APPENDIX 1: HEALTH AND SOCIAL CARE BILL
Memorandum by the Department of Health
Introduction
1. This Memorandum describes the purpose and
content of the Health and Social Care Bill and identifies the
provisions of the Bill which confer powers to make delegated legislation.
It also explains in each case why the power has been taken and
the nature of, and reason for, the procedure selected.
Background and Purpose of the Bill
2. The Health and Social Care Bill was announced
as part of the Government's draft Third Session Legislative Programme
on 11 July 2007 and in The Queen's Speech on 6 November 2007.
As a portmanteau Bill, the Bill covers a wide range of areas.
3. The main purposes of the Health and Social
Care Bill are to:
- create a new integrated regulator
for health and adult social care, the Care Quality Commission,
bringing together existing health and social care regulators into
one regulatory body
- reform professional regulation to enhance public
and professional confidence and strengthen clinical governance
as part of the Government's response to the Shipman Inquiry
- reform public health protection to help prevent
the spread of disease from infection or contamination
- include provisions to make a one off payment
to expectant mothers in the final weeks of pregnancy
4. The four main areas of the Bill are set out
below in more detail.
The Creation of the Care Quality Commission
5. The largest measure in the Health and Social
Care Bill is to establish a new integrated health and adult social
care regulator for England, the Care Quality Commission, from
existing regulators.
6. The Bill will define the functions of the
new regulator in the areas of safety and quality assurance, information
and performance assessment and safeguarding the rights of patients
subject to the Mental Health Act 1983, and will update the system
of registration that applies to providers of health and social
care services and enable this to cover all providers of health
and social care, including NHS providers, without duplicating
the functions of other public bodies.
Regulation of Health Professions and Health
and Social Care Workforce
7. The second largest part of the Health and
Social Care Bill is a package of measures to reform the system
of professional regulation. Specifically, the Bill will, among
other measures for professional regulation:
- introduce legislation to impose
the civil, rather than criminal standard of proof in proceedings
relating to fitness to practice proceedings concerning health
care professionals and in proceedings concerning the suitability
of a social care worker to be or remain registered in England
and Wales
- create an independent adjudicator to undertake
independent and objective formal adjudication for the healthcare
professional regulatory bodies
- ensure that all specified healthcare organisations
employing or contracting with doctors appoint a 'responsible officer'
with personal responsibility to work with the General Medical
Council (GMC) to identify and handle cases of poor professional
performance by doctors
- take new powers to enable modification of the
regulation of social care workers
8. These measures will help to implement, following
the inquiry into the case of Harold Shipman, the manifesto commitment
to strengthen clinical governance, and will ensure professional
activity is more accountable to the public.
Measures to Enhance Public Health Protection
9. The third largest measure in the Health and
Social Care Bill is the modernisation of the Public Health (Control
of Disease) Act 1984, to help prevent the incidence or spread
of infection or contamination.
10. By modernising legislation to take into account
new scientific understanding, these measures provide for a more
flexible and proportionate response to outbreaks of infectious
disease or contamination, and reflect the International Health
Regulations 2005, issued by the World Health Organisation.
11. The legislation includes safeguards, taking
into account human rights, designed to ensure that the powers
are used only when it is appropriate to do so.
The Creation of a Health in Pregnancy Grant
12. The last of the larger measures in the Health
and Social Care Bill is the creation of a Health in Pregnancy
Grant, which will be a one-off payment to expectant mothers ordinarily
resident in the UK, who have received the necessary health advice,
to help with the costs of a healthy lifestyle, including diet,
in the later stages of pregnancy and other additional costs at
this time. The payment is designed to support the expectant mother's
individual health needs during the pregnancy in order to give
her children the best start in life.
Other measures in the Health and Social Care
Bill
13. The Bill also includes other smaller measures
aimed at modernising health & social care provisions:
- the transfer of the Global Sum
for Pharmaceutical Services
- the power to extend membership of NHS indemnity
schemes
- the extension of Direct Payments
- amendments to the National Assistance Act
- the creation of a power for the Secretary of
State to give financial assistance to social enterprises
- the creation of the National Information Governance
Board for Health and Social Care
- the abolition of the National Biological Standards
Board and the transfer of its functions to the Health Protection
Agency
- Legislative cover for performance management
and feedback to parents as part of the National Child Measurement
Programme
Provisions for Delegated Legislation
14. The Bill contains 165 clauses and 15 schedules.
15. In considering whether matters should be
specified on the face of the Bill or allocated to delegated legislation,
the Department has carefully considered the need to:
- avoid too much technical and administrative
detail on the face of the Bill
- ensure flexibility in responding to changing
circumstances, for example scientific developments, so that the
legislation can be brought up to date without requiring further
primary legislation
- allow detailed administrative arrangements to
be set up and kept up to date within the basic structures and
principles set out in the primary legislation, subject to Parliament's
right to challenge inappropriate use of powers.
16. This document also includes, as an annex,
a Statement of Intent for NHS Indemnity, to more fully demonstrate
how the measure, including the delegated powers examined within
the main text of this document, is intended to be used by the
Department.
Part 1: The creation of the Care Quality Commission
17. The Care Quality Commission (the Commission)
will be established as a new regulator for health and social
care (other than care regulated by OFSTED) in England in place
of three existing statutory bodies, namely (a) the Commission
for Healthcare Audit and Inspection (CHAI); (b) the Commission
for Social Care Inspection (CSCI); and (c) the Mental Health Act
Commission (MHAC). The Care Quality Commission inherits the functions
of CHAI, CSCI and MHAC. The Bill will allow for the Care Quality
Commission to be responsible, in England, for the review and regulation
of health and social care services whether publicly or privately
provided or funded. The precise scope will be subject to consultation.
It will not duplicate the functions of other public bodies with
functions in respect of health and social care such as OFSTED,
the Human Fertilisation and Embryology Authority, and the Human
Tissue Authority.
Clause 1: The Care Quality Commission
Powers conferred on: no powers are conferred directly
by this section
Power exercised by: not applicable
Parliamentary procedure: not applicable
18. Clause 1 creates a new body called "the
Care Quality Commission". No delegated powers are
conferred on the Secretary of State by this clause. However, subsection
(3) provides that Schedule 1 shall have effect. The delegated
powers in Schedule 1 are addressed by reference to Schedule 1.
Clause 2: The Commission's functions
Powers conferred on: Secretary of State
Power exercised by: directions
Parliamentary procedure: none
19. Clause 2 sets out the general purpose of
the Commission. It also provides for matters that the Commission
must have regard to in performing those functions.
20. Subsection (4) provides that the Secretary
of State may direct the Commission to have regard to aspects of
government policy in performing its functions.
21. The Secretary of State may want the Commission
to take account of broad aspects of government policy as these
change over time, so that these are given priority in the regulation
of health and adult social care services. For instance, improving
care pathways across services for people with long-term conditions
or the needs of vulnerable older people. This power allows him
to direct the Commission to do so. These requests may change over
time so it would not be appropriate to set these out on the face
of the Bill.
22. This power will need to be exercised at short
notice and it does not therefore seem appropriate for any Parliamentary
procedure to apply. A direction making power currently applies
to the precursors to this clause, sections 130 and 131 of the
Health and Social Care (Community and Standards) Act 2003 (2003
Act).
Clause 3: Transfers of property, rights and liabilities
Powers conferred on: no powers are conferred directly
by this section
Power exercised by: not applicable
Parliamentary procedure: not applicable
23. Clause 3 relates to Schedule 2 (which makes
provision for the transfer of property, rights and liabilities).
24. No delegated powers are conferred on the
Secretary of State by this clause. However, this clause provides
that Schedule 2 shall have effect. The delegated powers in Schedule
2 are addressed by reference to Schedule 2.
Clause 4: Regulated activity
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: affirmative resolution
25. Clause 4 provides for the definition of "regulated
activity" for the purposes of Part 1 of the Bill. Subsection
(1) enables the Secretary of State to make regulations prescribing
what a regulated activity is.
26. A wide range of services need to be regulated
by the Commission. It would not be practicable to define all of
these in primary legislation because new types of services will
evolve over time - a regulation making power will enable the legislation
to take this into account. The description of regulated activity
is also expected to change as new service models evolve. The Secretary
of State may also decide in the future that other services should
also be regulated by the Commission. This power therefore allows
for these details to be set in secondary legislation where they
can be amended more easily.
27. These regulations will determine the activities
which will be regulated by the Commission. The affirmative procedure
would therefore seem to be appropriate in this case. Given the
impact on services to be brought into (or removed from) the scope
of registration, any changes to these regulations would also be
subject to a public consultation.
Clause 6: Requirement to register as a service
provider
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
28. Clause 6 establishes that it is an offence
for a person to carry on a regulated activity without being registered
and provides for sanctions in respect of that offence.
29. Subsection (2) provides that the Secretary
of State may make regulations in relation to a regulated activity
carried on by two or more persons acting in different capacities,
determining which of those persons is to be regarded as the person
carrying on the activity.
30. The change from "undertaking" in
the Care Standards Act 2000 (the Care Standards Act) to "activity"
in this Bill means that it may be more difficult to identify the
person who carries on the activity. One can more readily regard
employees as "carrying on" the activity in which their
employer is engaged than as carrying on his undertaking. Subsection
(2) therefore enables regulations to determine which of two or
more persons is to be regarded as carrying on an activity. This
power enables the Secretary of State expressly to exclude employees
etc and to resolve any uncertainties. It would not be possible
to do this in the Bill as regulated activities themselves will
be determined in secondary legislation.
31. These regulations will deal with clarifying
administrative details associated with the applications to register
and the negative procedure is therefore appropriate.
Clause 9: Condition requiring registered manager
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
32. Clause 9 makes provision for the imposition
of a condition requiring a registered manager.
33. Subsection (1) enables the Secretary of State
by regulations to prescribe cases in which a person's registration
as a service provider must be subject to a registered manager
condition.
34. Subsection (2) enables the Secretary of State
to make regulations requiring the Commission to have regard to
prescribed matters when deciding whether to impose a registered
manager condition under clause 8(3) or (5) (b), in a case where
subsection (1) does not require such a condition to be to be imposed.
35. The purpose behind both regulation-making
powers is to ensure that for cases where there needs to be an
individual with day-to-day responsibility for the provision of
care who is accountable for that care in addition to the person
with overall responsibility for carrying on the care, then the
Commission will make the registration of a manager an additional
condition of registration. Activities that will require registration
with the Commission will be set out in regulations and may change
over time so it will not be possible to set out when a registered
manager will be required on the face of the Bill.
36. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
Clause 12: Regulations about registration
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
37. Clause 12 enables the Secretary of State
to make regulations providing for keeping of registers by the
Commission, the registration process, applications for registration
and notifying the Commission of addresses for service of documents.
38. This clause enables regulations to prescribe
requirements relating to the registration process, such as requirements
for interviewing applicants, or situations when the Commission
should be notified about a change in circumstances following an
application to register (for example, to ensure that the Commission
can be kept abreast of changes of address which will be required
should the Commission need to serve warning notices or other documents
as in clause 89). These requirements may differ for different
regulated activities and circumstances where a registered manager
is required, all of which will be dealt with by regulations. It
is therefore necessary to deal with these details through secondary
legislation.
39. These regulations will deal with administrative
details associated with the applications to register and the negative
procedure is therefore appropriate. The negative procedure is
used in the precursor to this clause in section 16 of the Care
Standards Act, which applies to independent healthcare and social
care services regulated under this Act. We therefore think the
negative procedure is also appropriate in this case.
Clause 13: Cancellation of Registration
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
40. Clause 13 sets out the circumstances in which
the Commission may cancel registration of a regulated activity
as a service provider or manager.
41. Subsection (1)(e) provides that these may
include grounds specified by the Secretary of State in regulations.
42. The Secretary of State may decide that additional
matters should be grounds for cancellation that might not covered
by (1)(a)-(d). Setting out additional grounds for cancellation
in regulations will provide flexibility to ensure they are kept
up to date.
43. The negative procedure applies to the precursor
to this clause in section 14 of the Care Standards Act and seems
appropriate here also.
44. Subsection (2)(d) provides that the offences
that the Commission may take into account under subsection (1)
include such other offences as may be prescribed.
45. This power is necessary to ensure that relevant
offences that might be created in other legislation can be included
as grounds for cancellation.
46. This power does not allow offences to be
created. It only allows for provision to be made for other offences
to be taken into account when making a decision regarding the
cancellation of registration so the negative procedure seems to
be the most appropriate in this case.
Clause 16: Regulation of regulated activities
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
47. Clause 16(1) provides that the Secretary
of State may by regulations impose such requirements in relation
to regulated activities as the Secretary of State thinks fit for
the purposes of Chapter 2.
48. Subsections (2) to (5) set out what, in particular,
regulations made under (1) will cover. Subsection (2) provides
that those regulations may make provision with a view to: (a)
securing that any service provided is of appropriate quality and
(b) securing the health, safety and welfare of persons for who
any service is provided.
49. Subsection (3) to (5) relate to particular
provision which the Secretary of State has power to make. In particular,
subsection (4) provides that they may cover the use of restraint.
50. Subsection (5) provides that the regulations
may also make provision for the prevention and control of health
and associated infections (HCAI).
51. This power enables the Secretary of State
to prescribe essential requirements around safety, quality and
general probity and governance for ensuring the fitness for purpose
of registered activities and those who apply to be registered
to provide or manage such activities. It is important that these
requirements can be changed as necessary based on advice from
the Commission or to respond to changes in service provision to
ensure that adequate requirement apply. A regulation making power
therefore seems appropriate. The Commission will develop criteria
under clause 19 to use in assessing whether registered services
are complying with these regulations. The Secretary of State may
also issue a Code of Practice under clause 17 about compliance
with regulations that relate to the prevention and control of
HCAIs.
52. A regulation making power is particularly
appropriate as it may be necessary for the Secretary of State
to amend the regulations at short notice to ensure they provide
adequate protection for people using registered services.
53. The negative procedure applies to the precursor
to this clause in section 22 of the Care Standards Act. We therefore
think the negative procedure is also appropriate in this case.
Clause 17: Code of practice relating to health
care associated infections
Powers conferred on: Secretary of State
Power exercised by: not applicable
Parliamentary procedure: none
54. Clause 17 gives the Secretary of State the
power to issue a code of practice about compliance with requirements
of regulations under Clause 16 which relate to the prevention
and control of healthcare associated infection (HCAI).
55. This clause takes forward the power given
by the Health Act 2006 to the Secretary of State to issue a code
of practice for the prevention and control of HCAIs. The purpose
of that code of practice is to help NHS bodies plan and implement
how they can prevent and control HCAI. The new code will be capable
of applying to all registered providers of health and social care.
It will describe the ways in which managers of NHS organisations
and other health and social care providers should ensure that
patients and service users are cared for in a clean environment,
where the risk of HCAI is kept as low as possible.
56. The code of practice must be consulted upon
(under clause 18) and it will be based on an accumulating body
of evidence that takes account of current clinical practices -
as such, it is considered that no Parliamentary procedure is necessary.
Clause 19: Guidance as to compliance with requirements
Powers conferred on: The Commission
Power exercised by: not applicable
Parliamentary procedure: none
57. Clause 19 obliges the Commission to produce
guidance about compliance with the requirements of regulations
under clause 16, other than requirements relating to the prevention
and control of HCAIs. The guidance may relate to compliance with
requirements in any other legislation for the purposes of Chapter
2.
58. The guidance can make different provision
for different circumstances or cases and can operate by reference
to provisions in other documents.
59. Regulations under clause 16 are intended
to be applicable to all regulated activities. As such it is important
that providers, managers, and indeed users of those activities
understand what they are expected to do by way of compliance.
The Commission will be better placed than the Secretary of State
to produce guidance on this.
60. The guidance will need to be kept up to date
and revised as necessary and may need to be amended as new service
models develop. It therefore seems appropriate for no parliamentary
procedure to apply.
Clause 26: Urgent procedure for cancellation
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
61. The Commission may apply to a justice of
the peace for an order cancelling a registration. Under subsection
(3) notice of the application must, in specified circumstances,
be given to Strategic Health Authorities (SHAs) or the Independent
Regulator of NHS Foundation Trusts (Monitor) and may be given
to such other people as the Commission considers appropriate.
Which SHA must be given notice may be determined by regulations.
Notice must also be given to Primary Care Trusts (PCTs) and
Local Authorities (LAs) as may be determined by regulations.
62. It is important that PCTs and LAs are notified
so that they can comply with their statutory duties, for example,
in the case of LAs, to provide or arrange alternative care for
service users in accordance with their duties under section 47(1)
of the National Health Service and Community Care Act 1990. The
relevant bodies will need to make alternative provision for services.
A number of different PCTs or LAs may commission services from
a particular service provider. As the activities that will require
registration will be set out in regulations it is therefore necessary
to take a regulation making power to set how the Commission will
determine what bodies it should notify in different circumstances.
63. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
Clause 31: Contravention of regulations
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: this depends on the procedure
applicable to regulations under Part 1, Chapter 2 which make use
of this power
64. Clause 31 provides that the Secretary of
State may make regulations providing that a contravention or failure
to comply with a specified provision of regulations under Chapter
2 of Part 1 of the Bill is to be an offence. Offences relating
to regulations under clause 16 could attract a maximum fine of
up to £50,000 and other offences a maximum fine of up to
level 4 on the standard scale (£2,500).
65. Some of the regulation-making powers in the
Bill, particularly those under clause 16, will impose requirements
on registered services that will deal with matters that are important
for ensuring the fitness for purpose of those services. For this
reason, it is important that the Secretary of State should be
able to make it an offence to fail to comply with some of those
requirements. This clause allows for that possibility and for
different fines to apply depending on the severity of the offence.
66. This power relates to regulations that may
be made under other clauses in this Chapter of the Bill and the
relevant parliamentary procedure will be the procedure applicable
to those regulations.
Clause 34: Provision of copies of registers
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
67. Clause 34 (3) enables the Secretary of State
to make regulations in relation to circumstances and parts of
a register which subsections (1) and (2) do not apply to i.e.
which parts or in what circumstances the register is not to be
available for inspection and copying.
68. It may not be acceptable to release some
information contained in registers (for example, particular information
in relation to services for certain offenders who have been released
at the end of their sentences or other sensitive services registered
with the Commission in a given area). This clause enables regulations
to be made providing that the register may not be inspected, or
copies of the register or extracts are not to be made available,
in such circumstances as the appropriate Minister may prescribe.
These details may need to vary for different regulated activities
or to enable varying levels of access to different categories
of people. The level of detail and need for flexibility mean it
is more appropriate to deal with this in regulations.
69. A charge may be made except where prescribed
in regulations or where the Commission decides it should be provided
free of charge. Subsection (4)(a) enables the Secretary of State
to make regulations about the circumstances in which a fee determined
by the Commission is not payable for a copy of the register. This
will allow for certain people or bodies to access necessary information
in particular circumstances. Given the level of detail required
and need for flexibility it is more appropriate to deal with this
in secondary legislation.
70. These powers take forward section 36 of the
Care Standards Act specifically for care registered with the Care
Quality Commission. For reasons of parity with the Care Standards
Act, which will remain in force for children's services registered
with Ofsted, and for services registered in Wales, the negative
procedure remains appropriate.
Clause 35: Bodies required to be notified of certain
matters
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
71. Clause 35(1) enables the Secretary of State
to make regulations determining the PCT, LA or SHA to whom specified
notices must be given.
72. It is important that PCTs, LAs or SHAs are
notified where the Commission takes action against a registered
person of the kind listed in subsection (2). As with notices under
clause 26, which deals with urgent cancellations, the relevant
bodies may need to make alternative provision for services. The
failure to which any enforcement action relates may represent
a breach of contract with a person commissioning health or social
care or simply be of such concern to prompt them to seek better
provision from another provider. A number of different PCTs or
LAs may commission services from a particular provider. Rather
than set out complex details for determining what PCTs or LAs
are relevant in different circumstances on the face of the Bill
, subsection (1)(a) provides a regulation making power to do this
in secondary legislation.
73. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
74. In some cases, notices relating to matters
covered in subsection (2) may be given by the Commission for procedural
reasons - such as a change of manager, in which cases no one else
need be sent a copy. Rather than set out the detail about circumstances
when notifications are not required on the face of the Bill, subsection
(4) creates a regulation making power to set out when notices
need not be sent.
75. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
Clause 36: Periodic returns
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
76. Clause 36(1) enables the Secretary of State
to make regulations requiring the person carrying on a regulated
activity to make a return to the Commission at such intervals
as may be prescribed.
77. The kind of information supplied might include,
for care homes, details of the number of beds occupied and the
number and type of staff currently employed.
78. The level of detail required in the return
means it is better to set the requirement out in regulations rather
than in the Bill. The negative procedure applies to existing power
under section 33 of the Care Standards Act and therefore seems
appropriate in this case.
Clause 37: Liquidators etc.
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
79. Clause 37(1) enables the Secretary of State
to make regulations that;
a) require any person to whom this section applies
to give notice of the person's appointment to the Commission;
b) require any person to whom this section applies
to appoint a person to manage the regulated activity in question.
80. The Commission will need to know if another
individual has taken over the running of a regulated activity
because of financial difficulty. Regulations will set out the
procedural details for how this should work and provide for the
appointment of a suitable manager to ensure the regulated activity
complies with the relevant requirements. Given the detail required
and the need to ensure flexibility to amend the requirements as
required where changes are made to the activities regulated by
the Commission it seems most appropriate to deal with this in
secondary legislation.
81. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure. The negative procedure applies to the existing power
under section 34 of the Care Standards Act and therefore seems
appropriate in this case.
Clause 38: Death of registered person
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
82. Clause 38 enables the Secretary of State
to make regulations that:
a) provide for the provisions of this Chapter
to apply with prescribed modifications in cases where the only
person registered under this Chapter in respect of a regulated
activity as a service provider has died;
b) require the personal representatives of a
deceased person who was registered in respect of a regulated activity
as a service provider to notify the Commission of the person's
death.
83. Clause 38(2) sets out that regulations under
subsection (1)(a) may, in particular, provide for a registered
activity to be carried on by a person who is not registered in
respect of it and for the Commission to extend the time which
this can continue for.
84. The Commission will need to know if a registered
service provider dies. In this situation it will clearly be important
that there is some continuity of service provision, at least in
the short term, but equally that they are provided by somebody
with the appropriate skills. This will be particularly important
where the service provider is also managing the services. Regulations
under this clause will set out the procedure for notifying the
Commission of the death of a service provider and allow for someone
else to provide the services for a limited period without the
proper registration. These regulations may need to make different
provision for different circumstances which will depend on what
activities the Commission regulates. The level of detail makes
this an appropriate matter to be dealt with in regulations
85. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure. The negative procedure applies to the existing power
under section 35 of the Care Standards Act and therefore seems
appropriate in this case.
