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Human Fertilisation and Embryology Bill [HL]


Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

8

 

9       

Power to assist other public authorities

After section 8D (inserted by section 8 above) insert—

“8E     

Power to assist other public authorities

(1)   

The Authority may if it thinks it appropriate to do so provide assistance

to any other public authority in the United Kingdom for the purpose of

5

the exercise by that authority of its functions.

(2)   

Assistance provided by the Authority under this section may be

provided on such terms, including terms as to payment, as it thinks fit.”

10      

Power to delegate and establish committees

For section 9 (licence committees and other committees) of the 1990 Act

10

substitute—

“9A     

Power to delegate and establish committees

(1)   

The Authority may delegate a function to a committee, to a member or

to staff.

(2)   

The Authority may establish such committees or sub-committees as it

15

thinks fit (whether to advise the Authority or to exercise a function

delegated to it by the Authority).

(3)   

Subject to any provision made by regulations under section 20A

(appeals committees), the members of the committees or sub-

committees may include persons who are not members of the

20

Authority.

(4)   

Subsection (1) has effect subject to any enactment requiring a decision

to be taken by members of the Authority or by a committee consisting

of members of the Authority.”

Scope of licences

25

11      

Activities that may be licensed

(1)   

In section 11 of the 1990 Act (licences for treatment, storage or research), in

subsection (1)(b), for “and embryos” substitute “, embryos or inter-species

embryos”.

(2)   

Schedule 2 contains amendments of Schedule 2 to the 1990 Act (which relates

30

to the activities for which licences may be granted under the Act).

(3)   

The Human Fertilisation and Embryology (Research Purposes) Regulations

2001 (S. I. 2001/188) (which are superseded by the amendments made by

Schedule 2) cease to have effect.

Licence conditions

35

12      

General conditions of licences

In section 12 of the 1990 Act (general conditions of licences under that Act), in

subsection (1)—

 
 

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

9

 

(a)   

in paragraph (c) (condition relating to compliance with Schedule 3 to

the Act), omit “or non-medical fertility services”, and

(b)   

in paragraphs (e) and (f) (which relate to the supply of gametes or

embryos), for “or embryos” substitute “, embryos or inter-species

embryos”.

5

13      

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

Schedule 3 contains amendments of Schedule 3 to the 1990 Act (which relates

to consent to the use or storage of gametes or embryos).

14      

Conditions of licences for treatment

(1)   

Section 13 of the 1990 Act (conditions of licences for treatment) is amended in

10

accordance with subsections (2) to (4).

(2)   

In subsection (5), omit—

(a)   

“, other than basic partner treatment services,”, and

(b)   

“(including the need of that child for a father)”.

(3)   

For subsection (6) substitute—

15

“(6)   

A woman shall not be provided with treatment services of a kind

specified in Part 1 of Schedule 3ZA unless she and any man or woman

who is to be treated together with her have been given a suitable

opportunity to receive proper counselling about the implications of her

being provided with treatment services of that kind, and have been

20

provided with such relevant information as is proper.

(6A)   

A woman shall not be provided with treatment services after the

happening of any event falling within any paragraph of Part 2 of

Schedule 3ZA unless (before or after the event) she and the intended

second parent have been given a suitable opportunity to receive proper

25

counselling about the implications of the woman being provided with

treatment services after the happening of that event, and have been

provided with such relevant information as is proper.

(6B)   

The reference in subsection (6A) to the intended second parent is a

reference to—

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(a)   

any man as respects whom the agreed fatherhood conditions in

section 37 of the Human Fertilisation and Embryology Act 2008

(“the 2008 Act”) are for the time being satisfied in relation to

treatment provided to the woman being treated, and

(b)   

any woman as respects whom the agreed female parenthood

35

conditions in section 44 of the 2008 Act are for the time being

satisfied in relation to treatment provided to the woman to be

treated.

(6C)   

Where the person responsible receives from a person (“X”) notice under

section 37(1)(c) or 44(1)(c) of the 2008 Act of X’s withdrawal of consent

40

to X being treated as the parent of any child resulting from the

provision of treatment services to a woman (“W”), the person

responsible—

(a)   

must notify W in writing of the receipt of the notice from X, and

 
 

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

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(b)   

no person to whom the licence applies may place an embryo or

sperm and eggs in W, or artificially inseminate W, until W has

been so notified.

(6D)   

Where the person responsible receives from a woman (“W”) who has

previously given notice under section 37(1)(b) or 44(1)(b) of the 2008

5

Act that she consents to another person (“X”) being treated as a parent

of any child resulting from the provision of treatment services to W—

(a)   

notice under section 37(1)(c) or 44(1)(c) of the 2008 Act of the

withdrawal of W’s consent, or

(b)   

a notice under section 37(1)(b) or 44(1)(b) of the 2008 Act in

10

respect of a person other than X,

   

the person responsible must take reasonable steps to notify X in writing

of the receipt of the notice mentioned in paragraph (a) or (b).”

