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On further consideration of the exception for cells from children, it became clear that it was also desirable to make provision to enable the use of cells from an adult who lacked capacity in very limited circumstances. This would be to address situations where, for example, rare genetic conditions lead to the sudden onset of lifelong incapacity. Following the precedent of the Mental Capacity Act, the Government’s amendments propose that in such cases the researcher would need to approach an individual’s carer and consult them on their views about the wishes of the person.

The Government felt, for several reasons, that it was appropriate to extend the provisions to adults who lack capacity: first, for the sake of consistency. Without the provisions, cells could be taken from a “child” of 17 if they were unable to consent, perhaps because of illness rather than a lack of understanding, whereas tissue could not be taken from someone who was a year older in the same situation. In addition, if this provision was not made, researchers might favour using tissue or cells from children rather than adults when researching these serious medical conditions,

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because exceptions were made only for these circumstances. It is my view that this would not be appropriate.

Again, the exception relating to cells from adults who lack capacity is subject to a number of stringent safeguards. The HFEA must be satisfied that, at the time, the adult lacks capacity and is unlikely to have capacity again; that the adult suffers from a serious medical condition; that the proposed research is intended to increase knowledge about that condition or about its treatment; that there is no evidence that the adult would have refused to participate; and, most importantly, that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out using the cells of a person who could give consent themselves.

In all cases, it will be for the researcher to provide evidence that satisfies the HFEA that all the conditions have been met before a licence to undertake the research may be given. The safeguards set out in the Bill are modelled on the protection provided under the Mental Capacity Act 2005. Research involving people who lack capacity, and the use of their tissue to create embryos, are excluded from the Mental Capacity Act by provisions in the Bill. This prevents any overlap between the two pieces of legislation.

These amendments follow the precedent of the Mental Capacity Act and set out stringent safeguards that must be adhered to before the research can take place. Specifically, there is a requirement for the researcher to approach a carer of the person who lacks capacity to consult them on their views about the wishes of the person.

Moved, accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 56 to 91

Lord Darzi of Denham: My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 56 to 91, to which I have spoken with earlier amendments.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 92

92: Page 66, line 5, at end insert-

“Cases where human cells etc. can be used without consent of person providing them

After paragraph 15 (as inserted by paragraph 13 above) insert-

“Parental consent conditions

15A(1) In relation to a person who has not attained the age of 18 years (“C”), the parental consent conditions referred to in paragraphs 6(3ZA) and 13(4) are as follows.

(2) Condition A is that C suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

(3) Condition B is that either-

(a) C is not competent to deal with the issue of consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or

(b) C has attained the age of 16 years but lacks capacity to consent to such use of C's human cells.

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(4) Condition C is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about-

(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or

(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

(5) Condition D is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who-

(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or

(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

(6) In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications-

(a) for sub-paragraph (3) substitute-

“(3) Condition B is that C does not have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.”,

(b) in sub-paragraph (5)(a), for “have capacity to consent” substitute “are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent”, and

(c) in sub-paragraph (5)(b), for “are competent to deal with the issue of” substitute “have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to”.

Adults lacking capacity: exemption relating to use of human cells etc.

15B(1) If, in relation to the proposed use under a licence of the human cells of a person who has attained the age of 18 years (“P”), the Authority is satisfied-

(a) that the conditions in paragraph 15C are met,

(b) that paragraphs (1) to (4) of paragraph 15D have been complied with, and

(c) that the condition in paragraph 15D(5) is met,

the Authority may in the licence authorise the application of this paragraph in relation to P.

(2) Where a licence authorises the application of this paragraph, this Schedule does not require the consent of P-

(a) to the use (whether during P's life or after P's death) of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research,

(b) to the storage or the use for those purposes (whether during P's life or after P's death) of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of P's human cells.

(3) This paragraph has effect subject to paragraph 15E.

Consent to use of human cells etc. not required: adult lacking capacity

15C(1) The conditions referred to in paragraph 15B(1)(a) are as follows.

(2) Condition A is that P suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

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(3) Condition B is that P lacks capacity to consent to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.

(4) Condition C is that the person responsible under the licence has no reason to believe that P had refused such consent at a time when P had that capacity.

