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64 Matters to have regard to in exercise of functions

In exercising its functions, Monitor must have regard to—

(a) the need to maintain the safety of people who use health care services,

(b) the desirability of securing continuous improvement in the quality of
5health care services provided for the purposes of the NHS,

(c) the desirability of securing continuous improvement in the efficiency
with which health care services are provided for the purposes of the
NHS,

(d) the need for commissioners of health care services for the purposes of
10the NHS to ensure that the provision of access to the services for those
purposes operates fairly,

(e) the need for commissioners of health care services for the purposes of
the NHS to ensure that people who require health care services for
those purposes are provided with access to them,

(f) 15the need for commissioners of health care services for the purposes of
the NHS to make the best use of resources when doing so,

(g) the desirability of persons who provide health care services for the
purposes of the NHS co-operating with each other in order to improve
the quality of health care services provided for those purposes,

(h) 20the desirability of promoting investment by persons who provide
health care services for the purposes of the NHS in the provision of
health care services for those purposes,

(i) the need to promote research into matters relevant to the NHS by
persons who provide health care services for the purposes of the NHS,

(j) 25the need for high standards in the education and training of health care
professionals who provide health care services for the purposes of the
NHS,

(k) the manner in which the Secretary of State performs the duty under
section 1A(1) of the National Health Service Act 2006 (improvement in
30quality of services),

(l) the manner in which the National Health Service Commissioning
Board performs the duties under section 1G(3) of that Act
(commissioning of services), and

(m) the manner in which the National Health Service Commissioning
35Board performs the duty under section 13E(1) of that Act
(improvement in quality of services).

65 Conflicts between functions

(1) In a case where Monitor considers that any of its general duties conflict with
each other, it must secure that the conflict is resolved in the manner it considers
40best.

(2) Monitor must act so as to secure that there is not, and could not reasonably be
regarded as being, a conflict between—

(a) its exercise of any of its functions under Chapter 5 of Part 2 of the
National Health Service Act 2006 (regulation of NHS foundation trusts)
45or under sections 111 and 113 of this Act (imposition of licence
conditions on NHS foundation trusts during transitional period) or
under paragraph 17 of Schedule 8 to this Act (accounts of NHS
foundation trusts), and

(b) its exercise of any of its other functions.

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(3) Monitor must ignore the functions it has under sections 111 and 113 when
exercising—

(a) its functions under Chapter 2 (competition);

(b) its functions under Chapter 4 (pricing).

(4) 5If Monitor secures the resolution of a conflict between its general duties in a
case that comes within subsection (5), or that Monitor considers is otherwise of
unusual importance, it must publish a statement setting out—

(a) the nature of the conflict,

(b) the manner in which it decided to resolve it, and

(c) 10its reasons for deciding to resolve it in that manner.

(5) A case comes within this subsection if it involves—

(a) a matter likely to have a significant impact on persons who provide
health care services for the purposes of the NHS;

(b) a matter likely to have a significant impact on people who use health
15care services provided for the purposes of the NHS;

(c) a matter likely to have a significant impact on the general public in
England (or in a particular part of England);

(d) a major change in the activities Monitor carries on;

(e) a major change in the standard conditions of licences under Chapter 3
20(see section 95).

(6) Where Monitor is required to publish a statement under subsection (4), it must
do so as soon as reasonably practicable after making its decision.

(7) The duty under subsection (4) does not apply in so far as Monitor is subject to
an obligation not to publish a matter that needs to be included in the statement.

(8) 25Every annual report of Monitor must include—

(a) a statement of the steps it has taken in the financial year to which the
report relates to comply with the duty under subsection (2), and

(b) a summary of the manner in which, in that financial year, Monitor has
secured the resolution of conflicts between its general duties arising in
30cases of the kind referred to in subsection (5).

(9) Monitor’s general duties for the purposes of this section are its duties under
sections 61 and 64.

66 Duty to review regulatory burdens

(1) Monitor must keep the exercise of its functions under review and secure that
35in exercising its functions it does not—

(a) impose burdens which it considers to be unnecessary, or

(b) maintain burdens which it considers to have become unnecessary.