Clause 39: Power to modify Chapter in relation
to newly regulated activities
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: affirmative resolution
86. Clause 39 enables the Secretary of State
to make regulations modifying this Chapter in its application
to newly regulated activities of a prescribed description.
87. The registration provisions are designed
to work for care which is already subject to regulation and to
cover care directly provided by NHS bodies. When other forms of
care are eventually brought within the ambit of the registration
regime, there may be unforeseeable issues which necessitate modification
of the registration procedures. This power allows for that eventuality.
The power to modify the provisions of Chapter 2 of Part 1 under
this clause would not apply to the registration of NHS bodies
and other providers registered with the Commission from the outset.
88. This is not dissimilar to a Henry VIII power
and it therefore seems appropriate that the affirmative procedure
should apply.
Clause 41: Standards set by Secretary of State
Powers conferred on: Secretary of State
Power exercised by: directions
Parliamentary procedure: none
89. Clause 41 enables the Secretary of State
to prepare and publish standards in relation to the provision
of NHS care. The Secretary of State may direct any person to prepare
a draft statement of those standards, submit it to the Secretary
of State for approval, and keep the standards under review.
90. This power is necessary so that the Secretary
of State can delegate these functions to make use of professional
expertise on the matters covered by standards in a way that represents
best value. The standards will require the Secretary of State's
approval before being published so that the Secretary of State
can ensure they are appropriate benchmarks of expected behaviour.
There is also a requirement to consult on standards before they
are issued or approved.
91. A direction making power has been taken so
that flexibility is provided for the Secretary of State to direct
different people to develop standards or keep them under review.
Clause 42: Periodic reviews
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument and directions
Parliamentary procedure: negative resolution as
regards the regulations; none as regards the directions
92. Clause 42(1) provides that the Commission
must conduct periodic reviews of the provision of health care
by the PCT and by other persons pursuant to arrangements made
by the PCT.
93. Subsection (2) provides that the Commission
must conduct periodic reviews of the provision of health care
by an English NHS provider. Subsection (3) provides for reviews
of adult social services provided by local authorities.
94. Subsection (5) provides that the Secretary
of State may direct the Commission to devise indicators for the
purpose of assessing the performance of those bodies.
95. This power is necessary so that the Secretary
of State can delegate the function of setting performance assessment
criteria to the Commission in relation to some bodies. The setting
of criteria is primarily a responsibility for the Secretary of
State so as to ensure that they reflect the priorities of the
public and encourage health and adult social care services to
work towards outcomes that are shared priorities across the public
sector. However, the Secretary of State may decide that the Commission
is best placed to set the detailed criteria in relation to some
services and this power would enable the function to be delegated
to it where appropriate.
96. The Commission must prepare a statement describing
the method it proposes to use to assess and evaluate a body's
performance and publish a report of its assessment following such
reviews.
97. Subsection (9) provides that the Secretary
of State may, after consulting the Commission, make regulations
to provide for the procedure to be followed in respect of making
representations to the Commission before the publication of a
report under this clause.
98. This power enables the Secretary of State
to prescribe what processes should apply to ensure that there
is a fair system for allowing services to make representations
before the findings of reviews under this clause are made public.
It is important that bodies that are subject to review by the
Commission should have the chance to respond if they think that
there are mitigating factors, errors or other circumstances that
might have affected the Commission's findings which they do not
think have been taken into account. It is in everyone's interest
to ensure that the results of reviews by the Commission present
an accurate picture of the quality of the services they cover.
99. These regulations will deal with administrative
details associated with the making of representations to the Commission
which it seems more appropriate to deal with in regulations. The
negative procedure currently applies to regulations under the
precursors to this clause, sections 79(9) and 50(6) in the 2003
Act dealing with annual reviews and seems appropriate here.
Clause 44: Special reviews and investigations
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
100. Clause 44 provides that the Commission may
conduct special reviews and investigations and must conduct such
special reviews and investigations as the Secretary of State may
request.
101. Where the Commission conducts such a review
or investigation it must publish a report. Subsection (5) provides
that the Secretary of State may, after consulting the Commission,
make regulations providing for the procedure to be followed in
respect of the making of any representations to the Commission
before publication of such a report.
102. This power enables the Secretary of State
to prescribe what processes should apply to ensure that there
is a fair system for allowing bodies to make representations before
the findings of reviews under this clause are made public. It
is important that bodies that are subject to review by the Commission
should have the chance to respond if they think that there are
mitigating factors, errors or other circumstances that might have
affected the Commission's findings which they do not think have
been taken into account. It is in everyone's interest to ensure
that the results of reviews by the Commission present an accurate
picture of the quality of the services they cover.
103. These regulations will deal with administrative
details associated with the making of representations to the Commission
which it seems more appropriate to deal with in regulations. The
negative procedure currently applies to regulations under the
precursors to this clause, sections 52(8) and 80(8) in the 2003
Act, and this seems to still be appropriate.
Clause 45: Power to extend periodic review function
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
104. Clause
45 enables the Secretary of State to make regulations extending
the requirement for the Commission to conduct periodic reviews
so that the Commission could be required to review any regulated
activity carried on by a registered service provider. These reviews
would be additional to those already required under clause 42.
In relation to regulated activities carried on by a PCT, English
NHS provider or an English local authority, to the extent that
those activities are already covered by periodic reviews to be
carried out under clause 42, subsection (1) does not apply. But
regulations under subsection (1) could be made requiring the Commission
to conduct periodic reviews of a particular aspect of those activities.
The Commission will be required to either publish reports of reviews
carried out under these regulations or to assess the performance
of the service provider and publish the results of its assessment.
105. The Secretary of State may decide that it
is important that performance information on particular regulated
activities, for instance hospitals or care homes, is available
to the public to enable them to make informed choices. Where services
are providing publicly funded care this is also important in terms
of providing public accountability that services represent good
value for money. It may not be appropriate for every type of regulated
activity to be subject to performance review as some may be very
small services providing care to small numbers of people. This
power therefore enables the Secretary of State to provide in secondary
legislation which types of regulated activity should be covered.
This power is needed so that additional activities can be specified
for review once the scope of registration has been determined
following consultation. It will also allow flexibility if there
are changes to the scope of registration in the future.
106. It is intended that any proposal to extend
the range of services that are covered by reviews will be subject
to consultation. Given that such an extension will result in a
greater (rather than lesser) amount of comparative information
about services provided, such an extension is unlikely to be controversial.
We therefore, consider the negative procedure is therefore appropriate.
Clause 48: Transfer and amendment of functions
under Mental Health Act 1983
Powers conferred on: not applicable
Power exercised by: not applicable
Parliamentary procedure: not applicable
107. No delegated powers are conferred by clause
48. However, subsection (5) provides that Schedule 3 shall have
effect. The delegation of powers under provisions set out in Schedule
3 is addressed by reference to that Schedule.
Clause 51: Publication of results of studies under
Section 50
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
108. Clause 50 provides that the Commission may
undertake or promote comparative or other studies as to economy
and efficiency in the provision of health services by English
NHS bodies and in the provision of adult social services by English
local authorities and the making of arrangements by PCTs and LAs
for healthcare and adult social services to be provided.
109. Clause 51(1) provides that the Commission
must publish any recommendations made under section 50(1) and
the results of any studies undertaken or promoted under that section.
110. Clause 51(2) enables the Secretary of State
to make regulations, after consulting the Commission, as to the
procedure to be followed in respect of the making of representations
to the Commission before any publication under subsection (1).
111. This power enables the Secretary of State
to prescribe what processes should apply to ensure that there
is a fair system for allowing services to make representations
before the findings of reviews under this clause are made public.
It is important that bodies that are subject to review by the
Commission should have the chance to respond if they think that
there are mitigating factors, errors or other circumstances that
might have affected the Commission's findings which they do not
think have been taken into account. It is in everyone's interest
to ensure that the results of reviews by the Commission present
an accurate picture of the quality of the services they cover.
112. These regulations are needed to deal with
administrative details associated with the making of representations
to the Commission and the negative procedure therefore seems appropriate.
The negative procedure currently applies to regulations under
the precursors to this clause, sections 82(5) and 57(5) in the
2003 Act.
Clause 55: Additional functions
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
113. Clause 55 enables the Secretary of State
to make regulations providing that the Commission is to have additional
functions of a kind related to its functions specified in the
Bill. The Secretary of State must consult Monitor before making
any regulations which extend the functions of the Commission in
relation to NHS Foundation Trusts.
114. The sectors that will be regulated by the
Commission are constantly changing, which might necessitate giving
additional functions to the Commission which have not yet been
identified and therefore cannot be dealt with on the face of the
Bill itself. The purpose of this power therefore is to ensure
that sufficient flexibility is retained to ensure that the Commission
can be given additional functions by means of secondary legislation,
where this would be desirable, in order to enable it to be responsive
to changing trends in health and adult social care provision or
in its approach to monitoring the application of the Mental Health
Act 1983 (the Mental Health Act).
115. The negative procedure applies to the precursors
to this clause in the 2003 Act (sections 58 and 84). We therefore
think the negative procedure is appropriate in this case.
Clause 57: Inspections carried out for registration
purposes
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
116. The power in subsection (1) enables the
Secretary of State to prescribe how often the Commission carries
out inspections to assess compliance with requirements of the
registration system under Chapter 2, who should carry them out
and how they should be carried out. Different approaches to inspection
may be required for different types of services or for different
types of issue. In particular, the Secretary of State may want
inspections into requirements around the control of infections
to be carried out in a particular way and by people with particular
skills. The Secretary of State may want to make different provision
in respect of particular registration requirements or other relevant
requirements, or in respect of particular regulated activities
and it therefore necessary to deal with circumstances when inspection
is required in secondary legislation.
117. These regulations will deal with procedural
details of the inspection process and the negative procedure is
therefore appropriate.
118. The power in subsection (4) enables the
Secretary of State to prescribe what processes should apply to
ensure that there is a fair system for allowing services to make
representations before the findings of reviews under this clause
are made public. It is important that bodies that are inspected
by the Commission should have the chance to respond before reports
of inspections are made public if they think that there are mitigating
factors, errors or other circumstances that might have affected
the Commission's findings which they do not think have been taken
into account. These regulations will set out details about what
procedures should apply which it would seem more appropriate to
deal with in regulations rather than in the Bill. The same regulations
may cover procedure for making representations in relation to
a number of clauses.
119. These regulations will deal with procedural
details of the inspection process and the negative procedure is
therefore appropriate.
Clause 61: Power to require explanation
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
120. This clause gives the Secretary of State
the power to make regulations to prescribe individuals who can
be obliged by the Commission to explain documents or other information
obtained by the Commission or persons authorised by it to act
on its behalf. The regulations may also prescribe the circumstances
(e.g. times and places) under which explanations may be given.
121. The power to require an explanation of the
information obtained by it is an important tool for the Commission.
It will enable it to question those in positions of responsibility
about perceived discrepancies in the data it has received or about
instances where information it has obtained provides evidence
of failings in the provision of services.
122. Subsection (4) provides that any person
who fails to comply with any requirement imposed by virtue of
this clause will be guilty of a criminal offence. It is thus very
important that the individuals whom the Commission may call upon
are properly defined, as are the circumstances under which they
may be called.
123. The regulations will be used to specify
types of person who must give an explanation and the times and
places where explanations must be given. They may make different
provision for different cases. Provisions covering areas such
as these will be highly detailed and are more appropriate to secondary
legislation than the face of the Bill. The provisions may also
need to change in order to be responsive to the changing ways
in which services are organised.
124. Regulations under this clause are subject
to the negative procedure. The primary legislation gives the Secretary
of State the power to require persons to provide an explanation
of documents or other information. The secondary legislation will
set out who is required to provide these explanations and deal
with procedural matters. For example, the Commission for Social
Care Inspection (Explanation and Co-operation) Regulations 2004
(2004/555) give CSCI the power to require explanations both in
person and in writing from a number of prescribed persons including
Local Authorities and service providers. The negative procedure
applies to the powers that currently apply under sections 69 and
91 of the 2003 Act and this continues to seem appropriate.
Clause 62: Interaction with other authorities
Powers conferred on: no powers are conferred directly
by this clause
Power exercised by: not applicable
Parliamentary procedure: none
125. No delegated powers are conferred by this
clause, which provides that Schedule 4 shall have effect. The
delegated powers provided for by Schedule 4 are addressed by reference
to that Schedule.
Clause 64: Avoidance of unreasonable burdens in
exercise of regulatory powers
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
126. Clause 64(2) gives the Secretary of State
power to make regulations prescribing regulatory authorities (in
addition to the Commission) who are to be required to have regard
to guidance published by the Secretary of State, about steps that
may be taken to avoid imposing unreasonable burdens on health
and social care organisations when carrying out inspections or
collecting information.
127. Regulatory authorities should operate to
avoid unreasonable burdens being imposed on organisations where
possible. The purpose of this clause is to allow the Secretary
of State to issue guidance to help regulatory authorities to avoid
these burdens. Specifying the regulatory authorities in regulations
will allow the list of regulatory authorities to be determined
when the scope of registration has been consulted on. If there
are changes to the scope of registration, the list of regulatory
authorities will be able to be more easily updated if necessary
than if the regulatory authorities were specified on the face
of the Bill.
128. The negative procedure applies as these
regulations will deal with the administrative detail of guidance
issued by the Secretary of State in reducing the burdens of regulation.
Clause 69: Arrangements with Ministers
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
129. Clause 69(1)(a) provides that the Commission
and a Minister of the Crown may make arrangements for the Commission
to perform any of its functions in relation to a prescribed health
or social care scheme for which the Minister has responsibility.
130. Other Ministers may have responsibility
for health services that are not subject to regulation by the
Commission. The purpose of this clause is to allow other Ministers
to benefit from the experience and expertise that the Commission
will be able to lend in managing such schemes. Attempting to define
these schemes on the face of the Bill could risk limiting the
scope for the Commission to do this as new schemes may be created
in the future. It is therefore necessary to take a power to define
the relevant schemes in regulations.
131. The negative procedure applies to the precursors
to this clause in the 2003 Act (sections 124(1) and 125(1). We
therefore think the negative procedure is also appropriate in
this case.
Clause 71: Inquiries
Powers conferred on: Secretary of State
Power exercised by: directions
Parliamentary procedure: none
132. Clause 71 provides that the Secretary of
State may cause an inquiry to be held into any matter connected
with the exercise by the Commission of any of its functions.
133. Subsection (2) provides that the Secretary
of State may give a direction that it is held in private.
134. Where he decides to call an inquiry the
Secretary of State may determine that it is appropriate that it
be held in private, for instance to protect patient confidentiality.
135. This power will need to be exercised at
short notice and it does not therefore seem appropriate for any
Parliamentary procedure to apply. A direction making power currently
applies to the precursors to this clause, sections 134(3) and
135(2) in the 2003 Act.
Clause 76: Code of practice on confidential personal
information
Powers conferred on: the Commission
Power exercised by: not applicable
Parliamentary procedure: none
136. Clause 76 requires the Commission to prepare
and publish a code in respect of the practice it proposes to follow
in relation to confidential personal information. Before publishing
this code, the new regulator must consult with the National Information
Governance Board (also being established by this Bill - clauses
149 and 150).
137. This power has been taken to ensure that
service users know how confidential information held by the Commission
will be handled.
138. The Code will need to be kept up to date
and will reflect the Commission's own policy. It therefore seems
appropriate that no Parliamentary procedures should apply. No
Parliamentary procedure applies to the Codes of Practice that
CHAI and CSCI are currently required to produce under sections
140 and 141 of the 2003 Act.
Clause 77: Publication of programme of reviews
etc.
Powers conferred on: Secretary of State
Power exercised by: order made by statutory instrument
Parliamentary procedure: negative resolution
139. This clause requires the Commission to publish
a document setting out what plans it has to carry out special
reviews and investigations under clause 44, studies under clause
50 and reviews under clause 53.
140. Subsection (1) provides that the Commission
must prepare such a document at such times as the Secretary of
State may specify by order.
141. This document will relate closely to the
inspection programmes and frameworks that the Commission will
be required to publish under Schedule 4. The Secretary of State
may therefore want to ensure that the publication of a document
under this clause coincides with the development of its inspection
programmes or frameworks, or that it is produced at a certain
time of the year. This may need to change at different times.
An order-making power will allow for that.
142. The negative procedure is appropriate since
the power is limited to a procedural matter and as such is not
a matter that Parliament would necessarily want to debate.
143. Subsection (2) requires the Commission to
consult the Secretary of State and any other person or body the
Secretary of State may specify by order.
144. The Secretary of State may want the Commission
to consult other relevant public authorities who have remits that
are relevant to the health and adult social care services that
will be regulated by the Commission, or which are created in the
future to ensure their plans in this regard are co-ordinated and
avoid areas of overlap or duplication. The power to specify by
order is required to allow flexibility to change the list of persons
or bodies that the Commission must consult, for example when new
bodies are created.
145. The negative procedure is appropriate since
the power is limited to a procedural matter.
Clause 78: Failure by the Care Quality Commission
in discharge of its functions
Powers conferred on: Secretary of State
Power exercised by: direction
Parliamentary procedure: none
146. Clause 78 provides that the Secretary of
State may give a direction to the Commission if it considers that
the Commission is, to a significant extent, failing to:
- discharge any its functions
- properly discharge any of its functions
147. This power is necessary so that the Secretary
of State can take action should the Commission fail to carry out
its function properly. Should such a situation occur it would
jeopardise the safety and quality of services regulated by the
Commission and public confidence in those services and the Commission's
ability to regulate them. In that event it is appropriate that
the Secretary of State should have a mechanism to give it direction
in respect of a particular issue, or should the problem be serious,
to make alternative arrangements for functions to be carried out.
148. Such circumstances might be outside the
Commission's control, for instance an issue that affected its
staff or the premises it uses, but might require that alternative
arrangements can be made to ensure the Commission's functions
are still carried out effectively. Such action is likely to need
to be made quickly and may well apply for a limited period. The
power to direct (with "no procedure"), follows the precedent
set for CHAI and CSCI under s132 and s133 of the 2003 Act and,
therefore, seems most appropriate.
Clause 79: Reports for each financial year etc
Powers conferred on: Secretary of State
Power exercised by: direction
Parliamentary procedure: none
149. Clause 79 provides that the Commission must
make annual reports.
150. Subsection (3) provides that the Secretary
of State may direct the Commission to include separate reports
as to:
a) the way in which it has exercised its functions
during the year,
b) the provision of health care by and on behalf
of registrable persons during the year,
c) the provision of adult social care by and
on behalf of registrable persons during the year.
151. The Commission will have to produce one
or more reports on the way it has exercised its functions, the
provision of health care and the provision of adult social care.
For example, if the Secretary of State feels a function is of
particular importance or is concerned that the Commission did
not previously, or may not, cover one of its functions adequately
or clearly enough, a direction could be given to it to deal separately
with the way it has exercised this function when it produces a
report under this clause.
Clause 81: Fees
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
152. Clause 81 enables the Commission, from time
to time, to make and publish provision for the payment of fees
in respect of an application under chapter 2, including an application
under 15(1), the grant or subsistence of any such registration.
It also enables the Commission to charge fees to English NHS bodies,
English local authorities, people registered under Chapter 2 and
other prescribed people in relation to the exercise by the Commission
of such of its other functions under Part 1 of the Bill as may
be prescribed.
153. Subsection (5) enables the Secretary of
State to make regulations providing for the manner in which the
Commission is to make and publish provision for fees and the matters
to be taken into account before making provision in that respect.
154. Specifying matters in regulations that the
Commission must take into account and the manner in which they
must do so will ensure that the Commission will make and publish
provision for the payment of fees on an appropriate basis and
in a way that ensures transparency for those subject to the fees.
For instance, the Commission could be required to publish certain
types of information to explain the amount of fees charged. To
include these matters on the face of the Bill would not provide
the flexibility to amend matters the Commission must take into
account in the future, or the manner in which they must make provision,
should that be necessary or desirable.
155. The negative procedure applies to the precursor
to this clause in the 2003 Act (sections 62(1) and 86(1)). We
therefore think the negative procedure is also appropriate in
this case.
156. Subsection (6) enables the Secretary of
State to make regulations making alternative provision determining
the amount of any fee payable under this clause and the time at
which it is payable.
157. The Government has set a limit on the operating
costs in relation to the Commission as part of its policy to reduce
the cost of public sector regulation. This will be made up of
income generated from fees and grant in aid from the Government.
The Commission will have the power to determine what fees it will
charge, how they are calculated and when they should be paid.
It is therefore also important that the Secretary of State is
able to make alternative provision if the Commission does not
strike a reasonable balance in making provision on fees or attempts
to set fees at a level that would exceed the cost limit it will
be tasked with operating within.
158. The Secretary of State is required to consult
the Commission and other appropriate persons before making regulations
under this clause. The negative procedure applied to the precursor
to this power in section 113A of the Care Standards Act and therefore
also seems appropriate.
Clause 82: Penalty notices
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
159. Payment of a penalty notice prevents the
Commission from taking further action in relation to the offence
in question. Subsection (2) provides for regulations to prescribe
what offences under Part 1 this applies to.
160. The penalty notice is intended to be a way
for the Commission to take action against registered managers
and service providers where there is admission that an offence
has been committed but the Commission does not feel further action
is necessary. However, penalty notices are not appropriate in
all cases, for example where the offence involves significant
issues of intent. New offences may be created by virtue of clause
31. The power in subsection (2) is therefore needed to ensure
that the Secretary of State can specify those offences in respect
of which it is appropriate for the penalty notice procedure to
apply.
161. It is necessary to set these out in regulations
as new offences may be created in regulations or under the powers
to modify chapter 2 or give the Commission additional functions.
162. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
163. In subsection (4), where a person is given
a penalty notice, proceedings for the offence to which the notice
relates may not be instituted before the end of such period as
may be prescribed.
164. There needs to be a period following the
serving of a notice to allow the person to consider and respond.
However, the Commission must not be prevented from taking further
action if no response is forthcoming. The regulations are intended
to address the administrative detail of how long a person is given
to decide what to do.
165. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
Clause 83: Penalty notices: supplementary provision
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
166. This clause enables the Secretary of State
to make regulations about penalty notices, and in particular:
- the form and content of penalty
notices
- the amount of the penalty
- action to be taken if it is not paid
- such other matters as the Secretary of State
thinks expedient
167. Penalty notices will provide an alternative
to prosecution for an offence under this Chapter where the registered
service admits liability and the Commission determines this to
be an appropriate punishment. It is important that a clear and
legally robust procedure exists to set out the procedures that
will apply to the serving of a penalty notice. Whilst the upper
limit of the penalty is established in subsection (2)(b), it will
be more appropriate to set out the details in secondary legislation
and we therefore propose to use a regulation making power. The
regulations will need to make different provision for different
offences. As offences can be created in regulations it is necessary
to make provision under this clause in secondary legislation as
well.
