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(11) Where the applicant under this section is a commissioning consortium, the
relevant persons are—

(a) every local authority in whose area the service is provided for the
purposes of the NHS,

(b) 5every local Healthwatch organisation in whose area the service is
provided for those purposes,

(c) every person who, in pursuance of arrangements with the consortium,
provides the service for the purposes of the NHS, and

(d) such other persons as the consortium considers appropriate.

(12) 10Where the applicant under this section is the Secretary of State, or a person
acting on the Secretary of State’s behalf, by virtue of section 13Z1 of the
National Health Service Act 2006, the relevant persons are—

(a) the Healthwatch England committee of the Care Quality Commission,

(b) every local authority,

(c) 15every local Healthwatch organisation in whose area the service is
provided,

(d) the National Health Service Commissioning Board, and

(e) such other persons as the Secretary of State or person acting on the
Secretary of State’s behalf considers appropriate.

80 20Complaint about grant of application for designation

(1) Where an application for the designation of a service under section 79 is
granted, Monitor must, on a complaint by a provider mentioned in subsection
(2), reconsider its decision to grant the application.

(2) The providers are—

(a) 25the provider of the designated service,

(b) any other provider of health care services who has sufficient interest in
the application.

(3) For the purposes of the reconsideration, Monitor must—

(a) where the provider mentioned in subsection (2)(a) made the complaint,
30consult the commissioner who applied for the designation;

(b) where a provider mentioned in subsection (2)(b) made the complaint,
consult the commissioner and the provider mentioned in subsection
(2)(a).

(4) Monitor may remove the designation if, having regard to the matters in
35subsection (4) of section 79, it is satisfied that the criterion in subsection (3) of
that section is not met.

(5) If Monitor removes the designation—

(a) an appeal by the commissioner against the decision to remove it lies to
the First-tier Tribunal, and

(b) 40where a provider mentioned in subsection (2)(b) made the complaint,
an appeal by the provider mentioned in subsection (2)(a) against the
decision also lies to the First-tier Tribunal.

(6) If Monitor does not remove the designation—

(a) an appeal by the provider mentioned in subsection (2)(a) against the
45decision not to remove the designation lies to the First-tier Tribunal,
and

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(b) where a provider mentioned in subsection (2)(b) made the complaint,
an appeal by that provider against the decision also lies to the First-tier
Tribunal.

81 Complaint about refusal of application for designation

(1) 5Where an application for the designation of a service under section 79 is
refused, Monitor must, on a complaint by the commissioner who applied for
the designation or by the provider of the service, reconsider the application.

(2) For the purposes of the reconsideration, Monitor must—

(a) where the commissioner made the complaint, consult the provider;

(b) 10where the provider made the complaint, consult the commissioner.

(3) Monitor may grant the application if, having regard to the matters in
subsection (4) of section 79, it is satisfied that the criterion in subsection (3) of
that section is met.

(4) If Monitor grants the application—

(a) 15the service is designated and this Part applies in relation to it
accordingly, and

(b) an appeal by the provider against the decision to grant the application
lies to the First-tier Tribunal.

(5) If Monitor refuses the application, an appeal by the commissioner or the
20provider against the decision to refuse the application lies to the First-tier
Tribunal.

82 Reviews and removals of designations

(1) The commissioner of a designated service must, during each review period,
review the designation so as to establish whether, having regard to the matters
25in subsection (4) of section 79, it is satisfied that the criterion in subsection (3)
of that section continues to be met.

(2) The first review period is a period which is of such duration as Monitor may
by direction specify but which—

(a) must not begin before the expiry of the period of one year after the date
30of the notice under section 79(7), and

(b) must end before the expiry of the period of ten years after that date.

(3) Each subsequent review period is a period which is of such duration as
Monitor may by direction specify but which—

(a) must not begin before the expiry of the period of one year after the date
35on which the previous review under subsection (1) was completed, and

(b) must end before the expiry of the period of ten years after that date.

(4) For the purposes of subsections (2) and (3), Monitor may specify—

(a) the same period in respect of all designated services, or

(b) different periods in respect of different designated services or
40designated services of different descriptions.

(5) The commissioner of a designated service may (whether or not in consequence
of a review under subsection (1)) apply to Monitor for the removal of the
designation.

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(6) The commissioner may make the application only if—

(a) it has consulted the relevant persons, and

(b) having regard to the matters in subsection (4) of section 79, it is satisfied
that the criterion in subsection (3) of that section is no longer met.

(7) 5An application under subsection (5) must be accompanied by copies of the
responses the commissioner received to the consultation under subsection
(6)(a).

(8) Monitor may grant an application under subsection (5) only if—

(a) having regard to the matters in subsection (4) of section 79, it is satisfied
10that the criterion in subsection (3) of that section is no longer met, and

(b) it is satisfied that the commissioner carried out consultation in
accordance with subsection (6)(a).

