Health and Social Care Act 2012
- (4) In Schedule 1 to the Local Authority Social Services Act 1970 (social services functions), in the entry for the Mental Health Act 1983, at the appropriate place insert—
| Section 130A | Making arrangements to enable independent mental health advocates to be available to help qualifying patients |
|---|---|
.
Patients’ correspondence
44
- (1) In section 134 of the Mental Health Act 1983 (patients' correspondence), in subsection (1)—
- (a) before “the approved clinician” insert “or”, and
- (b) omit “or the Secretary of State”.
- (2) Subsection (1) of this section does not affect the validity of any requests made to the Secretary of State under section 134(1) of that Act and having effect immediately before the commencement of this section.
Notification of hospitals having arrangements for special cases
45
- (1) In section 140 of the Mental Health Act 1983 (notification of hospitals having arrangements for special cases)—
- (a) after “the duty of” insert “every clinical commissioning group and of”,
- (b) omit “every Primary Care Trust and of”,
- (c) after “the area of the” insert “clinical commissioning group or”,
- (d) omit “Primary Care Trust or” in the first place it appears,
- (e) after “available to the” insert “clinical commissioning group or”, and
- (f) omit “Primary Care Trust or” in the second place it appears.
- (2) In consequence of the repeals made by this section, in the National Health Service Reform and Health Care Professions Act 2002, in Schedule 2, omit paragraph 48(a) and (c).
Emergency powers
Role of the Board and clinical commissioning groups in respect of emergencies
46
For the cross-heading preceding section 253 of the National Health Service Act 2006 substitute “Emergencies: role of the Secretary of State, the Board and clinical commissioning groups” and after the cross-heading insert—
(252A) (1) The Board and each clinical commissioning group must take appropriate steps for securing that it is properly prepared for dealing with a relevant emergency. (2) The Board must take such steps as it considers appropriate for securing that each clinical commissioning group is properly prepared for dealing with a relevant emergency. (3) The steps taken by the Board under subsection (2) must include monitoring compliance by each clinical commissioning group with its duty under subsection (1). (4) The Board must take such steps as it considers appropriate for securing that each relevant service provider is properly prepared for dealing with a relevant emergency. (5) The steps taken by the Board under subsection (4) must include monitoring compliance by the service provider with any requirements imposed on it by its service arrangements for the purpose of securing that it is properly prepared for dealing with a relevant emergency. (6) The Board may take such steps as it considers appropriate for facilitating a co-ordinated response to an emergency by the clinical commissioning groups and relevant service providers for which it is a relevant emergency. (7) The Board may arrange for any body or person to exercise any functions of the Board under subsections (2) to (6). (8) Where the Board makes arrangements with another body or person under subsection (7) it may also arrange for that other body or person to exercise any functions that the Board has, by virtue of being a Category 1 responder, under Part 1 of the Civil Contingencies Act 2004. (9) A relevant service provider must appoint an individual to be responsible for— (a) securing that the provider is properly prepared for dealing with a relevant emergency, (b) securing that the provider complies with any requirements mentioned in subsection (5), and (c) providing the Board with such information as it may require for the purpose of discharging its functions under this section. (10) In this section— - “relevant emergency”— 1. in relation to the Board or a clinical commissioning group, means any emergency which might affect the Board or the group (whether by increasing the need for the services that it may arrange or in any other way); 2. in relation to a relevant service provider, means any emergency which might affect the provider (whether by increasing the need for the services that it may provide or in any other way); - “relevant service provider” means any body or person providing services in pursuance of service arrangements; - “service arrangements”, in relation to a relevant service provider, means arrangements made by the Board or a clinical commissioning group under or by virtue of section 3, 3A, 3B, 4 or 7A or Schedule 1.
Secretary of State’s emergency powers
47
- (1) Section 253 of the National Health Service Act 2006 (emergency powers) is amended as follows.
- (2) In subsection (1) for the words from “it is necessary” to the end of the subsection substitute “it is appropriate to do so”.
- (3) After subsection (1) insert—
(1A) A direction under this section may be given to— (a) an NHS body other than a Local Health Board; (b) the National Institute for Health and Care Excellence; (c) the Health and Social Care Information Centre; (d) any body or person, other than an NHS body, providing services in pursuance of arrangements made— (i) by the Secretary of State under section 12, (ii) by the Board or a clinical commissioning group under section 3, 3A, 3B or 4 or Schedule 1, (iii) by a local authority for the purpose of the exercise of its functions under or by virtue of section 2B or 6C(1) or Schedule 1, or (iv) by the Board, a clinical commissioning group or a local authority by virtue of section 7A.
- (4) For subsection (2) substitute—
(2) In relation to a body within subsection (1A)(a) to (c), the powers conferred by this section may be exercised— (a) to give directions to the body about the exercise of any of its functions; (b) to direct the body to cease to exercise any of its functions for a specified period; (c) to direct the body to exercise any of its functions concurrently with another body or person for a specified period; (d) to direct the body to exercise any function conferred on another body or person under or by virtue of this Act for a specified period (whether to the exclusion of, or concurrently with, that body or person). (2A) In relation to a body or person within subsection (1A)(d), the powers conferred by this section may be exercised— (a) to give directions to the body or person about the provision of any services that it provides in pursuance of arrangements mentioned in subsection (1A)(d); (b) to direct the body or person to cease to provide any of those services for a specified period; (c) to direct the body or person to provide other services for the purposes of the health service for a specified period.