168. These regulations will deal with administrative
details associated with the serving of penalty notices and the
negative procedure is therefore appropriate.
Clause 84: Guidance by the Commission in relation
to enforcement action
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
169. Subsection (4) requires the Commission to
consult such people as may be prescribed before issuing guidance
in relation to enforcement action.
170. The Commission's enforcement powers have
the potential to have a big impact on a registered person. The
Secretary of State may want the Commission to consult other relevant
public authorities who have remits that are relevant to the health
and adult social care services that will be regulated by the Commission,
or which are created in the future to ensure that they are aware
of the way the Commission intends to approach its enforcement
powers, that their views are taken into account and that the Commission
takes account of the way they approach any enforcement powers
they may have. It is necessary to deal with this in regulations
so that the list of prescribed people can be amended to account
for future changes to the Commission's powers or the powers of
other existing bodies or any new ones that are created.
171. These regulations will deal with administrative
details associated with the preparation of guidance and the negative
procedure is therefore appropriate.
Clause 85: Publication of information relating
to enforcement action etc.
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
172. Clause 85(1) gives the Secretary of State
the power to make regulations which may enable or require the
Commission to publish prescribed information relating to enforcement
action taken by the Commission and prescribing the time and manner
in which information should be published. If the regulations require
information to be published in relation to warning notices under
(1)(e) the Commission is obliged to provide people with an opportunity
to make representations to it before it does so and the regulations
will set out the procedure that should apply.
173. It will be important that members of the
public are made aware of what enforcement action the Commission
has taken in order to be fully informed about the quality of provision
PCTs and LAs are commissioning on their behalf and for them to
exercise an informed choice about what services to use. Because
changes to conditions of registration and other actions covered
by this clause may not always occur as a result of enforcement
action a regulation making power has been taken so that the details
about when such information should be published can be addressed
in secondary legislation.
174. There is also no right of appeal in respect
of warning notices so we feel it is important that some procedure
for making representations should apply. The procedure for similar
provision for making representations is also dealt with in secondary
legislation.
175. These regulations will set out procedural
details about how the circumstances in which information can or
must be published and how the procedure for making representations
should work so the negative procedure therefore seems appropriate.
Schedule 1: The Care Quality Commission
Paragraph 3: Chair and other members
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
176. Paragraph 3 provides that the Commission
is to consist of a chair and other members.
177. Sub-paragraph (2) provides that the Secretary
of State may remove the chair or a member in the circumstances
specified. The Secretary of State may make regulations in respect
of the manner of removal.
178. Sub-paragraph (3) enables the Secretary
of State to make regulations providing for:
- appointment of the chair and other
members
- the tenure of office
- circumstances in which a person shall cease to
holds office, and
- disqualification and suspension.
179. It is important that Parliament is assured
that proper procedures apply in respect of the terms of employment
of the Chair and Board of the Commission. This power will enable
the Secretary of State to set out procedural details in this regard.
Given the level of detail required it seems more appropriate to
deal with by secondary legislation rather than in the Bill.
180. The negative procedure currently applies
to regulations under the precursors to these provisions in Schedules
6 and 7 of the 2003 Act.
Paragraph 6: Procedure
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
181. Paragraph 6(1) provides that the Commission
must appoint an advisory committee for the purpose of giving advice
or information to it about the exercise of its functions.
182. Sub-paragraph (5) provides that the advisory
committee must include persons of a prescribed description. The
Secretary of State may make regulations in that respect.
183. The purpose of the advisory group is to
ensure that the Commission takes account of the views of users
and providers of registered services and others with an interest
when deciding how it exercises its functions. This power will
enable the Secretary of State to ensure that a range of stakeholder
views are adequately reflected on the advisory group. The type
of stakeholders that would be relevant will depend on what activities
the Commission will regulate. These will be set out in regulations
and may change over time so it therefore seems appropriate to
set out who should be on the advisory committee in secondary legislation.
184. The regulations will set out the type of
person who should be included on an advisory group. These regulations
will include a relatively uncontroversial level of detail which
would justify the negative procedure.
Schedule 2: Transfers of property and staff etc.
Paragraph 1: Transfer schemes
Powers conferred on: Secretary of State
Power exercised by: transfer scheme
Parliamentary procedure: none
185. Paragraph 1 of Schedule 2 enables the Secretary
of State to make one or more transfer schemes for the transfer
of property, rights and liabilities. This will enable the administrative
details to be set out regarding the property, rights and liabilities
that, for example, may be transferred from CHAI, CSCI and MHAC
to the Commission. It also allows for transfers from CHAI and
CSCI to the Crown, from the Crown to the CQC and, in the case
of MHAC, for transfers to Welsh Ministers. This power, and the
procedure to be followed, match that in Schedule 8 to the Health
and Social Care (Community Health and Standards) Act 2003, which
provided for similar transfer schemes when property, rights and
liabilities were transferred to the existing regulators. The same
procedure is therefore regarded as appropriate here.
Schedule 3: Amendments of the Mental Health Act
1983
Paragraph 9: Section 120 A to C of the Mental
Health Act
186. Paragraph 9 of Schedule 3 inserts sections
120A to D into the Mental Health Act. Sections 120A to C contain
regulation making powers.
Section 120A
Powers conferred on: Secretary of State and the
Welsh Ministers
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
187. Section 120A provides that the regulatory
authority (in England this is the Commission, in Wales it is Welsh
Ministers) may publish a report on an investigation or review
carried out under section 120(1) of the Mental Health Act (as
substituted by paragraph 8 of Schedule 3 to the Bill) concerning
the exercise of the powers and the discharge of duties under the
Mental Health Act.
188. Subsection (2) of section 120A provides
that the Secretary of State may by regulations make provision
as to the procedure to be followed in respect of representations
to the Commission before the publication of any report under subsection
(1). Subsection (4) gives Welsh Ministers similar power in relation
to Wales.
189. These powers enable the Secretary of State
and the Welsh Ministers to prescribe the procedure that should
be followed in making representations. This is required to ensure
that there is a transparent and fair system that allows service
providers to make representations before the findings of reviews
and investigations made under section 120(1) are made public.
It is important that people who are subject to review and investigation
should have the chance to comment before a report is published.
They may think that there are mitigating factors, that there have
been errors or that there are other circumstances that might have
affected the findings which have not been adequately taken into
account. It is in everyone's interests to ensure that the reports
of reviews and investigations present an accurate picture. These
regulations will set out details about what procedures should
apply which it would seem more appropriate to deal with in regulations
rather than in the Bill.
190. These regulations will be subject to the
negative procedure in Parliament and in the National Assembly
for Wales (as appropriate) by virtue of section 143 of the Mental
Health Act. That procedure is appropriate because the regulations
will deal with administrative details associated with the making
of representations to the Commission and the Welsh Ministers.
This power is equivalent to other powers in Part 1 of the Bill
concerning the procedure for making representations before publication
of reports - see, for example, the powers in clauses 42 (periodic
reviews) and 44 (special reviews and investigations.) Those powers
are also to be subject to the negative procedure.
Section 120B
Powers conferred on: Secretary of State and Welsh
Ministers
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
191. Section 120 B (1) and (2) provides that
the regulatory authority (again, the Commission in relation to
England and the Welsh Ministers in relation to Wales) may direct
the managers of an NHS or independent hospital or local social
services authorities to publish a statement about the action they
propose to take as a result of a review or investigation under
section 120(1) of the Mental Health Act.
192. Section 120B(2)(c) provides that the Secretary
of State and the Welsh Ministers, in relation to England and Wales
respectively, may make regulations extending the list of people
who may be required to publish such a statement.
193. The Mental Health Act confers powers and
duties on a variety of people, including individual professionals
and both statutory and private sector bodies. For the most part,
the people to whom these powers and duties fall are either responsible
for hospitals (known as hospital managers in the Act) which care
for patients subject to the Mental Health Act or are local social
services authorities, or are individuals working within such hospitals
or on behalf of such authorities.
194. However, it is not only hospital managers
and social services authorities and their staff who exercise relevant
functions under the Mental Health Act and contribute to the operation
of the Mental Health Act. There may, therefore, be circumstances
in which reviews or investigations make recommendations that are
addressed (in whole or in part) to others. In these cases, it
would make sense for the people concerned to be asked directly
to publish a report of the action they propose to take as a result.
This might include, for example, other NHS bodies that are responsible
for providing or commissioning services for patients subject to
the Mental Health Act.
195. The power to extend the powers of direction
in section 120B to such people by means of regulations will enable
the list of relevant people to be subject to a process of consultation
following the passage of the Bill and to be revised expeditiously,
as necessary, in the light of experience.
196. Such regulations will be subject to the
negative procedure in Parliament and in the National Assembly
for Wales (respectively), again by virtue of section 143 of the
Mental Health Act. That procedure is appropriate because the additional
obligations that may be imposed on people by any such regulations
will be of a limited nature, relating only to matters concerning
the operation of the Mental Health Act.
197. Section 120B(3) provides that the Secretary
of State (in relation to England) and Welsh Ministers (in relation
to Wales) may use regulations to make further provision about
the content and publication of statements made under this section.
Such regulations could, for example, specify the time limit within
which a report must be published or require the hospital managers
or other people required to publish such a report to obtain the
consent of another person before including particular information
in a report.
198. Such regulations will again be subject to
the negative procedure in Parliament and in the National Assembly
for Wales, again by virtue of section 143 of the Mental Health
Act. The use of regulations and of the negative procedure is appropriate
in this case because the regulations will only be dealing with
questions of detail concerning the content and publication of
reports.
Section 120C
Powers conferred on: Secretary of State and Welsh
Ministers
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
199. Section 120C provides that the persons specified
in subsection (1) must provide the Commission (in relation to
England) and the Welsh Ministers (in relation to Wales) with such
information as they may reasonably request for or in connection
with their functions under section 120 of the Mental Health Act
(as substituted by paragraph 8 of Schedule 3 to the Bill). For
these purposes, information includes records and documents. The
same duty applies to information requested by people authorised
by the Commission or the Welsh Ministers to carry out functions
under section 120.
200. Subsection (1) provides that the people
who must provide information on request include the managers of
an NHS or independent hospital, a local social services authority
and any person prescribed in regulations.
201. It is important that the Commission and
the Welsh Ministers (and any people whom they authorise to act
on their behalf) should have access to the information that they
need to carry out effective reviews and investigations under section
120 in order to help safeguard the rights of patients subject
to the Mental Health Act.
202. Under subsection (7) of the new section
120, people authorised by the Commission and by the Welsh Ministers
will have the right to inspect records relating to individual
patients. However, for an effective review or investigation to
be carried out, it may also be important for them to be able to
access records and information that relate to patients generally,
rather than to individual patients. This might, for example, include
statistical information about the demographic characteristics
of patients treated for mental disorder in a particular area or
hospital.
203. Such information is likely to be held in
the main by bodies who act as hospital managers or by local social
services authorities. However, information relevant to reviews
and investigations may be held by other bodies and people involved
in the care and treatment of patients who are subject to the provisions
of the Mental Health Act.
204. Regulations under subsection (1)(c) will
therefore be used, as appropriate, to extend the powers of the
Commission and the Welsh Ministers to cover other people from
whom they may reasonably require information. This might, for
example, include other NHS bodies (e.g. PCTs or local health boards
who do not themselves manage hospitals) or independent providers
who provide services for patients outside hospital on behalf of
PCTs, local social services authorities or independent hospitals.
Again, a power to do this by means of regulations will enable
the list of such people to be subject to a process of consultation
following the passage of the Bill. It will also enable the list
to be revised expeditiously, as necessary, in the light of experience.
205. The regulations will be subject to the negative
procedure in Parliament and in the National Assembly for Wales,
again by virtue of section 143 of the Mental Health Act. This
procedure is appropriate because the additional obligations that
may be imposed by such regulations will be of a limited nature,
relating only to matters concerning the operation of the Mental
Health Act.
Paragraph 12: section 134A of the Mental Health
Act
Powers conferred on: Secretary of State and Welsh
Ministers
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
206. Section 134 provides for the withholding
of postal packets in specified circumstances. Paragraph
12 of Schedule 3 inserts section 134A into the Mental Health Act
to make further provision in relation to the withholding of postal
packets.
207. Section 134A(1) provides that the Commission
(in relation to England) and Welsh Ministers (in relation to Wales)
must review any decision to withhold a postal packet or anything
contained in it on application by a specified person.
208. Subsection (5) provides that the Secretary
of State may, by regulations, make provision in connection with
applications to the Commission and the determination of any such
application. This includes provision for the production to the
Commission of any postal packet in question. Subsection (6) gives
Welsh Ministers a similar power to make regulations about the
making of applications to them.
209. These provisions are the equivalent of powers
that already exist in section 121 of the Mental Health Act in
relation to the review by the Mental Health Act Commission of
decisions to withhold postal packets under section 134 of the
Mental Health Act. Section 121 will cease to have effect as a
result of subsection (4) of clause 48, as MHAC is to be abolished.
210. Subsections (5) and (6) of the new section
134A are, in effect, a restatement of the power to make regulations
in subsection (9) of section 121 of the Mental Health Act as it
stands now. The provision made under that power is currently to
be found in Regulation 18 of the Mental Health (Hospital, Guardianship
and Consent to Treatment) Regulations 1983 (SI 1983/893). Regulation
18 provides, in particular, that an application for a review of
a decision to withhold a postal packet may be made to MHAC in
any form that the Commission accepts as sufficient in the circumstances,
and need not be in writing. Applicants must let the Commission
have a copy of the notice of withholding provided by the relevant
hospital. Regulation 18 also empowers the Commission to direct
people to produce any documents, information or other evidence
it reasonably requires for its review of the decision.
211. The powers in subsection (5) of the new
section 134A will be used to make similar regulations in relation
to England once the functions of MHAC have been transferred to
the Commission. It is likely that Welsh Ministers will make similar
provision in relation to Wales.
212. As now, the regulations under this provision
will be subject to the negative procedure in Parliament and in
the National Assembly for Wales, by virtue of section 143 of the
Mental Health Act. The right to require the production of the
relevant postal packet is expressly provided for in the enabling
provision (new section 134A(5) and (6)) and otherwise the regulations
will be of a procedural nature. The negative procedure is therefore
appropriate.
Schedule 4: Interaction with other authorities
Part 2 - Exercise of Functions
Paragraph 5: Inspection programmes and inspection
frameworks
Powers conferred on: Secretary of State
Power exercised by: order made by statutory instrument
Parliamentary procedure: negative resolution
213. Paragraph 5(1) provides that the Commission
must from time to time, or at such times as the Secretary of State
may specify by order, prepare inspection programmes and inspection
frameworks.
214. The preparation of inspection programmes
and frameworks will be an important element of how the Commission
will work with the other inspection authorities to co-ordinate
its inspection activity. The order making power in subsection
(1) will enable Secretary of State to specify when the Commission
should produce these to ensure they are produced at such times
as to enable such co-ordination.
215. The negative procedure is appropriate since
the power is limited to a procedural matter.
216. Sub-paragraph (2)(c) requires the Commission
to consult the Secretary of State and any other person or body
the Secretary of State may specify by order.
217. The Secretary of State may want the Commission
to consult other relevant public authorities who have remits that
are relevant to the health and adult social care services that
will be regulated by the Commission, or which are created in the
future to ensure their plans in this regard are co-ordinated and
avoid areas of overlap or duplication.
218. The negative procedure is appropriate since
the power is limited to a procedural matter.
219. Sub-paragraph (3) further provides that
the Secretary of State may by order specify the form of any inspection
programme or framework.
220. Again, it will be important that the Commission's
inspection programmes and frameworks contain the information necessary
to enable it to co-ordinate its inspection activity with the other
inspection authorities. The information contained in them may
change over time. This power will enable the Secretary of State
to ensure that any programme or framework prepared by the Commission
will be in a form that corresponds with that adopted by other
inspection authorities (so far as is appropriate). It will also
ensure that providers and users of services regulated by the Commission
can make best use of the information.
221. An order under this clause will deal with
procedural details associated with the preparation of inspection
programmes and frameworks by the Commission and the negative procedure
is therefore appropriate.
Paragraph 6: Inspections by other inspectors of
registrable undertakings
Powers conferred on: Secretary of State
Power exercised by: order made by statutory instrument
Parliamentary procedure: negative resolution
222. Paragraph 6 provides for inspections by
other inspectors of specified organisations.
223. Sub-paragraph (1) provides that the Commission,
where the Commission is notified of a proposed inspection by a
specified inspector and considers that it would impose an unreasonable
burden on a specified person, or would do so if carried out in
a particular way, may notify the inspector that the inspection
is not to be carried out.
224. Sub-paragraph (2) provides for the definition
of a "specified inspector". It includes an inspection
authority and, at paragraph (b), provides that the Secretary of
State may specify that it also includes any other person specified
by order.
225. This power is being taken so that this clause
can be applied to other people who, in future, may carry out relevant
inspections. This power will ensure the list of relevant inspectors
is kept up to date.
226. Sub-paragraph (3) provides that a "specified
organisation", for the purpose of paragraph 6, means a person
specified by the Secretary of State by order. This power
is being taken to provide for flexibility in relation to those
organisations that may be regulated by the Commission. Sub-paragraphs
(4) and (5) provide that such an order may limit inspection of
a specified organisation to particular functions or activities
carried out by that organisation.
227. Any such order would operate in the context
of remits of the other inspection authorities as set in secondary
legislation. The power therefore allows for the remits of the
respective inspection authorities to be agreed across government.
This would not seem to be a matter that Parliament would want
to debate and the negative procedure therefore seems appropriate.
228. Sub-paragraph (6) provides that the Secretary
of State may by order specify the cases or circumstances in respect
of which a notice under sub-paragraph (1) need not be given.
229. Sub-paragraph (9) provides that the Secretary
of State may by order make supplementary provision in respect
of this paragraph.
230. The power in sub-paragraph (6) is being
taken because there may be some circumstances in which the Secretary
of State feels it would not be appropriate for the Commission
to exercise the power under this paragraph, for example where
it would prevent another body from carrying out its statutory
functions. As the definition of 'specified inspector' may change
over time it is not possible to provide all the circumstances
in which a notice may not be required on the face of the Bill.
231. The power in sub-paragraph (9) is being
taken so that the Secretary of State can set out procedural details
about how notices under this clause are to operate in secondary
legislation. This is to avoid including excessive detail on the
face of the Bill and to ensure that the requirements can be amended
if necessary.
232. Orders under this clause will deal with
procedural details associated with the serving of notices by the
Commission and the negative procedure is therefore appropriate.
Paragraph 7: Co-operation
Powers conferred on: Secretary of State
Power exercised by: order made by statutory instrument
Parliamentary procedure: negative resolution
233. Paragraph 7 provides that the Commission
must cooperate with:
- the inspection authorities -
(a) Her Majesty's Chief Inspector of Prisons,
(b) Her Majesty's Inspectors of Constabulary,
(c) Her Majesty's Chief Inspector of the Crown Prosecution
Service,
(d) Her Majesty's Inspectorate of the National Probation
Service for England and Wales,
(e) Her Majesty's Inspectorate of Court Administration,
(f) Her Majesty's Chief Inspector of Education, Children's
Services and Skills, and
(g) the Audit Commission for Local Authorities and
the National Health Service in England, and
- any other public authority specified by the Secretary
of State by order
where it is appropriate to do so for the efficient
and effective exercise of the Commission's functions.
234. There are a number of other public authorities
who have remits that are relevant to the health and adult social
care services that will be regulated by the Commission. New ones
may also be created in the future. This power will enable the
Secretary of State to specify that the Commission must co-operate
with any other public authorities that are relevant bodies.
235. The negative procedure will apply as this
essentially deals with procedures of the Commission.
Paragraph 10: Inspections carried out under arrangements
Powers conferred on: Secretary of State
Power exercised by: order made by statutory instrument
Parliamentary procedure: negative
236. Under paragraph 10 the Commission may make
arrangements to carry out inspections for other inspection authorities.
Those authorities are listed in paragraph 1 of Schedule 4.
237. Paragraph 10(1)(b) enables the Secretary
of State to specify by order other public authorities for the
purposes of this paragraph. There are a number of other public
authorities who have remits that are relevant to the health and
adult social care services that will be regulated by the Commission.
New ones may also be created in the future. This will allow for
the Commission to be given authority to carry out inspections
on their behalf if appropriate.
238. The negative procedure will apply as this
is essentially a deregulatory matter, helping to reduce the number
of inspections carried out by different inspection authorities.
Schedule 5: Further amendments relating to Part
1
Paragraph 25: Penalty Notices
Powers conferred on: Welsh Ministers
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
239. Payment of a penalty notice prevents the
Welsh Ministers from taking further action in relation to the
offence in question. Subsection (2) provides for regulations to
prescribe which offences this applies to.
240. The penalty notice is intended to be a way
for the Welsh Ministers to take action against registered persons
where there is admission that an offence has been committed but
the Welsh Ministers do not feel further action is necessary. However,
penalty notices are not appropriate in all cases, for example
where the offence involves significant issues of intent. The power
in subsection (2) is therefore needed to ensure that the Welsh
Ministers can provide for those offences in respect of which it
is appropriate for the penalty notice procedure to apply.
241. It is necessary to set these out in regulations
as new offences may be created in regulations or under the powers
to extend the application of Part II of the Care Standards Act
2000.
242. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
243. In subsection (5), where a person is given
a penalty notice, proceedings for the offence to which the notice
relates may not be instituted before the end of such period as
may be prescribed.
244. There needs to be a period following the
serving of a notice to allow the person to consider and respond.
However, the Welsh Ministers must not be prevented from taking
further action if no response is forthcoming. The regulations
are intended to address the administrative detail of how long
a person is given to decide what to do.
245. These regulations will include a relatively
uncontroversial level of detail which would justify the negative
procedure.
Penalty notices: supplementary provision
Powers conferred on: Welsh Ministers
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
246. This enables the Welsh Ministers to make
regulations about penalty notices, and in particular:
- the form and content of penalty
notices
- the amount of the penalty
- action to be taken if it is not paid
- such other matters as the Welsh Ministers think
expedient
247. Penalty notices will provide an alternative
to prosecution for an offence under the Care Standards Act where
the registered person admits liability and the Welsh Ministers
determine this to be an appropriate punishment. It is important
that a clear and legally robust procedure exists to set out the
procedures that will apply to the serving of a penalty notice.
Whilst the upper limit of the penalty is established in subsection
(2)(b), it will be more appropriate to set out the details in
secondary legislation and we therefore propose to use a regulation
making power. The regulations will need to make different provision
for different offences. As offences can be created in regulations
it is necessary to make provision under this clause in secondary
legislation as well.
248. These regulations will deal with administrative
details associated with the serving of penalty notices and the
negative procedure is therefore appropriate.