(4)   

After subsection (7) insert—

“(8)   

Subsections (9) and (10) apply in determining any of the following—

15

(a)   

the persons who are to provide gametes for use in pursuance of

the licence in a case where consent is required under paragraph

5 of Schedule 3 for the use in question;

(b)   

the woman from whom an embryo is to be taken for use in

pursuance of the licence, in a case where her consent is required

20

under paragraph 7 of Schedule 3 for the use of the embryo;

(c)   

which of two or more embryos to place in a woman.

(9)   

Persons or embryos that are known to have a gene, chromosome or

mitochondrion abnormality involving a significant risk that a person

with the abnormality will have or develop—

25

(a)   

a serious physical or mental disability,

(b)   

a serious illness, or

(c)   

any other serious medical condition,

   

must not be preferred to those that are not known to have such an

abnormality.

30

(10)   

Embryos that are known to be of a particular sex and to carry a

particular risk, compared with embryos of that sex in general, that any

resulting child will have or develop—

(a)   

a gender-related serious physical or mental disability,

(b)   

a gender-related serious illness, or

35

(c)   

any other gender-related serious medical condition,

   

must not be preferred to those that are not known to carry such a risk.

(11)   

For the purposes of subsection (10), a physical or mental disability,

illness or other medical condition is gender-related if—

(a)   

it affects only one sex, or

40

(b)   

it affects one sex significantly more than the other.

(12)   

No embryo appropriated for the purpose of training persons in the

testing of embryos shall be kept or used for the provision of treatment

services.

(13)   

The person responsible shall comply with any requirement imposed on

45

that person by section 31ZD.”

 
 

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

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(5)   

After Schedule 3 to the 1990 Act insert the Schedule set out in Schedule 4 to this

Act (circumstances in which offer of counselling required as condition of

licence for treatment).

(6)   

In any licence under paragraph 1 of Schedule 2 to the 1990 Act (licences for

treatment) that is in force immediately before the commencement of subsection

5

(2)(b) of this section, the condition required by virtue of section 13(5) of that Act

is to have effect as the condition required by that provision as amended by

subsection (2)(b) of this section.

15      

Conditions of storage licences

(1)   

Section 14 of the 1990 Act (conditions of storage licences) is amended as

10

follows.

(2)   

In subsection (1)—

(a)   

for “authorising the storage of gametes or embryos” substitute

“authorising the storage of gametes, embryos or inter-species

embryos”,

15

(b)   

for paragraph (a) substitute—

“(a)   

that gametes of a person shall be placed in storage only

if—

(i)   

received from that person,

(ii)   

acquired in circumstances in which by virtue of

20

paragraph 9 or 10 of Schedule 3 that person’s

consent to the storage is not required, or

(iii)   

acquired from a person to whom a licence or

third party agreement applies,

(aa)   

that an embryo taken from a woman shall be placed in

25

storage only if—

(i)   

received from that woman, or

(ii)   

acquired from a person to whom a licence or

third party agreement applies,

(ab)   

that an embryo the creation of which has been brought

30

about in vitro otherwise than in pursuance of that licence

shall be placed in storage only if acquired from a person

to whom a licence or third party agreement applies,

(ac)   

that an inter-species embryo the creation of which has

been brought about in vitro otherwise than in pursuance

35

of that licence shall be placed in storage only if acquired

from a person to whom a licence under paragraph 2 or 3

of Schedule 2 applies,”,

(c)   

after paragraph (b) insert—

“(ba)   

that inter-species embryos shall not be supplied to a

40

person unless that person is a person to whom a licence

applies,”, and

(d)   

in paragraph (c), for “or embryos” substitute “, embryos or inter-species

embryos”.

(3)   

In subsection (4), for “five years” substitute “ten years”.

45

 
 

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

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(4)   

After subsection (4) insert—

“(4A)   

The statutory storage period in respect of inter-species embryos is such

period not exceeding ten years as the licence may specify.”

(5)   

In subsection (5)—

(a)   

for “or (4)” substitute “, (4) or (4A)”, and

5

(b)   

omit “or, as the case may be, five years”.

Grant, revocation and suspension of licences

16      

Grant of licence

(1)   

Section 16 of the 1990 Act (grant of licence) is amended as follows.

(2)   

For subsection (1) substitute—

10

“(1)   

The Authority may on application grant a licence to any person if the

requirements of subsection (2) below are met.”

(3)   

In subsection (2)—

(a)   

for “licence committee” substitute “Authority” in each place it occurs,

(b)   

in paragraph (ca), for “or embryos” substitute “, embryos or inter-

15

species embryos”, and

(c)   

in paragraph (d), after “granted” insert “and any premises which will

be relevant third party premises”.

(4)   

In subsection (4) for “licence committee” substitute “Authority”.

(5)   

In subsection (5) for “licence committee” substitute “Authority”.

20

(6)   

Omit subsections (6) and (7) (which concern the power to charge fees).

