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Health and Social Care Bill


Health and Social Care Bill
Part 5 — Miscellaneous

103

 

152     

Duty to consult Board in relation to regulations about patient information

For section 252 of the National Health Service Act 2006 (c. 41) substitute—

“252    

Consultation with National Information Governance Board

(1)   

Before laying before Parliament a draft of any statutory instrument

containing regulations under section 251(1), or making any regulations

5

pursuant to section 251(5)(b), the Secretary of State must seek and have

regard to the views of the National Information Governance Board for

Health and Social Care on the proposed regulations.

(2)   

The Secretary of State must publish, in such manner as the Secretary of

State considers appropriate, any views received from the Board on the

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proposed regulations.”

Functions of Health Protection Agency in relation to biological substances

153     

Functions of Health Protection Agency in relation to biological substances

(1)   

The National Biological Standards Board is abolished (and, accordingly, the

Biological Standards Act 1975 (c. 4) ceases to have effect).

15

(2)   

The Health Protection Agency Act 2004 (c. 17) is amended as follows.

(3)   

After section 2 insert—

“2A     

Functions in relation to biological substances

(1)   

The Agency has such functions in relation to a matter specified in

subsection (2) as the relevant authority directs.

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(2)   

Those matters are—

(a)   

the establishment of standards for biological substances;

(b)   

the preparation, approval and provision of standard

preparations of biological substances;

(c)   

the testing of biological substances.

25

(3)   

The relevant authority shall be deemed to have directed under

subsection (1) that the Agency is to have the functions specified in

paragraphs (a) to (f) of Article 2 of the 1976 Order (the pre-abolition

functions of the National Biological Standards Board).

(4)   

The direction under subsection (3)—

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(a)   

shall be deemed to have been given on the commencement of

that subsection;

(b)   

may be varied in the same way as any other direction under

subsection (1);

(c)   

is not affected by the repeal of the Biological Standards Act 1975

35

or by the 1976 Order ceasing to have effect as a result of that

repeal.

(5)   

In this section—

“biological substance” means a substance whose purity or potency

cannot, in the opinion of the Secretary of State, be adequately

40

tested by chemical means;

“the relevant authority” means—

 
 

Health and Social Care Bill
Part 5 — Miscellaneous

104

 

(a)   

the Secretary of State, and

(b)   

the Department of Health, Social Services and Public

Safety in Northern Ireland,

acting jointly;

“the 1976 Order” means the National Biological Standards Board

5

(Functions) Order 1976.

(6)   

The generality of section 2(1) is to be taken not to be prejudiced by this

section; and the generality of subsections (1) to (4) is to be taken not to

be prejudiced by section 2.”

(4)   

In section 6 (meaning of “appropriate authority”), after subsection (5) insert—

10

“(6)   

Subsections (2) to (5) do not apply in relation to biological-substances

functions.

(7)   

In relation to any biological-substances function, the appropriate

authority is—

(a)   

the Secretary of State, and

15

(b)   

the Department of Health, Social Services and Public Safety in

Northern Ireland,

   

acting jointly.

(8)   

In subsections (6) and (7) “biological-substances function” means—

(a)   

a function of the Agency under section 2A, or

20

(b)   

a function of the Agency under section 2(1), (2)(a) or (b), (3), (4)

or (10) that is a function in relation to a matter specified in

section 2A(2).”

(5)   

In section 8 (power to make transfer schemes)—

(a)   

after subsection (4) insert—

25

“(4A)   

The Secretary of State and the Department of Health, Social

Services and Public Safety in Northern Ireland, acting jointly,

may make a scheme for the transfer of property, rights and

liabilities of the National Biological Standards Board to the

Agency.”, and

30

(b)   

in subsection (7), after “section 2” insert “, 2A”.

