Health and Social Care Bill (HL Bill 132)

(b) the failure is sufficiently serious.

(5) On a declaration being made by virtue of subsection (3), the arrangement is
void; but that does not affect—

(a) the validity of anything done pursuant to the arrangement,

(b) 5any right acquired or liability incurred under the arrangement, or

(c) any proceedings or remedy in respect of such a right or liability.

(6) Regulations under section 75 may confer on Monitor a power to direct the
National Health Service Commissioning Board or a clinical commissioning
group—

(a) 10to put in place measures for the purpose of preventing failures to
comply with requirements imposed by the regulations or mitigating
the effect of such failures;

(b) to remedy a failure to comply with such a requirement;

(c) not to exercise in a prescribed manner prescribed functions in relation
15to arrangements for the provision of health care services;

(d) to vary or withdraw an invitation to tender for the provision of health
care services;

(e) to vary an arrangement for the provision of health care services made
in consequence of putting the provision of the services out to tender.

(7) 20A failure to comply with a requirement imposed by regulations under section
75 which causes loss or damage is actionable, except in so far as the regulations
restrict the right to bring such an action.

(8) Regulations under section 75 may—

(a) provide for a specified defence to such an action;

(b) 25prevent a person who has brought such an action under the Public
Contracts Regulations 2006 (S.I. 2006/5S.I. 2006/5) from bringing such an action
under the regulations under section 75 in respect of the whole or part
of the same loss or damage.

77 Requirements under section 75: undertakings

(1) 30Regulations under section 75 may confer on Monitor a power to accept an
undertaking (referred to in this Chapter as a “section 77 undertaking”) from the
National Health Service Commissioning Board or a clinical commissioning
group to take such action of a kind mentioned in subsection (2) as is specified
in the undertaking within such period as is so specified.

(2) 35The specified action must be—

(a) action of a description given in paragraphs (a) to (e) of section 76(6), or

(b) action of such a description as may be prescribed.

(3) Where Monitor accepts a section 77 undertaking then, unless the Board, or (as
the case may be) the clinical commissioning group from whom the
40undertaking is accepted, has failed to comply with the undertaking or any part
of it, Monitor may not—

(a) continue to carry out the investigation in question,

(b) make a declaration by virtue of subsection (3) of section 76 in relation
to the arrangement in question, or

(c) 45give a direction by virtue of subsection (6) of that section in relation to
the failure in question.

(4) Where the Board, or (as the case may be) the clinical commissioning group
from whom Monitor has accepted a section 77 undertaking, has failed to
comply fully with the undertaking but has complied with part of it, Monitor
must take the partial compliance into account in deciding whether to do
5something mentioned in paragraphs (a) to (c) of subsection (3).

(5) Schedule 9 (which makes further provision about section 77 undertakings) has
effect.

78 Guidance

(1) Monitor must publish guidance about—

(a) 10compliance with requirements imposed by regulations under section
75;

(b) how it intends to exercise powers conferred on it by regulations under
that section.

(2) Before publishing guidance under subsection (1)(a) or (b), Monitor must
15consult—

(a) the National Health Service Commissioning Board, and

(b) such other persons as Monitor considers appropriate.

(3) Before publishing guidance under subsection (1)(a) or (b), Monitor must obtain
the approval of the Secretary of State.

(4) 20Monitor may revise guidance under this section and, if it does so, must publish
the guidance as revised.

(5) Before publishing guidance revised under subsection (4), Monitor must
consult the persons mentioned in subsection (2).

79 Mergers involving NHS foundation trusts

(1) 25For the purposes of Part 3 of the Enterprise Act 2002 (completed and
anticipated mergers), each of the following cases is to be treated as being (in so
far as it would not otherwise be) a case in which two or more enterprises cease
to be distinct enterprises.

(2) The first case is where the activities of two or more NHS foundation trusts
30cease to be distinct activities.

(3) The second case is where the activities of one or more NHS foundation trusts
and the activities of one or more businesses cease to be distinct activities.

