Human Fertilisation and Embryology Bill [HL]

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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
6

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Duties in relation to carrying out its functions
After section 8 (general functions of the Authority) insert—
“8ZA
Duties in relation to carrying out its functions
(1)
The Authority must carry out its functions effectively, efficiently and
economically.
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(2)
In carrying out its functions, the Authority must, so far as relevant,
have regard to the principles of best regulatory practice (including the
principles under which regulatory activities should be transparent,
accountable, proportionate, consistent and targeted only at cases in
which action is needed).”
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8
Power to contract out functions etc.
After section 8A of the 1990 Act (duty of Authority to communicate with
competent authorities of other EEA states) insert—
“8B
Agency arrangements and provision of services
(1)
Arrangements may be made between the Authority and a government
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department, a public authority or the holder of a public office (“the
other authority”) for—
(a)
any functions of the Authority to be exercised by, or by
members of the staff of, the other authority, or
(b)
the provision by the other authority of administrative,
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professional or technical services to the Authority.
(2)
Arrangements under subsection (1)(a) do not affect responsibility for
the carrying-out of the Authority’s functions.
(3)
Subsection (1)(a) does not apply to any function of making subordinate
legislation (within the meaning of the Interpretation Act 1978).
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8C
Contracting out functions of Authority
(1)
This section applies to any function of the Authority other than—
(a)
any function which, by virtue of any enactment, may be
exercised only by members of the Authority,
(b)
a function excluded from this section by subsection (2), or
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(c)
a function excluded from this section by the Secretary of State
by order.
(2)
A function is excluded from this section if—
(a)
it relates to the grant, revocation or variation of any licence,
(b)
it is a power or right of entry, search or seizure into or of any
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property, or
(c)
it is a function of making subordinate legislation (within the
meaning of the Interpretation Act 1978).
(3)
The Authority may make arrangements with any person (“the
authorised person”) for the exercise by that person, or by the employees
40
of that person, of any function of the Authority to which this section
applies.
(4)
Any arrangements made by the Authority under this section—

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
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(a)
may be revoked at any time by the Authority, and
(b)
do not prevent the Authority from exercising any function to
which the arrangements relate.
(5)
Subject to subsection (6), anything done or omitted to be done by or in
relation to the authorised person (or an employee of the authorised
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person) in, or in connection with, the exercise or purported exercise of
any function to which the arrangements relate is to be treated for all
purposes as done or omitted to be done by or in relation to the
Authority.
(6)
Subsection (5) does not apply—
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(a)
for the purposes of so much of any contract between the
authorised person and the Authority as relates to the exercise of
the function, or
(b)
for the purposes of any criminal proceedings brought in respect
of anything done or omitted to be done by the authorised
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person (or any employee of the authorised person).
(7)
Section 38A(2) of this Act (which relates to the keeping of embryos,
human admixed embryos and gametes) applies in relation to the
authorised person or any employee of the authorised person, when
exercising functions of the Authority, as it applies in relation to any
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member or employee of the Authority exercising functions as member
or employee.
8D
Disclosure of information where functions of Authority exercised by
others
(1)
This section applies to—
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(a)
the Authority,
(b)
any public authority or other person exercising functions of the
Authority by virtue of section 8B,
(c)
any member of staff of any person falling within paragraph (b),
(d)
any person exercising functions of the Authority by virtue of
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section 8C,
(e)
an employee of any person falling within paragraph (d), or
(f)
any person engaged by the Authority to provide services to the
Authority.
(2)
No obligation of confidence is to prevent the disclosure of information
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by a person to whom this section applies to another such person if the
disclosure is necessary or expedient for the purposes of the exercise of
any function of the Authority.”
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Power to assist other public authorities
After section 8D (inserted by section 8 above) insert—
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“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
the exercise by that authority of its functions.

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
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(2)
Assistance provided by the Authority under this section may be
provided on such terms, including terms as to payment, as it thinks fit.”
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Power to delegate and establish committees
For section 9 (licence committees and other committees) of the 1990 Act
substitute—
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“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
thinks fit (whether to advise the Authority or to exercise a function
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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
Authority.
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(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
11
Activities that may be licensed
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(1)
In section 11 of the 1990 Act (licences for treatment, storage and research), in
subsection (1)(b), for “and embryos” substitute “, embryos or human admixed
embryos”.
(2)
Schedule 2 contains amendments of Schedule 2 to the 1990 Act (which relates
to the activities for which licences may be granted under the Act).
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(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
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General conditions of licences
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(1)
Section 12 of the 1990 Act (general conditions of licences under that Act) is
amended as follows.
(2)
In subsection (1)—
(a)
in paragraph (c) (condition relating to compliance with Schedule 3 to
the Act), omit “or non-medical fertility services”, and
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(b)
in paragraphs (e) and (f) (which relate to the supply of gametes or
embryos), for “or embryos” substitute “, embryos or human admixed
embryos”.
(3)
In subsection (2)—

