new definition of Xembryo" will lead to further uncertainty; it will not lead to settled law. Failure to resolve this will simply lead to fresh applications to the courts in due course.

This is a Bill dealing with criminal law. As the noble Lord, Lord Brennan, said earlier, the Bill carries a long prison sentence upon which juries will have to determine an outcome and/or the equivalent of a #1 million fine. Therefore, to leave a glaring ambiguity at the heart of the Bill exposes members of the scientific community in the United Kingdom to criminal proceedings. It leaves the Government open to fresh legal challenge and it leaves it likely that through this coach and horses gap will come galloping the very practices which every Member of your Lordships' House has sought today to outlaw.

If the Minister does nothing else today, I should be grateful if he would set out for us his definition of the human embryo. Earlier, in answer to an intervention I made, he upheld the provision of Section 1(1)(b) of the

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principal terms of the 1990 Act. I hope that in this context he will reiterate that. I also invite him to clarify three other brief points. First, when does an embryo cease to be an embryo and become a foetus? That is the point to which the noble Baroness, Lady Blatch, alluded during the Second Reading debate earlier. If, for the sake of argument, for instance, a cloned embryo were to be gestated in an animal until it becomes a foetus, would the current Bill still apply? That, of course, is not merely an academic concern, horrific though it sounds; it has already been mooted in many parts of the scientific community overseas.

Secondly, would it be possible for the Human Fertilisation and Embryology Authority inspectors to distinguish between normally fertilised human embryos and those that have been created by cell nuclear replacement? How is that policing to be carried out? How will it be done in practical terms?

Thirdly, given his remark that the Bill will prohibit exportation of cloned embryos from the United Kingdom, will he say how that conforms with the judgment? The Minister shakes his head to indicate that he did not say that. In that case, will he clarify at this point in the Committee proceedings that it will indeed be possible for cloned human embryos which have not been implanted in a woman to be exported from this country and implanted overseas? Is that in conformity with the judgment, for instance, in the Diane Blood case which allowed her to go abroad for posthumous conception?

With those comments and with those questions I reiterate my support of the amendment which the noble Baroness, Lady Blatch, has laid before the Committee this evening.

10.45 p.m.

Lord Walton of Detchant: I am puzzled as to whether this amendment is absolutely necessary. Can the Minister clarify one or two points? First, it is perfectly clear that once a sperm has penetrated an ovum the single cell so created is an embryo. I accept that. However, is a single cell into which a nucleus has been transplanted at that stage an embryo or, as the legal judgment on 15th November suggested, does it not become an embryo until it has reached the two-cell stage?

Of course, totally potent embryonic stem cells can be produced only by the development of such cells from embryos, however they are created. I would like such matters clarified before considering the amendment so eloquently proposed by the noble Baroness, Lady Blatch, and the noble Lord, Lord Alton.

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