Mark
Simmonds: Again, I thank the hon. Member for Oxford, West
and Abingdon for his contribution. I also thank the Minister for her
response. She confirmed that the consent provisions mirrored those for
human embryos and that discussions were taking place to
clarify the disparities in the Bill that have been highlighted. On that
basis, I beg to ask leave to withdraw the amendment.
Amendment,
by leave, withdrawn.
Dawn
Primarolo: I beg to move amendment No. 65, in
schedule 3, page 60, line 1, leave
out sub-paragraph (4) and
insert— ‘(4) For
sub-paragraph (2)
substitute— “(2)
A consent to the storage of any gametes, any embryo or any human
admixed embryo must— (a)
specify the maximum period of storage (if less than the statutory
storage period), (b) except in
a case falling within paragraph (c), state what is to be done with the
gametes, embryo or human admixed embryo if the person who gave the
consent dies or is unable, because the person lacks capacity to do so,
to vary the terms of the consent or to withdraw it,
and (c) where the consent is
given by virtue of paragraph 8(2ZA) or 14(2), state what is to be done
with the embryo or human admixed embryo if the person to whom the
consent relates dies, and may
(in any case) specify conditions subject to which the gametes, embryo
or human admixed embryo may remain in
storage. (2A) A consent to the
use of a person’s human cells to bring about the creation in
vitro of an embryo or human admixed embryo is to be taken unless
otherwise stated to include consent to the use of the cells after the
person’s death. (2B) In
relation to Scotland, the reference in sub-paragraph (2)(b) to the
person lacking capacity is to be read as a reference to the
person— (a) lacking
capacity within the meaning of the Age of Legal Capacity (Scotland) Act
1991, or (b) being incapable
within the meaning of section 1(6) of the Adults with Incapacity
(Scotland) Act
2000.”’.
The
Chairman: With this it will be convenient to discuss the
following: Government amendments Nos. 66 to 71.
Amendment No.
32, in
schedule 3, page 63, line 25, leave
out ‘18’ and insert
‘16’. Government
amendments Nos. 82 and
99. Amendment
No. 9, in
schedule 3, page 65, line 7, at
end insert— ‘Cases where
consent not required for storage and use for
research 12A (1) The human
cells of a person (“the donor”) may be used to bring
about the creation of an embryo or a human admixed embryo in vitro; and
any embryo or human admixed embryo so created may be used or stored for
the purposes of any project of research without the donor’s
consent if the following conditions are
met. (2) Condition A is that
the human cells are lawfully taken from or provided by the
donor. (3) Condition B is that
the human cells were first stored or used prior to the day on which
Schedule 3 to the Human Fertilisation and Embryology Act 2008 comes
into force. (4) Condition C is
that the human cells, embryos or human admixed embryos are used in
circumstances such that the person carrying out the research
(“the researcher”) is not in possession, and not likely
to come into possession, of information from which the donor can be
identified. (5) Condition D is
that it is not reasonably possible to contact the donor to obtain their
consent.
(6) Condition E is that there are reasonable grounds
for believing that research of comparable effectiveness cannot be
carried out if the project of research for which the human cells,
embryos or human admixed embryos are stored or used has to be confined
to, or relate only to, material in relation to which there is an
effective consent. (7)
Condition F is that it does not appear to the researcher that the donor
has indicated any objection to such use or storage (as
applicable).’. Amendment
No. 10, in
schedule 3, page 65, line 7, at
end insert— ‘Consent in
relation to children for storage and use for
research 12A (1) The human
cells of a person (“the child”) may be used to bring
about the creation of an embryo or inter-species embryo in vitro, and
any embryo or inter-species embryo so created, used or stored for the
purposes of any project of research without the child’s consent
if the following conditions are
met. (2) Condition A is that
the human cells are lawfully taken from or provided by the child before
the child attains the age of 18
years. (3) Condition B is that,
at the time when the human cells are first used, the child is not
competent to deal with the issue of consent in relation to either the
storage or use of the human cells, embryos or inter-species
embryos. (4) Condition C is
that the child does not appear to the person storing or using the human
cells, embryos or inter-species embryos to have indicated any objection
to such storage or use. (5)
Condition D is that a person who has parental responsibility for the
child has given their consent in writing and signed
it. (6) Condition E is that
there are reasonable grounds for believing that research of comparable
effectiveness cannot be carried out if the project of research for
which the human cells, embryos or inter-species embryos are stored or
used has to be confined to, or relate only to, persons who have
capacity to consent to it. (7)
Condition F is that the research is directed towards a serious medical
condition from which the child
suffers. (8) In relation to
Scotland, in sub-paragraph (2), for “18” substitute
“16”.’. Amendment
No. 8, in
schedule 3, page 65, line 7, at
end add— ‘12A After
paragraph 8
insert— “Cases
where consent not required for use in research to preserve