(2) In keeping the exercise of its functions under review, Monitor must have
regard to such principles as appear to it to represent best regulatory practice.

(3) 40Subsection (1) does not require the removal of a burden which has become
unnecessary where its removal would, having regard to all the circumstances,
be impractical or disproportionate.

(4) Monitor must from time to time publish a statement setting out—

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(a) what it proposes to do pursuant to subsection (1) in the period to which
the statement relates,

(b) what it has done pursuant to that subsection since publishing the
previous statement, and

(c) 5where a burden relating to the exercise of the function which has
become unnecessary is maintained pursuant to subsection (3), the
reasons why removal of the burden would, having regard to all the
circumstances, be impractical or disproportionate.

(5) The first statement—

(a) 10must be published as soon as practicable after the commencement of
this section, and

(b) must relate to the period of 12 months beginning with the date of
publication.

(6) A subsequent statement—

(a) 15must be published during the period to which the previous statement
related or as soon as reasonably practicable after that period, and

(b) must relate to the period of 12 months beginning with the end of the
previous period.

(7) Monitor must, in exercising its functions, have regard to the statement that is
20in force at the time in question.

(8) Monitor may revise a statement before or during the period to which it relates;
and, if it does so, it must publish the revision as soon as reasonably practicable.

67 Duty to carry out impact assessments

(1) This section applies where Monitor is proposing to do something that it
25considers would be likely—

(a) to have a significant impact on persons who provide health care
services for the purposes of the NHS;

(b) to have a significant impact on people who use health care services
provided for the purposes of the NHS;

(c) 30to have a significant impact on the general public in England (or in a
particular part of England);

(d) to involve a major change in the activities Monitor carries on;

(e) to involve a major change in the standard conditions of licences under
Chapter 3 (see section 95).

(2) 35But this section does not apply to—

(a) the carrying out by Monitor of an analysis of how markets involving
the provision of health care services are operating, or

(b) the exercise of functions under or by virtue of Chapter 2.

(3) Nor does this section apply if it appears to Monitor that the urgency of the
40matter makes compliance with this section impracticable or inappropriate.

(4) Before implementing the proposal, Monitor must either—

(a) carry out and publish an assessment of the likely impact of
implementation, or

(b) publish a statement setting out its reasons for concluding that it does
45not need to carry out an assessment under paragraph (a).

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(5) The assessment must set out Monitor’s explanation of how the discharge of its
general duties (within the meaning of section 65)—

(a) would be secured by implementation of the proposal, but

(b) would not be secured by the exercise of functions that Monitor has by
5virtue of section 70 or 71.

(6) The assessment may take such form, and relate to such matters, as Monitor
may determine; and in determining the matters to which the assessment is to
relate, Monitor must have regard to such general guidance on carrying out
impact assessments as it considers appropriate.

(7) 10The assessment must specify the consultation period within which
representations with respect to the proposal may be made to Monitor; and for
that purpose the consultation period must not be less than 28 days beginning
with the day after that on which the assessment is published under subsection
(4).

(8) 15Monitor may not implement the proposal unless the consultation period has
ended.

(9) Where Monitor is required (apart from this section) to consult about, or afford
a person an opportunity to make representations about, a proposal that comes
within subsection (1), the requirements of this section—

(a) 20are in addition to the other requirement, but

(b) may be met contemporaneously with it.

(10) Every annual report of Monitor must set out—

(a) a list of the assessments carried out under this section during the
financial year to which the report relates, and

(b) 25a summary of the decisions taken during that year in relation to
proposals to which assessments carried out during that year or a
previous financial year relate.

68 Information

(1) Information obtained by, or documents, records or other items produced to,
30Monitor in connection with any of its functions may be used by Monitor in
connection with any of its other functions.

(2) For the purposes of exercising a function under this Part, the Secretary of State
may request Monitor to provide the Secretary of State with such information
as the Secretary of State may specify.