(9) Monitor must give notice of its decision on an application under subsection (5)
to —

(a) 15the commissioner, and

(b) every relevant person.

(10) Where Monitor grants the application, a notice under subsection (9) given to a
provider of a service for the purposes of the NHS must explain the rights
conferred by section 83.

(11) 20Where Monitor refuses the application, the notice under subsection (9) given
to the commissioner must—

(a) give the reasons for the refusal, and

(b) explain the rights conferred by section 84.

(12) The relevant persons for the purposes of this section are the persons who are
25the relevant persons for the purposes of section 79.

83 Complaint about grant of application for removal of designation

(1) Where an application for the removal of a designation under section 82(3) is
granted, Monitor must, on a complaint by the provider of the service,
reconsider its decision to grant the application.

(2) 30For the purposes of the reconsideration, Monitor must consult the
commissioner who applied for the removal of the designation.

(3) Monitor may revoke the removal of the designation if, having regard to the
matters in subsection (4) of section 79, it is satisfied that the criterion in
subsection (3) of that section is met.

(4) 35If Monitor revokes the removal of the designation—

(a) the service is designated and this Part applies accordingly, and

(b) an appeal by the commissioner against the decision to revoke the
removal of the designation lies to the First-tier Tribunal.

(5) If Monitor does not revoke the removal of the designation, an appeal by the
40provider against the decision not to revoke it lies to the First-tier Tribunal.

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84 Complaint about refusal of application for removal of designation

(1) Where an application for the removal of a designation under section 82(3) is
refused, Monitor must, on a complaint by the commissioner who applied for
the removal of the designation or by a provider mentioned in subsection (2),
5reconsider its decision to refuse the application.

(2) The providers are—

(a) the provider of the designated service,

(b) any other provider of health care services who has sufficient interest in
the application.

(3) 10For the purposes of the reconsideration, Monitor must—

(a) where the commissioner made the complaint, consult the provider of
the designated service;

(b) where the provider mentioned in subsection (2)(a) made the complaint,
consult the commissioner;

(c) 15where a provider mentioned in subsection (2)(b) made the complaint,
consult the commissioner and the provider of the designated service.

(4) Monitor may grant the application if, having regard to the matters in
subsection (4) of section 79, it is satisfied that the criterion in subsection (3) of
that section is no longer met.

(5) 20If Monitor grants the application—

(a) the service ceases to be designated, and

(b) an appeal by the provider mentioned in subsection (2)(a) against the
decision to grant the application lies to the First-tier Tribunal.

(6) If Monitor does not grant the application—

(a) 25an appeal by the commissioner or the provider mentioned in
subsection (2)(a) against the decision not to grant the application lies to
the First-tier Tribunal, and

(b) where the provider mentioned in subsection (2)(b) made the complaint,
an appeal by that provider against the decision also lies to the First-tier
30Tribunal.

85 Complaints: general provisions

(1) This section applies in relation to a complaint under section 80, 81, 83 or 84.

(2) The complaint must be made before the end of the period of 28 days beginning
with the day on which notice of the decision to which the complaint relates was
35received.

(3) No individual involved in the decision to which the complaint relates may be
involved in the reconsideration of the decision.

(4) Monitor must give notice of its decision on the reconsideration to—

(a) the commissioner who applied for the designation of the service or (as
40the case may be) for the removal of the designation,

(b) the provider of the designated service, and

(c) where, in a case within section 80 or 84, the person who makes the
complaint is the provider mentioned in subsection (2)(b) of that section,
that provider.

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(5) The grounds for an appeal against Monitor’s decision on the reconsideration
are that the decision was—

(a) based on an error of fact,

(b) wrong in law, or

(c) 5unreasonable.

(6) On the appeal, the First-tier Tribunal may confirm Monitor’s decision or direct
that it is not to have effect.

86 Designations affecting more than one commissioner

(1) The National Health Service Commissioning Board must make arrangements
10for facilitating agreement between commissioning consortia as to—

(a) whether to apply for designation of a service under section 79;

(b) which consortium is to apply for designation of a service under that
section (and is accordingly, if the application is granted, to have power
to review and apply for the removal of the designation).

(2) 15Where commissioning consortia fail to reach agreement on a matter in
pursuance of arrangements under subsection (1), the National Health Service
Commissioning Board may determine the matter; and the consortia concerned
must comply with that determination.

(3) Regulations may make provision as to the determination of matters on which
20commissioning consortia fail to reach agreement in pursuance of arrangements
under subsection (1).

(4) Where regulations under subsection (3) are in force, the power conferred on the
National Health Service Commissioning Board by subsection (2) must be
exercised in accordance with the regulations.

87 25Guidance

(1) Monitor must publish guidance on—

(a) applying for designation of a service under section 79;

(b) reviewing a designation under section 82;

(c) applying for removal of a designation under that section.

(2) 30Before publishing guidance under this section, Monitor must—

(a) consult the persons mentioned in subsection (3), and

(b) obtain the approval of the National Health Service Commissioning
Board.

