Health and Social Care Bill (HC Bill 221)

(5) Regulations 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) 5in such circumstances as may be prescribed, or

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

Licence conditions

101 Standard conditions

(1) 10Monitor must determine and publish the conditions to be included in each
licence 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) 15For the purposes of subsection (2) a description of licences may in particular be
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) 20But different standard conditions must not be determined for different
descriptions 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) 25the standard conditions in question relate to the governance of licence
holders, 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
30for the purpose of ensuring that the burdens to which different licence holders
are 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) 35Those persons are—

(a) the Secretary of State,

(b) the National Health Service Commissioning Board,

(c) every commissioning consortium,

(d) the Care Quality Commission and its Healthwatch England committee,
40and

(e) such other persons as are likely to be affected by the inclusion of the
conditions 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.

102 Special conditions

(1) 5Monitor may—

(a) with 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) 10Before including a special condition or making such modifications Monitor
must 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) 15such commissioning consortia as are likely to be affected by the
proposed 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) 20state that Monitor proposes to include the special condition or make the
modifications and set out its or their proposed effect,

(b) set 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) 25The 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) In this section, a reference to modifying a condition includes a reference to
amending, omitting or adding a condition.

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

(1) 30This section applies to the following functions of Monitor—

(a) the duty to determine the standard conditions to be included in each
licence under this Chapter or in licences of a particular description (see
section 101),

(b) the powers to include a special condition in a licence and to modify
35such a condition (see section 102),

(c) the power to modify the standard conditions applicable to all licences,
or to licences of a particular description (see section 105).

(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
40health care services for the purposes of the NHS;

(b) for the purpose of preventing anti-competitive behaviour in the
provision 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;

(d) for the purpose of ensuring the continued provision of designated
services;

(e) 5for purposes connected with the governance of persons providing
health care services for the purposes of the NHS;

(f) for purposes connected with Monitor’s functions in relation to the
register of NHS foundation trusts required to be maintained under
section 39 of the National Health Service Act 2006;

(g) 10for purposes connected with the operation of the licensing regime
established by this Chapter;

(h) for such purposes as may be prescribed for the purpose of enabling
Monitor to discharge its duties under section 58.

(3) Monitor must not exercise a function to which this section applies in a way
15which it considers would result in a particular licence holder or holders of
licences of a particular description being put at an unfair advantage or
disadvantage in competing with others in the provision of health care services
for the purposes of the NHS as a result of—

(a) being in the public or (as the case may be) private sector, or

(b) 20some other aspect of its or their status.

104 Conditions: supplementary

(1) The standard or special conditions of a licence under this Chapter may in
particular include conditions—

(a) requiring the licence holder to pay to Monitor such fees of such
25amounts as Monitor may determine in respect of the exercise by
Monitor of its functions under this Chapter,

(b) requiring the licence holder to comply with any requirement imposed
on it by Monitor under Chapter 7 (financial assistance in health special
administration cases),

(c) 30requiring the licence holder to do, or not to do, specified things or
things of a specified description (or to do, or not to do, any such things
in a specified manner) within such period as may be specified in order
to prevent anti-competitive behaviour in the provision of health care
services for the purposes of the NHS which is against the interests of
35people who use such services,

(d) requiring the licence holder to give notice to the Office of Fair Trading
before entering into an arrangement under which, or a transaction in
consequence of which, the licence holder’s activities, and the activities
of one or more other businesses, cease to be distinct activities,

(e) 40requiring the licence holder to provide Monitor with such information
as Monitor considers necessary for the purposes of the exercise of its
functions under this Part,

(f) requiring the licence holder to publish such information as may be
specified or as Monitor may direct,

(g) 45requiring the licence holder to charge for the provision of health care
services for the purposes of the NHS in accordance with the national
tariff (see section 119),

(h) requiring the licence holder to comply with other rules published by
Monitor about the charging for the provision of health care services for
50the purposes of the NHS,

(i) requiring the licence holder—

(i) to do, or not to do, specified things or things of a specified
description (or to do, or not to do, any such things in a specified
manner) within such period as may be specified in order to
5ensure the continued provision of designated services,

(ii) to give Monitor notice (of such period as may be determined by
or under the licence) of the licence holder’s intention to cease
providing a designated service, and

(iii) if Monitor so directs, to continue providing that service for a
10period determined by Monitor,

(j) about the use or disposal by the licence holder of assets used in the
provision of designated services, and

(k) about the making by the licence holder of investment in relation to the
provision of designated services.

(2) 15In subsection (1) “specified” means specified in a condition.