(6)   

In section 9 (directions)—

(a)   

in subsection (2) (certain directions to be given in regulations made by

statutory instrument), after “section 2(2), (3) or (4)” insert “or 2A(1),”;

and

35

(b)   

in subsection (3) (certain statutory instruments making regulations

giving directions to be subject to annulment), after “section 2(2)(a) or

(3)” insert “or 2A(1)”.

Further amendments

154     

Minor and consequential amendments relating to Part 5

40

Schedule 14 (which contains further amendments related to the provisions of

this Part) has effect.

 
 

Health and Social Care Bill
Part 6 — General

105

 

Part 6

General

155     

Orders, regulations and directions: general provisions

(1)   

Orders and regulations made under this Act by the Secretary of State, the

Treasury, the Privy Council or the Welsh Ministers are to be made by statutory

5

instrument.

(2)   

Regulations made by the Department of Health, Social Services and Public

Safety in Northern Ireland under section 115 and orders made by that

Department under section 164(2) are to be made by statutory rule for the

purposes of the Statutory Rules (Northern Ireland) Order 1979 (S.I. 1979/1573

10

(N.I. 12)).

(3)   

Any power to make orders or regulations mentioned in subsection (1) or (2)

and any power of the Secretary of State to give directions under this Act—

(a)   

may be exercised either in relation to all cases to which the power

extends, or in relation to all cases subject to specified exceptions, or in

15

relation to any specified cases or classes of case,

(b)   

may be exercised 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),

20

(ii)   

the same provision for all cases in relation to which the power

is exercised, or different provision for different cases or

different classes of case, or different provision as respects the

same case or class of case for different purposes of this Act,

(iii)   

any such provision either unconditionally or subject to any

25

specified condition, and

(c)   

may, in particular, be exercised so as to make different provision for

different areas.

(4)   

Any such power includes power—

(a)   

to make such supplementary, incidental, consequential or transitional

30

provision or savings as the person exercising the power considers to be

appropriate, and

(b)   

to provide for a person to exercise a discretion in dealing with any

matter.

156     

Orders and regulations: Parliamentary control

35

(1)   

Subject to subsection (2), a statutory instrument containing—

(a)   

an order or regulations made by the Secretary of State under this Act,

(b)   

an order made by the Privy Council under section 104 (rules of Office

of the Health Professions Adjudicator), or

(c)   

regulations made by the Privy Council under Schedule 6 (Office of the

40

Health Professions Adjudicator),

   

is subject to annulment in pursuance of a resolution of either House of

Parliament.

(2)   

Subsection (1) does not apply to—

(a)   

a statutory instrument to which subsection (3) applies, or

45

 
 

Health and Social Care Bill
Part 6 — General

106

 

(b)   

a statutory instrument containing an order made only under section

164(2) (commencement).

(3)   

The Secretary of State may not make a statutory instrument containing

(whether alone or with other provision)—

(a)   

regulations under section 4(1) (regulated activities),

5

(b)   

regulations under section 16 (regulation of regulated activities) which

provide that a contravention of or failure to comply with a specified

provision of the regulations is an offence punishable with a maximum

fine exceeding level 4 on the standard scale,

(c)   

regulations under section 39 (power to modify Chapter 2 of Part 1 in

10

relation to newly regulated activities),

(d)   

regulations under section 83(1)(b) (penalty notices: monetary amount

of the penalty) which make provision for a penalty payable under a

penalty notice to be of an amount which exceeds that equal to level 4 on

the standard scale,

15

(e)   

the first regulations made by the Secretary of State under section 115

(additional responsibilities of responsible officers),

(f)   

regulations under section 119 (regulation of social care workers) or

section 121 (education and training of approved mental health

professionals), or

20

(g)   

an order under section 161 which amends or repeals any provision of

an Act of Parliament,

   

unless a draft of the instrument has been laid before, and approved by a

resolution of, each House of Parliament.

157     

Orders and regulations: control by National Assembly for Wales

25

(1)   

Subject to subsection (2), a statutory instrument containing—

(a)   

regulations made under this Act by the Welsh Ministers, or

(b)   

an order under section 161(2) (transitional provision etc.) made by the

Welsh Ministers,

   

is subject to annulment in pursuance of a resolution of the National Assembly

30

for Wales.

