Human Fertilisation and Embryology Bill [HL]

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Session 2007 - 08
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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

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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
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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2001 (S. I. 2001/188) (which are superseded by the amendments made by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
10

(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
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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—
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(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.
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(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
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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”.
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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
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(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
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(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
35
(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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