(4) Where the Office of Fair Trading decides to carry out an investigation under
Part 3 of the Enterprise Act 2002 of a matter involving an NHS foundation
35trust, it must as soon as reasonably practicable notify Monitor.

(5) As soon as reasonably practicable after receiving a notification under
subsection (4), Monitor must provide the Office of Fair Trading with advice
on—

(a) the effect of the matter under investigation on benefits (in the form of
40those within section 30(1)(a) of the Enterprise Act 2002 (relevant
customer benefits)) for people who use health care services provided
for the purposes of the NHS, and

(b) such other matters relating to the matter under investigation as
Monitor considers appropriate.

(6) In subsections (2) and (3), a reference to the activities of an NHS foundation
trust or a business includes a reference to part of its activities.

(7) In this section, “enterprise” and “business” each have the same meaning as in
Part 3 of the Enterprise Act 2002.

80 5Co-operation with the Office of Fair Trading

(1) Monitor and the Office of Fair Trading must co-operate with each other in the
exercise of their respective functions under the Competition Act 1998 and the
Enterprise Act 2002.

(2) In particular each must give the other—

(a) 10such information in its possession as the other may require to enable it
to exercise those functions,

(b) such other information in its possession as it considers would assist the
other in exercising those functions, and

(c) such other assistance as the other may require to assist it in exercising
15those functions.

CHAPTER 3 Licensing

Licensing requirement

81 Requirement for health service providers to be licensed

(1) Any person who provides a health care service for the purposes of the NHS
20must hold a licence under this Chapter.

(2) Regulations may make provision for the purposes of this Chapter for
determining, in relation to a service provided by two or more persons acting in
different capacities, which of those persons is to be regarded as the person who
provides the service.

82 25Deemed breach of requirement to be licensed

(1) This section applies where a licence holder—

(a) in providing a health care service for the purposes of the NHS, carries
on a regulated activity (within the meaning of Part 1 of the Health and
Social Care Act 2008), but

(b) 30is not registered under Chapter 2 of Part 1 of that Act in respect of the
carrying on of that activity.

(2) The licence holder is to be regarded as providing the service in breach of the
requirement under section 81 to hold a licence.

83 Exemption regulations

(1) 35Regulations (referred to in this section and section 84 as “exemption
regulations”) may provide for the grant of exemptions from the requirement
under section 81 in respect of—

(a) a prescribed person or persons of a prescribed description;

(b) the provision of a prescribed health care service or a health care service
of a prescribed description.

(2) Exemption regulations may grant an exemption—

(a) either generally or to the extent prescribed;

(b) 5either unconditionally or subject to prescribed conditions;

(c) indefinitely, for a prescribed period or for a period determined by or
under the exemption.

(3) Conditions subject to which an exemption may be granted include, in
particular, conditions requiring any person providing a service pursuant to the
10exemption—

(a) to comply with any direction given by Monitor about such matters as
are specified in the exemption or are of a description so specified,

(b) except to the extent that Monitor otherwise approves, to do, or not to
do, such things as are specified in the exemption or are of a description
15so specified (or to do, or not to do, such things in a specified manner),
and

(c) to refer for determination by Monitor such questions arising under the
exemption as are specified in the exemption or are of a description so
specified.

(4) 20Before making exemption regulations the Secretary of State must give
notice to—

(a) Monitor,

(b) the National Health Service Commissioning Board, and

(c) the Care Quality Commission and its Healthwatch England committee.

(5) 25The Secretary of State must also publish a notice under subsection (4).

(6) A notice under subsection (4) must—

(a) state that the Secretary of State proposes to make exemption
regulations and set out their proposed effect,

(b) set out the Secretary of State’s reasons for the proposal, and

(c) 30specify the period (“the notice period”) within which representations
with respect to the proposal may be made.

(7) The notice period must be not less than 28 days beginning with the day after
that on which the notice is published under subsection (5).

(8) Where an exemption is granted the Secretary of State—

(a) 35if the exemption is granted to a prescribed person, must give notice of
it to that person, and

(b) must publish the exemption.

