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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

25

 

(e)   

arrange for samples of the DNA of such persons to be analysed

at their request,

(f)   

make such arrangements as it thinks fit for the disclosure of

information on the register between persons who appear to the

Authority to be genetically related, and

5

(g)   

impose such conditions as it thinks fit to prevent a person (“A”)

from disclosing information to a person to whom A is

genetically related (“B”) where that information would identify

any person who is genetically related to both A and B.

(3)   

The Authority may make arrangements with any person by whom a

10

voluntary contact register is kept before the commencement of this

section for the supply by that person to the Authority of the

information contained in the register maintained by that person.

31ZG    

Financial assistance for person setting up or keeping voluntary contact

register

15

(1)   

The Authority may, instead of keeping a voluntary contact register,

give financial assistance to any person who sets up or keeps a voluntary

contact register.

(2)   

Financial assistance under subsection (1) may be given in any form, and

in particular, may be given by way of—

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(a)   

grants,

(b)   

loans,

(c)   

guarantees, or

(d)   

incurring expenditure for the person assisted.

(3)   

Financial assistance under subsection (1) may be given on such terms

25

and conditions as the Authority considers appropriate.

(4)   

A person receiving assistance under subsection (1) must comply with

the terms and conditions on which it is given, and compliance may be

enforced by the Authority.”

25      

Restrictions on disclosure of information

30

For section 33 of the 1990 Act (restrictions on disclosure of information)

substitute—

“33A    

Disclosure of information

(1)   

No person shall disclose any information falling within section 31(2)

which the person obtained (whether before or after the coming into

35

force of section 24 of the Human Fertilisation and Embryology Act

2008) in the person’s capacity as—

(a)   

a member or employee of the Authority,

(b)   

any person exercising functions of the Authority by virtue of

section 8B or 8C of this Act (including a person exercising such

40

functions by virtue of either of those sections as a member of

staff or as an employee),

(c)   

any person engaged by the Authority to provide services to the

Authority,

(d)   

any person employed by, or engaged to provide services to, a

45

person mentioned in paragraph (c),

 
 

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

26

 

(e)   

a person to whom a licence applies,

(f)   

a person to whom a third party agreement applies, or

(g)   

a person to whom directions have been given.

(2)   

Subsection (1) does not apply where—

(a)   

the disclosure is made to a person as a member or employee of

5

the Authority or as a person exercising functions of the

Authority as mentioned in subsection (1)(b),

(b)   

the disclosure is made to or by a person falling within

subsection (1)(c) for the purpose of the provision of services

which that person is engaged to provide to the Authority,

10

(c)   

the disclosure is made by a person mentioned in subsection

(1)(d) for the purpose of enabling a person falling within

subsection (1)(c) to provide services which that person is

engaged to provide to the Authority,

(d)   

the disclosure is made to a person to whom a licence applies for

15

the purpose of that person’s functions as such,

(e)   

the disclosure is made to a person to whom a third party

agreement applies for the purpose of that person’s functions

under that agreement,

(f)   

the disclosure is made in pursuance of directions given by

20

virtue of section 24,

(g)   

the disclosure is made so that no individual to whom the

information relates can be identified,

(h)   

the disclosure is of information falling within section 31(2)(a)

and is made with the consent required by subsection (4),

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(i)   

the disclosure is of information falling within any of paragraphs

(b) to (e) of subsection (2) of section 31 and is made—

(i)   

with the consent of the individual to whom it relates,

and

(ii)   

with the consent of any other individual who may be

30

identified from that information,

(j)   

the disclosure is of information which shows that an individual

who has attained the age of 18 is a relevant individual and is

made—

(i)   

with the consent of that individual,

35

(ii)   

in a case where the disclosure of that information would

also disclose any information falling within section

31(2)(a), with the consent required by subsection (4),

and

(iii)   

with the consent of any other individual who may be

40

identified from that information,

(k)   

the disclosure is of information which has been lawfully made

available to the public before the disclosure is made,

(l)   

the disclosure is made in accordance with sections 31ZA to

31ZE,

45

(m)   

the disclosure is required or authorised to be made—

(i)   

under regulations made under section 33C, or

(ii)   

in relation to any time before the coming into force of the

first regulations under that section, under regulations

made under section 251 of the National Health Service

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Act 2006,

 
 

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

27

 

(n)   

the disclosure is made by a person acting in the capacity

mentioned in subsection (1)(a) or (b) for the purpose of carrying

out the Authority’s duties under section 8A,

(o)   

the disclosure is made by a person acting in the capacity

mentioned in subsection (1)(a) or (b) in pursuance of an order of

5

a court under section 34 or 35,

(p)   

the disclosure is made by a person acting in the capacity

mentioned in subsection (1)(a) or (b) to the Registrar General in

pursuance of a request under section 32,

(q)   

the disclosure is made by a person acting in the capacity

10

mentioned in subsection (1)(a) or (b) to any body or person

discharging a regulatory function for the purpose of assisting

that body or person to carry out that function,

(r)   

the disclosure is made for the purpose of establishing in any

proceedings relating to an application for an order under

15

subsection (1) of section 54 of the Human Fertilisation and

Embryology Act 2008 whether the condition specified in

paragraph (a) or (b) of that subsection is met,

(s)   

the disclosure is made under section 3 of the Access to Health

Records Act 1990,

20

(t)   

the disclosure is made under Article 5 of the Access to Health

Records (Northern Ireland) Order 1993, or

(u)   

the disclosure is made necessarily for—

(i)   

the purpose of the investigation of any offence (or

suspected offence), or

25

(ii)   

any purpose preliminary to proceedings, or for the

purposes of, or in connection with, any proceedings.

