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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

 

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 “inter-species

embryo”)—

(a)   

embryo means a live human embryo and does not include an

10

inter-species 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

 
HL Bill 654/3
 
 

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)—

(a)   

may not provide for anything containing any nuclear or

20

mitochondrial DNA that is not human to be treated as an

embryo or as eggs, sperm or gametes, but

(b)   

may make any amendment of section 4A(11) or (12) that

appears to the Secretary of State to be appropriate in

consequence of the provision falling within subsection (6).

25

(8)   

For the purposes of subsection (7)(b), “amendment of” includes

addition to and repeal of.”

2       

Meaning of “nuclear DNA”

In section 2(1) of the 1990 Act (other terms), after the definition of “non-medical

fertility services” insert—

30

““nuclear DNA”, in relation to an embryo, includes DNA in the

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

35

as follows.

(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

40

(b)   

any gametes other than permitted eggs or permitted sperm (as

so defined).”

 
 

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

3

 

(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

on which the process of creating the embryo began”.

5

(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

10

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

15

(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

20

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

25

(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—

30

(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.

35

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

40

(b)   

in subsection (5), after “section 3” insert “or 4A”.

 
 

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

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(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)   

an embryo other than a human embryo,

(b)   

an inter-species embryo, or

5

(c)   

any gametes other than human gametes.

(2)   

No person shall—

(a)   

mix human gametes with animal gametes,

(b)   

bring about the creation of an inter-species embryo, or

(c)   

keep or use an inter-species embryo,

10

   

except in pursuance of a licence.

(3)   

A licence cannot authorise the keeping or using of an inter-species

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

15

which the process of creating the inter-species embryo began,

but not counting any time during which the inter-species

embryo is stored.

(4)   

A licence cannot authorise placing an inter-species embryo in an

animal.

20

(5)   

For the purpose of this Act an inter-species embryo is—

(a)   

an embryo created by using—

(i)   

human gametes and animal gametes, or

(ii)   

one human pronucleus and one animal pronucleus,

(b)   

an embryo created by replacing the nucleus of an animal egg or

25

of an animal cell, or two animal pronuclei with—

(i)   

two human pronuclei,

(ii)   

one nucleus of a human cell, or

(iii)   

one human cell,

(c)   

a human embryo that has been altered by the introduction of

30

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.

35

(6)   

In subsection (5)—

(a)   

references to animal cells are to cells of an animal or of an

animal embryo and, in paragraph (b) of that subsection, do not

include such cells which are cells of the female or male germ

line, and

40

(b)   

references to human cells are to cells of a human or of a human

embryo and, in paragraph (b) of that subsection, do not include

such cells which are cells of the female or male germ line.

(7)   

Regulations may make any amendment of the definition of inter-

species embryo in subsection (5).

45

 
 

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

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(8)   

Regulations under subsection (7) which amend subsection (5) may

make any amendment of subsection (6), (11), or (12) or of paragraph

3(3) or (5) of Schedule 2 that appears to the Secretary of State to be

appropriate in consequence of the amendment of subsection (5).

(9)   

For the purposes of subsections (7) and (8), “amend” includes add to

5

and repeal, and references to “amendment” are to be read accordingly.

(10)   

For the purposes of this section an “animal” is an animal other than

man.

(11)   

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

10

of resulting in an embryo.

(12)   

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

15

process capable of resulting in an embryo, and

(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.”

The Human Fertilisation and Embryology Authority

20

5       

Membership of Authority: disqualification and tenure

Schedule 1 contains amendments of Schedule 1 to the 1990 Act (which are

about disqualification for appointment to membership of the Authority and

the tenure of office of members).

6       

Additional general functions of Authority

25

(1)   

In section 8 of the 1990 Act (general functions of the Authority), renumber the

existing provision as subsection (1) of that section.

(2)   

In that subsection—

(a)   

omit the word “and” immediately after paragraph (c), and

(b)   

after that paragraph insert—

30

“(ca)   

maintain a statement of the general principles which it

considers should be followed—

(i)   

in the carrying-on of activities governed by this

Act, and

(ii)   

in the carrying-out of its functions in relation to

35

such activities,

(cb)   

promote, in relation to activities governed by this Act,

compliance with—

(i)   

requirements imposed by or under this Act, and

(ii)   

the code of practice under section 25 of this Act,

40

and”.

 
 

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

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(3)   

After that subsection, insert—

“(2)   

The Authority may, if it thinks fit, charge a fee for any advice provided

under subsection (1)(c).”

7       

Duties in relation to carrying out its functions

After section 8 (general functions of the Authority) insert—

5

“8ZA    

Duties in relation to carrying out its functions

(1)   

The Authority must carry out its functions effectively, efficiently and

economically.

(2)   

In carrying out its functions, the Authority must, so far as relevant,

have regard to the principles of best regulatory practice (including the

10

principles under which regulatory activities should be transparent,

accountable, proportionate, consistent and targeted only at cases in

which action is needed).”

8       

Power to contract out functions etc.

After section 8A of the 1990 Act (duty of Authority to communicate with

15

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

department, a public authority or the holder of a public office (“the

other authority”) for—

20

(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,

professional or technical services to the Authority.

(2)   

Arrangements under subsection (1)(a) do not affect responsibility for

25

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 (c. 30)).

8C      

Contracting out functions of Authority

(1)   

This section applies to any function of the Authority other than—

30

(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

(c)   

a function excluded from this section by the Secretary of State

by order.

35

(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

property, or

(c)   

it is a function of making subordinate legislation (within the

40

meaning of the Interpretation Act 1978).

 
 

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

7

 

(3)   

The Authority may make arrangements with any person (“the

authorised person”) for the exercise by that person, or by the employees

of that person, of any function of the Authority to which this section

applies.

(4)   

Any arrangements made by the Authority under this section—

5

(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

10

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—

15

(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

20

person (or any employee of the authorised person).

(7)   

Section 38A(2) of this Act (which relates to the keeping of embryos,

inter-species 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

25

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—

30

(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

35

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

40

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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