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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.

59

 

(f)   

developing more effective techniques of contraception,

(g)   

developing methods for detecting the presence of gene,

chromosome or mitochondrion abnormalities in embryos

before implantation, or

(h)   

increasing knowledge about the development of

5

embryos.”

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

10

embryos) is amended as follows.

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

15

3          

For paragraph 1 substitute—

“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.

20

      (2)  

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

because of illness, injury or physical disability (“the incapacitated

person”), and any notice under paragraph 4 by such a person

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

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

25

signature if it is signed at the direction of the incapacitated person,

in the presence of the incapacitated person 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Schedule which has not been withdrawn.”

30

Terms of consent

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”.

35

      (3)  

After sub-paragraph (1) insert—

   “(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.”

40

 

 

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

60

 

      (4)  

In sub-paragraph (2)—

(a)   

for “or any embryo” substitute “, any embryo or any human admixed

embryo”, and

(b)   

for “or embryo”, in both places, substitute “, embryo or human

admixed embryo”.

5

      (5)  

For sub-paragraph (4) substitute—

    “(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,

10

to the use or storage of—

(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

15

creation may be brought about using such an

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

20

relation to—

(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

25

5          

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

“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

30

human admixed embryo”.

      (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

35

storage or other embryological techniques, or”.

      (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

40

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

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).

 

 

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

61

 

      (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

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

5

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

of a human admixed embryo or embryo whose creation may be

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

10

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

research.”

Withdrawal of consent to storage: notification of interested persons

7          

After paragraph 4 insert—

“4A   (1)  

This paragraph applies where—

15

(a)   

a permitted embryo, the creation of which was brought

about in vitro, is in storage,

(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

20

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

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

(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

25

reasonable steps to notify each interested person in relation to the

embryo of P’s withdrawal of consent.

      (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.

30

      (4)  

Storage of the embryo remains lawful until—

(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

35

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

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

40

be read in accordance with section 3ZA.”

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”.

 

 

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

62

 

In vitro fertilisation and subsequent use of embryo

9     (1)  

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

as follows.

      (2)  

In sub-paragraph (1)—

(a)   

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

5

(b)   

after “to any embryo” insert a comma,

(c)   

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

(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

10

relevant person in relation to”, and

(b)   

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

      (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—

15

   “(3A)  

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

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

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,

20

(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

bring about the creation of embryo A, and

(c)   

each person whose gametes or human cells were used to

25

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.”

Use of embryos obtained by lavage etc.

10    (1)  

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

30

      (2)  

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

(1) and (2) do”.

      (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

35

in vitro.”

Consents in relation to storage

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”.

40

 

 

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

63

 

      (3)  

After sub-paragraph (2) insert—

   “(2A)  

For the purposes of sub-paragraph (2), each of the following is a

relevant person in relation to an embryo the creation of which was

brought about in vitro (“embryo A”)—

(a)   

each person whose gametes or human cells were used to

5

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

bring about the creation of embryo A, and

10

(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.”

      (4)  

After sub-paragraph (3) insert—

15

    “(4)  

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

sub-paragraph (2) has effect subject to paragraph 4A(4).”

12         

After paragraph 8 insert—

“Cases where consent not required for storage

9     (1)  

The gametes of a person (“the child donor”) may be kept in storage

20

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.

25

      (3)  

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

30

the fertility of the child donor, and

(b)   

the storage of the gametes is in the best interests of the

child donor.

      (4)  

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

either—

35

(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

storage of the gametes, or

(b)   

the child donor has attained that age but, although not

lacking capacity to consent to the storage of the gametes, is

40

not competent to deal with the issue of consent to their

storage.

      (5)  

Condition D is that the child donor has not, since becoming

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

gametes—

45

 

 

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

64

 

(a)   

given consent under this Schedule to the storage of the

gametes, or

(b)   

given written notice to the person keeping the gametes that

he does not wish them to continue to be stored.

      (6)  

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

5

with the following modifications—

(a)   

in sub-paragraph (2), for “18” substitute “16”,

(b)   

for sub-paragraph (4), substitute—

“(4)   

Condition C is that, at the time when the gametes

are first stored, the child donor does not have

10

capacity (within the meaning of section 2(4) of the

Age of Legal Capacity (Scotland) Act 1991 (c. 50))

to consent to the storage of the gametes.”, and

(c)   

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

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

15

substitute “acquiring such capacity”.

10    (1)  

The gametes of a person (“the patient”) may be kept in storage

without the patient’s consent if the following conditions are met.

      (2)  

Condition A is that the gametes are lawfully taken from or

provided by the patient after the patient has attained the age of 16

20

years.

      (3)  

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

medical practitioner certifies in writing that the patient is expected

to undergo medical treatment and that in the opinion of the

registered medical practitioner—

25

(a)   

the treatment is likely to cause a significant impairment of

the patient’s fertility,

(b)   

the patient lacks capacity to consent to the storage of the

gametes,

(c)   

the patient is likely to regain that capacity, and

30

(d)   

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

      (4)  

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

the patient lacks capacity to consent to their storage.

      (5)  

Condition D is that the patient has not, after regaining capacity to

give a consent under this Schedule—

35

(a)   

given consent to the storage of the gametes, or

(b)   

given written notice to the person keeping the gametes that

the patient does not wish them to continue to be stored.

      (6)  

In relation to Scotland—

(a)   

references in sub-paragraphs (3) and (4) to the patient

40

lacking capacity to consent are to be read as references to

the patient being incapable, within the meaning of section

1(6) of the Adults with Incapacity (Scotland) Act 2000 (asp

2), of giving such consent,

(b)   

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

45

regaining capacity are to be read as references to the

patient no longer being so incapable, and

 

 

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

65

 

(c)   

that Act applies to the storage of gametes under this

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

11         

References in paragraphs 9 and 10 to capacity to consent are, in

relation to England and Wales, to be read in accordance with the

Mental Capacity Act 2005.

5

12         

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

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

Creation, use and storage of human admixed embryos

13         

After paragraph 12 (as inserted by paragraph 12 above) insert—

“Creation, use and storage of human admixed embryos

10

13    (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

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

15

any project of research.

      (2)  

A human admixed embryo the creation of which was brought

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

20

for the purposes of any project of research.

      (3)  

A human admixed embryo the creation of which was brought

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

25

relation to the human admixed embryo to the use of the

human admixed embryo for that purpose, and

(b)   

the human admixed embryo is used in accordance with

those consents.

14         

A human admixed embryo the creation of which was brought

30

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

(b)   

the human admixed embryo is stored in accordance with

35

those consents.

15         

For the purposes of paragraphs 13 and 14, 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”)—

40

(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

45

about the creation of human admixed embryo A, and

 

 

 
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