(3) 35Monitor must comply with a request under subsection (2).

69 Failure to perform functions

(1) This section applies if the Secretary of State considers that Monitor is failing, or
has failed, to perform any function of Monitor’s and that the failure is
significant.

(2) 40The Secretary of State may direct Monitor to perform such of those functions,
and in such manner and within such period, as the direction specifies.

(3) But the Secretary of State may not give a direction under subsection (2) in
relation to the performance of functions in a particular case.

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(4) If Monitor fails to comply with a direction under subsection (2), the Secretary
of State may—

(a) perform the functions to which the direction relates, or

(b) make arrangements for some other person to perform them on the
5Secretary of State’s behalf.

(5) Where the Secretary of State exercises a power under subsection (2) or (4), the
Secretary of State must publish the reasons for doing so.

(6) Reference in subsection (1) to failure to perform a function includes a reference
to failure to perform it properly.

CHAPTER 2 10Competition

70 Functions under the Competition Act 1998

(1) The functions referred to in subsection (2) are concurrent functions of Monitor
and the Office of Fair Trading.

(2) The functions are those that the Office of Fair Trading has under Part 1 of the
15Competition Act 1998, other than sections 31D(1) to (6), 38(1) to (6) and 51, so
far as relating to any of the following which concern the provision of health
care services in England—

(a) agreements, decisions or concerted practices of the kind mentioned in
section 2(1) of that Act (anti-competitive practices),

(b) 20conduct of the kind mentioned in section 18(1) of that Act (abuse of
dominant position),

(c) agreements, decisions or concerted practices of the kind mentioned in
Article 101 of the Treaty on the Functioning of the European Union
(anti-competitive practices),

(d) 25conduct which amounts to abuse of the kind mentioned in Article 102
of that Treaty (abuse of dominant position).

(3) So far as necessary for the purposes of subsections (1) and (2), references in Part
1 of the Competition Act 1998 to the Office of Fair Trading are to be read as
including references to Monitor, except in sections 31D(1) to (6), 38(1) to (6), 51,
3052(6) and (8) and 54).

71 Functions under Part 4 of the Enterprise Act 2002

(1) The functions referred to in subsection (2) are concurrent functions of Monitor
and the Office of Fair Trading.

(2) The functions are those that the Office of Fair Trading has under Part 4 of the
35Enterprise Act 2002 (market investigations), other than sections 166 and 171, so
far as relating to activities which concern the provision of health care services
in England.

(3) So far as necessary for the purposes of subsections (1) and (2), references in Part
4 of the Enterprise Act 2002 to the Office of Fair Trading (including references
40in provisions of that Act applied by that Part) are to be read as including
references to Monitor, except in sections 166 and 171.

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(4) Before the Office of Fair Trading or Monitor first exercises functions which are
exercisable concurrently by virtue of this section, it must consult the other.

(5) Neither the Office of Fair Trading nor Monitor may exercise in relation to any
matter functions which are exercisable concurrently by virtue of this section if
5functions which are so exercisable have been exercised in relation to that
matter by the other.

(6) Section 117 of the Enterprise Act 2002 (offences of supplying false or
misleading information) as applied by section 180 of that Act is to have effect
so far as relating to functions exercisable by Monitor by virtue of this section as
10if the references in section 117(1)(a) and (2) to the Office of Fair Trading
included references to Monitor.

72 Competition functions: supplementary

(1) No objection may be taken to anything done by or in relation to Monitor under
the Competition Act 1998 or Part 4 of the Enterprise Act 2002 on the ground
15that it should have been done by or in relation to the Office of Fair Trading.

(2) Subject to subsection (3), sections 61 and 64 (general duties of Monitor) do not
apply in relation to anything done by Monitor in the carrying out of its
functions by virtue of section 70 or 71.

(3) In the carrying out of any functions by virtue of section 70 or 71, Monitor may
20nevertheless have regard to any of the matters in respect of which a duty is
imposed by section 61 or 64 if it is a matter to which the Office of Fair Trading
is entitled to have regard in the carrying out of those functions.