(3) Monitor must not include a condition under subsection (1)(c) that requires the
licence holder (A) to provide another licence holder with access to facilities of
A.

(4) A condition under subsection (1)(d)—

(a) 20may be included only in the licence of an NHS foundation trust or a
body which (or part of which) used to be an NHS trust established
under section 25 of the National Health Service Act 2006, and

(b) ceases to have effect at the end of the period of five years beginning
with the day on which it is included in the licence.

(5) 25The references in subsection (1)(d) to the activities of a licence holder or other
business include a reference to part of the activities concerned.

(6) The references in subsections (1)(d) and (5) to the activities of a business
include a reference to the activities of an NHS foundation trust in so far as its
activities would not otherwise be the activities of a business.

(7) 30A condition of a licence under this Chapter may provide that it is to have effect,
or cease to have effect, at such times and in such circumstances as may be
determined by or under the conditions.

105 Modification of standard conditions

(1) Monitor may, subject to the requirements of this section, modify the standard
35conditions applicable to all licences under this Chapter or to licences of a
particular description.

(2) Before making any such modifications Monitor must give notice to—

(a) each relevant licence holder,

(b) the Secretary of State,

(c) 40the National Health Service Commissioning Board,

(d) every commissioning consortium, 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) 45state that Monitor proposes to make the modifications,

(b) set out the proposed effect of the modifications,

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

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

(5) 5The 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) Monitor may not make any modifications under this section unless—

(a) no relevant licence holder has made an objection to Monitor about the
proposal within the notice period, or

(b) 10subsection (7) applies to the case.

(7) This subsection applies where—

(a) one or more relevant licence holders make an objection to Monitor
about the proposal within the notice period,

(b) the objection percentage is less than the percentage prescribed for the
15purposes of this paragraph, and

(c) the share of supply percentage is less than the percentage prescribed for
the purposes of this paragraph.

(8) In subsection (7)—

(a) the “objection percentage” is the proportion (expressed as a percentage)
20of the relevant licence holders who objected to the proposals;

(b) the “share of supply percentage” is the proportion (expressed as a
percentage) of the relevant licence holders who objected to the
proposals, weighted according to their share of the supply in England
of such services as may be prescribed.

(9) 25Regulations prescribing a percentage for the purposes of subsection (7)(c) may
include provision prescribing the method to be used for determining a licence
holder’s share of the supply in England of the services concerned.

(10) Where Monitor modifies the standard conditions applicable to all licences or
(as the case may be) to licences of a particular description under this section,
30Monitor—

(a) may also make such incidental or consequential modifications as it
considers necessary or expedient of any other conditions of a licence
which is affected by the modifications,

(b) must make (as nearly as may be) the same modifications of those
35conditions for the purposes of their inclusion in all licences or (as the
case may be) licences of that description granted after that time, and

(c) must publish the modifications.

(11) In this section and section 106, “relevant licence holder”—

(a) in relation to proposed modifications of the standard conditions
40applicable to all licences, means any licence holder, and

(b) in relation to proposed modifications of the standard conditions
applicable to licences of a particular description, means a holder of a
licence of that description.

(12) In this section, a reference to modifying a condition includes a reference to
45amending, omitting or adding a condition.

106 Modification references to the Competition Commission

(1) Subsection (2) applies where—

(a) Monitor has given notice under section 102(2) of a proposal to include
a special condition in a licence or modify such a condition, and

(b) 5the applicant or (as the case may be) licence holder concerned has
refused consent to the inclusion of the condition or the making of the
modifications.

(2) Monitor may make a reference to the Competition Commission which is so
framed as to require the Commission to investigate and report on the
10questions—

(a) whether any matters which relate to the provision, or proposed
provision, of a health care service for the purposes of the NHS by the
applicant or (as the case may be) licence holder concerned and which
are specified in the reference, operate, or may be expected to operate,
15against the public interest, and

(b) if so, whether the effects adverse to the public interest which those
matters have or may be expected to have could be remedied or
prevented by the inclusion of a special condition in the applicant’s
licence or by modifications of a special condition of the licence holder’s
20licence.

(3) Subsection (4) applies where—

(a) Monitor has given notice under section 105(2) of a proposal to make
modifications to the standard conditions applicable to all licences
under this Chapter, or to licences of a particular description, and

(b) 25section 105 operates to prevent Monitor from making the
modifications.

(4) Monitor may make a reference to the Competition Commission which is so
framed as to require the Commission to investigate and report on the
questions—

(a) 30whether any matters which relate to the provision of health care
services for the purposes of the NHS by the relevant licence holders,
and which are specified in the reference, operate, or may be expected to
operate, against the public interest, and

(b) if so, whether the effects adverse to the public interest which those
35matters have or may be expected to have could be remedied or
prevented by modifications of the standard conditions applicable to all
licences under this Chapter, or to licences of a particular description.