84 Exemption regulations: supplementary

(1) Regulations may revoke exemption regulations by which an exemption was
40granted to a person, or amend such regulations by which more than one
exemption was so granted so as to withdraw any of the exemptions—

(a) at the person’s request,

(b) in accordance with any provision of the exemption regulations by
which the exemption was granted, or

(c) if the Secretary of State considers it to be inappropriate for the
exemption to continue to have effect.

(2) Regulations may revoke exemption regulations by which an exemption was
granted to persons of a prescribed description, or amend such regulations by
5which more than one exemption was so granted so as to withdraw any of the
exemptions—

(a) in accordance with any provision of the exemption regulations by
which the exemption was granted, or

(b) if the Secretary of State considers it to be inappropriate for the
10exemption to continue to have effect.

(3) The Secretary of State may by direction withdraw an exemption granted to
persons of a description prescribed in exemption regulations for any person of
that description—

(a) at the person’s request,

(b) 15in accordance with any provision of the exemption regulations by
which the exemption was granted, or

(c) if the Secretary of State considers it to be inappropriate for the
exemption to continue to have effect in the case of the person.

(4) Subsection (5) applies where the Secretary of State proposes to—

(a) 20make regulations under subsection (1)(b) or (c) or (2), or

(b) give a direction under subsection (3)(b) or (c).

(5) The Secretary of State must—

(a) consult the following about the proposal—

(i) Monitor;

(ii) 25the National Health Service Commissioning Board;

(iii) the Care Quality Commission and its Healthwatch England
committee;

(b) where the Secretary of State is proposing to make regulations under
subsection (1)(b) or (c), give notice of the proposal to the person to
30whom the exemption was granted;

(c) where the Secretary of State is proposing to make regulations under
subsection (2), publish the notice;

(d) where the Secretary of State is proposing to give a direction under
subsection (3)(b) or (c), give notice of the proposal to the person from
35whom the Secretary of State proposes to withdraw the exemption.

(6) The notice must—

(a) state that the Secretary of State proposes to make the regulations or give
the direction (as the case may be),

(b) set out the Secretary of State’s reasons for the proposal, and

(c) 40specify the period within which representations with respect to the
proposal may be made.

(7) The period so specified must be not less than 28 days beginning with the day
after that on which the notice is received or (as the case may be) published.

Licensing procedure

85 Application for licence

(1) A person seeking to hold a licence under this Chapter must make an
application to Monitor.

(2) 5The application must be made in such form, and contain or be accompanied by
such information, as Monitor requires.

86 Licensing criteria

(1) Monitor must set and publish the criteria which must be met by a person in
order for that person to be granted a licence under this Chapter.

(2) 10Monitor may revise the criteria and, if it does so, must publish them as revised.

(3) Monitor may not set or revise the criteria unless the Secretary of State has by
order approved the criteria or (as the case may be) revised criteria.

87 Grant or refusal of licence

(1) This section applies where an application for a licence has been made under
15section 85.

(2) If Monitor is satisfied that the applicant meets the criteria for holding a licence
for the time being published under section 86 it must as soon as reasonably
practicable grant the application; otherwise it must refuse it.

(3) On granting the application, Monitor must issue a licence to the applicant.

(4) 20A licence issued under this section is subject to—

(a) such of the standard conditions (see section 94) as are applicable to the
licence,

(b) such other conditions included in the licence by virtue of section 95
(referred to in this Chapter as “the special conditions”), and

(c) 25any conditions included in the licence by virtue of section 111
(imposition of licence conditions on NHS foundation trusts during
transitional period).

88 Application and grant: NHS foundation trusts

(1) This section applies where an NHS trust becomes an NHS foundation trust
30pursuant to section 36 of the National Health Service Act 2006 (effect of
authorisation of NHS foundation trust).

(2) The NHS foundation trust is to be treated by Monitor as having—

(a) duly made an application for a licence under section 85, and

(b) met the criteria for holding a licence for the time being published under
35section 86.