(2)   

Subsection (1) does not apply to a statutory instrument to which subsection (3)

applies.

(3)   

The Welsh Ministers may not make a statutory instrument containing (whether

alone or with other provision)—

35

(a)   

the first regulations made by the Welsh Ministers under section 115

(additional responsibilities of responsible officers), or

(b)   

regulations under section 119 (regulation of social care workers) or

section 121 (education and training of approved mental health

professionals),

40

unless a draft of the instrument has been laid before, and approved by a

resolution of, the National Assembly for Wales.

158     

Regulations: control by Northern Ireland Assembly

(1)   

A statutory rule containing regulations made by the Department of Health,

Social Services and Public Safety in Northern Ireland under section 115

45

(additional responsibilities of responsible officers), other than a statutory rule

 
 

Health and Social Care Bill
Part 6 — General

107

 

to which subsection (2) applies, is subject to negative resolution within the

meaning of section 41(6) of the Interpretation Act (Northern Ireland) 1954 (c. 33

(N.I.)).

(2)   

The Department of Health, Social Services and Public Safety in Northern

Ireland may not make a statutory rule containing (whether alone or with other

5

provision) the first regulations made by the Department under section 115

unless a draft of the statutory rule has been laid before, and approved by a

resolution of, the Northern Ireland Assembly.

159     

Directions

(1)   

Any power of the Secretary of State or the Privy Council to give directions

10

under this Act includes power to vary or revoke the directions by subsequent

directions.

(2)   

A direction under this Act by the Secretary of State or the Privy Council must

be given by an instrument in writing.

160     

Repeals

15

The enactments mentioned in Schedule 15 are repealed to the extent specified.

161     

Power to make transitional and consequential provision etc.

(1)   

The Secretary of State may by order make—

(a)   

such transitional or transitory provisions or savings as the Secretary of

State considers appropriate in connection with the coming into force of

20

any provision of this Act in relation to which the Secretary of State is the

appropriate authority for the purposes of section 164(2), and

(b)   

such supplementary, incidental or consequential provision as the

Secretary of State considers appropriate for the purposes of, in

consequence of, or for giving full effect to, any provision of this Act.

25

(2)   

The Welsh Ministers may by order make such transitional or transitory

provisions or savings as the Welsh Ministers consider appropriate in

connection with the coming into force of any provision of this Act in relation to

which the Welsh Ministers are the appropriate authority for the purposes of

section 164(2).

30

(3)   

An order under this section may amend, repeal, revoke or otherwise modify

any enactment.

(4)   

An order under this section may, in particular, provide for any provision of

this Act which comes into force before another such provision has come into

force to have effect, until that other provision has come into force, with such

35

modifications as are specified in the order.

(5)   

Before making an order under this section containing provision which would,

if included in an Act of the Scottish Parliament, fall within the legislative

competence of that Parliament, the Secretary of State must consult the Scottish

Ministers.

40

(6)   

The power under this section is not restricted by any other provision of this

Act.

 
 

Health and Social Care Bill
Part 6 — General

108

 

(7)   

In this section “enactment” means an enactment contained in, or in an

instrument made under—

(a)   

an Act of Parliament,

(b)   

an Act of the Scottish Parliament,

(c)   

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

5

(d)   

Northern Ireland legislation.

162     

Financial provisions

(1)   

There is to be paid out of money provided by Parliament—

(a)   

any expenditure incurred by virtue of this Act by a Minister of the

Crown or government department, and

10

(b)   

any increase attributable to this Act in the sums payable under any

other Act out of money so provided.

(2)   

There are to be paid into the Consolidated Fund sums received by a Minister

of the Crown or government department by virtue of this Act.

163     

Extent

15

(1)   

Subject to the following provisions of this section, this Act extends to England

and Wales only.