(3)   

Subsection (1) does not apply to the disclosure of information in so far

as—

(a)   

the information identifies a person who, but for sections 27 to 29

30

of this Act or sections 33 to 47 of the Human Fertilisation and

Embryology Act 2008, would or might be a parent of a person

who instituted proceedings under section 1A of the Congenital

Disabilities (Civil Liability) Act 1976, and

(b)   

the disclosure is made for the purpose of defending such

35

proceedings, or instituting connected proceedings for

compensation against that parent.

(4)   

For the purpose of subsection (2)(h) and (j)(ii), the consent required by

this subsection is—

(a)   

where any person is identifiable from the information, the

40

consent of that person, or

(b)   

where treatment services were provided to two persons

together and both persons are identifiable, if disclosure is made

for the purpose of disclosing information about the provision of

treatment services to one of them, the consent of that person.

45

(5)   

For the purposes of subsection (2)(h), (i) and (j), consent to disclosure

given at the request of another shall be disregarded unless, before it is

given, the person requesting it takes reasonable steps to explain to the

individual from whom it is requested the implications of compliance

with the request.

50

 
 

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

28

 

(6)   

Information falling within section 31(2) cannot be disclosed by virtue of

subsection (2)(h), (i) or (j) to a person who has not attained the age of 18.

(7)   

Paragraph (u) of subsection (2), so far as relating to disclosure for the

purpose of the investigation of an offence or suspected offence, or for

any purpose preliminary to, or in connection with proceedings, does

5

not apply—

(a)   

to disclosure of information enabling a person to be identified

as a person whose gametes were used in accordance with

consent given under paragraph 5 of Schedule 3 for the purposes

of treatment services or non-medical fertility services, in

10

consequence of which an identifiable individual was, or may

have been, born, or

(b)   

to disclosure, in circumstances in which subsection (1) of section

34 of this Act applies, of information relevant to the

determination of the question mentioned in that subsection,

15

made by any person acting in a capacity mentioned in any of

paragraphs (c) to (g) of subsection (1).

(8)   

In the case of information which relates to the provision of treatment

services for any identifiable individual, subsection (1) does not apply to

disclosure in an emergency, that is to say, disclosure made—

20

(a)   

by a person who is satisfied that it is necessary to make the

disclosure to avert an imminent danger to the health of an

individual with whose consent the information could be

disclosed under subsection (2)(h), and

(b)   

in circumstances where it is not reasonably practicable to obtain

25

that individual’s consent.

(9)   

In the case of information which shows that any identifiable individual

was, or may have been, born in consequence of treatment services,

subsection (1) does not apply to any disclosure which is necessarily

incidental to disclosure under subsection (2)(h) or (8).

30

(10)   

Subsection (1) does not apply to the disclosure to any individual of

information which—

(a)   

falls within subsection (2) of section 31 of this Act by virtue of

any of paragraphs (a) to (e) of that subsection, and

(b)   

relates only to that individual or, in the case of an individual

35

treated together with another, only to that individual and that

other.

(11)   

In subsection (2)—

(a)   

in paragraph (j) “relevant individual” has the same meaning as

in section 31,

40

(b)   

in paragraph (q) “regulatory function” has the same meaning as

in section 32 of the Legislative and Regulatory Reform Act 2006,

and

(c)   

in paragraph (u) references to “proceedings” include any formal

procedure for dealing with a complaint.

45

33B     

Power to provide for additional exceptions from section 33A(1)

(1)   

Regulations may provide for additional exceptions from section

33A(1).

 
 

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

29

 

(2)   

No exception may be made under this section for—

(a)   

disclosure of a kind mentioned in paragraph (a) or (b) of

subsection (7) of section 33A, or

(b)   

disclosure in circumstances in which section 32 of this Act

applies of information having the tendency mentioned in

5

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.

33C     

Disclosure for the purposes of medical or other research

(1)   

Regulations may—

10

(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

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

of improving patient care, and

15

(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

considers is necessary or expedient in the public interest.

(2)   

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

20

(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

conditions (including conditions requiring prescribed

undertakings to be obtained from such persons as to the

25

processing of such information),

(b)   

for securing that, where prescribed protected information is

processed by a person in accordance with the regulations,

anything done by that person in so processing the information

must be taken to be lawfully done despite any obligation of

30

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

the disclosure to those persons of protected information under

those regulations,

35

(d)   

for the establishment of one or more bodies to exercise

prescribed functions in relation to the processing of protected

information under those regulations,

(e)   

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

(f)   

as to the payment of remuneration and allowances to any

40

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

research, such regulations may enable any approval given under

regulations made under section 251 of the National Health Service Act

45

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

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

Wales.

(4)   

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

 
 

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

30

 

(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

reasonably practicable to achieve that purpose otherwise than pursuant

5

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

inconsistent with any provision made by or under the Data Protection

10

Act 1998.

(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

shall consult such bodies appearing to the Secretary of State to

15

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

this section,

20

“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

“protected information” means information falling within section

25

31(2).”

Mitochondrial donation

26      

Mitochondrial donation

After section 35 of the 1990 Act insert—

“Mitochondrial donation

30

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)

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

35

(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—

(a)   

the following provisions of this Act—

40

(i)   

section 13(6C) (information whose provision to

prospective parents is required by licence condition),

(ii)   

section 31 (register of information),

(iii)   

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

 
 

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

31

 

(iv)   

Schedule 3 (consents to use or storage of gametes,

embryos or human admixed embryos etc.), and

(b)   

section 54 of the Human Fertilisation and Embryology Act 2008

(parental orders).”

Miscellaneous

5

27      

Fees

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

“Fees

35B     

Fees

(1)   

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

10

(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

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

15

(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

third party premises in relation to a licence, or

20

(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

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

25

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

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

30

(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—

(a)   

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

35

(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.

(6)   

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

40

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

circumstances.”

 
 

 
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