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
1

[NOTE: The words marked in bold type were inserted by the Lords to avoid
questions of privilege.]
A
Bill
To
Amend the Human Fertilisation and Embryology Act 1990 and the Surrogacy
Arrangements Act 1985; to make provision about the persons who in certain
circumstances are to be treated in law as the parents of a child; and for
connected purposes.
Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and
consent of the Lords Spiritual and Temporal, and Commons, in this present
Parliament assembled, and by the authority of the same, as follows:—
Part 1
Amendments of the Human Fertilisation and Embryology Act 1990
Principal terms used in the 1990 Act
1
Meaning of “embryo” and “gamete”
(1)
Section 1 of the 1990 Act (meaning of “embryo”, “gamete” and associated
5
expressions) is amended as follows.
(2)
For subsection (1) substitute—
“(1)
In this Act (except in section 4A or in the term “human admixed
embryo”)—
(a)
embryo means a live human embryo and does not include a
10
human admixed embryo (as defined by section 4A(5)), and
(b)
references to an embryo include an egg that is in the process of
fertilisation or is undergoing any other process capable of
resulting in an embryo.”
(3)
In subsection (2), for paragraph (a) substitute—
15
“(a)
references to embryos the creation of which was brought about
in vitro (in their application to those where fertilisation or any
other process by which an embryo is created is complete) are to
those where fertilisation or any other process by which the

Bill 70 54/3

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
2

embryo was created began outside the human body whether or
not it was completed there, and”.
(4)
For subsection (4) substitute—
“(4)
In this Act (except in section 4A)—
(a)
references to eggs are to live human eggs, including cells of the
5
female germ line at any stage of maturity, but (except in
subsection (1)(b)) not including eggs that are in the process of
fertilisation or are undergoing any other process capable of
resulting in an embryo,
(b)
references to sperm are to live human sperm, including cells of
10
the male germ line at any stage of maturity, and
(c)
references to gametes are to be read accordingly.”
(5)
After subsection (5) insert—
“(6)
If it appears to the Secretary of State necessary or desirable to do so in
the light of developments in science or medicine, regulations may
15
provide that in this Act (except in section 4A) “embryo”, “eggs”,
“sperm” or “gametes” includes things specified in the regulations
which would not otherwise fall within the definition.
(7)
Regulations made by virtue of subsection (6) may not provide for
anything containing any nuclear or mitochondrial DNA that is not
20
human to be treated as an embryo or as eggs, sperm or gametes.”
2
Meaning of “nuclear DNA”
In section 2(1) of the 1990 Act (other terms), after the definition of “non-medical
fertility services” insert—
““nuclear DNA”, in relation to an embryo, includes DNA in the
25
pronucleus of the embryo,”.
Activities governed by the 1990 Act
3
Prohibitions in connection with embryos
(1)
Section 3 of the 1990 Act (prohibitions in connection with embryos) is amended
as follows.
30
(2)
For subsection (2) substitute—
“(2)
No person shall place in a woman—
(a)
an embryo other than a permitted embryo (as defined by section
3ZA), or
(b)
any gametes other than permitted eggs or permitted sperm (as
35
so defined).”
(3)
In subsection (3)—
(a)
at the end of paragraph (b), insert “or”, and
(b)
omit paragraph (d) and the word “or” immediately before it.
(4)
In subsection (4), for “the day when the gametes are mixed” substitute “the day
40
on which the process of creating the embryo began”.

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
3

(5)
After section 3 insert—
“3ZA
Permitted eggs, permitted sperm and permitted embryos
(1)
This section has effect for the interpretation of section 3(2).
(2)
A permitted egg is one—
(a)
which has been produced by or extracted from the ovaries of a
5
woman, and
(b)
whose nuclear or mitochondrial DNA has not been altered.
(3)
Permitted sperm are sperm—
(a)
which have been produced by or extracted from the testes of a
man, and
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(b)
whose nuclear or mitochondrial DNA has not been altered.
(4)
An embryo is a permitted embryo if—
(a)
it has been created by the fertilisation of a permitted egg by
permitted sperm,
(b)
no nuclear or mitochondrial DNA of any cell of the embryo has
15
been altered, and
(c)
no cell has been added to it other than by division of the
embryo’s own cells.
(5)
Regulations may provide that—
(a)
an egg can be a permitted egg, or
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(b)
an embryo can be a permitted embryo,

