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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.

60

 

Schedule 3

Section 13

 

Consent to use or storage of gametes, embryos or human admixed embryos etc.

Introductory

1          

Schedule 3 to the 1990 Act (giving of consent to use or storage of gametes or

embryos) is amended as follows.

5

2          

In the title to that Schedule, for “OF GAMETES OR EMBRYOS”, substitute

“OR STORAGE OF GAMETES,             EMBRYOS OR HUMAN ADMIXED

EMBRYOS ETC”.

General requirements as to consent

3          

For paragraph 1 substitute—

10

“1    (1)  

A consent under this Schedule, and any notice under paragraph 4

varying or withdrawing a consent under this Schedule, must be in

writing and, subject to sub-paragraph (2), must be signed by the

person giving it.

      (2)  

A consent under this Schedule by a person who is unable to sign

15

because of illness, injury or physical disability (a “person unable to

sign”), and any notice under paragraph 4 by a person unable to

sign varying or withdrawing a consent under this Schedule, is to

be taken to comply with the requirement of sub-paragraph (1) as

to signature if it is signed at the direction of the person unable to

20

sign, in the presence of the person unable to sign and in the

presence of at least one witness who attests the signature.

      (3)  

In this Schedule “effective consent” means a consent under this

Schedule which has not been withdrawn.”

Terms of consent

25

4     (1)  

Paragraph 2 (terms etc. of consent) is amended as follows.

      (2)  

In sub-paragraph (1), for the “or” at the end of paragraph (b) substitute—

“(ba)   

use for the purpose of training persons in embryo biopsy,

embryo storage or other embryological techniques, or”.

      (3)  

After sub-paragraph (1) insert—

30

   “(1A)  

A consent to the use of any human admixed embryo must specify

use for the purposes of a project of research and may specify

conditions subject to which the human admixed embryo may be

so used.”

      (4)  

For sub-paragraph (2) substitute—

35

    “(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

40

to be done with the gametes, embryo or human admixed

embryo if the person who gave the consent dies or is

 

 

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

61

 

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(2A) or

13(2), state what is to be done with the embryo or human

admixed embryo if the person to whom the consent relates

5

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

10

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—

15

(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.”

      (5)  

For sub-paragraph (4) substitute—

20

    “(4)  

A consent under this Schedule may apply—

(a)   

to the use or storage of a particular embryo or human

admixed embryo, or

(b)   

in the case of a person providing gametes or human cells,

to the use or storage of—

25

(i)   

any embryo or human admixed embryo whose

creation may be brought about using those

gametes or those cells, and

(ii)   

any embryo or human admixed embryo whose

creation may be brought about using such an

30

embryo or human admixed embryo.

      (5)  

In the case of a consent falling within sub-paragraph (4)(b), the

terms of the consent may be varied, or the consent may be

withdrawn, in accordance with this Schedule either generally or in

relation to—

35

(a)   

a particular embryo or particular embryos, or

(b)   

a particular human admixed embryo or particular human

admixed embryos.”

Information to be given to a person giving consent

5          

In paragraph 3 (procedure for giving consent), in sub-paragraph (2), after

40

“paragraph 4” insert “and, if relevant, paragraph 4A”.

Variation and withdrawal of consent

6     (1)  

Paragraph 4 (variation and withdrawal of consent) is amended as follows.

      (2)  

In sub-paragraph (1), for “or embryo” substitute “, human cells, embryo or

human admixed embryo”.

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

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      (3)  

In sub-paragraph (2)—

(a)   

for “The” substitute “Subject to sub-paragraph (3), the”, and

(b)   

for the “or” at the end of paragraph (a) substitute—

“(aa)   

in training persons in embryo biopsy, embryo

storage or other embryological techniques, or”.

5

      (4)  

After sub-paragraph (2) insert—

    “(3)  

Where the terms of any consent to the use of an embryo (“embryo

A”) include consent to the use of an embryo or human admixed

embryo whose creation may be brought about in vitro using

embryo A, that consent to the use of that subsequent embryo or

10

human admixed embryo cannot be varied or withdrawn once

embryo A has been used for one or more of the purposes

mentioned in sub-paragraph (2)(a) or (b).

      (4)  

Subject to sub-paragraph (5), the terms of any consent to the use of

any human admixed embryo cannot be varied, and such consent

15

cannot be withdrawn, once the human admixed embryo has been

used for the purposes of any project of research.

      (5)  

Where the terms of any consent to the use of a human admixed

embryo (“human admixed embryo A”) include consent to the use

of a human admixed embryo or embryo whose creation may be

20

brought about in vitro using human admixed embryo A, that

consent to the use of that subsequent human admixed embryo or

embryo cannot be varied or withdrawn once human admixed

embryo A has been used for the purposes of any project of

research.”