(3) An NHS foundation trust in existence on the day on which this section comes
into force is to be treated for the purposes of this section as having become an
NHS foundation trust pursuant to section 36 of the National Health Service Act
2006 on that day.

89 Revocation of licence

Monitor may at any time revoke a licence under this Chapter—

(a) on the application of the licence holder, or

(b) if Monitor is satisfied that the licence holder has failed to comply with
5a condition of the licence.

90 Right to make representations

(1) Monitor must give notice—

(a) to an applicant for a licence under this Chapter of a proposal to refuse
the application;

(b) 10to the licence holder of a proposal to revoke a licence under
section 89(b).

(2) A notice under this section must—

(a) set out Monitor’s reasons for its proposal;

(b) specify the period within which representations with respect to the
15proposal may be made to Monitor.

(3) The period so specified must be not less than 28 days beginning with the day
after that on which the notice is received.

91 Notice of decisions

(1) This section applies if Monitor decides to—

(a) 20refuse an application for a licence under section 87, or

(b) revoke a licence under section 89(b).

(2) Monitor must give notice of its decision to the applicant or the licence holder
(as the case may be).

(3) A notice under this section must explain the right of appeal conferred by
25section 92.

(4) A decision of Monitor to revoke a licence under section 89(b) takes effect on
such day as may be specified by Monitor, being a day no earlier than—

(a) if an appeal is brought under section 92, the day on which the decision
on appeal is confirmed or the appeal is abandoned,

(b) 30where the licence holder notifies Monitor before the end of the period
for bringing an appeal under section 92 that the licence holder does not
intend to appeal, the day on which Monitor receives the notification, or

(c) the day after that period.

92 Appeals to the Tribunal

(1) 35An appeal lies to the First-tier Tribunal against a decision of Monitor to—

(a) refuse an application for a licence under section 87, or

(b) revoke a licence under section 89(b).

(2) The grounds for an appeal under this section are that the decision was—

(a) based on an error of fact,

(b) 40wrong in law, or

(c) unreasonable.

(3) On an appeal under this section, the First-tier Tribunal may—

(a) confirm Monitor’s decision,

(b) direct that the decision is not to have effect, or

(c) remit the decision to Monitor.

93 5Register of licence holders

(1) Monitor must maintain and publish a register of licence holders.

(2) The register may contain such information as Monitor considers appropriate
for the purpose of keeping members of the public informed about licence
holders including, in particular, information about the revocation of any
10licence under this Chapter.

(3) Monitor must secure that copies of the register are available at its offices for
inspection at all reasonable times by any person.

(4) Any person who asks Monitor for a copy of, or an extract from, the register is
entitled to have one.

(5) 15Regulations may provide that subsections (3) and (4) do not apply—

(a) in such circumstances as may be prescribed, or

(b) to such parts of the register as may be prescribed.

(6) A fee determined by Monitor is payable for the copy or extract except—

(a) in such circumstances as may be prescribed, or

(b) 20in any case where Monitor considers it appropriate to provide the copy
or extract free of charge.

Licence conditions

94 Standard conditions

(1) Monitor must determine and publish the conditions to be included in each
25licence under this Chapter (referred to in this Chapter as “the standard
conditions”).

(2) Different standard conditions may be determined for different descriptions of
licences.

(3) For the purposes of subsection (2) a description of licences may, in particular,
30be framed wholly or partly by reference to—

(a) the nature of the licence holder,

(b) the services provided under the licence, or

(c) the areas in which those services are provided.

(4) But different standard conditions must not be determined for different
35descriptions of licences to the extent that the description is framed by reference
to the nature of the licence holder unless Monitor considers that at least one of
requirements 1 and 2 is met.

(5) Requirement 1 is that—

(a) the standard conditions in question relate to the governance of licence
40holders, and

(b) it is necessary to determine different standard conditions in order to
take account of differences in the status of different licence holders.

(6) Requirement 2 is that it is necessary to determine different standard conditions
for the purpose of ensuring that the burdens to which different licence holders
5are subject as a result of holding a licence are broadly consistent.

