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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

29

 

(b)   

disclosure in circumstances in which section 32 of this Act

applies of information having the tendency mentioned in

subsection (2) of that section, made by any person acting in a

capacity mentioned in any of paragraphs (c) to (g) of subsection

(1) of section 33A.

5

33C     

Disclosure for the purposes of medical or other research

(1)   

Regulations may—

(a)   

make such provision for and in connection with requiring or

regulating the processing of protected information for the

purposes of medical research as the Secretary of State considers

10

is necessary or expedient in the public interest or in the interests

of improving patient care, and

(b)   

make such provision for and in connection with requiring or

regulating the processing of protected information for the

purposes of any other research as the Secretary of State

15

considers is necessary or expedient in the public interest.

(2)   

Regulations under subsection (1) may, in particular, make provision—

(a)   

for requiring or authorising the disclosure or other processing

of protected information to or by persons of any prescribed

description subject to compliance with any prescribed

20

conditions (including conditions requiring prescribed

undertakings to be obtained from such persons as to the

processing of such information),

(b)   

for securing that, where prescribed protected information is

processed by a person in accordance with the regulations,

25

anything done by that person in so processing the information

must be taken to be lawfully done despite any obligation of

confidence owed by the person in respect of it,

(c)   

for requiring fees of a prescribed amount to be paid to the

Authority in prescribed circumstances by persons in relation to

30

the disclosure to those persons of protected information under

those regulations,

(d)   

for the establishment of one or more bodies to exercise

prescribed functions in relation to the processing of protected

information under those regulations,

35

(e)   

as to the membership and proceedings of any such body, and

(f)   

as to the payment of remuneration and allowances to any

member of any such body and the reimbursement of expenses.

(3)   

Where regulations under subsection (1) require or regulate the

processing of protected information for the purposes of medical

40

research, such regulations may enable any approval given under

regulations made under section 251 of the National Health Service Act

2006 (control of patient information) to have effect for the purposes of

the regulations under subsection (1) in their application to England and

Wales.

45

(4)   

Subsections (1) to (3) are subject to subsections (5) to (8).

(5)   

Regulations under subsection (1) may not make any provision

requiring or authorising the disclosure or other processing, for any

purpose, of protected information, where that information is

information from which an individual may be identified, if it would be

50

 
 

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

30

 

reasonably practicable to achieve that purpose otherwise than pursuant

to such regulations, having regard to the cost of and technology

available for achieving that purpose.

(6)   

Regulations under this section may not make provision for or in

connection with the processing of protected information in a manner

5

inconsistent with any provision made by or under the Data Protection

Act 1998 (c. 29).

(7)   

Subsection (6) does not affect the operation of provisions made under

subsection (2)(b).

(8)   

Before making any regulations under this section the Secretary of State

10

shall consult such bodies appearing to the Secretary of State to

represent the interests of those likely to be affected by the regulations

as the Secretary of State considers appropriate.

(9)   

In this section—

“prescribed” means prescribed by regulations made by virtue of

15

this section,

“processing”, in relation to information, means the use, disclosure,

or obtaining of the information or the doing of such other things

in relation to it as may be prescribed for the purposes of this

definition, and

20

“protected information” means information falling within section

31(2).”

Mitochondrial donation

26      

Mitochondrial donation

After section 35 of the 1990 Act insert—

25

“Mitochondrial donation

35A     

Mitochondrial donation

(1)   

Regulations may provide for any of the relevant provisions to have

effect subject to specified modifications in relation to cases where—

(a)   

an egg which is a permitted egg for the purposes of section 3(2)

30

by virtue of regulations made under section 3ZA(5), or

(b)   

an embryo which is a permitted embryo for those purposes by

virtue of such regulations,

   

has been created from material provided by two women.

(2)   

In this section “the relevant provisions” means—

35

(a)   

the following provisions of this Act—

(i)   

section 31 (register of information),

(ii)   

sections 31ZA to 31ZE (provision of information), and

(iii)   

Schedule 3 (consents to use or storage of gametes,

embryos or inter-species embryos etc.), and

40

(b)   

section 54 of the Human Fertilisation and Embryology Act 2008

(parental orders).”

 
 

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

31

 

Miscellaneous

27      

Fees

After section 35A of the 1990 Act (as inserted by section 26 above) insert—

“Fees

35B     

Fees

5

(1)   

The Authority may charge a fee in respect of any of the following—

(a)   

an application for a licence,

(b)   

the grant or renewal of a licence,

(c)   

an application for the revocation or variation of a licence, or

(d)   

the exercise by the Authority of any other function conferred on

10

it by or under this Act or by or under any other enactment—

(i)   

in relation to a licence,

(ii)   

in relation to premises which are or have been premises

to which a licence relates,

(iii)   

in relation to premises which are or have been relevant

15

third party premises in relation to a licence, or

(iv)   

in relation to premises which, if an application is

granted, will be premises to which a licence relates or

relevant third party premises.