25

Withdrawal of consent to storage: notification of interested persons

7          

After paragraph 4 insert—

“4A   (1)  

This paragraph applies where—

(a)   

a permitted embryo, the creation of which was brought

about in vitro, is in storage,

30

(b)   

it was created for use in providing treatment services,

(c)   

before it is used in providing treatment services, one of the

persons whose gametes were used to bring about its

creation (“P”) gives the person keeping the embryo notice

withdrawing P’s consent to the storage of the embryo, and

35

(d)   

the embryo was not to be used in providing treatment

services to P alone.

      (2)  

The person keeping the embryo must as soon as possible take all

reasonable steps to notify each interested person in relation to the

embryo of P’s withdrawal of consent.

40

      (3)  

For the purposes of sub-paragraph (2), a person is an interested

person in relation to an embryo if the embryo was to be used in

providing treatment services to that person.

      (4)  

Storage of the embryo remains lawful until—

 

 

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

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(a)   

the end of the period of 12 months beginning with the day

on which the notice mentioned in sub-paragraph (1) was

received from P, or

(b)   

if, before the end of that period, the person keeping the

embryo receives a notice from each person notified of P’s

5

withdrawal under sub-paragraph (2) stating that the

person consents to the destruction of the embryo, the time

at which the last of those notices is received.

      (5)  

The reference in sub-paragraph (1)(a) to a permitted embryo is to

be read in accordance with section 3ZA.”

10

Application of consent provisions to non-medical fertility services

8          

In paragraph 5 (use of gametes for treatment of others), in sub-paragraph (1),

after “treatment services” insert “or non-medical fertility services”.

In vitro fertilisation and subsequent use of embryo

9     (1)  

Paragraph 6 (in vitro fertilisation and subsequent use of embryo) is amended

15

as follows.

      (2)  

In sub-paragraph (1)—

(a)   

after “person’s gametes” insert “or human cells”,

(b)   

after “to any embryo” insert a comma,

(c)   

after “those gametes” insert “or human cells,”, and

20

(d)   

for “paragraph 2(1)” substitute “paragraph 2(1)(a), (b) and (c)”.

      (3)  

In sub-paragraph (2)—

(a)   

for the words from “each person” to “creation of” substitute “each

relevant person in relation to”, and

(b)   

for “paragraph 2(1)” substitute “paragraph 2(1)(a), (b), (ba) and (c)”.

25

      (4)  

In sub-paragraph (3), for the words from “person” to “creation of” substitute

“relevant person in relation to”.

      (5)  

After sub-paragraph (3) insert—

   “(3A)  

If the Authority is satisfied that the parental consent conditions in

paragraph 15 are met in relation to the proposed use under a

30

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 (3B) in relation to C.

     (3B)  

Where the licence authorises the application of this sub-

paragraph, the effective consent of a person having parental

35

responsibility for C—

(a)   

to the use of C’s human cells to bring about the creation of

an embryo in vitro for use for the purposes of a project of

research, or

(b)   

to the use for those purposes of an embryo in relation to

40

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.

 

 

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

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     (3C)  

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

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 (3B)

5

ceases to apply in relation to C.

     (3D)  

Sub-paragraphs (1) to (3) have effect subject to paragraphs 16 and

20.

     (3E)  

For the purposes of sub-paragraphs (2), (3) and (3B) each of the

following is a relevant person in relation to an embryo the creation

10

of which was brought about in vitro (“embryo A”)—

(a)   

each person whose gametes or human cells were used to

bring about the creation of embryo A,

(b)   

each person whose gametes or human cells were used to

bring about the creation of any other embryo, the creation

15

of which was brought about in vitro, which was used to

bring about the creation of embryo A, and

(c)   

each person whose gametes or human cells were used to

bring about the creation of any human admixed embryo,

the creation of which was brought about in vitro, which

20

was used to bring about the creation of embryo A.”

Use of embryos obtained by lavage etc.

10    (1)  

Paragraph 7 (embryos obtained by lavage etc.) is amended as follows.

      (2)  

In sub-paragraph (3), for “This paragraph does” substitute “Sub-paragraphs

(1) and (2) do”.

25

      (3)  

After sub-paragraph (3) insert—

    “(4)  

An embryo taken from a woman must not be used to bring about

the creation of any embryo in vitro or any human admixed embryo

in vitro.”

Consents in relation to storage

30

11    (1)  

Paragraph 8 (storage of gametes and embryos) is amended as follows.