(4) In section 9E of the Company Directors Disqualification Act 1986 (specified
regulators in cases of disqualification for competition infringements), in
25subsection (2) after paragraph (e) insert ;

(f) Monitor.

(5) In section 54 of the Competition Act 1998, in subsection (1) (definition of
“regulator” for the purposes of Part 1 of that Act)—

(a) omit the “and” preceding paragraph (g), and

(b) 30after that paragraph insert ; and

(h) Monitor.

(6) In section 136 of the Enterprise Act 2002 (investigations and reports on market
investigation references)—

(a) in subsection (7) (meaning of “relevant sectoral enactment”), at the end
35insert—

(i) in relation to Monitor, section 71 of the Health and Social
Care Act 2012.,

(b) in subsection (8) (meaning of “relevant sectoral regulator”), for
“Communications or” substitute “Communications,”, and

(c) 40in that subsection, after “Utility Regulation” insert “or Monitor”.

(7) In section 168 of that Act (regulated markets)—

(a) in subsection (3) (meaning of “relevant action”), after paragraph (o)
insert—

(p) modifying the conditions of a licence issued under
45section 88 of the Health and Social Care Act 2012.,

(b) in subsection (4) (meaning of “relevant statutory functions”), after

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paragraph (q) insert—

(r) in relation to any licence issued under section 88 of the
Health and Social Care Act 2012, the duties of Monitor
under sections 61 and 64 of that Act., and

(c) 5in subsection (5) (meaning of “sectoral regulator”), after paragraph (i)
insert—

(ia) Monitor;.

73 Requirements as to procurement, patient choice and competition

(1) Regulations may impose requirements on the National Health Service
10Commissioning Board and clinical commissioning groups for the purpose of
securing that, in commissioning health care services for the purposes of the
NHS, they—

(a) adhere to good practice in relation to procurement;

(b) protect and promote the right of patients to make choices with respect
15to treatment or other health care services provided for the purposes of
the NHS;

(c) do not engage in anti-competitive behaviour which is against the
interests of people who use such services.

(2) Requirements imposed by regulations under this section apply to an
20arrangement for the provision of goods and services only if the value of the
consideration attributable to the services is greater than that attributable to the
goods.

(3) Regulations under this section may, in particular, impose requirements
relating to—

(a) 25competitive tendering for the provision of services;

(b) the management of conflicts between the interests involved in
commissioning services and the interests involved in providing them.

(4) The regulations may provide for the requirements imposed, or such of them as
are prescribed, not to apply in relation to arrangements of a prescribed
30description.

74 Requirements under section 73: investigations, declarations and directions

(1) Regulations under section 73 may confer on Monitor—

(a) a power to investigate a complaint that the National Health Service
Commissioning Board or a clinical commissioning group has failed to
35comply with a requirement imposed by the regulations;

(b) a power to investigate on its own initiative whether the Board or a
clinical commissioning group has failed to comply with a requirement
imposed by virtue of section 73(1)(c);

(c) a power to require the Board or a clinical commissioning group to
40provide it with such information as Monitor may specify for the
purposes of an investigation it carries out by virtue of paragraph (a) or
(b);

(d) a power to require the Board or a clinical commissioning group to
provide an explanation of such information as it provides by virtue of
45paragraph (c).

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(2) A power conferred by virtue of subsection (1)(a) is exercisable only where
Monitor considers that the person making the complaint has sufficient interest
in the arrangement to which the complaint relates.

(3) Regulations under section 73 may confer on Monitor a power to declare that an
5arrangement for the provision of health care services for the purposes of the
NHS is ineffective.

(4) A power conferred by virtue of subsection (3) is exercisable only in prescribed
circumstances and subject to prescribed restrictions and only where Monitor is
satisfied that—

(a) 10the National Health Service Commissioning Board or a clinical
commissioning group has failed to comply with a requirement of
regulations under section 73, and

(b) the failure is sufficiently serious.

