Human Fertilisation and Embryology Bill [HL]

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Session 2007 - 08
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Human Fertilisation and Embryology Bill [HL]

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or human admixed embryos etc.
67

Creation, use and storage of human admixed embryos
13
After paragraph 11 (as inserted by paragraph 12 above) insert—
“Creation, use and storage of human admixed embryos
12    (1)
A person’s gametes or human cells must not be used to bring
about the creation of any human admixed embryo in vitro unless
5
there is an effective consent by that person to any human admixed
embryo, the creation of which may be brought about with the use
of those gametes or human cells, being used for the purposes of
any project of research.
      (2)
A human admixed embryo the creation of which was brought
10
about in vitro must not be received by any person unless there is
an effective consent by each relevant person in relation to the
human admixed embryo to the use of the human admixed embryo
for the purposes of any project of research.
      (3)
A human admixed embryo the creation of which was brought
15
about in vitro must not be used for the purposes of a project of
research unless—
(a)
there is an effective consent by each relevant person in
relation to the human admixed embryo to the use of the
human admixed embryo for that purpose, and
20
(b)
the human admixed embryo is used in accordance with
those consents.
      (4)
If the Authority is satisfied that the parental consent conditions in
paragraph 15 are met in relation to the proposed use under a
licence of the human cells of a person who has not attained the age
25
of 18 years (“C”), the Authority may in the licence authorise the
application of sub-paragraph (5) in relation to C.
      (5)
Where the licence authorises the application of this sub-
paragraph, the effective consent of a person having parental
responsibility for C—
30
(a)
to the use of C’s human cells to bring about the creation of
a human admixed embryo in vitro for use for the purposes
of a project of research, or
(b)
to the use for those purposes of a human admixed embryo
in relation to which C is a relevant person by reason only
35
of the use of C’s human cells,

is to be treated for the purposes of sub-paragraphs (1) to (3) as the
effective consent of C.
      (6)
If C attains the age of 18 years or the condition in paragraph 15(3)
ceases to be met in relation to C, paragraph 4 has effect in relation
40
to C as if any effective consent previously given under sub-
paragraphs (1) to (3) by a person having parental responsibility for
C had been given by C but, subject to that, sub-paragraph (5)
ceases to apply in relation to C.
      (7)
Sub-paragraphs (1) to (3) have effect subject to paragraphs 16 and
45
20.

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or human admixed embryos etc.
68

13    (1)
A human admixed embryo the creation of which was brought
about in vitro must not be kept in storage unless—
(a)
there is an effective consent by each relevant person in
relation to the human admixed embryo to the storage of
the human admixed embryo, and
5
(b)
the human admixed embryo is stored in accordance with
those consents.
      (2)
Where a licence authorises the application of paragraph 12(5) in
relation to a person who has not attained the age of 18 years (“C”),
the effective consent of a person having parental responsibility for
10
C to the storage of a human admixed embryo in relation to which
C is a relevant person by reason only of the use of C’s human cells
is to be treated for the purposes of sub-paragraph (1) as the
effective consent of C.
      (3)
If C attains the age of 18 years or the condition in paragraph 15(3)
15
ceases to be met in relation to C, paragraph 4 has effect in relation
to C as if any effective consent previously given under sub-
paragraph (1) by a person having parental responsibility for C had
been given by C but, subject to that, sub-paragraph (2) ceases to
apply in relation to C.
20
      (4)
Sub-paragraph (1) has effect subject to paragraphs 16 and 20.
14
For the purposes of paragraphs 12 and 13, each of the following is
a relevant person in relation to a human admixed embryo the
creation of which was brought about in vitro (“human admixed
embryo A”)—
25
(a)
each person whose gametes or human cells were used to
bring about the creation of human admixed embryo A,
(b)
each person whose gametes or human cells were used to
bring about the creation of any embryo, the creation of
which was brought about in vitro, which was used to bring
30
about the creation of human admixed embryo A, and
(c)
each person whose gametes or human cells were used to
bring about the creation of any other human admixed
embryo, the creation of which was brought about in vitro,
which was used to bring about the creation of human
35
admixed embryo A.”
Cases where human cells etc. can be used without consent of person providing them
14
After paragraph 14 (as inserted by paragraph 13 above) insert—
“Parental consent conditions
15    (1)
In relation to a person who has not attained the age of 18 years
40
(“C”), the parental consent conditions referred to in paragraphs
6(3A) and 12(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.
45
      (3)
Condition B is that either—

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or human admixed embryos etc.
69

(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
5
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
10
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.
15
      (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—
20
(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
25
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
30
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.”,
35
(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
40
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.
16    (1)
If, in relation to the proposed use under a licence of the human
45
cells of a person who has attained the age of 18 years (“P”), the
Authority is satisfied—
(a)
that the conditions in paragraph 17 are met,

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or human admixed embryos etc.
70

(b)
that paragraphs (1) to (4) of paragraph 18 have been
complied with, and
(c)
that the condition in paragraph 18(5) is met,

the Authority may in the licence authorise the application of this
paragraph in relation to P.
5
      (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
10
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.
15
      (3)
This paragraph has effect subject to paragraph 19.
Consent to use of human cells etc. not required: adult lacking capacity
17    (1)
The conditions referred to in paragraph 16(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
20
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.
25
      (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.
30
      (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
35
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
40
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
45
consent to the use of their human cells to bring about the

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or human admixed embryos etc.
71

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 18 references to the person
5
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
10
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
15
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
20
(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
25
18    (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
30
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
35
(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
40
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
45
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

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or human admixed embryos etc.
72

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 16(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
5
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
10
(Scotland) Act 2000) of giving such consent.
Effect of acquiring capacity
19    (1)
Paragraph 16 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
15
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 16 does not apply to the storage or use of an embryo or
20
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
25
(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
30
Adults with Incapacity (Scotland) Act 2000) of giving such
consent.
Use of cell lines in existence before relevant commencement date
20    (1)
Where a licence authorises the application of this paragraph in
relation to qualifying cells, this Schedule does not require the
35
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
40
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
45
before the commencement date, or

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or human admixed embryos etc.
73

(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
5
embryo) comes into force.
Conditions for grant of exemption in paragraph 20
21    (1)
A licence may not authorise the application of paragraph 20 unless
the Authority is satisfied—
(a)
that there are reasonable grounds for believing that
10
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—
15
(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 16 can be
20
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.
25
      (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
30
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.
35
      (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
40
(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.
45
      (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,