      (2)  

In sub-paragraph (2), for the words from “person” to “creation of” substitute

“relevant person in relation to”.

      (3)  

After sub-paragraph (2) insert—

   “(2A)  

Where a licence authorises the application of paragraph 6(3B) in

35

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 an 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 (2) as the effective consent of C.

40

     (2B)  

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

to C as if any effective consent previously given under sub-

paragraph (2) by a person having parental responsibility for C had

 

 

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

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been given by C but, subject to that, sub-paragraph (2A) ceases to

apply in relation to C.

     (2C)  

For the purposes of sub-paragraphs (2) and (2A), each of the

following is a relevant person in relation to an embryo the creation

of which was brought about in vitro (“embryo A”)—

5

(a)   

each person whose gametes or human cells were used to

bring about the creation of embryo A,

(b)   

each person whose gametes or human cells were used to

bring about the creation of any other embryo, the creation

of which was brought about in vitro, which was used to

10

bring about the creation of embryo A, and

(c)   

each person whose gametes or human cells were used to

bring about the creation of any human admixed embryo,

the creation of which was brought about in vitro, which

was used to bring about the creation of embryo A.”

15

      (4)  

After sub-paragraph (3) insert—

    “(4)  

Sub-paragraph (1) has effect subject to paragraphs 9 and 10; and

sub-paragraph (2) has effect subject to paragraphs 4A(4), 16 and

20.”

12         

After paragraph 8 insert—

20

“Cases where consent not required for storage

9     (1)  

The gametes of a person (“C”) may be kept in storage without C’s

consent if the following conditions are met.

      (2)  

Condition A is that the gametes are lawfully taken from or

provided by C before C attains the age of 18 years.

25

      (3)  

Condition B is that, before the gametes are first stored, a registered

medical practitioner certifies in writing that C 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

30

C’s fertility, and

(b)   

the storage of the gametes is in C’s best interests.

      (4)  

Condition C is that, at the time when the gametes are first stored,

either—

(a)   

C has not attained the age of 16 years and is not competent

35

to deal with the issue of consent to the storage of the

gametes, or

(b)   

C has attained that age but, although not lacking capacity

to consent to the storage of the gametes, is not competent

to deal with the issue of consent to their storage.

40

      (5)  

Condition D is that C has not, since becoming competent to deal

with the issue of consent to the storage of the gametes—

(a)   

given consent under this Schedule to the storage of the

gametes, or

(b)   

given written notice to the person keeping the gametes that

45

C does not wish them to continue to be stored.

 

 

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

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      (6)  

In relation to Scotland, sub-paragraphs (1) to (5) are to be read

with the following modifications—

(a)   

for sub-paragraph (4), substitute—

“(4)   

Condition C is that, at the time when the gametes

are first stored, C does not have capacity (within

5

the meaning of section 2(4) of the Age of Legal

Capacity (Scotland) Act 1991) to consent to the

storage of the gametes.”, and

(b)   

in sub-paragraph (5), for “becoming competent to deal

with the issue of consent to the storage of the gametes”

10

substitute “acquiring such capacity”.

10    (1)  

The gametes of a person (“P”) may be kept in storage without P’s

consent if the following conditions are met.

      (2)  

Condition A is that the gametes are lawfully taken from or

provided by P after P has attained the age of 16 years.

15

      (3)  

Condition B is that, before the gametes are first stored, a registered

medical practitioner certifies in writing that P 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

20

P’s fertility,

(b)   

P lacks capacity to consent to the storage of the gametes,

(c)   

P is likely at some time to have that capacity, and

(d)   

the storage of the gametes is in P’s best interests.

      (4)  

Condition C is that, at the time when the gametes are first stored,

25

P lacks capacity to consent to their storage.

      (5)  

Condition D is that P has not subsequently, at a time when P has

capacity to give a consent under this Schedule—

(a)   

given consent to the storage of the gametes, or

(b)   

given written notice to the person keeping the gametes that

30

P does not wish them to continue to be stored.

      (6)  

In relation to Scotland—

(a)   

references in sub-paragraphs (3) and (4) to P lacking

capacity to consent are to be read as references to P being

incapable, within the meaning of section 1(6) of the Adults

35

with Incapacity (Scotland) Act 2000, of giving such

consent,

(b)   

the references in sub-paragraphs (3) and (5) to P having

capacity are to be read as references to P not being so

incapable, and

40

(c)   

that Act applies to the storage of gametes under this

paragraph to the extent specified in section 84A of that Act.

11         

A person’s gametes must not be kept in storage by virtue of

paragraph 9 or 10 after the person’s death.”

 

 

 
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