fertility 9A (1) The
gametes of a person (‘the child donor’) may be kept in
use without the child donor’s consent if the following
conditions are met. (2)
Condition A is that the gametes are lawfully taken from or provided by
the child donor before the child donor attains the age of 18
years. (3) Condition B is that,
before the gametes are used, a registered medical practitioner
certifies in writing that the child donor is expected to undergo
medical treatment and that in the opinion of the registered medical
practitioner— (a) the
treatment is likely to cause a significant impairment of the fertility
of the child donor, (b) the use
of the gametes is in the best interests of the child donor,
and (c) the use of the gametes
for research is necessary to preserve the fertility of the child
donor. (4) Condition C is that,
at the time when the gametes are used,
either— (a) the child
donor has not attained the age of 16 years and is not competent to deal
with the issue of consent to the use of the gametes,
or
(b) the child donor has attained that age but,
although not lacking capacity to consent to the use of the gametes, is
not competent to deal with the issue of consent to their
use. (5) Condition D is that
the child donor has not, since becoming competent to deal with the
issue of consent to the use of the
gametes— (a) given
consent under this Schedule to the use of the gametes,
or (b) given written notice to
the person keeping the gametes that he does not wish them to be
used. (6) In relation to
Scotland, subparagraphs (1) to (5) are to be read with the following
modifications— (a) in
subparagraph (2), for ‘18’ substitute
‘16’, (b) for
subparagraph (4),
substitute— ‘(4)
Condition C is that, at the time when the gametes are used, the child
donor does not have capacity (within the meaning of section 2(4) of the
Age of Legal Capacity (Scotland) Act 1991 (c. 50)) to consent to the
use of the gametes.’,
and (c) in subparagraph (5),
for ‘becoming competent to deal with the issue of consent to the
use of the gametes’ substitute ‘acquiring such
capacity’.”’. Government
amendments Nos. 100 and
101. Government
amendment No. 102, in schedule 3, 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. (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. (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. (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— (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
responsible under the licence (“R”) has taken all
reasonable steps to contact the person falling within sub-paragraph
(1)(b) (“P”) but has been unable to do
so, (b) R does not have any
reason to believe P to have died,
and (c) 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. (4) Condition C is
that— (a) the person
falling within sub-paragraph (1)(b) (“P”) has died since
P’s human cells were first
stored, (b) the information
relating to P that is available to the person responsible under the
licence (“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
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. (5) The HTA consent
provisions apply in relation to consent for the purposes of
sub-paragraph (4)(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
(4)(c).”’. Amendment
(a) to Government amendment No. 102, in proposed new paragraph
15G(1)(a), leave out ‘to a significant
extent’. Amendment
(b) to Government amendment No. 102, in proposed new paragraph
15G(3)(b), leave out ‘have any reason to believe’
and insert
‘know’. Amendment
No. 7, in
schedule 3, page 66, line 5, at
end add— ‘13A After
paragraph 15 (as inserted by paragraph 13 above)
insert— “Cases
where consent not required for storage and
research 15A The human
cells of a person (‘the donor’) may be used to bring
about the creation of an embryo or a human admixed embryo in vitro; and
any embryo or human admixed embryo so created may be used or stored for
the purposes of any project of research without the donor’s
consent if the following conditions are
met: (a) Condition A is that
the human cells are lawfully taken from or provided by the
donor; (b) Condition B is that
the human cells were first stored or used prior to the day on which
Schedule 3 to the Human Fertilisation and Embryology Act 2008 comes
into force; (c) Condition C is
that the human cells, embryos or human admixed embryos are used in
circumstances such that the person carrying out the research
(‘the researcher’) is not in possession, and not likely
to come into possession, of information from which the donor can be
identified;
(d) Condition D is that it is not reasonably
possible to contact the donor to obtain their
consent; (e) Condition E is
that there are reasonable grounds for believing that research of
comparable effectiveness cannot be carried out if the project of
research for which the human cells, embryos or human admixed embryos
are stored or used has to be confined to, or related only to, material
in relation to which there is an effective consent;
and (f) Condition F is that it
does not appear to the researcher that the donor has indicated any
objection to such use or storage (as
applicable).”.’. Government
amendments Nos. 103, 107 and 109 to
114. Hon.
Members will have noticed that amendments (a) and (b) have been tabled
to amendment No. 102. Before I put the question on that amendment
formally, therefore, the hon. Member for Oxford, West and Abingdon may
want to indicate whether he wishes to move his amendments to it. I hope
that that is clear.
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