(7) Before determining the first set of the standard conditions Monitor must
consult the persons mentioned in subsection (8) on the conditions it is
proposing to determine (“the draft standard conditions”).

(8) Those persons are—

(a) 10the Secretary of State,

(b) the NHS Commissioning Board Authority,

(c) every Primary Care Trust,

(d) the Care Quality Commission, and

(e) such other persons as are likely to be affected by the inclusion of the
15conditions in licences under this Chapter as Monitor considers
appropriate.

(9) Monitor must also publish the draft standard conditions.

(10) The Secretary of State may direct Monitor not to determine that the standard
conditions will be the draft standard conditions.

(11) 20If, at the time Monitor discharges the function under subsection (7), the day
specified by the Secretary of State for the purposes of section 14A of the
National Health Service Act 2006 has passed or section 9 or 181 has come into
force—

(a) in the case of section 14A of the National Health Service Act 2006, the
25reference in subsection (8)(c) to every Primary Care Trust is to be read
as a reference to every clinical commissioning group;

(b) in the case of section 9, the reference in subsection (8)(b) to the NHS
Commissioning Board Authority is to be read as a reference to the
National Health Service Commissioning Board;

(c) 30in the case of section 181, the reference in subsection (8)(d) to the Care
Quality Commission is to be read as including a reference to its
Healthwatch England committee.

95 Special conditions

(1) Monitor may—

(a) 35with the consent of the applicant, include a special condition in a
licence under this Chapter, and

(b) with the consent of the licence holder, modify a special condition of a
licence.

(2) Before including a special condition or making such modifications Monitor
40must give notice to—

(a) the applicant or the licence holder (as the case may be),

(b) the Secretary of State,

(c) the National Health Service Commissioning Board,

(d) such clinical commissioning groups as are likely to be affected by the
45proposed inclusion or modifications, and

(e) the Care Quality Commission and its Healthwatch England committee.

(3) Monitor must also publish the notice under subsection (2).

(4) The notice under subsection (2) must—

(a) state that Monitor proposes to include the special condition or make the
modifications and set out its or their proposed effect,

(b) 5set out Monitor’s reasons for the proposal, and

(c) specify the period (“the notice period”) within which representations
with respect to the proposal may be made to Monitor.

(5) The notice period must be not less than 28 days beginning with the day after
that on which the notice is published under subsection (3).

(6) 10In this section, a reference to modifying a condition includes a reference to
amending, omitting or adding a condition.

96 Limits on Monitor’s functions to set or modify licence conditions

(1) This section applies to the following functions of Monitor—

(a) the duty to determine the standard conditions to be included in each
15licence under this Chapter or in licences of a particular description (see
section 94);

(b) the powers to include a special condition in a licence and to modify
such a condition (see section 95);

(c) the power to modify the standard conditions applicable to all licences,
20or to licences of a particular description (see section 100).

(2) Monitor may only exercise a function to which this section applies—

(a) for the purpose of regulating the price payable for the provision of
health care services for the purposes of the NHS;

(b) for the purpose of preventing anti-competitive behaviour in the
25provision of health care services for those purposes which is against the
interests of people who use such services;

(c) for the purpose of protecting and promoting the right of patients to
make choices with respect to treatment or other health care services
provided for the purposes of the NHS;

(d) 30for the purpose of ensuring the continued provision of health care
services for the purposes of the NHS;

(e) for the purpose of enabling health care services provided for the
purposes of the NHS to be provided in an integrated way where
Monitor considers that this would achieve one or more of the objectives
35referred to in subsection (3);

(f) for the purpose of enabling the provision of health care services
provided for the purposes of the NHS to be integrated with the
provision of health-related services or social care services where
Monitor considers that this would achieve one or more of the objectives
40referred to in subsection (3);

(g) for the purpose of enabling co-operation between providers of health
care services for the purposes of the NHS where Monitor considers that
this would achieve one or more of the objectives referred to in
subsection (3);

(h) 45for purposes connected with the governance of persons providing
health care services for the purposes of the NHS;