(5) Condition D is that it appears unlikely that P will at some time have that capacity.

(6) Condition E is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about-

(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or

(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

(7) Condition F is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who-

(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or

(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

(8) In this paragraph and paragraph 15D references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

(9) In relation to Scotland-

(a) references in sub-paragraphs (3) to (5) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent, and

(b) sub-paragraph (7) is to be read with the following modifications-

(i) in paragraph (a), for “have capacity to consent” substitute “are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent”, and

(ii) in paragraph (b), for “are competent to deal with the issue of” substitute “have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to”.

Consulting carers etc. in case of adult lacking capacity

15D(1) This paragraph applies in relation to a person who has attained the age of 18 years (“P”) where the person responsible under the licence (“R”) wishes to use P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, in a case where P lacks capacity to consent to their use.

(2) R must take reasonable steps to identify a person who-

(a) otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P's welfare, and

(b) is prepared to be consulted by R under this paragraph of this Schedule.

(3) If R is unable to identify such a person R must nominate a person who-

(a) is prepared to be consulted by R under this paragraph of this Schedule, but

(b) has no connection with the project.

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(4) R must provide the person identified under sub-paragraph (2) or nominated under sub-paragraph (3) ("F") with information about the proposed use of human cells to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project and ask F what, in F's opinion, P's wishes and feelings about the use of P's human cells for that purpose would be likely to be if P had capacity in relation to the matter.

(5) The condition referred to in paragraph 15B(1)(c) is that, on being consulted, F has not advised R that in F's opinion P's wishes and feelings would be likely to lead P to decline to consent to the use of P's human cells for that purpose.

(6) In relation to Scotland, the references in sub-paragraphs (1) and (4) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Effect of acquiring capacity

15E(1) Paragraph 15B does not apply to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo if, at a time before the human cells are used for that purpose, P-

(a) has capacity to consent to their use, and

(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

(2) Paragraph 15B does not apply to the storage or use of an embryo or human admixed embryo whose creation in vitro was brought about with the use of P's human cells if, at a time before the embryo or human admixed embryo is used for the purposes of the project of research, P-

(a) has capacity to consent to the storage or use, and

(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

(3) In relation to Scotland, the references in sub-paragraphs (1)(a) and (2)(a) to P having capacity to consent are to be read as references to P not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Use of cell lines in existence before relevant commencement date

15F(1) Where a licence authorises the application of this paragraph in relation to qualifying cells, this Schedule does not require the consent of a person (“P”)-

(a) to the use of qualifying cells of P to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or

(b) to the storage or the use for those purposes of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of qualifying cells of P.

(2) “Qualifying cells” are human cells which-

(a) were lawfully stored for research purposes immediately before the commencement date, or

(b) are derived from human cells which were lawfully stored for those purposes at that time.

(3) The “commencement date” is the date on which paragraph 9(2)(a) of Schedule 3 to the Human Fertilisation and Embryology Act 2008 (requirement for consent to use of human cells to create an embryo) comes into force.

Conditions for grant of exemption in paragraph 15F

15G(1) A licence may not authorise the application of paragraph 15F unless the Authority is satisfied-

(a) that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are-

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(i) human cells in respect of which there is an effective consent to their use to bring about the creation in vitro of embryos or human admixed embryos for use for those purposes, or

(ii) human cells which by virtue of paragraph 15B can be used without such consent, and

(b) that any of the following conditions is met in relation to each of the persons whose human cells are qualifying cells which are to be used for the purposes of the project of research.

(2) Condition A is that-

(a) it is not reasonably possible for the person responsible under the licence (“R”) to identify the person falling within sub-paragraph (1)(b) ("P"), and

(b) where any information that relates to P (without identifying P or enabling P to be identified) is available to R, that information does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(3) Condition B is that-

(a) the person falling within sub-paragraph (1)(b) (“P”) is dead or the person responsible under the licence (“R”) believes on reasonable grounds that P is dead,

(b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, and

(c) a person who stood in a qualifying relationship to P immediately before P died (or is believed to have died) has given consent in writing to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(4) Condition C is that-

(a) the person responsible under the licence (“R”) has taken all reasonable steps to contact-

(i) the person falling within sub-paragraph (1)(b) (“P”), or

(ii) in a case where P is dead or R believes on reasonable grounds that P is dead, persons who could give consent for the purposes of sub-paragraph (3)(c),

but has been unable to do so, and

(b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(5) The HTA consent provisions apply in relation to consent for the purposes of sub-paragraph (3)(c) as they apply in relation to consent for the purposes of section 3(6)(c) of the Human Tissue Act 2004; and for the purposes of this sub-paragraph the HTA consent provisions are to be treated as if they extended to Scotland.