even though the egg or embryo has had applied to it in prescribed
circumstances a prescribed process designed to prevent the
transmission of serious mitochondrial disease.
(6)
In this section—
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(a)
“woman” and “man” include respectively a girl and a boy (from
birth), and
(b)
“prescribed” means prescribed by regulations.”
(6)
The Human Reproductive Cloning Act 2001 (c. 23) (which is superseded by the
preceding provisions of this section) ceases to have effect.
30
4
Prohibitions in connection with genetic material not of human origin
(1)
In section 4 of the 1990 Act (prohibitions in connection with gametes)—
(a)
in subsection (1), omit—
(i)
paragraph (c), and
(ii)
the word “or” immediately before it, and
35
(b)
in subsection (5), after “section 3” insert “or 4A”.
(2)
After section 4 of the 1990 Act insert—
“4A
Prohibitions in connection with genetic material not of human origin
(1)
No person shall place in a woman—
(a)
a human admixed embryo,
40
(b)
any other embryo that is not a human embryo, or
(c)
any gametes other than human gametes.

Human Fertilisation and Embryology Bill [HL]
Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990
4

(2)
No person shall—
(a)
mix human gametes with animal gametes,
(b)
bring about the creation of a human admixed embryo, or
(c)
keep or use a human admixed embryo,

except in pursuance of a licence.
5
(3)
A licence cannot authorise the keeping or using of a human admixed
embryo after the earliest of the following—
(a)
the appearance of the primitive streak, or
(b)
the end of the period of 14 days beginning with the day on
which the process of creating the human admixed embryo
10
began, but not counting any time during which the human
admixed embryo is stored.
(4)
A licence cannot authorise placing a human admixed embryo in an
animal.
(5)
For the purposes of this Act a human admixed embryo is—
15
(a)
an embryo created by replacing the nucleus of an animal egg or
of an animal cell, or two animal pronuclei, with—
(i)
two human pronuclei,
(ii)
one nucleus of a human gamete or of any other human
cell, or
20
(iii)
one human gamete or other human cell,
(b)
any other embryo created by using—
(i)
human gametes and animal gametes, or
(ii)
one human pronucleus and one animal pronucleus,
(c)
a human embryo that has been altered by the introduction of
25
any sequence of nuclear or mitochondrial DNA of an animal
into one or more cells of the embryo,
(d)
a human embryo that has been altered by the introduction of
one or more animal cells, or
(e)
such other thing as may be specified in regulations.
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(6)
In subsection (5)—
(a)
references to animal cells are to cells of an animal or of an
animal embryo, and
(b)
references to human cells are to cells of a human or of a human
embryo.
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(7)
For the purposes of this section an “animal” is an animal other than
man.
(8)
In this section “embryo” means a live embryo, including an egg that is
in the process of fertilisation or is undergoing any other process capable
of resulting in an embryo.
40
(9)
In this section—
(a)
references to eggs are to live eggs, including cells of the female
germ line at any stage of maturity, but not including eggs that
are in the process of fertilisation or are undergoing any other
process capable of resulting in an embryo, and
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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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(b)
references to gametes are to eggs (as so defined) or to live
sperm, including cells of the male germ line at any stage of
maturity.
(10)
If it appears to the Secretary of State necessary or desirable to do so in
the light of developments in science or medicine, regulations may—
5
(a)
amend (but not repeal) paragraphs (a) to (d) of subsection (5);
(b)
provide that in this section “embryo”, “eggs” or “gametes”
includes things specified in the regulations which would not
otherwise fall within the definition.
(11)
Regulations made by virtue of subsection (10)(a) may make any
10
amendment of subsection (6) that appears to the Secretary of State to be
appropriate in consequence of any amendment of subsection (5).”
The Human Fertilisation and Embryology Authority
5
Membership of Authority: disqualification and tenure
Schedule 1 contains amendments of Schedule 1 to the 1990 Act (which are
15
about disqualification for appointment to membership of the Authority and
the tenure of office of members).
6
Additional general functions of Authority
(1)
In section 8 of the 1990 Act (general functions of the Authority), renumber the
existing provision as subsection (1) of that section.
20
(2)
In that subsection—
(a)
omit the word “and” immediately after paragraph (c), and
(b)
after that paragraph insert—
“(ca)
maintain a statement of the general principles which it
considers should be followed—
25
(i)
in the carrying-on of activities governed by this
Act, and
(ii)
in the carrying-out of its functions in relation to
such activities,
(cb)
promote, in relation to activities governed by this Act,
30
compliance with—
(i)
requirements imposed by or under this Act, and
(ii)
the code of practice under section 25 of this Act,
and”.
(3)
After that subsection, insert—
35
“(2)
The Authority may, if it thinks fit, charge a fee for any advice provided
under subsection (1)(c).”