House of Commons Public Bill Committee Proceedings

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Session 2007 - 08
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Other Bills before Parliament

Public Bill Committee Proceedings: 5th June 2008
14

Human Fertilisation and Embryology Bill [Lords] continued

      (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”.’.

Dr Evan Harris

Not called  8

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—

Public Bill Committee Proceedings: 5th June 2008
15

Human Fertilisation and Embryology Bill [Lords] continued

  ‘(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’.”’.

Mr David Amess

Not selected  126

Schedule  3,  page  65,  line  11,  after ‘(1)’, insert ‘Without any exception’.

Mr David Amess

Not selected  127

Schedule  3,  page  65,  line  13,  after ‘effective’, insert ‘explicit’.

Dawn Primarolo

Agreed to  100

Schedule  3,  page  65,  line  29,  at end insert—

  ‘(4)
If the Authority is satisfied that the parental consent conditions in paragraph

15A are met in relation to the proposed use under a licence of the human cells

of a person who has not attained the age 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—

(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 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 15A(3) 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-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 15B and 15F.’.

Dawn Primarolo

Agreed to  101

Schedule  3,  page  65,  line  36,  at end insert—

  ‘(2)
Where a licence authorises the application of paragraph 13(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 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 15A(3) 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.

Public Bill Committee Proceedings: 5th June 2008
16

Human Fertilisation and Embryology Bill [Lords] continued

      (4)
Sub-paragraph (1) has effect subject to paragraphs 15B and 15F.’.

Dawn Primarolo

Agreed to  102

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
5
(“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.
10
      (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
15
(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—
20
(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
25
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
30
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
35
(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—
40
  “(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

Public Bill Committee Proceedings: 5th June 2008
17

Human Fertilisation and Embryology Bill [Lords] continued

cells to bring about the creation in vitro of an embryo or

human admixed embryo for use for the purposes of a
45
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
50
(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.
55
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
60
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
65
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,
70
(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.
75
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.
80
      (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
85
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.

Public Bill Committee Proceedings: 5th June 2008
18

Human Fertilisation and Embryology Bill [Lords] continued

      (6)
Condition E is that any embryo or human admixed embryo to be
90
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
95
(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
100
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
105
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
110
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
115
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
120
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
125
(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
130
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
135
capacity to consent to their use.

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

Public Bill Committee Proceedings: 5th June 2008
19

Human Fertilisation and Embryology Bill [Lords] continued

(a)
otherwise than in a professional capacity or for

remuneration, is engaged in caring for P or is interested in

P’s welfare, and
140
(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
145
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
150
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
155
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
160
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
165
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.
170
      (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—
175
(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
180
P not being incapable (within the meaning of section 1(6) of the

Adults with Incapacity (Scotland) Act 2000) of giving such

consent.

Public Bill Committee Proceedings: 5th June 2008
20

Human Fertilisation and Embryology Bill [Lords] continued

Use of cell lines in existence before relevant commencement date

15F(1)
Where a licence authorises the application of this paragraph in
185
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
190
(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
195
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
200
(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—
205
(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
210
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
215
(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
220
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
225
(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
230
the purposes of the project.