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Public Bill Committee: 3rd June 2008                  

87

 

Human Fertilisation and Embryology Bill [Lords ], continued

 
 

‘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

 

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


 
 

Public Bill Committee: 3rd June 2008                  

88

 

Human Fertilisation and Embryology Bill [Lords ], continued

 
 

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.

 

      (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—


 
 

Public Bill Committee: 3rd June 2008                  

89

 

Human Fertilisation and Embryology Bill [Lords ], continued

 
 

(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—

 

(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.


 
 

Public Bill Committee: 3rd June 2008                  

90

 

Human Fertilisation and Embryology Bill [Lords ], continued

 
 

      (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.

 

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”)—


 
 

Public Bill Committee: 3rd June 2008                  

91

 

Human Fertilisation and Embryology Bill [Lords ], continued

 
 

(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.

 

      (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,

235

(b)    

R does not have any reason to believe P to have died, and


 
 

Public Bill Committee: 3rd June 2008                  

92

 

Human Fertilisation and Embryology Bill [Lords ], continued

 
 

(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

240

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

245

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

250

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

255

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

260

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

265

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).”’.

 

As Amendments to Dawn Primarolo’s proposed Amendment (No. 102):—

 

Dr Evan Harris

 

(a)

 

Parliamentary Star    

Line  206,  leave out ‘to a significant extent’.

 

Dr Evan Harris

 

(b)

 

Parliamentary Star    

Line  235,  leave out ‘have any reason to believe’ and insert ‘know’.

 

Mark Simmonds

 

Mr Andrew Lansley

 

7

 

Schedule  3,  page  66,  line  5,  at end add—

 

‘13A      

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


 
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