(5) Schedule 10 (which makes further provision about references to the
Competition Commission) has effect in relation to a reference under subsection
40(2) or (4); and, for that purpose, the relevant persons are—

(a) in paragraphs 3, 6(6) and 7(6)—

(i) the applicant or licence holder concerned or (as the case may be)
relevant licence holders,

(ii) the National Health Service Commissioning Board, and

(iii) 45such commissioning consortia as are likely to be affected by
matters to which the reference relates,

(b) in paragraph 5(6), the applicant or licence holder concerned or (as the
case may be) relevant licence holders, and

(c) in paragraph 8(10)—

(i) the applicant or licence holder concerned or (as the case may be)
relevant licence holders,

(ii) Monitor,

(iii) the National Health Service Commissioning Board, and

(iv) 5such commissioning consortia as are likely to be affected by the
proposal concerned.

(6) In investigating the question under subsection (2)(a) or (4)(a) the Competition
Commission must have regard to—

(a) the matters in respect of which Monitor has duties under section 58,
10and

(b) the matters to which Monitor must have regard by virtue of section 61.

(7) Where the standard conditions applicable to all licences or (as the case may be)
to licences of a particular description are modified pursuant to a reference
made under subsection (4), Monitor—

(a) 15may also make such incidental or consequential modifications as it
considers necessary or expedient of any other conditions of a licence
which is affected by the modifications,

(b) must make (as nearly as may be) the same modifications of those
conditions for the purposes of their inclusion in all licences or (as the
20case may be) licences of that description granted after that time, and

(c) must publish any modifications made under this subsection.

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

107 Modification of conditions by order under other enactments

(1) 25This section applies where the Office of Fair Trading, Competition
Commission or Secretary of State (the “relevant authority”) makes a relevant
order.

(2) The relevant order may modify—

(a) the conditions of a particular licence, or

(b) 30the standard conditions applicable to all licences under this Chapter or
to licences of a particular description.

(3) The modifications which may be made by a relevant order are those which the
relevant authority considers necessary or expedient for the purpose of giving
effect to, or taking account of, any provision made by the order.

(4) 35In this section “relevant order” means—

(a) an order under section 75, 83 or 84 of, or paragraph 5, 10 or 11 of
Schedule 7 to, the Enterprise Act 2002 where one or more of the
enterprises which have, or may have, ceased to be distinct enterprises
were engaged in the provision of health care services for the purposes
40of the NHS;

(b) an order under any of those provisions of that Act where one or more
of the enterprises which will or may cease to be distinct enterprises is
engaged in the provision of health care services for the purposes of the
NHS;

(c) 45an order under section 160 or 161 of that Act where the feature, or
combination of features, of the market in the United Kingdom for

goods or services which prevents, restricts or distorts competition
relates to—

(i) the commissioning by the National Health Service
Commissioning Board or a commissioning consortium of health
5care services for the purposes of the NHS, or

(ii) the provision of those services.

(5) The modification under subsection (2)(a) of part of a standard condition of a
licence does not prevent any other part of the condition from continuing to be
regarded as a standard condition for the purposes of this Chapter.

(6) 10Where the relevant authority modifies the standard conditions applicable to all
licences or (as the case may be) to licences of a particular description under this
section, the relevant authority—

(a) may, after consultation with Monitor, make such incidental or
consequential modifications as the relevant authority considers
15necessary or expedient of any other conditions of any licence which is
affected by the modifications,

(b) must also make (as nearly as may be) the same modifications of those
conditions for the purposes of their inclusion in all licences or (as the
case may be) licences of that description granted after that time, and

(c) 20must publish any modifications it makes under paragraph (b).

(7) Expressions used in subsection (4) and in Part 3 or (as the case may be) Part 4
of the Enterprise Act 2002 have the same meaning in that subsection as in that
Part.

(8) A reference in this section to modifying a condition includes a reference to
25amending, omitting or adding a condition.

108 Standard condition as to transparency of certain criteria

(1) The standard conditions applicable to any licence under this Chapter must
include a condition requiring the licence holder to—

(a) set transparent eligibility and selection criteria, and

(b) 30apply those criteria in a transparent way to persons who, having a
choice of persons from whom to receive health care services for the
purposes of the NHS, choose to receive them from the licence holder.

(2) “Eligibility or selection criteria”, in relation to a licence holder, means criteria
for determining—

(a) 35whether a person is eligible, or is to be selected, to receive health care
services provided by the licence holder for the purposes of the NHS,
and

(b) if the person is selected, the manner in which the services are provided
to the person.