(2)   

The amount of any fee charged by virtue of subsection (1) is to be fixed

20

in accordance with a scheme made by the Authority with the approval

of the Secretary of State and the Treasury.

(3)   

In fixing the amount of any fee to be charged by virtue of that

subsection, the Authority may have regard to the costs incurred by it—

(a)   

in exercising the functions conferred on it by or under this Act

25

(apart from sections 31ZA to 31ZG and 33C), and

(b)   

in exercising any other function conferred on it by or under any

other enactment.

(4)   

The Authority may also charge such fee as it thinks fit in respect of any

of the following—

30

(a)   

the giving of notice under section 31ZA(1) or 31ZB(1), or

(b)   

the provision of information under section 31ZA, 31ZB or 31ZE.

(5)   

In fixing the amount of any fee to be charged by virtue of subsection (4)

the Authority may have regard to the costs incurred by it in exercising

the function to which the fee relates.

35

(6)   

When exercising its power to charge fees under section 8(2), 31ZF(2)(d)

or this section, the Authority may fix different fees for different

circumstances.”

28      

Inspection, entry, search and seizure

(1)   

Before section 39 of the 1990 Act (but after the heading “Enforcement”

40

 
 

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

32

 

immediately before that section) insert—

“38A    

Inspection, entry, search and seizure

(1)   

Schedule 3B (which makes provisions about inspection, entry, search

and seizure) has effect.

(2)   

Nothing in this Act makes it unlawful for a member or employee of the

5

Authority to keep any embryo, inter-species embryo or gametes in

pursuance of that person’s functions as such.”

(2)   

After Schedule 3A to the 1990 Act insert the Schedule set out in Schedule 5 to

this Act (inspection, entry, search and seizure).

(3)   

Section 39 of the 1990 Act (powers of members and employees of Authority)

10

and section 40 of that Act (power to enter premises) (which are superseded by

the amendments made by subsection (2)) cease to have effect.

29      

Offences under the 1990 Act

(1)   

Section 41 of the 1990 Act (offences) is amended as follows.

(2)   

In subsection (1)(a), for “4(1)(c)” substitute “4A(1) or (2)”.

15

(3)   

In subsection (2)—

(a)   

after paragraph (a) insert—

“(aa)   

contravenes section 3(1B) of this Act,”,

(b)   

after paragraph (ba) insert—

“(bb)   

contravenes section 4(1A) of this Act,”, and

20

(c)   

in paragraph (d), for “section 24(7)(a)” substitute “section 24(5D)”.

(4)   

In subsection (4), omit “, other than an offence to which subsection (4B)

applies,”.

(5)   

In subsection (5), for “section 33” substitute “section 33A”.

(6)   

In subsection (8)—

25

(a)   

for “or the nominal licensee” substitute “or the holder of the licence”,

and

(b)   

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

(7)   

In subsection (9), omit “(6), (7) or”.

(8)   

For subsection (10) substitute—

30

“(10)   

It is a defence for a person (“the defendant”) charged with an offence of

doing anything which, under section 3(1) or (1A), 4(1) or 4A(2), cannot

be done except in pursuance of a licence to prove—

(a)   

that the defendant was acting under the direction of another,

and

35

(b)   

that the defendant believed on reasonable grounds—

(i)   

that the other person was at the material time the person

responsible under a licence, a person designated by

virtue of section 17(2)(b) of this Act as a person to whom

a licence applied, or a person to whom directions had

40

been given under section 24(5A) to (5D), and

 
 

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

33

 

(ii)   

that the defendant was authorised by virtue of the

licence or directions to do the thing in question.

(10A)   

It is a defence for a person (“the defendant”) charged with an offence of

doing anything which, under section 3(1A) or (1B) or 4(1A), cannot be

done except in pursuance of a licence or a third party agreement to

5

prove—

(a)   

that the defendant was acting under the direction of another,

and

(b)   

that the defendant believed on reasonable grounds—

(i)   

that the other person was at the material time the person

10

responsible under a licence, a person designated by

virtue of section 17(2)(b) of this Act as a person to whom

a licence applied, a person to whom a third party

agreement applied, or a person to whom directions had

been given under section 24(5A) to (5D), and

15

(ii)   

that the defendant was authorised by virtue of the

licence, third party agreement or directions to do the

thing in question.”

(9)   

Omit subsections (2A), (4A), (4B), (6) and (7).

(10)   

Section 41(2) of the 1990 Act as amended by subsection (3) is to be treated as a

20

relevant enactment for the purposes of section 282 of the Criminal Justice Act

2003 (c. 44) (increase in maximum term that may be imposed on summary

conviction of offence triable either way).

30      

Regulations under the 1990 Act

(1)   

Section 45 of the 1990 Act (regulations) is amended as follows.

