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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 inter-species embryos etc

59

 

(h)   

increasing knowledge about the development of

embryos.”

Schedule 3

Section 13

 

Consent to use or storage of gametes, embryos or inter-species embryos etc

Introductory

5

1          

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

embryos) is amended as follows.

2          

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

“OR STORAGE OF GAMETES,             EMBRYOS OR INTER-SPECIES EMBRYOS

ETC”.

10

General requirements as to consent

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

15

person giving it.

      (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

20

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

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

25

Schedule which has not been withdrawn.”

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 the testing of

30

embryos, or”.

      (3)  

After sub-paragraph (1) insert—

   “(1A)  

A consent to the use of any inter-species embryo must specify use

for the purposes of a project of research and may specify

conditions subject to which the inter-species embryo may be so

35

used.”

      (4)  

In sub-paragraph (2)—

(a)   

for “or any embryo” substitute “, any embryo or any inter-species

embryo”, and

 

 

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or inter-species embryos etc

60

 

(b)   

for “or embryo”, in both places, substitute “, embryo or inter-species

embryo”.

      (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 inter-species

5

embryo, or

(b)   

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

to the use or storage of—

(i)   

any embryo or inter-species embryo whose

creation may be brought about using those

10

gametes or those cells, and

(ii)   

any embryo or inter-species embryo whose

creation may be brought about using such an

embryo or inter-species embryo.

      (5)  

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

15

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

withdrawn, in accordance with this Schedule either generally or in

relation to—

(a)   

a particular embryo or particular embryos, or

(b)   

a particular inter-species embryo or particular inter-

20

species embryos.”

Information to be given to a person giving consent

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

25

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

inter-species embryo”.

      (3)  

In sub-paragraph (2)—

(a)   

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

30

(b)   

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

“(aa)   

in training persons in the testing of embryos, 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 inter-species

35

embryo whose creation may be brought about in vitro using

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

inter-species 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).

40

      (4)  

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

any inter-species embryo cannot be varied, and such consent

cannot be withdrawn, once the inter-species embryo has been

used for the purposes of any project of research.

 

 

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or inter-species embryos etc

61

 

      (5)  

Where the terms of any consent to the use of an inter-species

embryo (“inter-species embryo A”) include consent to the use of

an inter-species embryo or embryo whose creation may be

brought about in vitro using inter-species embryo A, that consent

to the use of that subsequent inter-species embryo or embryo

5

cannot be varied or withdrawn once inter-species 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—

10

(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

15

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

20

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.

25

      (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

30

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

35

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”.

In vitro fertilisation and subsequent use of embryo

40

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”,

 

 

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or inter-species embryos etc

62

 

(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

5

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—

10

   “(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,

15

(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

20

bring about the creation of any inter-species 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.

25

      (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 inter-species embryo in

30

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”.

35

      (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

40

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

 

 

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or inter-species embryos etc

63

 

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 inter-species embryo, the

creation of which was brought about in vitro, which was

5

used to bring about the creation of embryo A.”

      (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 paragraph 4A(4).”

12         

After paragraph 8 insert—

10

“Cases where consent not required for storage

9     (1)  

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

without the child donor’s consent if the following conditions are

met.

      (2)  

Condition A is that the gametes are lawfully taken from or

15

provided by the child donor before the child donor attains the age

of 18 years.

      (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

20

the registered medical practitioner—

(a)   

the treatment is likely to cause a significant impairment of

the fertility of the child donor, and

(b)   

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

child donor.

25

      (4)  

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

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

storage of the gametes, or

30

(b)   

the child donor 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.

      (5)  

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

35

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

40

he does not wish them to continue to be stored.

      (6)  

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

with the following modifications—

(a)   

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

(b)   

for sub-paragraph (4), substitute—

45

 

 

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or inter-species embryos etc

64

 

“(4)   

Condition C is that, at the time when the gametes

are first stored, 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 storage of the gametes.”, and

5

(c)   

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

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

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.

10

      (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

years.

      (3)  

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

medical practitioner certifies in writing that the patient is expected

15

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 patient’s fertility,

(b)   

the patient lacks capacity to consent to the storage of the

20

gametes,

(c)   

the patient is likely to regain that capacity, and

(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.

25

      (5)  

Condition D is that the patient has not, after regaining 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

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

30

      (6)  

In relation to Scotland—

(a)   

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

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

35

2), of giving such consent,

(b)   

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

regaining capacity are to be read as references to the

patient no longer being so incapable, and

(c)   

that Act applies to the storage of gametes under this

40

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.

12         

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

45

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

 

 

Human Fertilisation and Embryology Bill [HL]
Schedule 3 — Consent to use or storage of gametes, embryos or inter-species embryos etc

65

 

Creation, use and storage of inter-species embryos

13         

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

“Creation, use and storage of inter-species embryos

13    (1)  

A person’s gametes or human cells must not be used to bring

about the creation of any inter-species embryo in vitro unless there

5

is an effective consent by that person to any inter-species 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)  

An inter-species embryo the creation of which was brought about

10

in vitro must not be received by any person unless there is an

effective consent by each relevant person in relation to the inter-

species embryo to the use of the inter-species embryo for the

purposes of any project of research.

      (3)  

An inter-species embryo the creation of which was brought about

15

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 inter-species embryo to the use of the inter-

species embryo for that purpose, and

20

(b)   

the inter-species embryo is used in accordance with those

consents.

14         

An inter-species 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

25

relation to the inter-species embryo to the storage of the

inter-species embryo, and

(b)   

the inter-species embryo is stored in accordance with those

consents.

15         

For the purposes of paragraphs 13 and 14, each of the following is

30

a relevant person in relation to an inter-species embryo the

creation of which was brought about in vitro (“inter-species

embryo A”)—

(a)   

each person whose gametes or human cells were used to

bring about the creation of inter-species embryo A,

35

(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

about the creation of inter-species embryo A, and

(c)   

each person whose gametes or human cells were used to

40

bring about the creation of any other inter-species embryo,

the creation of which was brought about in vitro, which

was used to bring about the creation of inter-species

embryo A.”

 

 

 
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