Part 2: Professional Regulation
Clause 95: Fitness to practise panels
Power conferred on: Office of the Health Professions
Adjudicator
Power exercisable by: rules, subject to approval
by order of the Privy Council (see clause 104)
Parliamentary procedure: none, but orders of the
Privy Council are subject to negative resolution
249. This clause sets out the structure and composition
of the panels by which the Office of the Health Professions Adjudicator
(OHPA) will operate in the adjudication of fitness to practise
cases. The members are to be drawn from lists held by OHPA and
must consist of at least 3 persons - a chair, a lay member and
a professionally qualified member. The chair may be a lay person,
a professionally qualified member or a legally qualified person
but must be on the list of persons eligible to serve as a chair.
250. The appointment of other lay or professionally
qualified members may be required by rules made by OHPA. Subsection
(3) provides for further provision about the selection of fitness
to practise panels also to be made through rules made by OHPA.
The rules might, for example, provide that professional panel
members must be of the same profession as the practitioner whose
fitness to practise is being considered.
251. Sub-section (4) allows OHPA to make particular
provision in its rules about the selection of a legally qualified
chair in specified circumstances. If OHPA decides to run a pilot
scheme for legal chairs, the rules can make provision for the
selection of cases to be chaired by a legally qualified person.
252. It is the intention that OHPA will draft
and consult widely on its rules before they are made to ensure
that the views of all parties are taken into consideration. There
is a statutory requirement for OHPA to carry out such a consultation
under clause 104(3).
253. Clause 104(4) provides that rules made by
OHPA will not come into force until they have been approved by
order of the Privy Council. Clause 153 provides that orders of
the Privy Council are to be made by statutory instrument and under
clause 154 this kind of statutory instrument will be subject to
annulment in pursuance of a resolution of either House of Parliament.
The Privy Council will be able to approve the rules as they stand,
or subject to any changes they think necessary. Where the Privy
Council intend to approve the rules subject to certain changes,
the clause requires them to notify OHPA and consider any observations
which OHPA may make on their changes.
254. Currently, the Medical Act 1983 and the
Opticians Act 1989 make provision for the GMC and General Optical
Council (GOC) respectively to make rules relating to fitness to
practise proceedings, subject to approval of those rules by order
of the Privy Council. Orders made by the Privy Council are subject
to the negative resolution procedure. There are therefore precedents
for the use of this kind of power. Similar powers are to be found
in legislation relating to the regulation of other health professions,
so this clause will help to ensure continuing consistency amongst
all of the regulatory bodies.
255. This use of delegated powers is considered
to be appropriate because the purpose of the rules which OHPA
is empowered to make is to add technical and procedural detail
to the statutory framework for adjudication of fitness to practise
cases. As the adjudicator, OHPA will be best placed to know what
is required in this respect. The powers conferred on OHPA will
also provide flexibility where it becomes apparent that procedural
changes are needed.
Clause 96: Lists of persons eligible for membership
of fitness to practise panels
Power conferred on: OHPA
Power exercisable by: rules, subject to approval
by order of the Privy Council (see clause 104)
Parliamentary procedure: none, but orders of the
Privy Council are subject to negative resolution
256. This clause requires OHPA to appoint people
to lists of persons eligible to sit on fitness to practise panels
and to chair the panels. It makes provision for rules to be made
by OHPA regarding such lists including provision about the division
of a list into parts and the information which is to appear on
a list about a person appointed to it. It also empowers OHPA to
prescribe the requirements for appointment to a list in its rules.
257. It is the intention that OHPA will draft
and consult widely on its rules before they are made, to ensure
that the views of all parties are taken into consideration. There
is a statutory requirement for OHPA to carry out such a consultation
under clause 104(3).
258. Clause 104(4) provides that rules made by
OHPA will not come into force until they have been approved by
the Privy Council. Clause 153 provides that orders of the Privy
Council are to be made by statutory instrument and under clause
154 this kind of statutory instrument will be subject to annulment
in pursuance of a resolution of either House of Parliament. The
Privy Council will be able to approve the rules as they stand,
or subject to any changes they think necessary. Where the Privy
Council intend to approve the rules subject to certain changes,
the clause requires them to notify OHPA and consider any observations
which OHPA may make on their changes.
259. Currently, the Medical Act 1983 and the
Opticians Act 1989 make provision for the GMC and GOC respectively
to make rules relating to fitness to practise proceedings, subject
to approval of those rules by order of the Privy Council. Orders
made by the Privy Council are subject to the negative resolution
procedure. There are therefore precedents for the use of this
kind of power. Similar powers are to be found in legislation relating
to the regulation of other health professions, so this clause
will help to ensure continuing consistency amongst all of the
regulatory bodies.
260. This use of delegated powers is considered
to be appropriate in this context because the purpose of the rules
which OHPA is empowered to make is to add technical and procedural
detail to the statutory framework for adjudication of fitness
to practise cases. As the adjudicator, OHPA will be best placed
to know what is required in this respect. The powers conferred
on OHPA will also provide flexibility where it becomes apparent
that procedural changes are needed.
Clause 98: Legal assessors
Power conferred on: OHPA
Power exercisable by: rules, subject to approval
by order of the Privy Council (see clause 104)
Parliamentary procedure: none, but orders of the
Privy Council are subject to negative resolution
261. This clause requires OHPA to appoint or
arrange for the appointment of legal assessors to give their fitness
to practise panels advice on questions of law. It gives OHPA the
power to make provision in its rules about the qualifications
which a person must have, and other conditions which must be satisfied,
in order to be eligible for appointment as a legal assessor. OHPA
may also make provision about the functions of these legal assessors
in its rules. The rules may also provide that a legal assessor
not be appointed when the panel is chaired by a legally qualified
person.
262. Clause 104(4) provides that rules made by
OHPA will not come into force until they have been approved by
the Privy Council. Clause 153 provides that orders of the Privy
Council are to be made by statutory instrument and under clause
154 this kind of statutory instrument will be subject to annulment
in pursuance of a resolution of either House of Parliament. The
Privy Council will be able to approve the rules as they stand,
or subject to any changes they think necessary. Where the Privy
Council intend to approve the rules subject to certain changes,
the clause requires them to notify OHPA and consider any observations
which OHPA may make on their changes.
263. Currently, the Medical Act 1983 and the
Opticians Act 1989 make provision for the GMC and GOC respectively
to make rules relating to fitness to practise proceedings, subject
to approval of those rules by order of the Privy Council. Orders
made by the Privy Council are subject to the negative resolution
procedure. There are therefore precedents for the use of this
kind of power. Similar powers are to be found in legislation relating
to the regulation of other health professions, so this clause
will help to ensure continuing consistency amongst all of the
regulatory bodies.
264. This use of delegated powers is considered
to be appropriate in this context because the purpose of the rules
which OHPA is empowered to make is to add technical and procedural
detail to the statutory framework for adjudication of fitness
to practise cases. As the adjudicator, OHPA will be best placed
to know what is required in this respect. The powers conferred
on OHPA will also provide flexibility where it becomes apparent
that procedural changes are needed.
Clause 99: Clinical and other specialist advisers
Power conferred on: OHPA
Power exercisable by: rules, subject to approval
by order of the Privy Council (see clause 104)
Parliamentary procedure: none, but orders of the
Privy Council are subject to negative resolution
265. This clause empowers OHPA to appoint or
arrange for the appointment of clinical advisors to give their
fitness to practise panels advice on issues relating to health.
It also allows OHPA to appoint other specialist advisers to give
advice to their fitness to practise panels on issues where OHPA
considers specialist knowledge is required.
266. For both clinical and other specialist advisers,
the clause gives OHPA the power to set out in rules the qualifications
a person must have and any other conditions a person must fulfil
in order to be eligible for appointment. It also allows OHPA to
make provisions about the functions of these advisers in its rules.
267. Current provision in the Opticians Act 1989
and rules made by the GMC and approved by the Privy Council allow
for the appointment of such persons. The purpose of this clause
is to enable OHPA to assume similar functions as are currently
exercised by the regulators for which it will adjudicate. It expands
on the existing powers in that it now enables OHPA to make rules
specifically about qualifications and functions. Existing powers
are being expanded to provide flexibility to make necessary changes
to the functions or expertise of such advisers.
268. It is the intention that OHPA will draft
and consult widely on its rules before they are made, to ensure
that the views of all parties are taken into consideration. There
is a statutory requirement for OHPA to carry out such a consultation
under clause 104(3).
269. Clause 104(4) provides that rules made by
OHPA will not come into force until they have been approved by
order of the Privy Council. Clause 153 provides that orders of
the Privy Council are to be made by statutory instrument and under
clause 154 this kind of statutory instrument will be subject to
annulment in pursuance of a resolution of either House of Parliament.
The Privy Council will be able to approve the rules as they stand,
or subject to any changes they think necessary. Where the Privy
Council intend to approve the rules subject to certain changes,
the clause requires them to notify OHPA and consider any observations
which OHPA may make on their changes.
270. Currently, the Medical Act 1983 and the
Opticians Act 1989 make provision for the GMC and GOC respectively
to make rules relating to fitness to practise proceedings, subject
to approval of those rules by order of the Privy Council, Orders
made by the Privy Council are subject to the negative resolution
procedure. There are therefore precedents for the use of this
kind of power. Similar powers are to be found in legislation relating
to the regulation of other health professions, so this clause
will help to ensure continuing consistency amongst all of the
regulatory bodies.
271. This use of delegated powers is considered
to be appropriate in this context because the purpose of the rules
which OHPA is empowered to make is to add technical and procedural
detail to the statutory framework for adjudication of fitness
to practise cases. As the adjudicator, OHPA will be best placed
to know what is required in this respect. The powers conferred
on OHPA will also provide flexibility where it becomes apparent
that procedural changes are needed.
Clause 100: Procedural Rules
Power conferred on: OHPA
Power exercisable by: rules, subject to approval
by order of the Privy Council (see clause 104)
Parliamentary procedure: none, but orders of the
Privy Council are subject to negative resolution
272. This clause sets out the requirement for
OHPA to make rules about procedures. The rules will make provision
about the procedure to be followed in making referrals to OHPA
under the Medical Act 1983 and the Opticians Act 1989 and the
procedure to be followed, and the rules of evidence to be observed,
in proceedings before OHPA's fitness to practise panels.
273. The rules may make provision for matters
relating to preliminary hearings, the giving of directions to
parties as to the conduct of proceedings and the consequences
of failure to comply with such directions. OHPA may also make
provision in its rules about a fitness to practise panel taking
account of undertakings given by the person to whom the proceedings
relate and about voting by fitness to practise panels, including
the taking of decisions by majority and the conferral of a casting
vote on the chair. OHPA's rules may also make provision about
the award and assessment of costs and expenses, and the review
by fitness to practise panels of their own decisions.
274. Rules about the award and assessment of
costs and expenses may require that regard be had to a person's
ability to pay; include provision for a legal representative's
costs or expenses to be disallowed because of their conduct of
the proceedings and provide for a costs award to be recoverable
as if it had been made by court order.
275. The rules must make provision for securing
that notice of proceedings and notice of decisions of a fitness
to practise panel are given to appropriate persons. They must
also make provision which allows each party to proceedings to
have the opportunity to put their case at a hearing, with an entitlement
to legal representation. They must also include provision securing
that proceedings are held in public except and to the extent that
the rules provide otherwise.
276. It is the intention that OHPA will draft
and consult widely on its rules before they are made, to ensure
that the views of all parties are taken into consideration. There
is a statutory requirement for OHPA to carry out such a consultation
under clause 104(3).
277. Clause 104(4) provides that rules made by
OHPA will not come into force until they have been approved by
order of the Privy Council. Clause 153 provides that orders of
the Privy Council are to be made by statutory instrument and under
clause 154 this kind of statutory instrument will be subject to
annulment in pursuance of a resolution of either House of Parliament.
The Privy Council will be able to approve the rules as they stand,
or subject to any changes they think necessary. Where the Privy
Council intend to approve the rules subject to certain changes,
the clause requires them to notify OHPA and consider any observations
which OHPA may make on their changes.
278. Currently, the Medical Act 1983 and the
Opticians Act 1989 make provision for the GMC and GOC respectively
to make rules relating to fitness to practise proceedings, subject
to approval of those rules by order of the Privy Council. Orders
made by the Privy Council are subject to the negative resolution
procedure. There are therefore precedents for the use of this
kind of power. Similar powers are to be found in legislation relating
to the regulation of other health professions, so this clause
will help to ensure continuing consistency amongst all of the
regulatory bodies.
279. This use of delegated powers is considered
to be appropriate in this context because the purpose of the rules
which OHPA is empowered to make is to add technical and procedural
detail to the statutory framework for adjudication of fitness
to practise cases. As the adjudicator, OHPA will be best placed
to know what is required in this respect. The powers conferred
on OHPA will also provide flexibility where it becomes apparent
that procedural changes are needed.
Clause 102: Duty to inform the public
Power conferred on: OHPA
Power exercisable by: rules, subject to approval
by order of the Privy Council (see clause 104)
Parliamentary procedure: none, but orders of the
Privy Council are subject to negative resolution
280. This clause provides that OHPA will be under
a general duty to publish information about the exercise of its
functions, including the decisions of its fitness to practise
panels. But subsection (3) enables OHPA to make rules allowing
it to withhold certain information.
281. It is the intention that OHPA will draft
and consult widely on its rules before they are made, to ensure
that the views of all parties are taken into consideration. There
is a statutory requirement for OHPA to carry out such a consultation
under clause 104(3).
282. Clause 104(4) provides that rules made by
OHPA will not come into force until they have been approved by
order of the Privy Council. Clause 153 provides that orders of
the Privy Council are to be made by statutory instrument and under
clause 154 this kind of statutory instrument will be subject to
annulment in pursuance of a resolution of either House of Parliament.
The Privy Council will be able to approve the rules as they stand,
or subject to any changes they think necessary. Where the Privy
Council intend to approve the rules subject to certain changes,
the clause requires them to notify OHPA and consider any observations
which OHPA may make on their changes.
283. Currently, the Medical Act 1983 and the
Opticians Act 1989 make provision for the GMC and GOC respectively
to make rules relating to fitness to practise proceedings, subject
to approval of those rules by order of the Privy Council. Orders
made by the Privy Council are subject to the negative resolution
procedure. There are therefore precedents for the use of this
kind of power. Similar powers are to be found in legislation relating
to the regulation of other health professions, so this clause
will help to ensure continuing consistency amongst all of the
regulatory bodies.
284. This use of delegated powers is considered
to be appropriate in this context because the purpose of the rules
which OHPA is empowered to make is to add technical and procedural
detail to the statutory framework for adjudication of fitness
to practise cases. As the adjudicator, OHPA will be best placed
to know what is required in this respect. The powers conferred
on OHPA will also provide flexibility where it becomes apparent
that procedural changes are needed
Clause 104: OHPA rules: supplementary
Power conferred on: the Privy Council
Power exercisable by: order of the Privy Council
Parliamentary procedure: negative resolution
285. Clause 104 requires all rules made by the
OHPA under clauses 95, 96, 98, 99, 100 and 102 to be approved
by an order of the Privy Council before they are able to come
into force.
286. The Privy Council will be able to approve
the rules as they stand, or approve them subject to any changes
they think necessary. Where the Privy Council intend to approve
the rules subject to certain changes, the clause requires them
to notify OHPA and consider any observations which OHPA may make
on their changes.
287. It is the intention that OHPA will draft
and consult widely on its rules before they are made, to ensure
that the views of all parties are taken into consideration. There
is a statutory requirement for OHPA to carry out such a consultation
under sub-section (3).
288. Negative resolution is the Parliamentary
procedure which currently applies to Orders of the Privy Council
approving rules made under the Medical Act 1983 and the Optical
Act 1989. It has been selected to ensure consistency with the
rule making powers of all the regulatory bodies.
Clause 105: Fees payable by the General Medical
Council and General Optical Council
Power conferred on: the Secretary of State
Power exercisable by: regulation made by statutory
instrument
Parliamentary procedure: negative resolution
289. Clause 105 introduces a fees regime from
which OHPA will secure the majority of its funding from the relevant
regulatory bodies (initially the GMC and later the GOC) for the
adjudication services which it provides.
290. Under subsection (2), the regulations will
provide that OHPA must follow the procedures set out in the regulations.
The regulations might for instance require OHPA to agree detailed
procedures with the relevant regulators and to publish them. It
might also require OHPA to review the procedures from time to
time.
291. The regulations would provide for a formula
to be devised which would enable a calculation to be made taking
into account OHPA's estimate of the costs of its hearings in the
current financial year and the relevant regulators' estimates
of volume and complexity. The estimate of OHPA's costs could be
on the basis of a "day rate" to be applied to the above
formula.
292. Under subsection (3), the regulations must
require OHPA to ensure that its fees are set at a level that will
cover its forecast of "chargeable costs". The regulations
will need to provide which costs are not chargeable costs. The
non-chargeable costs will be funded by the Secretary of State
(or the relevant Northern Ireland department). It is expected
that the non-chargeable costs will relate to set up and transitional
costs, High Court referrals and other exceptional costs.
293. Subsection (4) enables regulations to set
the date from which the chargeable costs would fall to be met
by the fees paid by the relevant regulatory bodies. Regulations
under this subsection can also exclude costs incurred for specified
purposes from being chargeable costs.
294. The regulations made under subsection (5)
will provide for the relevant regulatory bodies to be fully engaged
in the setting of the fee. As a result of applying the formula
OHPA will be able to calculate the amount of chargeable costs
that it needs to fund its budget for the following financial year.
The regulations will provide for this amount to be apportioned
between the relevant regulatory bodies to reflect their estimates,
which they will have provided at the start of the fee setting
cycle. OHPA will make a formal determination of these amounts
and notify the relevant regulatory bodies along with an explanation
of the calculation in such detail as will be prescribed in the
regulations. This will allow the relevant regulatory bodies to
make informed representations about the determination.
295. The regulations will provide that representations
must be made within a specified timescale and that any representations
made within these time limits must be considered. The regulations
will require OHPA to set out the administrative arrangements for
this process, including the process for considering representations
made on the determination. OHPA will notify the relevant regulatory
bodies of the final determination. These amounts will then become
payable at such times as may be specified in the regulations by
virtue of subsection (7).
296. The Bill has reserved a power under subsection
(6) for the Treasury to approve the fee. The regulations will
set out the arrangements for approval to be obtained.
297. It is anticipated that the making of a determination
will be on an annual basis and this will be provided for in regulations
under subsection (7). The regulations will make provision for
situations where it becomes clear that the fee level has not been
set at the correct level to ensure that OHPA will not be in surplus
or deficit beyond set parameters. In these circumstances, the
determination may be varied, replaced or revoked.
298. Subsection (8) requires the Secretary of
State to consult the relevant regulatory bodies and others who
he considers are appropriate, such as bodies representing the
interests of the professions, before making regulations under
this clause.
299. The power to make regulations about OHPA's
ability to raise fees is left to delegated legislation as it concerns
administrative procedures. It will also enable amendments to be
made in the light of practical experience. The more detailed financial
and management arrangements will be set out in a Management Statement
or Financial Memorandum.
300. Negative resolution is the Parliamentary
procedure which currently applies to Orders of the Privy Council
approving rules made under the Medical Act 1983 and the Optical
Act 1989.
Clause 109: Constitution etc of Council
Power conferred on: Secretary of State
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
301. Clause 108 changes the name of the Council
for the Regulation of Health Care Professionals to the 'Council
for Healthcare Regulatory Excellence' (the Council). Clause 109
makes changes to the constitution of the Council and subsection
(3) amends the enabling powers in paragraph 6 of Schedule 7 to
the National Health Service Reform and Health Care Professions
Act 2002 as a consequence of these changes. Paragraph 6 of that
Schedule as amended enables the Secretary of State to provide
by regulations for:
- the conditions which must be fulfilled
for appointment of the chair and other members of the Council
- the tenure of office of the chair and non-executive
members of the Council
- the appointment of a member as deputy chair and
the circumstances in which that member ceases to hold office or
may be removed from office as deputy chair.
- the appointment of, constitution of and exercise
of functions by committees and sub-committees of the Council.
302. It is intended that regulations will be
made to provide for the appointment of the Chair, Deputy Chair
and other non-executive members of the Council. The regulations
will specify, amongst other things, the types of people who would
not be eligible to be a non-executive member of the Council, e.g.
those with certain criminal convictions. Schedule 10 includes
provision for the delegation of the Privy Council's and the Secretary
of State's appointments process to the Appointments Commission.
303. The regulations will also set out the conditions
to be fulfilled by the Chair, Deputy Chair and the non-executive
members, as well as grounds for disqualification from holding
office and grounds for removal from office. The regulations will
also cover the appointment of Council Committees, sub-committees
and their membership.
304. It is intended that the regulations will
allow some flexibility to meet changing circumstances such as
the need to set up committees at short notice by enabling the
Council to appoint committees. It will also allow the conditions
to be amended if necessary to take into account future circumstances
without the need for primary legislation.
305. It is appropriate for such procedural and
technical matters to be dealt with by regulations, rather than
be on the face of the Bill. The regulations will be subject to
the negative Parliamentary procedure because it is appropriate
to retain the existing Parliamentary procedure provided for the
conditions for the appointment of the Chair and members and tenure
etc. It is our intention to consult on draft regulations which
will replace the SI 2002/ 2376 The Council for the Regulation
of Health Care Professionals (Appointment etc.) Regulations 2002.
Clause 111 - Powers of Secretary of State and
devolved administrations
Power conferred on Secretary of State
Power exercisable by: directions
Parliamentary procedure: None
306. Clause 111 inserts a new section 26A into
the National Health Service Reform and Health Care Professions
Act 2002. New section 26A(3) and (4) enables the Secretary of
State to give directions to the Council as to the manner in which
the Council exercises its functions. The power is only exercisable
after the Secretary of State has consulted Ministers of the devolved
administrations and the Council itself.
307. Directions are not subject to any parliamentary
procedure. The power to direct is appropriate as it will enable
the Secretary of State to respond quickly to different circumstances
as they arise, such as a need to direct CHRE to prioritise areas
of its workload.
Clause 114: Responsible officers and their duties
relating to medical profession
Powers conferred on: Secretary of State in relation
to England and Wales and Scotland and, in relation to Northern
Ireland, the Department of Health, Social Services and Public
Safety in Northern Ireland
Power exercised by: regulations by statutory instrument
(England and Wales and Scotland) or by statutory rule (Northern
Ireland)
Parliamentary procedure: negative resolution
308. Clause 114 inserts a new Part 5A (responsible
officers) into the Medical Act 1983, containing new sections 45A
to 45F. The new section 45A confers on the Secretary of State
in relation to England, Wales, and Scotland and the Department
of Health, Social Services and Public Safety in Northern Ireland
in relation to Northern Ireland, power to make regulations to
designate bodies which shall be required to nominate or appoint
persons, to be known as "responsible officers", with
responsibilities in relation to the professional regulation of
medical practitioners (i.e. doctors) who are employed by such
bodies, provide services to them or have a prescribed connection
to them.