25

(2)   

After subsection (1) insert—

“(1A)   

Subsection (1) does not enable the Secretary of State to make

regulations by virtue of section 19(6) or 19B(2) (which confer

regulation-making powers on the Authority).”

(3)   

In subsection (2), after “regulations” insert “under this Act”.

30

(4)   

For subsection (3) substitute—

“(3)   

The power to make regulations under this Act may be exercised—

(a)   

either in relation to all cases to which the power extends, or in

relation to those cases subject to specified exceptions, or in

relation to any specified cases or classes of case, and

35

(b)   

so as to make, as respects the cases in relation to which it is

exercised—

(i)   

the full provision to which the power extends or any less

provision (whether by way of exception or otherwise);

(ii)   

the same provision for all cases in relation to which the

40

power is exercised, or different provision as respects the

same case or class of case for different purposes;

(iii)   

any such provision either unconditionally, or subject to

any specified condition.

 
 

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

34

 

(3A)   

Any power of the Secretary of State or the Authority to make

regulations under this Act includes power to make such transitional,

incidental or supplemental provision as the Secretary of State or the

Authority considers appropriate.”

(5)   

For subsection (4) substitute—

5

“(4)   

The Secretary of State shall not make regulations by virtue of any of the

provisions specified in subsection (4A) unless a draft has been laid

before and approved by a resolution of each House of Parliament.

(4A)   

Those provisions are—

section 1(6);

10

section 3(3)(c);

section 3ZA(5);

section 4(2) or (3);

section 4A(5)(e) or (7);

section 24(4B);

15

section 31ZA(2)(a);

section 33B;

section 33C;

section 35A;

section 43;

20

paragraph 1(1)(g), 1ZC, 3(5) or 3A(1)(c) of Schedule 2.”

(6)   

In subsection (5), after “regulations” insert “made by the Secretary of State”.

31      

Power to make consequential provision

After section 45 of the 1990 Act (regulations) insert—

“45A    

Power to make consequential provision

25

(1)   

The Secretary of State may by order make such provision modifying

any provision made by or under any enactment as the Secretary of State

considers necessary or expedient in consequence of any provision

made by regulations under any of the relevant provisions of this Act.

(2)   

For the purposes of subsection (1), “the relevant provisions of this Act”

30

are—

(a)   

section 1(6) (power to include things within the meaning of

“embryo” and “gametes” etc.);

(b)   

section 4A(5)(e) (power to include things within the meaning of

“inter-species embryo”);

35

(c)   

section 4A(7) (power to amend the definition of “inter-species

embryo”).

(3)   

Before making an order under this section containing provision which

would, if included in an Act of the Scottish Parliament, be within the

legislative competence of that Parliament, the Secretary of State must

40

consult the Scottish Ministers.

(4)   

Before making an order under this section containing provision which

would be within the legislative competence of the National Assembly

for Wales if it were included in a Measure of the Assembly (or, if the

 
 

Human Fertilisation and Embryology Bill [HL]
Part 2 — Parenthood in cases involving assisted reproduction

35

 

order is made after the Assembly Act provisions come into force, an Act

of the Assembly), the Secretary of State must consult the Welsh

Ministers.

(5)   

Before making an order under this section containing provision which

would if included in an Act of the Northern Ireland Assembly, be

5

within the legislative competence of that Assembly, the Secretary of

State must consult the Department of Health, Social Services and Public

Safety.

(6)   

In this section—

“enactment” means—

10

(a)   

an Act of Parliament (other than this Act),

(b)   

an Act of the Scottish Parliament,

(c)   

a Measure or Act of the National Assembly for Wales, or

(d)   

Northern Ireland legislation,

whenever passed or made;

15

“modify” includes amend, add to, revoke or repeal;

“the Assembly Act provisions” has the meaning given by section

103(8) of the Government of Wales Act 2006.”

32      

Orders under the 1990 Act

After section 45A (inserted by section 31 above) insert—

20

“45B    

Orders

(1)   

The power to make an order under section 8C(1)(c) or 45A of this Act

shall be exercisable by statutory instrument.

(2)   

The power to make an order under section 8C(1)(c) or 45A of this Act

includes power to make such transitional, incidental or supplemental

25

provision as the Secretary of State considers appropriate.

(3)   

A statutory instrument containing an order made by the Secretary of

State by virtue of section 8C(1)(c) shall be subject to annulment in

pursuance of a resolution of either House of Parliament.

(4)   

The Secretary of State shall not make an order by virtue of section 45A

30

unless a draft has been laid before and approved by a resolution of each

House of Parliament.”

Part 2

Parenthood in cases involving assisted reproduction

Meaning of “mother”

35

33      

Meaning of “mother”

(1)   

The woman who is carrying or has carried a child as a result of the placing in

her of an embryo or of sperm and eggs, and no other woman, is to be treated

as the mother of the child.

(2)   

Subsection (1) does not apply to any child to the extent that the child is treated

40

by virtue of adoption as not being the woman’s child.

 
 

 
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