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
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(a)
omit the “and” at the end of paragraph (a), and
(b)
at the end of paragraph (b) insert “, and
(c)
every licence under paragraph 3 of that Schedule, so far
as authorising activities in connection with the
derivation from embryos of stem cells that are intended
5
for human application.”.
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Consent to use or storage of gametes, embryos, human admixed 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).
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Conditions of licences for treatment
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(1)
Section 13 of the 1990 Act (conditions of licences for treatment) is amended in
accordance with subsections (2) to (4).
(2)
In subsection (5)—
(a)
omit “, other than basic partner treatment services,”, and
(b)
for “a father” substitute “supportive parenting”.
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(3)
For subsection (6) substitute—
“(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
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being provided with treatment services of that kind, and have been
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
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second parent have been given a suitable opportunity to receive proper
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
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reference to—
(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
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(b)
any woman as respects whom the agreed female parenthood
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)
In the case of treatment services falling within paragraph 1 of Schedule
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3ZA (use of gametes of a person not receiving those services) or
paragraph 3 of that Schedule (use of embryo taken from a woman not
receiving those services), the information provided by virtue of
subsection (6) or (6A) must include such information as is proper
about—
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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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(a)
the importance of informing any resulting child at an early age
that the child results from the gametes of a person who is not a
parent of the child, and
(b)
suitable methods of informing such a child of that fact.
(6D)
Where the person responsible receives from a person (“X”) notice under
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section 37(1)(c) or 44(1)(c) of the 2008 Act of X’s withdrawal of consent
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
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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.
(6E)
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
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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—
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(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
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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
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(c)
any other gender-related serious medical condition,

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

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
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(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
(b)
it affects one sex significantly more than the other.
(12)
No embryo appropriated for the purpose mentioned in paragraph
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1(1)(ca) of Schedule 2 (training in embryological techniques) shall be
kept or used for the provision of treatment services.
(13)
The person responsible shall comply with any requirement imposed on
that person by section 31ZD.”
(5)
After Schedule 3 to the 1990 Act insert the Schedule set out in Schedule 4 to this
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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
(2)(b) of this section, the condition required by virtue of section 13(5) of that Act
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is to have effect as the condition required by that provision as amended by
subsection (2)(b) of this section.
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Conditions of storage licences
(1)
Section 14 of the 1990 Act (conditions of storage licences) is amended as
follows.
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(2)
In subsection (1)—
(a)
for “authorising the storage of gametes or embryos” substitute
“authorising the storage of gametes, embryos or human admixed
embryos”,
(b)
for paragraph (a) substitute—
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“(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
paragraph 9 or 10 of Schedule 3 that person’s
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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
storage only if—
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(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
about in vitro otherwise than in pursuance of that licence
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shall be placed in storage only if acquired from a person
to whom a licence or third party agreement applies,
(ac)
that a human admixed embryo the creation of which has
been brought about in vitro otherwise than in pursuance
of that licence shall be placed in storage only if acquired
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from a person to whom a licence under paragraph 2 or 3
of Schedule 2 applies,”,

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
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(c)
after paragraph (b) insert—
“(ba)
that human admixed embryos shall not be supplied to a
person unless that person is a person to whom a licence
applies,”, and
(d)
in paragraph (c), for “or embryos” substitute “, embryos or human
5
admixed embryos”.
(3)
In subsection (4), for “five years” substitute “ten years”.
(4)
After subsection (4) insert—
“(4A)
The statutory storage period in respect of human admixed embryos is
such period not exceeding ten years as the licence may specify.”
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(5)
In subsection (5)—
(a)
for “or (4)” substitute “, (4) or (4A)”, and
(b)
omit “or, as the case may be, five years”.
Grant, revocation and suspension of licences
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Grant of licence
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(1)
Section 16 of the 1990 Act (grant of licence) is amended as follows.
(2)
For subsection (1) substitute—
“(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)—
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(a)
for “licence committee” substitute “Authority” in each place it occurs,
(b)
in paragraph (c), after “application” insert “or a licence under
paragraph 3 of that Schedule authorising activities in connection with
the derivation from embryos of stem cells that are intended for human
application”,
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(c)
in paragraph (ca)—
(i)
for “or embryos” substitute “, embryos or human admixed
embryos”, and
(ii)
after “that Schedule” insert “authorising activities otherwise
than in connection with the derivation from embryos of stem
30
cells that are intended for human application”, and
(d)
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”.
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(6)
Omit subsections (6) and (7) (which concern the power to charge fees).
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The person responsible
(1)
Section 17 of the 1990 Act (the person responsible) is amended as follows.
(2)
In subsection (1)(c)—