309. The types of bodies which can be designated
for these purposes are those which appear to the Secretary of
State to provide, or arrange for the provision of, health care,
or to employ or contract with medical practitioners. Further provision
about what may be included in such regulations is made by the
new sections 45A to 45C, including a power to require designated
bodies or responsible officers to have regard to any guidance
given from time to time by the Secretary of State or the Department
of Health, Social Services and Public Safety in Northern Ireland
(as the case may be).
310. This is a new power and is linked to the
requirement (not yet in force) for doctors to be required to hold
a licence to practice and to be subject to re-licensing under
Part 3A of the Medical Act 1983. All medical practitioners will
be linked to a responsible officer and it is intended that part
of the re-licensing process will be the collection and evaluation
of information relating to fitness to practice of practitioners
by such officers, who will submit recommendations to the GMC.
Responsible officers will also be responsible for monitoring and
liaising with the GMC on the performance and fitness to practice
of doctors.
311. It is considered appropriate for the detailed
provisions needed, such as specifying which healthcare organisations
are to be designated bodies and the qualifications and responsibilities
of responsible officers, to be dealt with by regulations and guidance
will assist persons in carrying out their responsibilities. A
power to do this by means of regulations will also ensure that
those bodies designated and the detailed responsibilities of responsible
officers can be amended as necessary in the light of experience.
312. The new section 45C(1) provides a power
to create offences or to create other procedures for enforcement
of the regulations. This will enable provisions to be adopted
for enforcing the regulations should any problems with compliance
arise.
313. The negative resolution procedure is in
line with the procedure for regulations made under Part 3 of the
Health Act 2006, section 17 of which provides for the designation
of bodies who are to nominate or appoint accountable officers
with prescribed responsibilities in relation to the supervision
of management and use of controlled drugs. The proposed guidance
is intended to assist designated bodies and responsible officers
in performing their obligations and functions and will need to
be kept up to date and revised as necessary; it therefore seems
appropriate for no Parliamentary procedure to apply to it.
Clause 115: Additional responsibilities of responsible
officers: England and Wales and Northern Ireland
Powers conferred on: Secretary of State in relation
to England, the Welsh Ministers in relation to Wales and, in relation
to Northern Ireland, the Department of Health, Social Services
and Public Safety in Northern Ireland
Power exercised by: regulations by statutory instrument
(England and Wales) or by statutory rule (Northern Ireland)
Parliamentary procedure: negative resolution
314. Clause 115 provides the Secretary of State,
in relation to England, the Welsh Ministers, in relation to Wales,
and the Department of Health, Social Services and Public Safety
in Northern Ireland in relation to Northern Ireland with power
to confer additional responsibilities on responsible officers
nominated or appointed under section 45A of the Medical Act 1983
(as inserted in that Act by clause 114). Such additional responsibilities
will relate to ensuring that medical practitioners employed by,
or contracted with, the designated body have appropriate skills
and experience; for monitoring the conduct and performance of
medical practitioners; and, ensuring that appropriate action is
taken in response to concerns about such conduct or performance
(short of concerns about fitness to practice).
315. As with regulations made under section 45A
of the Medical Act 1983, it is appropriate for the detailed responsibilities
to be set down in regulations. Guidance may also be given to designated
bodies and responsible officers in relation to the performance
of such additional responsibilities.
316. The negative resolution procedure is in
line with the proposed procedure for regulations under section
45A of the Medical Act 1983. Similarly, it does not seem appropriate
for the guidance to be subject to any Parliamentary procedure.
Clause 116: Co-operation between prescribed bodies
Powers conferred on: Secretary of State in relation
to England and the Welsh Ministers in relation to Wales
Power exercised by: regulations by statutory instrument
Parliamentary procedure: negative resolution
317. Clause 116 provides the Secretary of State,
in relation to England, and the Welsh Ministers, in relation to
Wales, with power to designate bodies which are to co-operate
with each other in connection with sharing information about the
conduct or performance of any health care worker. Such bodies
shall also be under a duty to co-operate in considering any issues
which arise from such shared information and in taking any steps
which the regulations require to be taken following such consideration.
It also provides a power to create punishable offences for failure
to comply with regulations.
318. The regulations may require designated bodies
to have regard to guidance given by the appropriate authority.
The types of bodies which can be designated for these purposes
are those which appear to the Secretary of State to provide, or
arrange for the provision of, health care, or to employ or contract
with medical practitioners, as well as any other body specified
for the purposes of this clause.
319. This is a new power aimed at strengthening
the responsibilities and powers of healthcare organisations to
collaborate in handling information which might point to a possible
serious risk to patients. One recurrent theme in the Shipman and
Ayling cases was the failure of healthcare organisations to "join
up" the information that was available to them, singly and
collectively, and to realise that it was pointing to the possibility
of such a risk.
320. It is considered appropriate to designate
bodies by regulations as the bodies to which this duty to co-operate
needs to apply, as well as the steps that need to be taken where
a possible risk to patients is identified, may change over time.
321. The negative resolution procedure is in
line with the procedure for regulations made under section 18
of the Health Act 2006, which provide for bodies specified by
regulations to co-operate with each other in identifying cases
where action may need to be taken in respect of matters arising
in relation to management and use of controlled drugs. The proposed
guidance is intended to assist designated bodies in co-operating
with each other and will need to be kept up to date and revised;
it therefore does not seem appropriate for this to be subject
to any Parliamentary procedure.
Clause 118 - Regulation of social care workers
Powers conferred on: Secretary of State in relation
to England and Welsh Ministers in relation to Wales
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: affirmative resolution
322. Clause 118 confers on the Secretary of State,
in relation to England, and Welsh Ministers, in relation to Wales,
the power to make regulations to modify the regulation of social
care workers in England (social care workers are defined by reference
to the definition in section 55 of the Care Standards Act). This
modification may include repealing or amending any provision (other
than section 55) of the Care Standards Act, and any other enactment
or other instrument or document. The power is therefore a "Henry
VIII" power. It is the Care Standards Act that provides for
the regulation of the social care workforce by establishing a
General Social Care Council (GSCC) for England, and a Care Council
for Wales (CCW) (referred to collectively as "the Councils").
The Councils regulate the training of social workers and raise
standards in social care through codes of conduct and practice,
and by other means.
323. Schedule 9 supplements clause 118. Paragraph
2 of Schedule 9 provides an illustration of the matters about
which regulations may make provision. These include the functions
of the Councils, the keeping of registers of social care workers,
education and training, privileges of registered persons, removal
or suspension from the register, and codes of practice or guidance
for persons employing or seeking to employ social care workers.
324. The provisions providing for the regulation
of the social care workforce (currently to be found in the Care
Standards Act) may only be changed by means of primary legislation
unlike the healthcare professional regulators whose legislation
may be changed by an Order under section 60 of the Health Act.
The Government considers that there is a need for a similar mechanism
to enable legislation governing the social care workforce to be
kept up to date.
325. The regulation-making power would enable
the Government to be more responsive to changing public expectations
of the social care workforce and the social care workforce's own
views about the development of their regulation.
326. The power in clause 118 broadly mirrors
the equivalent power enabling changes to the regulation of the
healthcare professions which is contained in section 60 of the
Health Act 1999. This power has proved to be effective, allowing
the introduction of a number of changes to improve patient safety
such as modernising fitness to practise procedures and the widening
of regulation to include new professional groups.
327. The power in section 60 is a power to make
an Order in Council as the Privy Council has traditionally been
concerned with matters of professional regulation. However, under
Schedule 1 to the Care Standards Act, the Privy Council has no
functions in relation to the Councils. It is the Secretary of
State who appoints members of the GSCC (paragraph 5 of Schedule
1 to the Care Standards Act) and has the power to make regulations
about appointments, tenure of office, committees of the GSCC,
and procedure (paragraph 6 of Schedule 1 to the Care Standards
Act). The power in clause 114 has therefore been conferred on
the Secretary of State in relation to the GSCC and on the Welsh
Ministers in relation to the CCW.
328. The regulation-making power will enable
new responsibilities and powers to be given to the Councils. For
example, the GSCC have proposed changes to allow conditions to
be imposed on registration and new powers to require the production
of documents at proceedings. These changes will require amendments
to the Care Standards Act. It is anticipated that, like Orders
under section 60 of the Health Act 1999, the majority of changes
made under clause 118 will be at the request of the GSCC. Prior
to the drafting of regulations under clause 118, it is also intended
that there will be full consultation with the social care workforce
and other interested bodies such as the British Association of
Social Workers.
329. In order to make the kind of changes proposed,
the regulation-making power needs to be of sufficient scope. However,
Schedule 9 sets some important limits on the power:
- paragraph 7 places limits on the
ability of the power to create criminal offences to those where
the maximum punishment on summary conviction is a fine at level
5 on the standard scale. This is commensurate with the existing
penalty in section 61 of the Care Standards Act;
- paragraph 8(1) provides that regulations may
not abolish the GSCC or CCW; and
- paragraph 8(2) provides that where the four core
functions associated with the regulation of the social care workforce,
listed in paragraph 8(3), are exercised by the GSCC or the CCW,
or any of its committees or officers, regulations may not provide
for them to be exercised by anyone other than the GSCC or the
CCW (as the case may be).
330. A further limit on the power is set by subsection
(4) of clause 119 which provides that regulations under clause
118 may not amend or make any provision which is inconsistent
with the requirement (in clause 119) that the standard of proof
in proceedings relating to registration of social care workers
is the civil standard.
331. Paragraph 4 of the Schedule enables regulations
to make provision for the delegation of functions, including the
power to make, confirm or approve subordinate legislation. The
Care Standards Act confers powers on the Councils to make subordinate
legislation. For example, section 60 of the Care Standards Act
enables the GSCC to make rules about registration. This paragraph
enables regulations to confer the power to make rules on the GSCC.
It also enables regulations to make provision for the approval
of such rules (rules currently made by the GSCC are required to
be approved by the Secretary of State; see section 71(4) of the
Care Standards Act).
332. Paragraph 6 enables functions to be conferred
on Ministers of the Crown. This will enable regulations to make
provision for a Minister to pay grants to a body.
333. Paragraph 9 of Schedule 9 provides that,
once regulations have been drafted, the draft regulations must
be published at least three months in advance of the draft regulations
being laid before Parliament. Following publication the Secretary
of State must consult representatives of the social care workforce
on the draft regulations. Other interested parties, including
persons representing those provided with services by social care
workers (e.g. service user groups) must also be consulted.
334. After the consultation period, the draft
regulations, with any modifications the Secretary of State considers
appropriate in the light of the consultation, may be laid before
Parliament. The Secretary of State must also lay before Parliament
a report about the consultation; this report is intended to set
out the results of the consultation.
335. Clause 154(3) provides that the draft regulations
must be subject to the affirmative procedure. The arrangements
for consultation and the level of Parliamentary scrutiny match
that for the equivalent power in section 60 of the Health Act
1999.
Clause 120 - Education and Training of Approved
Mental Health Professionals
Powers conferred on: Secretary of State, in relation
to England, and the Welsh Ministers, in relation to Wales
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: affirmative resolution
336. Clause 120(1) enables the appropriate Minister
by regulations to make provision modifying the functions of the
Councils in relation to the education and training of persons
who are, or wish to become approved mental health professionals
(AMHPs). This includes repealing, amending or applying (with or
without modifications) any provision of any enactment or other
instrument or document. The appropriate Minister, in relation
to the GSCC, is the Secretary of State and, in relation to the
CCW, is the Welsh Ministers.
337. The Mental Health Act 1983[3]
provides for the approval of persons to act as AMHPs and confers
functions on the Council in relation to the education and training
of social workers when acting as AMHPs. When the relevant provisions
come into force, AMHPs will take on the functions previously exercised
by approved social workers, including the function of making applications
for a patient's admission and detention in hospital under Part
2 of the Mental Health Act. As well as social workers, a wider
group of professionals, for example nurses, occupational therapists
and psychologists, will potentially be eligible for approval as
AMHPs as long as individuals have the right skills, experience
and training.
338. Since the functions of the Councils in relation
to AMHPs may only be changed by means of primary legislation,
the regulation-making power in clause 120 is to be capable of
being used to modify the regulation of AMHPs in so far as the
Care Standards Act is applied to them (namely in relation to the
education and training of such persons). The rationale for taking
these powers is the same as that for taking the powers in relation
to the regulation of social care workers, namely that it allows
the Councils to update their functions in relation to AMHPs in
a timely manner.
339. Clause 120(3) applies the provisions of
paragraphs 4, 5, 6, 9 and 10 of Schedule 9 to the making of regulations
relating to the education and training of AMHPs. This means that
draft regulations must be published at least three months in advance
of the draft regulations being laid before Parliament, and that
following publication the Secretary of State must consult fully
with AMHPs and other interested bodies.
340. After the consultation period, the draft
regulations, with any modifications the Secretary of State considers
appropriate in the light of the consultation, may be laid before
Parliament. The Secretary of State must also lay before Parliament
a report about the consultation; this report is intended to set
out the results of the consultation.
341. The draft regulations must be subject to
the affirmative procedure. The arrangements for consultation and
the level of Parliamentary scrutiny match that for the equivalent
power in section 60 of the Health Act 1999.
Schedule 6: The Office of the Health Professions
Adjudicator
Paragraph 5
Power conferred on: Privy Council
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
342. Paragraph 5 gives to the Privy Council power
by regulation to prescribe requirements for appointment to membership
of OHPA. The Privy Council may prescribe requirements for the
appointment of the Chair and other members. The regulations might
specify, amongst other things, the types of people who would not
be eligible to be the Chair or member of the Council, e.g. those
with certain criminal convictions.
343. The regulations made by the Privy Council
are subject to negative resolution (see clause 154(1)(c)). The
regulation making power will enable the Privy Council to add detailed
requirements to the statutory framework for the membership of
OHPA for which Schedule 6 provides. The Privy Council is well
placed to co-ordinate the views of the Health Departments, the
professions and other interested parties as to the person specifications
for these appointments and then to delegate the responsibility
for recruiting the members through the Appointments Commission.
These powers will provide flexibility as the OHPA extends its
remit to other professions and it becomes apparent that changes
to the numbers of non-executive and executive members would be
beneficial to the performance of OHPA's functions.
Paragraph 7
Power conferred on: Privy Council
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
344. Paragraph 7 gives to the Privy Council power
by regulation to prescribe the number of executive and non-executive
members of OHPA. Paragraph 7(2) states that the regulations must
specify the number of executive and non-executive members (between
one and three in each case) and paragraph 7(3) that the number
of executives cannot exceed the number of non-executives.
345. The regulations made by the Privy Council
are subject to negative resolution (see clause 154(1)(c)). The
regulation making power will enable the Privy Council to add detailed
requirements to the statutory framework for the membership of
OHPA for which Schedule 6 provides. These powers will provide
flexibility as the OHPA extends its remit to other professions
and it becomes apparent that changes to the numbers of non-executive
and executive members would be beneficial to the performance of
OHPA's functions.
Schedule 8: Extension of powers under Section
60 of Health Act 1999
Power conferred on: Her Majesty in Council
Power exercisable by: Order in Council
Parliamentary procedure: affirmative resolution
Background
346. This clause extends the scope of section
60 of the Health Act 1999.
347. Section 60 was introduced in the Health
Act 1999 to enable changes to be made to the regulation of health
professions in an efficient and timely manner. Before the introduction
of the section 60 procedure, the enactments that regulated the
health professions made detailed provisions which, with very few
exceptions, could only be changed by means of primary legislation.
Section 60 allows changes to such provisions without the need
for an Act of Parliament, whilst strengthening the arrangements
for consultation of interested parties and maintaining an appropriate
level of Parliamentary scrutiny.
348. This power has proved to be effective, allowing
the introduction of a number of changes to improve patient safety,
such as modernising fitness to practise procedures and the widening
of regulation to include new professional groups.
349. The changes in the Bill will, in particular,
amend section 60 of and the associated Schedule 3 to, the Health
Act 1999 to:
1. include the new OHPA within the scope of section
60. This will enable the use of section 60 order making powers
to change the scope of the functions of the new regulator, and
will, in particular allow responsibility for adjudication of fitness
to practice cases in respect of further health professions to
be transferred to it in due course (should such a course of action
be considered appropriate and be agreed with the professional
regulatory bodies in question)
2. make provision that a new professional regulatory
body for pharmacy (the proposed General Pharmaceutical Council)
may be created by means of a section 60 order and that the regulatory
functions of the Royal Pharmaceutical Society of Great Britain
(RPSGB) and Pharmaceutical Society of Northern Ireland (PSNI)
(subject to a decision by Northern Ireland Ministers to proceed
in this way) may be transferred to that body
3. make provision for lay majorities. This will
help establish and sustain confidence in the independence of the
regulators. Under the current provisions, a section 60 order cannot
be used to impose a lay majority on a health professions regulatory
body. This provision will allow councils of health professions
bodies to have a lay majority, should they wish. It will be used
as and when such councils request such a change
4. remove a restriction that has prevented Orders
under section 60 from being used to make provisions allowing functions
conferred on the Privy Council in relation to some of the regulated
professions to be exercised by another person. The professions
affected are pharmacists, doctors, optometrists, osteopaths, chiropractors,
dentists and the other professions regulated, or to be regulated,
under the Dentists Act 1984. Of those professions currently regulated,
the restriction already does not apply to nurses, midwives, pharmacy
technicians and the thirteen professions currently regulated under
the Health Professions Order 2001. Removing the restriction as
regards the affected professions will allow new legislation to
be introduced to transfer functions of the Privy Council as regards
them to other bodies, where this is merited. In practice, it is
anticipated that this extended power will generally be used to
transfer functions from the Privy Council to the regulatory bodies
for the affected professions rather than to third parties.
350. Orders under section 60 have been used successfully
over a number of years to enable professional regulation to keep
pace with the changing needs of the health professionals, without
unnecessary delays due to limits on Parliamentary time. This includes
for the pharmacy profession the Pharmacists and Pharmacy Technicians
Order 2007.
351. There is precedent for using this power
to set up a new regulatory body. Both the Nursing and Midwifery
Council and the Health Professions Council were successfully established
by means of section 60 Orders.
Changes in Respect of Pharmacy
352. The Schedule contains a number of amendments,
which will extend the scope of section 60 to cover the regulation
of pharmacy in Northern Ireland and update references to pharmacy
legislation in Great Britain. This will enable the transfer of
the RPSGB's and PSNI's functions in respect of the regulation
of pharmacy professionals to the planned new General Pharmaceutical
Council, which the Department will be creating via an order under
section 60. The transfer of the regulatory functions of PSNI will
be subject to a decision by Northern Ireland Ministers to proceed
in this way.
353. The Schedule also extends the scope of section
60 to enable the transfer of the RPSGB's regulatory functions
(and those where undertaken by the PSNI) relating to the registration
and regulation of pharmacy premises and other inspection and enforcement
functions under the Medicines Act; compliance with those provisions
of the Poisons Act 1972 and the Poisons (Northern Ireland) Order
1976, which relate to pharmacists and those carrying on a retail
pharmacy business; and the grant of authorisation under s28 of
the Regulation of Investigatory Powers Act 2000 concerning directed
surveillance. Currently with limited exceptions, section 60 applies
to the regulation of individual pharmacy professionals and not
to premises.
354. Paragraph 4(2) makes a consequential change
so that the proposed new General Pharmaceutical Council cannot
be abolished by an order under section 60.
Lay Majorities
355. Paragraph 4(3) removes the restriction preventing
an Order in Council from imposing a lay majority. This means the
councils of health professions regulatory bodies will be able
to be composed of a lay majority, should they wish. Parity of
membership can already be made by an order under section 60.
OHPA
356. In paragraph 5(3), the insertion of sub-paragraph
(2A) extends the restriction on transferring the functions set
out in paragraph 8(2) of Schedule 3 of the Health Act 1999 to
the OHPA.
357. The insertion of (2A) is a consequential
amendment to bring the OHPA into the scope of this particular
restriction on Section 60.
358. Paragraph 6(2) makes changes to clarify
that where an Order under section 60 deals with more than one
profession, for example pharmacists and pharmacy technicians,
representations on the published draft Order should be invited
from persons appearing appropriate to represent any profession
covered by the Order. Similarly those persons appearing appropriate
to represent those provided with services by any profession to
be regulated should be consulted on the draft Order.
Procedure
359. An order under section 60 allows affected
health professions to be closely involved with development of
the legislation, including through the requirement to formally
consult on section 60 orders in draft. As a section 60 order is
subject to the affirmative resolution procedure, this allows for
an appropriate level of Parliamentary scrutiny. This is entirely
appropriate given the significant nature of the changes which
may be made by an order under section 60, and the fact that section
60 orders may amend primary legislation. The Department considers
that this procedure works well at present, as has been successfully
demonstrated on a number of occasions.
360. Orders made under section 60, as amended
by the Bill, will continue to be made in the same way as section
60 orders are presently made, that is by an Order in Council subject
to the affirmative resolution procedure.
Schedule 10 - Further amendments relating to Part
2
Paragraph 16
Power conferred on: Privy Council
Power exercisable by: directions
Parliamentary procedure: None
361. Paragraph 16 makes consequential amendments
to the enabling power in section 60 of the Health Act 2006 as
a result of the changes to the constitution of the Council and
the establishment of OHPA.
362. As amended, the Privy Council is able to
make directions delegating its function relating to the appointment
of the Chair of the Council and members of OHPA to the Appointments
Commission.
363. It is intended to make directions relating
to the process of appointment and the criteria to be applied.
364. The existing Parliamentary procedure enables
the delegation of the appointments process to the Appointments
Commission which has built up expertise in health professional
regulatory body appointments. The Department therefore considers
it appropriate to retain the existing Parliamentary procedure
for delegating the appointments process to the Appointments Commission.
Part 3: Public Health Protection
Background
365. The Public Health (Control of Disease) Act
1984 consolidates earlier legislation, much of it dating back
to the 19th century. Many of its assumptions, both
about risks and about how society operates, are now out of date.
It makes highly detailed provision on some matters (for example,
it is a criminal offence to expose a public library book to plague,
or to hold a wake over the body of a person who has died of cholera)
but does not address others that now seem more relevant, such
as contamination by chemicals or radiation. It provides for only
a limited range of actions (for example, detaining a person in
hospital), when other actions (such as requiring him to stay in
his own home, with appropriate health support) could be as effective
in terms of protecting public health and therefore more available
as they may also interfere less with the person's human rights.
366. There has been an increased recognition,
both domestically and internationally, of the case for taking
an "all hazards" approach to dealing with such health
threats. Within the UK, the Health Protection Agency (HPA) has
been created to provide support and advice in relation to radiation,
toxicology, and infectious disease, topics that were previously
handled by separate bodies.