(3) The persons to be consulted are—

(a) 35the Secretary of State,

(b) the Care Quality Commission and its Healthwatch England committee,

(c) every local authority in England,

(d) every commissioning consortium,

(e) every licence holder, and

(f) 40such other persons as Monitor considers appropriate.

(4) Monitor must give each consultee notice of the duration of the consultation
period in relation to the proposed guidance; and for that purpose the

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consultation period is the period of 28 days beginning with the day after that
on which the notice is given.

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

CHAPTER 4 5Licensing

Licensing requirement

88 Requirement for health service providers to be licensed

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

(2) 10Regulations 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.

89 Deemed breach of requirement to be licensed

(1) 15This 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) is not registered under Chapter 2 of Part 1 of that Act in respect of the
20carrying on of that activity.

(2) The licence holder is to be regarded as providing the service in breach of the
requirement under section 88 to hold a licence.

90 Exemption regulations

(1) Regulations (referred to in this section and section 91 as “exemption
25regulations”) may provide for the grant of exemptions from the requirement
under section 88 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) 30Exemption regulations may grant an exemption—

(a) either generally or to the extent prescribed;

(b) either unconditionally or subject to prescribed conditions;

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

(3) 35Conditions subject to which an exemption may be granted include, in
particular, conditions requiring a person providing a service pursuant to the
exemption—

(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,

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(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
so specified (or to do, or not to do, such things in a specified manner),
and

(c) 5to 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) Before making exemption regulations the Secretary of State must give
notice to—

(a) 10Monitor,

(b) the National Health Service Commissioning Board, and

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

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

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

(a) 15state 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) specify the period (“the notice period”) within which representations
with respect to the proposal may be made.

(7) 20The 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 to a person, the Secretary of State—

(a) must give the person notice of the exemption, and

(b) must publish the exemption.

91 25Exemption regulations: supplementary

(1) Regulations may revoke exemption regulations by which an exemption was
granted 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) 30in 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
35granted to persons of a prescribed description, or amend such regulations by
which 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) 40if the Secretary of State considers it to be inappropriate for the
exemption 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) 45at the person’s request,

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(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 in the case of the person.

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

(a) make 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) 10Monitor;

(ii) the 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
15subsection (1)(b) or (c), give notice of the proposal to the person to
whom 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
20subsection (3)(b) or (c), give notice of the proposal to the person from
whom 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) 25set out the Secretary of State’s reasons for the proposal, and

(c) specify 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.

30Licensing procedure

92 Application for licence

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

(2) The application must be made in such form, and contain or be accompanied by
35such information, as Monitor requires.

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

(3) 40Before setting or revising the criteria, Monitor must obtain the approval of the
Secretary of State.

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94 Grant or refusal of licence

(1) This section applies where an application for a licence has been made under
section 92.

(2) If Monitor is satisfied that the applicant meets the criteria for holding a licence
5for the time being published under section 93 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) A licence issued under this section is subject to—

(a) such of the standard conditions (see section 101) as are applicable to the
10licence,

(b) such other conditions included in the licence by virtue of section 102
(referred to in this Chapter as “the special conditions”), and

(c) any conditions included in the licence by virtue of section 117
(imposition of licence conditions on designated NHS foundation
15trusts).

95 Application and grant: NHS foundation trusts

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

(2) 20The NHS foundation trust is to be treated by Monitor as having—

(a) duly made an application for a licence under section 92, and

(b) met the criteria for holding a licence for the time being published under
section 93.

(3) An NHS foundation trust in existence on the day on which this section comes
25into 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.

96 Revocation of licence

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

(a) 30on the application of the licence holder, or

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

97 Right to make representations

(1) Monitor must give notice—

(a) 35to an applicant for a licence under this Chapter of a proposal to refuse
the application;

(b) to the licence holder of a proposal to revoke a licence under
section 96(b).

(2) A notice under this section must—

(a) 40set out Monitor’s reasons for its proposal;

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

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

98 Notice of decisions

(1) This section applies if Monitor decides to—

(a) 5refuse an application for a licence under section 94, or

(b) revoke a licence under section 96(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
10section 99.

(4) A decision of Monitor to revoke a licence under section 96(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 99, the day on which the decision
on the appeal is confirmed or the appeal is abandoned,

(b) 15where the licence holder notifies Monitor before the end of the period
for bringing an appeal under section 99 that the licence holder does not
intend to appeal, the day on which Monitor receives the notification, or

(c) the day after the end of that period.

99 Appeals to the Tribunal

(1) 20An appeal lies to the First-tier Tribunal against a decision of Monitor to—

(a) refuse an application for a licence under section 94, or

(b) revoke a licence under section 96(b).

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

(a) based on an error of fact,

(b) 25wrong 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) 30remit the decision to Monitor.

100 Register 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
35holders including, in particular, information about the revocation of any
licence 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
40entitled to have one.

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