(6) In sub-paragraph (5) “the HTA consent provisions” means subsections (4), (5), (6), (7) and (8)(a) and (b) of section 27 of the Human Tissue Act 2004.

(7) In this paragraph references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

(8) Paragraphs 1 to 4 of this Schedule do not apply in relation to a consent given for the purposes of sub-paragraph (3)(c).””

Baroness Thornton: My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 92.

Moved, That the House do agree with the Commons in their Amendment No. 92.—(Baroness Thornton.)

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8.15 pm

Baroness Knight of Collingtree moved, as an amendment to the Motion, Amendment No. 92A, leave out “agree” and insert “disagree”.

The noble Baroness said: My Lords, there can surely be no dispute that the subject we are debating, touching as it does on life and death, conscience and ethics, with the losing of freedoms and rights that we once thought were ours without question thrown in, is one of monumental importance. I am not alone in the view that, in a matter of such gravity—and there can be few subjects of greater gravity—this House and the other place should have been granted more time to debate and consider exactly what we are being asked to sanction in what is before us.

Amendment No. 92 is very long indeed. It stretches over six and a half pages and its very first words have a shadow of menace when they refer to:

“Cases where human cells ... can be used without consent of person providing them”.

This amendment is the main amendment allowing researchers to create cloned human or animal-human embryos from a person’s cells without their consent. In its new and extended guise, it has never been debated on the Floor of either House until now. Until now, it has been the common view that one’s body is one’s own and others have no right to take it over against one’s will. I am prepared to believe that, buried in various places in this lengthy amendment, there might be some good and just measures. However, because of the extremely limited time allowed to us for investigating and debating this possibility, I felt that there was nothing for it but to seek to delete the whole amendment; not only to preserve the rights that should be ours, but to bring more clarity and purpose to the Bill. That is why I challenge the whole of this sinister and unwieldy provision. More time might have permitted some parts of it to be agreed, but we shall never know.

Sub-paragraph (2) of new paragraph 15A states that permission to use a person’s cells can be granted because the patient was,

“likely to develop, a serious disease”.

Well, any one of us might become seriously ill at any time. None of us can bet that we will not. Surely, only a medically qualified person in full possession of our physical record and details of our parentage can say with any authority that anyone is likely to become ill. As I understand it, the decision on whether that person is likely to become ill will not be made by a doctor or a nurse or anyone medically qualified, but by a researcher. However, a researcher is surely anxious to go ahead with his or her research. I can envisage the temptation to get the raw materials by the simple means of expressing the view that the patient might get ill.

Why is there no sanction of a doctor’s opinion? All that seems to be necessary in the case of an under-18 year-old is parental agreement that the patient might get ill. That is not enough. If the young person in the frame were not competent to deal with the issue of consent for the use of his body, no one should believe for one moment, or act on the premise, that that person does agree; he has never been asked the question. People who are mentally or physically incompetent should be protected, not used against their will.

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I have spoken previously in this House about the use of the word “reasonable”. I have vivid memories of my time in another place, where Ministers refused to have that word in legislation because it meant all things to all men. What is reasonable to one person may be totally unreasonable to others. The word is sloppy and unclear and should be avoided. However, it comes up eight times in this amendment alone. This brings me to another point. In sub-paragraph (2) of new paragraph 15D, it says that the researcher must take “reasonable steps” to identify a person who is engaged in caring for a patient, or who is interested in the patient’s welfare. The patient in this case is an adult who is said to be lacking capacity. Well, anyone can say that they are interested in a person’s welfare. I am interested in the welfare of all noble Lords: I can sincerely say that. Anyone can allege that they are caring for somebody else. A researcher anxious to begin his research may take the easy option by accepting statements to this effect, which this amendment permits him to do.

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