367. Internationally, in May 2005 the World Health
Organization (WHO) adopted new International Health Regulations
(IHR) which, unlike their predecessors, are concerned with contamination
as well as infectious disease. The IHR came into effect in June
last year, further strengthening the case for updating the Public
Health (Control of Disease) Act 1984. The Department needs to
ensure that the appropriate Minister is able to take, where he
considers it appropriate, the sort of actions that WHO have indicated
they might recommend under the IHR in response to specific threats.
368. The new legislation will create flexible,
proportionate and comprehensive powers to deal swiftly with a
significant threat to public health brought about through the
incidence or spread of infection or contamination. The Department
intends to consult fully on all non urgent regulations under each
of the powers in accordance with Cabinet Office guidance.
Clause 123 (Section 45B): Public health protection
Health protection regulations: international travel
etc.
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Ministers
for Wales
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution (unless
amending primary legislation, in which case will be subject to
affirmative resolution)
369. New section 45B gives the appropriate Minister
power to make regulations to prevent danger to public health from
conveyances arriving at any place. It also enables regulations
to prevent the spread of infection or contamination by conveyances
leaving any place, or from the articles or persons on board (or
attempting to board) those conveyances. Airports, shipping ports
and international train terminals are places where large numbers
of people and articles enter and leave England and Wales. When
people arrive from abroad they may have been exposed to and be
carriers of health risks that are not prevalent in the UK. Borders
are therefore particularly vulnerable places in relation to the
incidence or spread of disease.
370. With the increase in international travel,
airports, train terminals and ports are extremely busy and an
interruption to conveyance timetables can have a substantial impact
on a large number of people. Therefore, any action to protect
public health needs to be taken swiftly and be proportionate to
avoid unnecessary interference with international traffic and
trade.
371. The Department believes secondary legislation
is the most appropriate way to address public health threats at
borders because threats can change and evolve, means of transport
and travel can develop, requiring different approaches, and new
international recommendations can be passed requiring a swift
response. For example, this year the Department updated the Public
Health (Ships) Regulations 1979, (S.I. 1979/1435) to adopt
the IHR ship sanitation certificates in time for the coming into
force of the IHR in June 2007.
372. The Public Health (Aircraft) Regulations
1979 (S.I. 1979/1434), the Public Health (Ships) Regulations
1979, and the Public Health (International Trains) Regulations
1994 (S.I. 1994/311) were made under section 13 of the Public
Health (Control of Disease) Act 1984. They deal with particular
measures that a local authority or port health authority may need
to take at an international border to prevent the spread of infectious
disease but for the most part reflect the circumstances of nearly
thirty years ago, when movement across borders was less common
and less rapid than it is now.
373. The Association of Port Health Authorities
has provided examples of how they would wish to be able to use
these powers in future. They mentioned a case where an aircraft
had a consignment of giant African Land snails, which resulted
in liquor at the bottom of the aircraft container bins. These
snails are known to sometimes have parasites that can cause meningitis.
The powers could ensure that regulations enable a port health
authority to require that, before the aircraft container bins
could be put back into use (e.g. for transporting goods which
could be foodstuffs) the airline disinfect the container bins.
374. In England, the Department intends to use
the powers in section 45B to update the existing regulations to
ensure they take account of modern circumstances, including the
new IHR and recognition of the risks posed by contamination as
well as infectious disease. The Department will also recast the
provisions so that they dovetail with the new broader and more
flexible 'in-country' powers afforded to a justice of the peace.
For example, the Department may introduce requirements for port
health authorities and local authorities to cooperate when an
individual at a point of entry has been found to be in need of
continued health monitoring.
375. The Department intends that local authorities
and port health authorities should continue to have powers with
regard to conveyances arriving at or leaving any place that would
under the new provisions otherwise be afforded to a justice of
the peace. Due to the volume of activity at borders and given
the need to avoid disruption to trade and travel, it would not
be practical to involve justices of the peace at points of entry.
For example, the intention is that local authorities will, as
now (although currently the powers are limited to infectious disease),
have the power to require an individual arriving in England who
is thought to be infected or contaminated to undergo a medical
examination. Article 23 of the IHR prohibits the regulations from
allowing any measure that is not the least intrusive that would
achieve the public health aim. It must also be a non-invasive
measure.
376. The IHR and other international agreements
such as the Universal Declaration of Human Rights provide safeguards
for human rights in the application of measures at points of entry.
The Department believes that rights under the European Convention
on Human Rights are fully covered by the IHR which means that
where regulations under section 45B give effect to the IHR there
should be no greater need for scrutiny with the new regulations
for Convention compliance purposes than there has been in the
past.
377. The Department has agreed to work with Scotland,
Wales and Northern Ireland to secure that regulations under section
45B are compatible with legislation in those countries, for the
convenience of conveyance operators across the UK. The regulations
are to be subject to the negative resolution procedure. The existing
powers are subject to the negative resolution procedure. To the
Department's knowledge, no provisions under them have been challenged
since 1979.
378. The regulation making powers in section
45B also enable regulations to be made for giving effect to any
international agreement or arrangement relating to the spread
of infection or contamination. An example might be the resolution
calling for voluntary early implementation of measures relevant
to avian flu with pandemic potential, passed unanimously on 26
May 2005 by the World Health Assembly, Global Health Security
Initiative and Group of 8.
379. The Department has worded the provision
in section 45B(1)(c) so as to enable the Government to choose
how to give effect to international agreements or arrangements.
It may be that the Government does not want to adopt a recommendation
wholesale, or the Government might in some cases want to go slightly
further than the recommendation requires. Secondary legislation
is the most appropriate vehicle for enabling the adoption of such
recommendations because it allows a rapid and flexible response
and it is not possible to know now what agreements, arrangements
or recommendations there will be in the future that the Government
may wish to give effect to. Consistently with the precursor power
in section 13 of the Act, the negative procedure is appropriate
to give effect to an international agreement which has already
undergone debate in international fora.
380. However, the Department realises that in
order to facilitate some of these recommendations it may at times
be necessary to amend domestic legislation. Section 45F(3) would
enable this. Where this is necessary the regulations would be
subject to the fullest Parliamentary scrutiny through an affirmative
resolution procedure (section 45Q(2)(b) and (4)). In cases of
urgency however, the need to act swiftly may override the immediate
need for full Parliamentary scrutiny, and section 45R allows for
this. Such regulations however (i) must contain a statement by
the appropriate Minister making them that the Minister is of the
opinion that it is necessary by reason of urgency for the regulations
to be made without undergoing the affirmative resolution procedure
described in section 45Q(4) (see section 45R(2)), (ii) the regulations
must be agreed by a resolution of each House of Parliament (or
in Wales by the National Assembly for Wales) within 28 days in
order to continue in force (section 45R(4)) and (iii) if at any
point during the 28 days, a debate under section 45R(5) ends with
a vote rejecting the regulations, the regulations will cease to
have force at the end of that day. These safeguards should help
ensure that the power is not abused.
Clause 123 (Section 45C): Public health protection
Health protection regulations: Domestic
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Ministers
for Wales
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: affirmative resolution,
unless the regulations contain a declaration that the person making
them is of the opinion that the instrument does not contain any
provision made by virtue of section 45C(3)(c) which imposes or
enables the imposition of a special restriction or requirement
or any other restriction or requirement which has or would have
a significant effect on a person's rights, in which case, subject
to negative resolution
381. New section 45C provides powers for the
appropriate Minister to make provision by regulations for the
purpose of preventing, protecting against, controlling or providing
a public health response to the incidence or spread of infection
or contamination. The wording "prevent, protect against,
control or provide a public health response to" is intended
to cover the range of potential responses to public health threats
arising from infection or contamination. By section 45A(3), the
infection or contamination is one which presents or could present
significant harm to human health.
382. This general regulation making power is
intended to be used for two purposes:
- to create standing regulations
regarding permanent preparedness; and
- to create regulations providing additional safeguards
for particular situations allowing the Secretary of State (or
the Welsh Ministers) to respond swiftly to a serious and imminent
threat to public health where it is not already covered by the
preparedness provisions.
383. The examples below set out how the Department
intends to use the powers.
Standing Preparedness
384. Examples of the standing preparedness provisions
the Government intends to make include:
- regulations requiring information
on cases of infection or contamination (previously called notifiable
diseases);
- regulations providing local authorities with
certain powers, including the power under section 45C(4)(a) for
infected children to be kept away from school for the protection
of other children and teachers.
Information regulations
385. The Department envisages that regulations
under section 45C(3)(a) will update the standing national information
requirements imposed on registered medical practitioners to notify
the local authority of cases or suspected cases of specified diseases
or disease syndromes. The regulations are likely to formalise
the arrangements whereby local authorities will continue, as they
do now, to pass the information on to the HPA (and see the proposed
regulations enabling notices to be given electronically under
new section 60A of the Public Health (Control of Disease) Act
1984). The Department intends that the regulations will also create
new standing national information requirements imposed on laboratories
to notify the local authority and HPA of the causative agents
of specified diseases or disease syndromes. The power is also
intended to be used to require laboratories that test food samples
to notify the local authority and the Food Standards Agency of
the detection of specified pathogens that may be harmful to human
health. The diseases, disease syndromes and their causative agents
will be those that require urgent investigation and action to
protect public health. It is envisaged that further urgent investigation
and action may be carried out in specified circumstances by the
local authority under regulations made under section 45C(3)(c).
386. The power in section 45C(3)(b) is needed
to enable statutory underpinning in future of the current voluntary
laboratory surveillance regime whereby laboratories provide information
to the HPA over long timescales to enable the HPA to monitor trends,
identify unusual disease patterns, identify and evaluate interventions
and inform healthcare planning.
387. The current regime splits notifiable diseases
between section 11 of the Public Health (Control of Disease) Act
1984, and the Public Health (Infectious Diseases) Regulations
1988 (S.I. 1988/1546) (the Infectious Diseases Regulations).
The Infectious Diseases Regulations then apply different primary
legislative measures to different diseases requiring the practitioner,
local authority or member of the public to refer to both the secondary
and the primary legislation to see what they could or should be
doing in relation to any particular disease.
388. The Department believes that placing all
the notification requirements in secondary legislation will ensure
that those concerned (registered medical practitioners, laboratories
and local authorities) will have one clear document stating what
they must do by way of notification. Delegated legislation is
appropriate to enable the lists of specified diseases or disease
syndromes to be amended to keep up to date with changes in epidemiology
and the emergence of new health risks.
389. Regulations under section 45C(3)(a) or (b)
(if not with other provision subject to the affirmative resolution
procedure in section 45Q(4)) would contain a declaration that
the person making them was of the opinion that the instrument
does not contain any provision made by virtue of section 45C(3)(c)
which imposes or enables the imposition of a special restriction
or requirement or any other restriction or requirement which has
or would have a significant effect on a person's rights in accordance
with section 45Q(3). The regulations would be subject to the negative
resolution procedure under section 45Q(1). The negative resolution
procedure is appropriate for such technical details. At present
the standing notification requirements in the Infectious Diseases
Regulations are subject to the negative resolution procedure.
The new regulations are not intended to be any more intrusive.
Local authority powers
390. The Public Health (Control of Disease) Act
1984 contains specific powers enabling local authorities to take
action without application to a justice of the peace. The Department
intends to provide in regulations under section 45C for some of
these powers which the Department believes are still relevant
to preventing the incidence or spread of infection or contamination
(but not for others such as the prohibition against a person infected
with plague returning a library book). For example, under section
21 of the Public Health (Control of Disease) Act 1984 a local
authority can require a child to stay away from school in certain
circumstances. The Department does not believe that requiring
a child to stay away from school should require an application
to a justice of the peace. In most cases, parents will voluntarily
cooperate to keep their child from infecting others.
391. The HPA reports that local authorities rarely
have to use the existing provision. The threat of using the provision
is usually enough to gain cooperation. However for the threat
to be effective, a legislative provision is needed. Section 45D
restricts use of the powers to make regulations under section
45C so that regulations under section 45C(3)(c) and (4)(a) enabling
a local authority to require a child to be kept away from school
would need to impose on a local authority the proportionality
test in section 45D(2). The regulations would need to provide
that a decision under the provision may only be taken if the person
taking the decision considers, when taking it, that keeping a
child away from school is proportionate to what is to be achieved
by imposing the requirement. Provision enabling a local authority
to require a child to be kept away from school under section 45C(3)(c)
and 45(4)(a) would normally apply for a short time only, and the
Department of Health and the Department for Children, Schools
and Families have a protocol to ensure that children who are ill
receive appropriate education even when they are kept away from
school[4]
so the provision is likely to be proportionate. Having a delegated
power will enable the regulations to specify the circumstances
in which a child should be kept away from school, and to ensure
that the provisions are commensurate with scientific knowledge
in relation to the spread of infection amongst children.
392. The likelihood is that such provision would
be included in the first set of regulations made under section
45C(3)(c) so would be with other provision subject to the affirmative
resolution procedure. However it is possible that subsequent regulations
amending the provision would contain a declaration that the person
making them was of the opinion that the instrument does not contain
any provision made by virtue of section 45C(3)(c) which imposes
or enables the imposition of a special restriction or requirement
or any other restriction or requirement which has or would have
a significant effect on a person's rights and would be subject
to the negative resolution procedure under section 45Q(1) for
the reasons indicated in the declaration.
393. Regulations under section 45C(1) and 45F(2)(a)
may be exercised to enable a local authority to offer disinfection
or decontamination services. Delegated legislative power enables
provision for such services to reflect new techniques or limitations
in relation to the use of particular products and to be kept up-to-date.
The proportionality test in section 45D(1) or (2) would not be
relevant as the regulations would not impose or enable the imposition
of any restriction or requirement. Therefore the regulations,
if not with other provision subject to the affirmative resolution
procedure, would contain a declaration that the person making
them was of the opinion that the instrument does not contain any
provision made by virtue of section 45C(3)(c) which imposes or
enables the imposition of a special restriction or requirement
or any other restriction or requirement which has or would have
a significant effect on a person's rights. Appropriately for regulations
on technical matters that are not intrusive, the regulations would
be subject to the negative resolution procedure under section
45Q(1).
394. Another potential use of the powers is
to impose in regulations a requirement that a local authority
in prescribed circumstances investigate an outbreak, for example
of a particular airborne infectious disease in its area by requiring
information from the owners of premises with air conditioning
units or other types of relevant establishments. The information
to be required may consist of names and contact details of persons
who had attended those types of premises within a prescribed period
of detection of the outbreak. Delegated legislation is appropriate
as the diseases that may need to be investigated as well as scientific
knowledge of the aetiology of the disease may change.
395. Under section 45D(1) the appropriate Minister
would need to consider when making the regulations whether the
requirement to investigate to be imposed on the local authority
was proportionate to what was sought to be achieved by it. Under
section 45D(2) the regulations would need to provide that the
local authority could only require the owner of relevant premises
to provide information if the person taking the decision on behalf
of the local authority considered, when taking the decision, that
the requirement was proportionate to what was sought to be achieved
by imposing it. As enabling the imposition of a requirement to
provide information consisting of the names and contact details
of a customer or other third party could engage the right to respect
for private and family life of a person the person making the
regulations would not be able to come to the view that the regulations
would not have a significant effect on a person's rights so as
to enable the regulations to contain the declaration set out at
section 45Q(3). The regulations would be subject to the affirmative
resolution procedure under section 45Q(4) by virtue of section
45Q(2). Affirmative resolution procedure is appropriate, amongst
other reasons as the measures used to investigate the outbreak
may affect a person's rights.
396. The Department intends that regulations
under section 45C(1) and 45F(2)(g) will enable local authorities
to meet or contribute to the costs that individuals incur, whether
the individuals incur such costs on a voluntary basis or under
a requirement set out in regulations, to prevent the spread of
disease. Delegated powers enable the provision to be tailored
to circumstances where the provision is appropriate. Regulations
containing such provision, if not with other provision subject
to the affirmative resolution procedure, would contain a declaration
that the person making them was of the opinion that the instrument
did not contain any provision made by virtue of section 45C(3)(c)
which imposes or enables the imposition of a special restriction
or requirement or any other restriction or requirement which has
or would have a significant effect on a person's rights. The regulations
would be subject to the negative resolution procedure under section
45Q(1) for the reasons indicated in the declaration.
Additional safeguards
397. Regulations providing additional safeguards
for particular situations would be made as and when they were
required, under sections 45C(1), 45C(3)(c) and 45C(4). They would
often be temporary to deal with a specific set of circumstances.
Section 45C(1) makes it clear that the regulations may only be
made for the purpose of preventing, protecting against, controlling,
or providing a public health response to the incidence or spread
of infection or contamination. Delegated powers are appropriate
to deal with future unpredictable circumstances including incidents
such as the polonium 210 poisoning in London and new diseases
such as SARS, to enable the provisions to be tailored to the circumstances.
However the Department does not intend to burden the statute book
with regulations for situations that are unlikely to arise in
practice, so the examples given are not intended to do more than
demonstrate how the powers and legislative procedures work.
398. Regulations under section 45C(1) and 45C(3)(c)
might, but by way of a hypothetical example only of an additional
safeguard, require local authorities to post in prominent places
the symptoms of a specific disease, so that anyone who suspects
they may be infected or contaminated could seek medical attention.
Such provision could not be included in regulations unless the
appropriate Minister considered when making the regulations that
the requirement was proportionate to what was to be achieved by
imposing it in accordance with section 45D(1). As the regulations
would not have a significant effect on a person's rights the regulations
would contain the declaration in section 45Q(3) and accordingly
be subject to the negative resolution procedure under section
45Q(1).
399. Any additional safeguard regulations which
imposed, or enabled a local authority or other person to impose
a restriction or requirement under section 45C(3)(c) would be
subject to the proportionality tests in section 45D(1) or (2)
(as are standing regulations under section 45C(3)(c)). By section
45D(1) the appropriate Minister would not be able to impose such
a restriction or requirement unless the appropriate Minister considered
when making the regulations that the restriction or requirement
was proportionate to what was sought to be achieved by imposing
it. Under section 45D(2) the regulations would not be able to
include provision enabling the imposition of a restriction or
requirement unless the regulations containing it provided that
a decision under the provision may only be taken if the person
taking the decision considers, when taking it, that the restriction
or requirement is proportionate to what is to be achieved by imposing
it.
400. Many of the actions that might be imposed
by way of additional safeguards would be similar to the measures
that could be required by a justice of the peace. If the person
making the regulations cannot say that regulations do not contain
any provision which imposes or enables the imposition of a restriction
or requirement which has or would have a significant effect on
a person's rights, then the regulations would be subject to the
affirmative resolution procedure by virtue of section 45Q(2).
It is appropriate that provision for such measures should be subject
to the additional Parliamentary scrutiny provided by an affirmative
resolution procedure. The Department believes that most 'additional
safeguard' regulations made under section 45C(3)(c) are likely
to be subject to the affirmative resolution procedure.
401. Under section 45C(3)(c), (4)(d), and 45D(3)
the appropriate Minister may by regulations impose a special restriction
or requirement that a justice of the peace could impose for example
a requirement to wear protective clothing in prescribed circumstances,
provided that it is not a measure requiring or restricting medical
examination, removal to or detention in hospital or another establishment
or the quarantine or isolation of persons. A "special restriction
or requirement" is defined in section 45C(6). The appropriate
Minister may impose such a restriction or requirement even in
the absence of a serious and imminent threat. This is to allow
for regulations needed to ensure preparedness and protection before
a threat becomes serious and imminent. However, the provisions
might not be for standing preparedness, as they might involve
one off actions to protect against a particular threat, such as
the risk of avian flu mutating into pandemic flu. The power is
in delegated legislation to enable a flexible and tailored response
to a future threat.
402. By section 45D(1) the appropriate Minister
would not be able to impose the measure unless the appropriate
Minister considered when making the regulations that the restriction
or requirement was proportionate to what was sought to be achieved
by imposing it. As the regulations would contain a special restriction
or requirement so could not contain the declaration in section
45Q(3) they would be subject to full debate in each House of Parliament
(or in Wales by the National Assembly for Wales) by virtue of
section 45Q(2)(a) under the affirmative resolution procedure in
section 45Q(4), so that Parliament would decide whether the measure
was appropriate.
403. Section 45D(4)(a) and (b) restrict the use
of powers under section 45C(3)(c) and 45C(4)(d) that enable a
local authority or other person to impose a restriction or requirement
that a justice of the peace could impose under sections 45G(2),
45H(2) or 45I(2) (other than those at section 45C(4)(a), (b) or
(c)), known as a "special restriction or requirement"
by virtue of section 45C(6). Regulations may not enable the imposition
of a special restriction or requirement except in response to
or contingent on there being a serious or imminent threat to public
health.
404. If the regulations required a local authority
or other person to impose the special restriction or requirement,
under section 45D(1) the appropriate Minister would need to consider
when making the regulations whether the requirement was proportionate
to what was sought to be achieved by it. As the regulations would
enable the local authority or other person to impose the measure,
under section 45D(2) the regulations would need to provide that
the restriction or requirement could only be imposed if, at the
time the decision to impose it is taken, the person taking the
decision considers that the restriction or requirement is proportionate
to what is sought to be achieved by imposing it. As the restriction
or requirement the decision maker is able to impose would be a
special restriction or requirement, under section 45D(4)(a) the
regulations would need to be made in response to a serious and
imminent threat. Alternatively under section 45D(4)(b) they could
be made in advance but the regulations would need to provide that
the decision to impose the measure could not be taken except in
the event of a serious and imminent threat to public health. As
the decision would be one by which a special restriction or requirement
was imposed on or in relation to a person, thing or premises the
regulations would need to include provision for a right of appeal
to a magistrates' court under section 45F(6) and, if the special
restriction or requirement were to continue, provision also for
a right of periodic review under section 45F(7). The regulations
could not contain the declaration set out at section 45Q(3) as
they would contain a special restriction or requirement. The regulations
would be subject to the affirmative resolution procedure under
section 45Q(4) by virtue of section 45Q(2)(a).
405. Such regulations could be made in advance
subject to the affirmative resolution procedure to allow provisions
to be in place in anticipation of a serious and imminent threat.
The measures in the regulations could be adapted and updated following
incidents, based on lessons learned. For these reasons of flexibility
amongst others it is appropriate for such matters to be dealt
with in delegated legislation. The affirmative resolution procedure
ensures that Parliament (and in Wales the National Assembly for
Wales) can decide whether the imposition of the measures would
be appropriate.
406. New section 45R will allow regulations under
section 45C declared by the appropriate Minister as necessary
by reason of urgency (section 45R(2)) to be made that can come
into effect immediately. In certain circumstances, the need to
act swiftly may override the immediate need for full Parliamentary
scrutiny. But such regulations must be agreed by a resolution
of each House (or in Wales by the National Assembly for Wales)
within 28 days in order to continue in force (section 45R(4)).