(2)   

The following provisions extend to England and Wales, Scotland and Northern

Ireland—

(a)   

section 69 (arrangements between Care Quality Commission and

20

Ministers),

(b)   

section 92 (general interpretation of Part 1),

(c)   

sections 93 to 114, 118, 122 and 123 and Schedules 6, 7, 8 and 10

(regulation of the health professions),

(d)   

sections 132 and 133 (health in pregnancy grant),

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(e)   

section 139 (Human Rights Act 1998: provision of certain social care to

be public function),

(f)   

section 153 (functions of Health Protection Agency in relation to

biological substances), and

(g)   

sections 155, 156, 159, 161, 162, this section and sections 164 to 167

30

(general provisions).

(3)   

The following provisions extend to England and Wales and Scotland only—

(a)   

sections 126 to 128 (health in pregnancy grant: Great Britain),

(b)   

the repeal effected by this Act in section 16(2)(a)(v) of the Maintenance

Orders Act 1950 (c. 37), and

35

(c)   

section 141(6), and Schedule 13, so far as relating to that repeal.

(4)   

The following provisions extend to England and Wales and Northern Ireland

only—

(a)   

section 70 (arrangements between Care Quality Commission and

Northern Ireland Ministers), and

40

(b)   

section 115 (additional responsibilities of responsible officers: England

and Wales and Northern Ireland) and section 117 (Crown application)

so far as relating to that section.

(5)   

The following provisions extend to Northern Ireland only—

 
 

Health and Social Care Bill
Part 6 — General

109

 

(a)   

sections 129 to 131 (health in pregnancy grant: Northern Ireland), and

(b)   

section 158 (regulations: control by Northern Ireland Assembly).

(6)   

The amendment, repeal or revocation by this Act of any enactment has the

same extent as the enactment amended, revoked or repealed, but subject to

subsection (7).

5

(7)   

Subsection (6) does not apply to the repeals in Part 5 of Schedule 15; and

accordingly those repeals, apart from the repeal mentioned in subsection

(3)(b), extend to England and Wales only.

164     

Commencement

(1)   

The following provisions come into force on the day on which this Act is

10

passed—

(a)   

the provisions of this Part, except section 160 and Schedule 15 (repeals),

and

(b)   

any other provision of this Act—

(i)   

so far as is necessary for enabling the exercise on or after the day

15

on which this Act is passed of any power to make orders or

regulations that is conferred by the provision or by any

amendment made by the provision, or

(ii)   

so far as the provision, or any amendment made by the

provision, defines any expression relevant to the exercise of any

20

such power.

(2)   

Except as provided by subsection (1), the provisions of this Act come into force

on such day as the appropriate authority (as determined by section 165) may

by order appoint.

(3)   

Different days may be appointed under subsection (2) for different purposes.

25

165     

The appropriate authority by whom commencement order is made

(1)   

This section has effect to determine who is the appropriate authority for the

purposes of section 164(2).

(2)   

Except as provided by subsections (3) to (5), the appropriate authority is the

Secretary of State.

30

(3)   

In relation to sections 114, 115 and 117 (responsible officers), so far as they

relate to Northern Ireland, the appropriate authority is the Department of

Health, Social Services and Public Safety in Northern Ireland.

(4)   

In relation to the following provisions—

(a)   

Part 3 (public health protection), including Schedule 11, and Part 3 of

35

Schedule 15 so far as they relate to Wales (and section 160 so far as it

relates to that Part of Schedule 15 in its application to Wales),

(b)   

section 135 (pharmaceutical services), so far as relating to Part 2 of

Schedule 12, together with that Part of that Schedule and the repeals in

the National Health Service (Wales) Act 2006 (c. 42) in Part 4 of

40

Schedule 15 (and section 160 so far as relating to those repeals),

(c)   

section 138 (weighing and measuring of children: Wales),

(d)   

subsections (1) to (7) of section 140 (direct payments in lieu of provision

of care services), so far as they relate to Wales,

 
 

 
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