40Enforcement

109 Power to require documents and information

(1) Monitor may require a person mentioned in subsection (2) to provide it with
any information, documents, records or other items which it considers it

necessary or expedient to have for the purposes of any of its regulatory
functions.

(2) The persons are—

(a) an applicant for a licence under this Chapter,

(b) 5a licence holder,

(c) a person who has provided, or is providing, a health care service for the
purposes of the NHS in accordance with an exemption by virtue of
section 90 from the requirement to hold a licence under this Chapter,

(d) a person who has provided, or is providing, a health care service for the
10purposes of the NHS in breach of that requirement,

(e) the National Health Service Commissioning Board, and

(f) a commissioning consortium.

(3) The power in subsection (1) includes, in relation to information, documents or
records kept by means of a computer, power to require the provision of the
15information, documents or records in legible form.

(4) For the purposes of subsection (1) Monitor’s regulatory functions are its
functions under—

(a) this Chapter,

(b) Chapter 3 and Chapters 5 to 7, and

(c) 20Chapter 5 of Part 2 of the National Health Service Act 2006 (NHS
foundation trusts).

110 Discretionary requirements

(1) Monitor may impose one or more discretionary requirements on a person if
Monitor is satisfied that the person—

(a) 25has provided, or is providing, a health care service for the purposes of
the NHS in breach of the requirement to hold a licence under this
Chapter (see section 88),

(b) is a licence holder who has provided, or is providing, a health care
service for the purposes of the NHS in breach of a condition of the
30licence, or

(c) is in breach of a requirement imposed by Monitor under section 109.

(2) In this Chapter, “discretionary requirement” means—

(a) a requirement to pay a monetary penalty to Monitor of such amount as
Monitor may determine (referred to in this Chapter as a “variable
35monetary penalty”),

(b) a requirement to take such steps within such period as Monitor may
specify, to secure that the breach in question does not continue or recur
(referred to in this Chapter as a “compliance requirement”), or

(c) a requirement to take such steps within such period as Monitor may
40specify, to secure that the position is, so far as possible, restored to what
it would have been if the breach in question was not occurring or had
not occurred (referred to in this Chapter as a “restoration
requirement”).

(3) Monitor must not impose discretionary requirements on a person on more
45than one occasion in relation to the same breach.

(4) A variable monetary penalty must not exceed 10% of the turnover in England
of the person on whom it is imposed, such amount to be calculated in the
prescribed manner.

(5) If the whole or any part of a variable monetary penalty is not paid by the time
5it is required to be paid, the unpaid balance from time to time carries interest
at the rate for the time being specified in section 17 of the Judgments Act 1838;
but the total interest must not exceed the amount of the penalty.

111 Enforcement undertakings

(1) Monitor may accept an enforcement undertaking from a person if Monitor has
10reasonable grounds to suspect that the person—

(a) has provided, or is providing, a health care service for the purposes of
the NHS in breach of the requirement to hold a licence under this
Chapter,

(b) is a licence holder who has provided, or is providing, a health care
15service for the purposes of the NHS in breach of a condition of the
licence, or

(c) is in breach of a requirement imposed by Monitor under section 109.

(2) In this Chapter, “enforcement undertaking” means an undertaking from a
person to take such action of a kind mentioned in subsection (3) as may be
20specified in the undertaking within such period as may be so specified.

(3) The specified action must be—

(a) action to secure that the breach in question does not continue or recur,

(b) action to secure that the position is, so far as possible, restored to what
it would have been if the breach in question was not occurring or had
25not occurred,

(c) action (including the payment of a sum of money) to benefit—

(i) any other licence holder affected by the breach, or

(ii) any commissioner of health care services for the purposes of the
NHS which is affected by the breach, or

(d) 30action of such a description as may be prescribed.

(4) Where Monitor accepts an enforcement undertaking then, unless the person
from whom the undertaking is accepted has failed to comply with the
undertaking or any part of it—

(a) Monitor may not impose on that person any discretionary requirement
35which it would otherwise have power to impose by virtue of section
110 in respect of the breach to which the undertaking relates, and

(b) if the breach to which the undertaking relates falls within subsection
(1)(b), Monitor may not revoke that person’s licence under section
96(b).

(5) 40Where a person from whom Monitor has accepted an enforcement
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—

(a) to impose a discretionary requirement on the person in respect of the
45breach to which the undertaking relates, or

(b) if the breach to which the undertaking relates falls within subsection
(1)(b), to revoke the person’s licence under section 96(b).