(5) On a declaration being made by virtue of subsection (3), the arrangement is
15void; but that does not affect—

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

(b) any 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 73 may confer on Monitor a power to direct the
20National Health Service Commissioning Board or a clinical commissioning
group—

(a) to 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) 25to remedy a failure to comply with such a requirement;

(c) not to exercise in a prescribed manner prescribed functions in relation
to 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) 30to vary an arrangement for the provision of health care services made
in consequence of putting the provision of the services out to tender.

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

(8) 35Regulations under section 73 may—

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

(b) prevent 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 73 in respect of the whole or part
40of the same loss or damage.

75 Requirements under section 73: undertakings

(1) Regulations under section 73 may confer on Monitor a power to accept an
undertaking (referred to in this Chapter as a “section 75 undertaking”) from the
National Health Service Commissioning Board or a clinical commissioning
45group to take such action of a kind mentioned in subsection (2) as is specified
in the undertaking within such period as is so specified.

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(2) The specified action must be—

(a) action of a description given in paragraphs (a) to (e) of section 74(6), or

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

(3) Where Monitor accepts a section 75 undertaking then, unless the Board, or (as
5the case may be) the clinical commissioning group from whom the
undertaking 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 74 in relation
10to the arrangement in question, or

(c) give 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 75 undertaking, has failed to
15comply fully with the undertaking but has complied with part of it, Monitor
must take the partial compliance into account in deciding whether to do
something mentioned in paragraphs (a) to (c) of subsection (3).

(5) Schedule 9 (which makes further provision about section 75 undertakings) has
effect.

76 20Guidance

(1) Monitor must publish guidance about—

(a) compliance with requirements imposed by regulations under section
73;

(b) how it intends to exercise powers conferred on it by regulations under
25that section.

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

(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
30the approval of the Secretary of State.

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

77 Mergers involving NHS foundation trusts

(1) Part 3 of the Enterprise Act 2002 (mergers) applies (in so far as it would not
35otherwise) to each of the following cases as it applies to a case where two or
more enterprises have ceased to be distinct enterprises.

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

(3) The second case is where the activities of one or more NHS foundation trusts
40and the activities of one or more businesses have ceased to be distinct activities.

(4) 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.

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

78 Reviews by the Competition Commission

(1) The Competition Commission must review—

(a) 5the development of competition in the provision of health care services
for the purposes of the NHS, and

(b) the exercise by Monitor of its functions under this Part in relation to the
provision of health care services for those purposes.

(2) Before beginning a review under this section, the Commission must publish a
10notice specifying the matters it proposes to consider in the review.

(3) In carrying out the review, the Commission must consider whether those
matters have or may be expected to have any effects adverse to the public
interest.

(4) The Commission must complete the review, and publish a report of it, before
15the end of the period of 12 months beginning with the day on which the notice
relating to the review was published under subsection (2).

(5) The Commission must send a copy of the report to—

(a) the Secretary of State,

(b) Monitor, and

(c) 20the National Health Service Commissioning Board.

(6) Where the Commission concludes that one or more of the matters it considered
in the review has or may be expected to have effects adverse to the public
interest, it must include in the report its recommendations to the Secretary of
State, Monitor and the National Health Service Commissioning Board as to
25how to remedy those effects.

(7) Each of those persons must reply to the Commission to say what the person
proposes to do in the light of the recommendations; the reply must be made
before the end of the period of six months beginning with the day on which the
report was published.

(8) 30Where the Commission is carrying out a review under this section, Monitor
must give the Commission—

(a) such information in Monitor’s possession as the Commission may
require to enable it to carry out the review,

(b) such other information in Monitor’s possession as it considers would
35assist the Commission in carrying out the review, and

(c) such other assistance as the Commission may require to assist it in
carrying out the review.

(9) The first review under this section must begin before the end of 2019.

(10) A subsequent review under this section must begin before the end of the
40period of seven years beginning with the date on which the Commission
published the report of the previous review under this section.

(11) For the purposes of the law of defamation, absolute privilege attaches to a
report under this section.