17      

The person responsible

(1)   

Section 17 of the 1990 Act (the person responsible) is amended as follows.

(2)   

In subsection (1)(c)—

(a)   

for “and embryos” substitute “, embryos and inter-species embryos”,

25

and

(b)   

for “or embryos” substitute “, embryos or inter-species embryos”.

(3)   

Omit subsection (3) (which defines “the nominal licensee”).

18      

Revocation and variation of licence

For section 18 of the 1990 Act (revocation and variation of licence) substitute—

30

“18     

Revocation of licence

(1)   

The Authority may revoke a licence on application by—

(a)   

the person responsible, or

(b)   

the holder of the licence (if different).

(2)   

The Authority may revoke a licence otherwise than on application

35

under subsection (1) if—

 
 

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

13

 

(a)   

it is satisfied that any information given for the purposes of the

application for the licence was in any material respect false or

misleading,

(b)   

it is satisfied that the person responsible has failed to discharge,

or is unable because of incapacity to discharge, the duty under

5

section 17,

(c)   

it is satisfied that the person responsible has failed to comply

with directions given in connection with any licence,

(d)   

it ceases to be satisfied that the premises specified in the licence

are suitable for the licensed activity,

10

(e)   

it ceases to be satisfied that any premises which are relevant

third party premises in relation to a licence are suitable for the

activities entrusted to the third party by the person who holds

the licence,

(f)   

it ceases to be satisfied that the holder of the licence is a suitable

15

person to hold the licence,

(g)   

it ceases to be satisfied that the person responsible is a suitable

person to supervise the licensed activity,

(h)   

the person responsible dies or is convicted of an offence under

this Act, or

20

(i)   

it is satisfied that there has been any other material change of

circumstances since the licence was granted.

18A     

Variation of licence

(1)   

The Authority may on application by the holder of the licence vary the

licence so as to substitute another person for the person responsible if—

25

(a)   

the application is made with the consent of that other person,

and

(b)   

the Authority is satisfied that the other person is a suitable

person to supervise the licensed activity.

(2)   

The Authority may vary a licence on application by—

30

(a)   

the person responsible, or

(b)   

the holder of the licence (if different).

(3)   

The Authority may vary a licence without an application under

subsection (2) if it has the power to revoke the licence under section

18(2).

35

(4)   

The powers under subsections (2) and (3) do not extend to making the

kind of variation mentioned in subsection (1).

(5)   

The Authority may vary a licence without an application under

subsection (2) by—

(a)   

removing or varying a condition of the licence, or

40

(b)   

adding a condition to the licence.

(6)   

The powers conferred by this section do not extend to the conditions

required by sections 12 to 15 of this Act.”

19      

Procedure for refusal, variation or revocation of licence

For section 19 of the 1990 Act (procedure for refusal, variation or revocation of

45

 
 

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

14

 

licence) substitute—

“19     

Procedure in relation to licensing decisions

(1)   

Before making a decision—

(a)   

to refuse an application for the grant, revocation or variation of

a licence, or

5

(b)   

to grant an application for a licence subject to a condition

imposed under paragraph 1(2), 1A(2), 2(2) or 3(7) of Schedule 2,

   

the Authority shall give the applicant notice of the proposed decision

and of the reasons for it.

(2)   

Before making a decision under section 18(2) or 18A(3) or (5) the

10

Authority shall give notice of the proposed decision and of the reasons

for it to—

(a)   

the person responsible, and

(b)   

the holder of the licence (if different).

(3)   

Where an application has been made under section 18A(2) to vary a

15

licence, but the Authority considers it appropriate to vary the licence

otherwise than in accordance with the application, before so varying

the licence the Authority shall give notice of its proposed decision and

of the reasons for it to—

(a)   

the person responsible, and

20

(b)   

the holder of the licence (if different).

(4)   

A person to whom notice is given under subsection (1), (2) or (3) has the

right to require the Authority to give him an opportunity to make

representations of one of the following kinds about the proposed

decision, namely—

25

(a)   

oral representations by him, or a person acting on his behalf;

(b)   

written representations by him.

(5)   

The right under subsection (4) is exercisable by giving the Authority

notice of the exercise of the right before the end of the period of 28 days

beginning with the day on which the notice under subsection (1), (2) or

30

(3) was given.

(6)   

The Authority may by regulations make such additional provision

about procedure in relation to the carrying out of functions under

sections 18 and 18A and this section as it thinks fit.

19A     

Notification of licensing decisions

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(1)   

In the case of a decision to grant a licence, the Authority shall give

notice of the decision to—

(a)   

the applicant, and

(b)   

the person who is to be the person responsible.

(2)   

In the case of a decision to revoke a licence, the Authority shall give

40

notice of the decision to—

(a)   

the person responsible, and

(b)   

the holder of the licence (if different).

(3)   

In the case of a decision to vary a licence on application under section

18A(1), the Authority shall give notice of the decision to—

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