However, section 45R(5) provides the security that at any point
during the 28 days, if a debate ends with a vote rejecting the
regulations, the regulations will cease to have force at the end
of that day.
407. A measure that is urgent will not necessarily
be highly intrusive. For example, the measure might be a requirement
that a person visiting another with a particular disease in hospital
wear a mask. It may therefore not be a high priority for debate
in the Houses of Parliament. The Department believes 28 days will
allow enough time to arrange a debate in each House even where
the requirement passed by regulations is a relatively minor yet
urgent one, where debating whether the measure stays in force
may not take priority over more pressing Parliamentary business.
Clause 123(Sections 45G(7), 45H(7) and 45I(7)):
Public health protection
Regulations making provisions about the evidence
that should be available to a justice of the peace
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Ministers
for Wales
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: the first set of regulations
under section 45G(7) are to be subject to affirmative resolution,
subsequent regulations subject to negative resolution; and regulations
under section 45H(7) or 45(I)(7) subject to negative resolution
unless in an instrument which also contains provisions mentioned
in section 45Q(2), in particular the first set of regulations
under section 45G(7), in which case, subject to affirmative resolution
408. A justice of the peace may make orders at
the request of the local authority to impose restrictions or requirements
on a person, or in relation to things or premises or in relation
to a group of persons, things or premises (known as a Part 2A
order). The regulation making power in section 45G(7) requires
the appropriate Minister to set out what evidence must be presented
to the justice of the peace before the justice can be satisfied
that it is necessary to make an order in relation to a person,
including an order to require a person to provide information
about the identity of a related party. The evidence might relate
to the nature of infection or contamination or the efficacy of
the measures that might be imposed under an order. The requirement
to make regulations under section 45G(7) will assist to ensure
that evidence presented to a justice of the peace in relation
to requirements or restrictions to be placed on persons is of
a consistent standard. For example the regulations may require
a recommendation from a registered medical practitioner with particular
expertise before an order may be made to detain or quarantine
someone who is or may be infected or contaminated with a particular
disease. As infections or contaminations may change, and scientific
knowledge about the nature of particular infections or contaminations
and the efficacy of measures is likely to change over time, the
matters are appropriate for delegated legislation.
409. The first set of regulations under section
45G(7) would be subject to an affirmative resolution procedure
allowing Parliament (and the National Assembly for Wales) to fully
scrutinise the parameters of the evidence to be put before justices
of the peace to assist them to decide whether an order in relation
to a person is necessary. Subsequent amending legislation is likely
to be used mostly to keep the provisions up to date with current
scientific knowledge so is appropriately subject to the negative
resolution procedure.
410. Similarly the appropriate Minister may make
regulations under the powers in sections 45H(7) and 45I(7) in
relation to evidence which must be produced when applying to a
justice of the peace for a Part 2A order regarding things or premises,
or information about related contacts of things or premises. It
may not be necessary to specify such requirements where, for example
premises are not private, or things are believed to have been
abandoned. As the evidence is likely to be routine though specialist
in nature, it is appropriate that provision in regulations for
evidence in relation to things or premises should be subject to
delegated legislation and to the negative resolution procedure.
Clause 123 (Section 45L(4)): Public health protection
Regulations prescribing the maximum period of
any extension by order of a justice of the peace under section
45L(2) in relation to restrictions or requirements mentioned in
section 45G(2)(c) or (d) that are imposed in a Part 2A order or
the maximum period for which any restriction or requirement other
than under section 45G(2)(c) or (d) may be imposed in a Part 2A
order or the maximum period of any extension of such restriction
or requirement
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Ministers
for Wales
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution,
unless in an instrument which also contains provisions mentioned
in section 45Q(2), in particular, the first set of regulations
under section 45G(7), in which case, subject to affirmative resolution
411. A Part 2A order is required by section 45L(1)
to specify the period for which any restriction or requirement
imposed by or under the order is to remain in force. A restriction
or requirement mentioned in section 45G(2)(c) or (d) consisting
of detention in hospital or other suitable establishment or quarantine
or isolation must not exceed 28 days, but a period in respect
of any restriction or requirement may be extended by a further
order of the justice of the peace. The regulation making power
in section 45L(4) enables the appropriate Minister to make provision
for the maximum period of an extension of a detention, or other
maximum periods in respect of other restrictions or requirements
or extensions of them. A regulation making power is needed to
be able to ensure consistency in the periods to which persons
affected by orders are subject to measures, and for the guidance
of justices of the peace in this technical area. It is appropriate
for such provision to be in delegated legislation for flexibility
in dealing with changing or as yet unknown infections or contaminations,
the aetiology of each disease including when the disease is no
longer able to spread, or circumstances relating to measures to
address a disease such as the length of time a course of training
or advice sessions might run. The negative resolution procedure
is appropriate to deal with technical and varied matters such
as lengths of infectiousness or time between exposure and expression
of different diseases or periods measures should be in force to
be effective.
Clause 123 (Section 45M(5)(e), (6)(c), (7)(c)
and (8)): Public health protection
Regulations prescribing persons who are affected
persons for the purpose of applying for variation or revocation
of a Part 2A order
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Minister
for Wales
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution unless
in an instrument which also contains provisions mentioned in section
45Q(2), in particular the first set of regulations under section
45G(7), in which case, subject to affirmative resolution
412. A Part 2A order may be varied or revoked
by a justice of the peace on the application of an affected person
(amongst others) under section 45M(4). The regulation making powers
in section 45M(5)(e), (6)(c), (7)(c) and (8) enable the appropriate
Minister to make provision for who may be an affected person in
the case of a Part 2A order under each of sections 45G, 45H(2),
45I(2) or section 45H(4) or 45I(4) respectively. Regulation making
powers are needed to be able to ensure consistency in magistrates'
courts throughout England or Wales respectively as to who may
apply for such orders and for the guidance of justices of the
peace in this technical area. Delegated legislation under the
negative resolution procedure is appropriate to deal with such
technical administrative matters.
Clause 123 (Section 45N)): Public health protection
Regulations about the taking of measures pursuant
to Part 2A orders
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Ministers
for Wales
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution unless
in an instrument which also contains provisions mentioned in section
45Q(2), in particular the first set of regulations under section
45G(7), in which case, subject to affirmative resolution
413. Regulations under the power in section 45N
may make provision about the taking of measures and help to set
the parameters within which measures imposed under orders of a
justice of the peace under sections 45G, 45H and 45I may operate.
Section 45N(2) lists the types of provision that may be included.
The provisions that might be made in regulations include how and
by whom measures in orders could be carried out. The appropriate
Minister may wish to stipulate, or restrict, which organisations
may assist the local authority in the monitoring of quarantine
orders, to ensure that only appropriately qualified staff is involved.
The powers allow the appropriate Minister to make regulations
regarding who is liable for the costs or compensation payable
in relation to measures imposed under justice of the peace orders.
For example, the appropriate Minister may wish to limit local
authority powers to recover costs from individuals in receipt
of income support.
414. These matters are appropriately addressed
in secondary legislation to keep them up to date so that, for
example, if private health firms hire individuals with the appropriate
qualifications to enforce quarantine, the regulations can include
them as possible enforcers. Alternatively if it becomes apparent
that an enforcement regime is not appropriate it can be prohibited.
While the powers provided to a justice of the peace under sections
45G, 45H and 45I sit well with the existing role of a justice
of the peace, and simply extend the role already afforded to justices
under the Public Health (Control of Disease) Act 1984, the regulations
are intended to ensure that the orders have a national consistency.
These are technical and administrative matters and as such are
suitable for delegated legislation subject to the negative resolution
procedure.
Schedule 11: Public health protection: further
amendments
Paragraph 15: Electronic communications
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Ministers
for Wales
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
415. Schedule 11, paragraph 15 introduces a new
section 60A. This section enables the appropriate Minister through
regulations to enable notices, orders and other documents to be
given or served electronically where the recipient has stated
in writing that they are willing to receive it in this way. The
power is expected to be most relevant in enabling provision for
registered medical practitioners and laboratories to email the
local authority and HPA with recorded cases of infection or contamination
under regulations made under section 45C(3)(a).
416. Delegated powers are needed so that the
provisions can be extended to cover any new notices, orders or
documents that may be created through regulation making powers
in sections 45B or 45C. It may not always be desirable to allow
a notice, order or document to be provided solely in electronic
format, which is why the provision was not appropriate for primary
legislation covering all documents. The regulations will deal
with administrative and technical matters and therefore the negative
resolution procedure is appropriate.
Schedule 11: Public health protection: further
amendments
Paragraph 25: Default Powers
Power conferred on: the appropriate Minister,
defined as the Secretary of State for England and the Welsh Ministers
for Wales
Powers exercisable by: orders made by statutory
instrument
Parliamentary procedure: none
417. Schedule 11, paragraph 25 replaces old section
71 with a new section 71. This enables the appropriate Minister
to make an order. The purpose of the order is to indicate that
the appropriate Minister considers the relevant health protection
authority named in the order to have failed to discharge its functions
and to direct the authority as to how the function should be discharged.
The provision also allows the appropriate Minister to enforce
the order by a further mandatory order or to make a further order
to provide for the functions of the authority in default to be
transferred to the appropriate Minister or another public authority.
418. Provision to deal with default by an authority
is appropriate for delegated legislation as the circumstances
in which an authority might be in default under the Act cannot
be anticipated and provided for on the face of the legislation.
The order making procedure is sufficiently formal to ensure transparency
and clarity. The orders do not require Parliamentary scrutiny.
This will enable an order to be made without delay when public
health may be at risk because a local authority is not carrying
out their functions effectively.
Part 4: Health in Pregnancy Grants
419. The Health in Pregnancy Grant clauses set
out the scope of this new policy, for which we propose to cover
the bulk of the detail in regulations. These will be made by HM
Treasury and the Commissioners for Her Majesty's Revenue and Customs
and will, in general, be subject to the negative resolution procedure.
On the whole this approach is consistent with that followed for
other social security benefits and is appropriate because the
matters in regulations need to have in built flexibility to enable
the grant to respond to changing requirements and to allow changes
to be reflected quickly. For example defining a "health professional"
in regulations rather than in primary legislation will allow for
changes to be made where there are changes in definition or additional
health professionals are to be included.
420. As a result, the grant will be able to respond
to the changing needs of expectant mothers, in order that during
this relatively short period of time, there is flexibility to
ensure that as many entitled women as possible are able to gain
the maximum benefit from any potential changes.
421. There are provisions that will be subject
to a mix of both negative and affirmative resolution by both Houses
of Parliament. These regulations concern decisions and appeals
and are made under the Social Security Act 1998 as inserted by
clauses 126 and 127, and the Northern Ireland equivalents clauses
129 and 130. This is appropriate because it is important that
the House will have the opportunity to readily apply closer scrutiny
to the matter of decisions and appeals. However, we still require
a degree of flexibility and therefore propose that the provisions
are detailed in regulations and not on the face of the Bill. Again,
this is consistent with overall approach followed for decision
and appeal provisions in respect of other social security benefits.
Clause 125: Entitlement: Great Britain
Power conferred on: HM Treasury
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
422. Clause 125 inserts a new section 140A(1)
into the Social Security Contributions and Benefits Act 1992.
This section provides for general conditions of entitlement to
the grant in relation to a pregnancy. We believe that the degree
of detail required for the entitlement provisions means it is
better to set the requirement out in regulations rather than in
the Bill. This will allow for greater flexibility should the provisions
require amending at a future date in order to respond to changes
in the delivery of maternity care.
423. Regulations of this type are routinely used
to define eligibility throughout the Social Security legislation,
for example in Child Benefit, and it is therefore considered that
the negative procedure is appropriate.
424. Section 140A(2) provides for conditions
in relation to a pregnancy under subsection (1) in order to be
entitled to the grant. This power is necessary to set out basic
conditions in respect of a woman who is pregnant and to accommodate
those cases where a woman has given birth before a claim could
otherwise be made.
425. In order that we might adapt to necessary
changes in entitlement quickly, prescribing conditions relating
to a pregnancy in secondary regulations rather than in primary
legislation will provide greater flexibility.
426. Section 140A(4) provides for HM Treasury
to prescribe for the purposes of subsection (3)(b), circumstances
in which a woman is treated as being or not being, in Great Britain.
As a consequence of the requirement under subsection (3)(b), a
pregnant woman must be resident in Great Britain at the time she
makes a claim.
427. Section 140A(4) is therefore necessary to
ensure that we do not exclude from entitlement those who are absent
from Great Britain in specific circumstances, such as the partners
of crown servants posted overseas, or the children of crown servants
posted overseas providing they are living with them. This is not
a contentious issue and precedent can also be found in relation
to other benefits including Child Benefit. The negative resolution
procedure is therefore appropriate in this case.
428. Section 140A(5) provides the definition
of a health professional for the purpose sub-section (3)(a). The
definition of a "health professional" may change as
definitions and health professions evolve. This power therefore
allows for these details to be set in secondary legislation where
they can be amended more easily. Any changes to definition or
health professions will not be regulated by Her Majesty's Revenue
and Customs but will need to be implemented for the purposes of
the grant quickly to ensure minimum disruption to claimants. The
negative procedure is therefore appropriate in this case.
429. Clause 125, section 140B(1) enables HM Treasury
to prescribe in regulations the amount of the grant. Prescribing
rates for benefits in regulations is commonplace although, as
a rule, such regulations require affirmative resolution. However,
we believe that given the short time window for applying for the
grant, the negative resolution procedure, which is followed in
respect of changes to the rate of the Sure Start Maternity Grant,
is appropriate in this instance. This will enable HM Treasury
to make changes in the rates as quickly as possible in order that
they have the maximum impact.
430. Section 140B(2) enables regulations to be
made to provide for different rates to be payable in different
circumstances. HM Treasury will not presently be exercising this
power. However there may be circumstances in the future in which
the Government should wish to alter the amount to be paid in different
cases as a result of desired changes to the financial support
provided to parents.
431. Clause 128 introduces the same provisions
into the equivalent Northern Ireland legislation by inserting
a new Part 8A into the Social Security Contributions and Benefits
(Northern Ireland) Act 1992.
Clause 126: Administration: Great Britain
Power conferred on: the Commissioners for Her
Majesty's Revenue and Customs
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution,
except for some regulations made under subsection (6) (see explanation
below)
Manner and time of claim
432. Clause 126, subsection (1) amends section
5, subsection (2) of the Social Security Administration Act 1992,
by inserting reference to the Health in Pregnancy Grant. Subsection
(2) provides the power for the Commissioners for Her Majesty's
Revenue and Customs to exercise the powers provided under section
5 of the Social Security Administration Act to prescribe in regulations
matters regarding the claiming and payment of the Health in Pregnancy
Grant.
433. Section 5 of the Social Security Administration
Act provides in respect of most social security benefits, powers
to prescribe in regulations the details concerning the making
of claims and payment of benefits. Bringing the Health in Pregnancy
Grant within the scope of this measure ensures consistency with
other social security benefits and will deliver a flexible system.
Regulations made under these powers will permit claims to be made
in a variety of ways in the future, for such documents and information
to be provided by claimants as may be required, and to allow for
another person to claim the grant on behalf of the pregnant woman,
when for particular reasons she is unable to act on her own behalf.
This provision deals with the clarification of administrative
details associated with applications to the grant and the negative
procedure is therefore appropriate.
434. Clause 129 inserts the same provision into
the equivalent Northern Ireland legislation by amending section
5 of the Social Security Administration (Northern Ireland) Act
1992.
Proof of Identity: Requirement to have a National
Insurance Number
435. Clause 126 subsection (3) inserts a new
section 12A to the Social Security Administration Act 1992 making
entitlement to Health in Pregnancy Grant conditional on the production
of proof of identity. As with other benefits, all women claiming
Health in Pregnancy Grant will be required either to state their
national insurance number if they have one, to give proof that
it is theirs, or to provide sufficient information that would
enable them to be allocated a national insurance number. Paragraph
5 of section 12A enables regulations to be made to exempt certain
categories of people from the requirement of producing a national
insurance number.
436. In consideration of the degree of detail
necessary to provide for the exemptions, and to enable it to react
quickly to future changes, the Department views secondary legislation
as being more suitable. This provision is found in other benefits,
including Child Benefit and does not seem to be a contentious
issue and therefore the negative procedure is appropriate.
437. Clause 129 introduces the same provision
into the equivalent Northern Ireland legislation by inserting
a new section 10A into the Social Security Administration (Northern
Ireland) Act 1992.
Recovery of overpayments
438. Clause 126 subsection (4) amends section
71(11) of the Social Security Administration Act 1992 (c.5) to
insert paragraph (ea) in order that Her Majesty's Revenue and
Customs are able to recover overpayments that arise as a direct
result of the misrepresentation of, or failure to disclose material
information by a claimant.
439. Section 71 of the Administration Act provides
the basis on which questions of whether overpaid social security
benefits are recoverable are determined. The section contains
regulation making powers. It is envisaged that we will make regulations
as necessary to provide for the recovery of overpayments of the
Health in Pregnancy Grant that are consistent with the general
approach adopted in respect of other benefits. The detail of such
provisions will be introduced by secondary legislation to enable
any changes to the provisions to be implemented as required. The
recovery of overpayments in relation to other Social Security
Benefits is subject to the negative resolution procedure and we
consider that an equivalent arrangement would therefore be suitable
for the Health in Pregnancy Grant.
440. Clause 129 makes the same amendment to the
equivalent Northern Ireland legislation by amending section
69 of the Social Security Administration (Northern Ireland) Act
1992.
Decision making and appeals
441. Clause 126 subsection (7) provides for the
Health in Pregnancy Grant to be treated as a relevant benefit
for the purposes of the Social Security Act 1998 in relation to
all matters relating to decision making and appeals, including
which decisions may be appealed and the appeal process. This will
ensure that Health in Pregnancy Grant appellants will have similar
rights of appeal as appellants in other social security appeal
cases and that appeals will be dealt with in the same manner.
Regulations made under these provisions are subject to a mix of
both negative and affirmative resolution in order that the House
can automatically apply closer scrutiny to these matters whilst
a degree of flexibility is still maintained by providing for these
provisions in regulations rather than in the Bill.
442. Clause 129 introduces the same provision
into the equivalent Northern Ireland legislation by inserting
a new section 10A into the Social Security (Northern Ireland)
Order 1998.
Clause 127: Penalty: Great Britain
Power conferred on: the Commissioners for Her
Majesty's Revenue and Customs
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative and affirmative
resolution
443. Clause 127 subsection (2) inserts Schedule
3A into the Social Security Administration Act 1992, providing
for a penalty to be imposed where a person fraudulently or negligently
makes an incorrect statement in connection with a claim to the
Health in Pregnancy Grant. Paragraph 2(1) of Schedule 3A provides
a right of appeal against a determination that a penalty should
be imposed and paragraph 2(6) provides the power to make regulations
under the provisions contained in the Social Security Act 1998
in relation to all matters relating to decision making and appeals
in relation to the imposition of a penalty. This approach ensures
that where a person is given notice of a determination imposing
a penalty, they will have the same appeal rights as other social
security appellants and that their appeal will be handled in the
same manner as social security appeals in general. Regulations
made under these provisions are subject to a mix of both negative
and affirmative resolution.
444. Clause 130 introduces the same provisions
into the equivalent Northern Ireland legislation by inserting
a new Schedule 3A into the Social Security (Northern Ireland)
Act 1992.
Clause 132: General and supplementary
Power conferred on: HM Treasury
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
445. Clause 132 subsection (1) amends section
115 of the Immigration and Asylum Act 1999 by inserting a reference
to the Health in Pregnancy Grant thereby excluding persons subject
to immigration control from entitlement to such benefits. Sub-section
(2) of Clause 132 amends subsection (5) of that section of that
Act by inserting reference to the Health in Pregnancy Grant.
446. This provision provides the power to make
regulations allowing exceptions to the exclusion from entitlement
for persons with certain immigration status. Provision will be
made in secondary legislation to provide entitlement to such persons.
This will enable regulations to be amended as necessary in the
future and parallels the structure that exists elsewhere in benefits
including Child Benefit. It is therefore appropriate that the
negative procedure be used.
Part 5: Miscellaneous
NHS Indemnity
Clause 135: Indemnity schemes in connection with
provision of health services
Power conferred on: Secretary of State, with the
consent of the Treasury
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
447. Clause 135 inserts into subsection (2) of
section 71 of the National Health Service Act 2006 additional
bodies and persons that can become members of schemes for meeting
losses and liabilities of certain bodies; the detail of the various
schemes that already exist under section 71 is set out in regulations
made under section 71(1) of that Act. The amended power will allow
extension of the membership of such schemes to include non-NHS
bodies and individuals that may provide health services for the
NHS as well as allowing the Secretary of State to be a member
of the scheme. The Secretary of State can limit the class or description
of bodies which, or other persons who, are eligible to participate
in any of the schemes by regulations. Regulations under section
71 can only be made with the consent of the Treasury.
448. The clause also substitutes subsection (5)
of section 71 of the National Health Service Act 2006. The Secretary
of State currently has power under section 71(4) to direct eligible
bodies to participate in the scheme. The existing subsection (5)
exempts NHS foundation trusts from this power of direction and
subsection (5) is being substituted to ensure that non-NHS bodies
are also exempt from this power of direction.
449. It is envisaged that the existing regulations
establishing the Clinical Negligence Scheme for Trusts (CNST)
will be amended to allow non-NHS bodies that provide certain health
services for the NHS to be members of CNST. This is to ensure
that the same indemnity arrangements can be put in place for certain
health services that are now being provided for the NHS by non-NHS
bodies or individuals.
450. Section 71 provides a framework power with
the detail of schemes set out in secondary legislation. This provides
the flexibility for schemes to be able to respond to the evolving
health service environment. Regulations made under section 71
are subject to the negative resolution procedure; the Department
does not consider that that the proposed amendments to the power
necessitate any change to the negative resolution procedure that
currently applies. The regulations will still require the consent
of the Treasury.
451. A Statement of Intent, which is annexed
to this document, gives more detail about how the Department intends
to use these provisions.
Weighing and measuring of children
Clause 136: Weighing and measuring of children:
England
Power conferred on: Secretary of State
Power exercisable by: regulations made by the
Secretary of State
Parliamentary procedure: negative resolution
452. This power enables the making of regulations
that lay down detailed provisions for the weighing and measuring
of children. It is intended that the weighing and measuring will
be conducted initially as part of the National Child Measurement
Programme, although it is not restricted to this.
453. It is intended that the Regulations will
provide for weighing and measuring of children to take place in
a room or screened area where their privacy will be respected.
454. The regulations will also cover the conditions
which must be satisfied where weighing and measuring take place
under the regulations. The first set of regulations under the
power will contain provisions which are intended to ensure that
weighing and measuring under the regulations complies with the
European Convention on Human Rights and data protection legislation
by including:
- a requirement that reasonable
steps must be taken to enable parents to withdraw their children
from the programme if they wish (opt out);
- a requirement that where parents indicate that
they do not wish to receive information on the height and weight
of their children, that reasonable steps are taken to ensure the
information will not be sent to them;
- provisions specifying how the information obtained
under the regulations may be processed: the first set of regulations
will provide for information to be sent to parents and, after
personal identifiers are removed, for it to be processed for management
and research purposes.
455. Parliamentary scrutiny under the affirmative
resolution procedure is not considered necessary for the detailed
provision which may be made under the regulation making power.
That is because:
- provision for the medical examinations
of pupils already appears in primary legislation (Schedule 1 to
the National Health Service Act 2006) and the power to weigh and
measure will be included within that Schedule; and the information
which it is proposed to gather under the new powers will be of
low sensitivity as it will comprise purely weight and height information,
information which in other contexts is not health information
at all;
- there is a policy commitment that no weighing
or measuring will take place if a child's parent "opts"
a child out of the programme or where a child refuses to take
part.
Clause 137: Weighing and measuring
children: Wales
Power conferred on: the Welsh Ministers
Power exercisable by: regulations made by the
Welsh Ministers
Procedure: negative resolution
456. The power enables the making of regulations
that lay down detailed provisions for the weighing and measuring
children. In particular the regulations will provide for:
- the selection of children for
a weighing and measuring programme;
- the conditions which must be satisfied where
weighing and measuring take place under the regulations.
457. Scrutiny under the affirmative resolution
procedure is not considered necessary for the detailed provision
which may be made under the regulation making power.
458. This is because provision for the medical
examinations of pupils already appears in primary legislation
(Schedule 1 to the National Health Service (Wales) Act 2006) and
the power to weigh and measure will be included within that Schedule.
In addition, the information which it is proposed to gather under
the new powers will be of low sensitivity as it will comprise
purely weight and height information, information which in other
contexts is not health information at all.
Direct Payments
Clause 138: Direct payments in lieu of provision
of care services
Power conferred on: Secretary of State and Welsh
Ministers
Power exercisable by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
459. Clause 138 inserts new subsections, and
makes amendments, to section 57 of the Health and Social Care
Act 2001 ("the 2001 Act"). Section 57 provides that
regulations can be made in connection with enabling individuals
to receive money from social services, in the form of a direct
payment, to secure the provision of certain community care services.
Currently, section 57 provides that direct payments can only be
made to individuals who can consent to receive the payment. Clause
138 amends section 57 of the 2001 Act, extending the direct payments
scheme to allow a designated 'suitable person' to receive and
manage a direct payment on behalf of an individual who lacks capacity.
460. The delegated powers arising from clause
138 can be found in subsections (1A), (3), (5B) and (5C) of section
57 (as amended by the clause) and in subsection (8) of the clause
which amends section 64 of the 2001 Act.
Section 57(1A) and (3) of the 2001 Act
461. Subsection (1A) provides that the Secretary
of State may, through regulations, make provision for and in connection
with requiring or authorising local authorities to make direct
payments to designated 'suitable persons' on behalf of individuals
who lack capacity to receive and manage the payments themselves.
462. Subsection (3) lists the type of provision
that regulations under section 57 may make and has therefore been
amended to ensure that the type of provision that can be made
by regulations caters for direct payments to suitable persons
on behalf of individuals lacking the relevant capacity. In particular,
paragraphs (j), (k) and (l) have been inserted into subsection
(3) which together provide that regulations made under section
57 may specify matters to which local authorities must or may
have regard when taking any decision under regulations made under
subsection (1) or (1A). It also sets out that regulations may
specify the steps that local authorities must (or may) take before
or after making such decisions and that regulations may make provision
for persons with fluctuating capacity and how they are to be treated
for the purposes of section 57.
463. The power under subsection (1A) (as supplemented
by the amended subsection (3)) will be used to set out the detail
of the extended direct payments scheme and it is envisaged that
the power will be used to amend the Community Care, Services for
Carers and Children's Services (Direct payments) (England) Regulations
2003 (S.I 2003/762) which sets out the detail of the current direct
payments scheme.
464. By creating a delegated power under subsection
(1A) of section 57 our intention is to mirror, as far as possible,
the provisions set out under subsection (1) of the 2001 Act. It
would not be proportionate to set out on the face of the Bill
the detailed provisions in connection with making direct payments
in respect of individuals who lack capacity, particularly when
the same provisions in relation to people who do have capacity
are set out in delegated legislation. In addition, the delegated
power allows flexibility to amend the detail of the operation
of the direct payments scheme in the future, should the need arise,
without having to revisit primary legislation.
465. The provisions under subsection (1) of the
2001 Act are subject to the negative resolution procedure: the
Department does not consider that the proposed amendments necessitate
any change to the use of the negative resolution procedure that
currently applies to regulations under section 57.
Section 57(5B) of the 2001 Act
466. Subsection (5B) provides for regulations
to set out those individuals who will fall into the category of
'representative', as defined in the new subsection (1C) of section
57. Representatives are those individuals who, by virtue of a
qualification which will be set out in regulations, are considered
'automatically' suitable to receive and manage a direct payment
for a person who lacks capacity[5].
Where a 'representative' exists, it is envisaged that the local
authority will consider this person to manage the direct payment
in the first instance.
467. Initially, it is envisaged that the power
will be used to limit 'representatives' to those individuals who
are donees of a Lasting Power of Attorney or who are deputies
appointed by the Court of Protection (i.e. those individuals who
are recognised in law as being suitable to make decisions on behalf
of another person). However, once the extended scheme is up and
running, it may prove practicable and sensible to expand the list
of 'representatives' to include other groups of individuals, for
example, those individuals who are donees of an enduring power
of attorney. The delegated power provides the flexibility to expand
the list of 'representatives' without the need for further primary
legislation. Given the limits of this delegated power, the Department
considers that the negative resolution procedure is the appropriate
procedure.
Section 57(5C) of the 2001 Act
468. Subsection (5C) defines the term 'surrogate'
as a deputy appointed for the person lacking capacity by the Court
of Protection pursuant to the Mental Capacity Act 2005 or a donee
of a lasting power of attorney created by that individual, who
has such powers as are prescribed in regulation. This will enable
regulations to limit the role of 'surrogates' under the section
to those 'surrogates' whose authority extends to matters relating
to securing the provision of community care services.
469. It is envisaged that the power will be used
to limit the category of 'surrogate' to those deputies/donees
whose authority can be interpreted as extending to making decisions
incorporating those matters covered by the direct payments.
470. The provisions in the Mental Capacity Act
2005 relating to lasting powers of attorney and the new Court
of Protection came into force on October 1 2007. At this early
stage it is difficult to predict how people will choose to construct
lasting powers of attorney, or what orders the Court of Protection
will make conferring authority on deputies to make decisions.
Therefore, it would seem sensible to take a delegated power in
respect of prescribing the authority of 'surrogates' in order
to avoid setting something out on the face of the Bill that may
not work in practice. This prescription of authority is primarily
a technical matter and it would therefore seem appropriate for
this delegated power to be subject to annulment by negative resolution.
Territorial extent
471. Clause 138 extends to England and Wales.
As section 57 of the 2001 Act currently extends to England and
Wales and clause 138 simply creates new provisions and amends
existing ones, then it would seem appropriate to mirror the territorial
extent of the 2001 Act.
472. Subsection (8) amends section 64 of the
2001 Act to make provision for the making of regulations under
section 57 by Welsh Ministers. Since the implementation of the
Government of Wales Act 2006, Acts of Parliament that create new
enabling powers for Welsh Ministers to make subordinate legislation
must also specify the Assembly procedures that will apply. If
it is appropriate for the negative procedure to apply to the making
of regulations by a Minister of the Crown, then the same procedure
should be adopted for the making of regulations by the Welsh Ministers.
Financial assistance related to provision of
health or social care services
Clause 141: Power of Secretary of State to give
financial assistance
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
473. Clause 141(2) allows the Secretary of State
to provide financial assistance to people for the purpose of them
setting up qualifying bodies, delivering health and social care
or related services. The conditions for being a qualifying body
are set out in clause 142. The intention is to enable funding
for the setting up of social enterprises in health and social
care.
474. Under clause 141(2), qualifying bodies will
need to satisfy certain conditions set out in regulations if their
founders are to be eligible for funding under the clause. Setting
additional conditions in regulations allows flexibility to reflect
the developmental nature of the emerging models and enables the
Department to specify in greater detail what the requirements
are for funding, in addition to the primary conditions under clause
142 (community benefit, restrictions on profits and carrying on
as a business). Flexibility on additional conditions is particularly
necessary in cases where the qualifying body has yet to be set
up, as a range of different organisations are likely to apply
for financial assistance.
475. The Parliamentary procedure adopted will
be negative resolution as regulations will deal with technical
matters, such as specific features of business models and legal
forms used by social enterprises.
Clause 142: Qualifying bodies
Powers conferred on: Secretary of State
Power exercised by: regulations made by statutory
instrument
Parliamentary procedure: negative resolution
476. Clause 142 sets out the conditions for being
a qualifying body. Under clause 141 the Secretary of State can
only give financial assistance to:
- bodies which are qualifying bodies;
or to
- persons in order for them to set up qualifying
bodies
477. Subsection (1)(b) provides that a body is
only a qualifying body if it satisfies conditions prescribed in
regulations relating to the distribution of profits. It also allows
an exception for bodies of a kind set out in regulations. Different
legal forms used by social enterprises have different restrictions
or arrangements for the distribution of profits. The power to
prescribe conditions on the distribution of profits will allow
us to reflect this range in more detail, and allow for flexibility,
as the sector matures.
478. Subsection (1)(b) includes a power to specify
in regulations the kinds of bodies which will not be required
to meet conditions relating to the distribution of profits. The
current proposal is that this will be exercised only in relation
to Community Interest Companies (CIC), although this power is
necessary in order to extend the exemption to other models which
may develop in the future. A CIC is a new legal form that is increasingly
being used by social enterprises, as this form has important features
for a social enterprise; balancing the needs of business with
social objectives and restrictions on the distribution of profits.
For example, a CIC limited by shares can obtain equity finance
but there are limits on the return that may be paid to investors.
479. Subsection (1)(d) provides that regulations
may set out other conditions that must be satisfied for an organisation
to be a qualifying body. As explained above, the power to impose
additional conditions will allow both flexibility and a greater
level of detail, enabling us to target a range of organisations.
For example, different legal forms have very different features
in relation to the distribution of profits and access to equity
finance. The additional conditions will enable us to clarify the
range within which bodies will qualify for funding.
480. Subsection (2)(a) allows regulations to
provide that an organisation can only be a qualifying body if
it is a body of a kind set out in regulations. This will allow
for restrictions on the type of body than can qualify, e.g. a
CIC is likely to be qualifying body. This, again, is a level of
detail that is more appropriate for regulations.
481. Subsection (2)(b) allows regulations to
set out which activities are to be treated as being carried on
for the benefit of the community and which activities are not
to be treated as such. For example, regulations may state that
political activities will not be treated as for the benefit of
the community. A list of such activities will provide greater
clarity but is a level of detail that would not be appropriate
for primary legislation.
482. These regulations will deal with technical
matters such as conditions relating to restrictions on profits,
so the negative resolution procedure is appropriate.
Clause 145: Directions to certain NHS bodies
Powers conferred on: Secretary of State
Power exercised by: directions given by an instrument
in writing
Parliamentary procedure: not applicable
483. Clause 145(1) allows the Secretary of State
make directions to certain NHS trusts, PCTs, Strategic Health
Authorities and Special Health Authorities. These directions would
authorise them to exercise the Secretary of State's powers to
provide financial assistance to certain qualifying bodies; as
well as people wanting to set up qualifying bodies.
484. Local authorities are excluded from this
power as provision for this is set out elsewhere in legislation.
485. In addition, where the Secretary of State
has given directions under clause 145(1), clause 145(2) allows
the Secretary of State to give directions about how those functions
are to be exercised. These would include directions as to the
written financial procedures which must be followed, e.g. a requirement
in certain cases to submit a business case for the proposed investment.
The intention is to ensure that appropriate safeguards are in
place to protect public monies.
486. Such directions will not be subject to any
Parliamentary procedure and will be given by an instrument in
writing. These directions would deal with matters of administrative
and technical detail, and adopt the same procedure as set out
in section 273 of the National Health Service Act 2006 for directions
given to NHS bodies under that Act.
The Creation of the National Information Governance
Board for Health and Social Care
Clause 149: National Information Governance Board
for Health and Social Care
487. This clause contains delegated powers to
make:
a) directions under a power in a new section
250A which the clause will insert into the National Health Service
Act 2006; and
b) regulations under a power in a new section
250C which the clause will insert into that Act.
(a) The powers to make directions:
Powers conferred on: Secretary of State
Powers exercisable by: directions made by the
Secretary of State
Parliamentary procedure: none
488. The power enables the Secretary of State
for Health to designate, by a direction in writing, the bodies
which the National Information Governance Board for Health and
Social Care (NIGB) will keep informed about the practice being
followed by relevant bodies in relation to the processing of patient
information and other information which is obtained or generated
either during the provision of the health service or during the
delivery of adult social services functions by local social services
authorities. Also, but separately, the matters relating to the
processing of this information on which the NIGB can offer advice
directly to the persons who are processing the information. It
is intended that this will allow the Secretary of State for Health
to:
- ensure that new bodies which are
established, for example Special Health Authorities or regulatory
bodies, or existing bodies which have their remit modified, which
have a requirement for information on the practices being followed
by relevant bodies in relation to the processing of patient information
and other information which is obtained or generated during either
the provision of the health service or the delivery of adult social
services functions by local social services authorities can be
provided with this information. It will also allow the NIGB to
cease to provide information to bodies when it is no longer appropriate
- direct the NIGB as to the matters on which it
may advise persons who process relevant information. The need
for direct advice could result from changes in information processing
practices in health and social care or from new information governance
issues, including those that the NIGB would not normally consider,
for example because of adverse publicity.
489. These powers of direction relate to administrative
matters. The first powers, in the proposed section 250A(2)(b),
enable provision to be made for the efficient distribution of
information. The second power, in the proposed section 250A(2)(e),
enables the making of provision under which the NIGB may give
advice directly to persons who process relevant information. It
is not considered that Parliamentary scrutiny of the exercise
of either of these administrative powers is warranted.
(b) The powers to make regulations:
Power conferred on: Secretary of State
Power exercisable by: regulations made by the
Secretary of State
Parliamentary procedure: negative resolution
490. The power enables the Secretary of State
to make regulations relating to the constitution and administration
of the NIGB. The regulations may make provision for the appointment,
payment and payment of expenses of the Chair and members of the
NIGB and its sub-committees. They may also enable the NIGB to
establish committees and sub-committees to support its activities.
491. It is intended that the NIGB will have flexibility
in relation to its committee and sub-committee arrangements, but
it is envisaged that:
- the committees will have specific
functions in their own right
- the sub-committee groups will be assembled to
undertake specific pieces of work on behalf of the NIGB. They
will cease to exist when their work is complete.
492. Information governance requires a wide range
of skills. It is not practical for experts in every field to attend
NIGB meetings. Meetings would become too large to function effectively.
Moreover, requiring the attendance of a wide range of experts
at large meetings would be an inappropriate use of their skills.
Adopting the proposed approach allows the NIGB to be both more
efficient and more effective.
493. Parliamentary scrutiny under the affirmative
procedure is not considered necessary for this procedural provision.
The NIGB is an advisory body and will produce an annual report.
How resources are deployed to formulate advice is largely an internal
administrative matter. Whilst the committees or sub-committees
will have an important role in the way the new NIGB carries out
its role, the NIGB itself will remain responsible for any advice
which they give on its behalf.
494. Moreover, subsection (5) of the proposed
section 250C limits the power to make regulations so that it cannot
be exercised to amend any provision in primary legislation.
Functions of the Health Protection Agency in
relation to biological substances
Clause 151: Functions of Health Protection Agency
in relation to biological substances
Powers conferred on: the Secretary of State and
the Department of Health, Social Services and Public Safety in
Northern Ireland, acting jointly
Power exercised by: directions to be given in
regulations by statutory instrument and a scheme for the transfer
of property rights and liabilities
Parliamentary procedure: the directions to be
given in regulations are subject to the negative resolution procedure
and a scheme is not subject to any Parliamentary procedure
495. Clause 151 makes a number of amendments
to the Health Protection Agency Act 2004 (the 2004 Act) to give
the HPA functions in relation to biological substances currently
performed by the National Biological Standards Board (the NBSB).
The NBSB is abolished and the Biological Standards Act 1975 (the
1975 Act) under which it was established, is repealed.
496. The Secretary of State and the Department
of Health, Social Services and Public Safety in Northern Ireland,
acting jointly, are given power to direct the HPA to carry out
functions in relation to biological substances (new section 2A(1)
of the 2004 Act). This power mirrors the power contained in the
1975 Act to direct the NBSB to carry out such functions. In line
with the similar power under the 1975 Act, directions are to be
given by regulations by statutory instrument and to be subject
to the negative resolution procedure. By virtue of the new section
2A(3) of the 2004 Act, the HPA is deemed to have the same functions
as the NBSB was previously directed to carry out by the National
Biological Standards Board (Functions) Order 1976.
497. The new section 8(4A) of the 2004 Act gives
the Secretary of State and the Department of Health, Social Services
and Public Safety in Northern Ireland, acting jointly, power to
make a scheme for the transfer of the property rights and liabilities
of the NBSB to the HPA. In line with powers to make similar schemes
under section 8 of the 2004 Act, and normal practice in respect
of such schemes, any such scheme is not subject to any Parliamentary
procedure.
Part 6: General
498. This Part lays down general provisions in
respect of the regulations, orders and directions that will be
made or given under powers conferred by or under the Bill. It
gives order-making powers to the Secretary of State and Welsh
Ministers to make transitional or transitory provisions and savings,
in connection with the coming into force of any provision of the
Bill, and to the Secretary of State to make supplementary, incidental
or consequential provisions. Such orders may modify any enactment.
Clause 159: Power to make transitional and consequential
provision etc
Powers conferred on: Secretary of State and the
Welsh Ministers
Power exercised by: order made by statutory instrument
Parliamentary procedure: affirmative if amending
or repealing any provision of an Act of Parliament, otherwise
negative
499. Clause 159 confers on the Secretary of State
and Welsh Ministers the power to make by order transitional or
transitory provisions and savings in connection with the commencement
of any provision made by or under the Bill. It also confers on
the Secretary of State the power to make by order such supplementary,
incidental or consequential provision as considered appropriate
for the purposes of, in consequence of, or for giving full effect
to any provision of the Bill. Such orders may amend, repeal, revoke
or otherwise modify any enactment (including Acts of Parliament,
Acts of the Scottish Parliament, Measures or Acts of the National
Assembly for Wales, and Northern Ireland legislation). These powers
are additional and without prejudice to any other provision of
the Bill.
500. This power is necessary to ensure that necessary
or expedient transitional arrangements can be made as the Bill
is commenced without creating any difficulty or unfairness. This
means that it will be possible to modify the application of the
Bill to existing situations and to ensure a smooth transition
from the old law and procedures to the new.
501. A number of transitional provisions will
be needed in relation to the establishment of the Commission and
the assumption by it of the functions of CHAI, CSCI and MHAC.
The Commission will assume the different functions of the three
existing regulators over a period of time and will take on some
earlier than others. A particular example of where transitional
provision will be needed is in relation to the transition from
the registration provisions of Part 2 of the Care Standards Act
to the new regime under Chapter 2 of Part 1 of the Bill.
502. Transitional provision will also need to
be made in relation to some of the provisions in Part 2 (regulation
of health professions and health and social care workforce) of
the Bill. This will be the case, for example, in connection with
the establishment of the Council and the winding down of the present
Council for the Regulation of Health Care Professionals in its
current form (clauses 108 to 113). Transitional provision will
also have to be made in connection with: (a) preserving existing
regulations, or parts of them, under the Public Health (Control
of Disease) Act 1984 (Part 3 of the Bill); and, (b) the abolition
of the NBSB and the assumption of identical functions by the HPA
(clause 151).
503. The power to make supplemental, incidental
or consequential provision is essential to ensure that the changes
made to the law by the Bill are reflected in other legislation
which refers to or is dependent on provisions repealed or amended
by the Bill. In particular, whilst Schedules 3 and 5 make amendments
to the Mental Health Act, the Care Standards Act, and the 2003
Act in connection with Part 1 of the Bill, amendments will need
to be made to other legislation which contain references to CHAI,
CSCI and MHAC.
504. The Parliamentary procedure to be followed
depends on the content of the order. If the order amends or repeals
any provision of an Act of Parliament, it may not be made unless
a draft has been laid before and approved by each House of Parliament
under clause 154(3)(d). In any other case, the negative resolution
procedure applies. This combination of procedures seems to the
Department to strike an appropriate balance between the need to
secure a quick and smooth transition between an old and a new
regime and to ensure that changes made by this Bill are reflected
in other legislation, and the need to respect Parliamentary involvement
where an Act of Parliament is to be amended.
Clause 162: Commencement
Powers conferred on: the "appropriate authority"
(as defined by clause 163: Secretary of State, the Department
of Health, Social Services and Public Safety in Northern Ireland,
the Welsh Ministers, or the Treasury)
Power exercised by: order made by statutory instrument
Parliamentary procedure: none
505. Clause 162(1) makes provision for certain
provisions of the Bill to come into force on the day that the
Bill receives Royal Assent. Subject to those specific provisions,
clause 162(2) provides for the "appropriate authority"
to appoint, by order, the day on which the provisions of the Bill
will come into force. Clause 163 provides that the appropriate
authority is the Secretary of State (subject to duties of consultation
set down in clause 164), except that it will be the Department
of Health, Social Services and Public Safety in Northern Ireland
in relation to clauses 114, 115 and 117 (responsible officers)
so far as they relate to Northern Ireland, the Welsh Ministers
in relation to specified provisions in so far as they apply to
Wales, and the Treasury in relation to Part 4 (health in pregnancy
grant). Consistent with the usual practice, commencement orders
under this clause are not subject to any Parliamentary procedure.
3 As amended by the Mental Health Act 2007; Back
4
Section 19 of the Education Act 1996 (c. 56) requires a local
education authority to arrange for provision of suitable education
for children who by reason of illness, exclusion from school or
otherwise, may not for any period receive suitable education unless
such suitable arrangements are made for them. Back
5
Although in the explanation of (1C) above we state people who
are 'representatives' will be considered 'automatically' suitable
to manage the direct payment, this simply means that local authorities
will automatically look to these individuals to receive and manage
the payment in the first instance. Ultimate responsibility for
deciding whether a third person is 'suitable' to manage a direct
payment on behalf of another person will rest with the local authority,
in the same way that local authorities currently determine whether
an individual with capacity is suitable to receive and manage
a direct payment. Back
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