- (5) After subsection (2A) insert—
(2B) The Secretary of State may direct the Board to exercise the functions of the Secretary of State under this section. (2C) The Secretary of State may give directions to the Board about its exercise of any functions that are the subject of a direction under subsection (2B). (2D) In this section, “specified” means specified in the direction.
- (6) Omit subsection (4) (exclusion of NHS foundation trusts from application of emergency powers).
- (7) In section 273 of that Act (further provision about orders and directions under the Act), in subsection (4)(c)(ii), for “or 120” substitute “, 120 or 253”.
Miscellaneous
New Special Health Authorities
48
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Primary care services: directions as to exercise of functions
49
- (1) After section 98 of the National Health Service Act 2006 insert—
(98A) (1) The Secretary of State may direct the Board to exercise any of the Secretary of State's functions relating to the provision of primary medical services. (2) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations. (3) The Secretary of State may give directions to the Board about its exercise of any functions relating to the provision of primary medical services (including functions which the Board has been directed to exercise under subsection (1)). (4) The Board may direct a clinical commissioning group to exercise any of the Board's functions relating to the provision of primary medical services. (5) The Board may give directions to a clinical commissioning group about the exercise by it of any functions relating to the provision of primary medical services (including functions which the group has been directed to exercise under subsection (4)). (6) Subsection (4) does not apply to such functions, or functions of such descriptions, as may be prescribed. (7) Where the Board gives a direction under subsection (4) or (5), it may disclose to the clinical commissioning group information it has about the provision of the primary medical services in question, if the Board considers it necessary or appropriate to do so in order to enable or assist the group to exercise the function specified in the direction. (8) A clinical commissioning group exercising a function specified in a direction under subsection (4) or (5) must report to the Board on matters arising out of the group's exercise of the function. (9) A report under subsection (8) must be made in such form and manner as the Board may specify. (10) The Board may, in exercising its functions relating to the provision of the primary medical services in question, have regard to a report under subsection (8).
- (2) After section 114 of that Act insert—
(114A) (1) The Secretary of State may direct the Board to exercise any of the Secretary of State's functions relating to the provision of primary dental services. (2) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations. (3) The Secretary of State may give directions to the Board about its exercise of any functions relating to the provision of primary dental services (including functions which the Board has been directed to exercise under subsection (1)).
- (3) After section 125 of that Act insert—
(125A) (1) The Secretary of State may direct the Board to exercise any of the Secretary of State's functions relating to the provision of primary ophthalmic services. (2) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations. (3) The Secretary of State may give directions to the Board about its exercise of any functions relating to the provision of primary ophthalmic services (including functions which the Board has been directed to exercise under subsection (1)). (4) The Board may direct a clinical commissioning group, a Special Health Authority or such other body as may be prescribed to exercise any of the Board's functions relating to the provision of primary ophthalmic services. (5) The Board may give directions to a clinical commissioning group, a Special Health Authority or such other body as may be prescribed about the exercise by the body of any functions relating to the provision of primary ophthalmic services (including functions which it has been directed to exercise under subsection (4)). (6) Subsection (4) does not apply to such functions, or functions of such descriptions, as may be prescribed. (7) Where the Board gives a direction to a body under subsection (4) or (5), it may disclose to the body the information it has about the provision of the primary ophthalmic services in question, if the Board considers it necessary or appropriate to do so in order to enable or assist the body to exercise the function specified in the direction. (8) A body which is given a direction under subsection (4) or (5) must report to the Board on matters arising out of the exercise of the function to which the direction relates. (9) A report under subsection (8) must be made in such form and manner as the Board may specify. (10) The Board may, in exercising its functions relating to the provision of the primary ophthalmic services in question, have regard to a report under subsection (8).
- (4) After section 168 of that Act insert—
(168A) (1) The Secretary of State may direct the Board to exercise any of the Secretary of State's functions relating to services that may be provided as pharmaceutical services, or as local pharmaceutical services, under this Part. (2) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations. (3) The Secretary of State may give directions to the Board about its exercise of any functions relating to pharmaceutical services or to local pharmaceutical services (including functions which the Board has been directed to exercise under subsection (1)).
Charges in respect of certain public health functions
50
- (1) After section 186 of the National Health Service Act 2006 insert—
(186A) (1) The Secretary of State may make charges under this subsection in respect of any step taken under section 2A. (2) The power conferred by subsection (1) does not apply in respect of the provision of a service or facility to an individual, or the taking of any other step in relation to an individual, for the purpose of protecting the individual's health. (3) Charges under subsection (1) may be calculated on such basis as the Secretary of State considers appropriate. (4) Regulations may provide for the making and recovery of charges in respect of— (a) the taking of prescribed steps by a local authority under section 2A (by virtue of regulations under section 6C(1)), and (b) the taking of prescribed steps by a local authority under section 2B. (5) Regulations under subsection (4) may make provision as to the calculation of charges authorised by the regulations, including provision prescribing the amount or the maximum amount that may be charged. (6) Nothing in this section affects any other power conferred by or under this Act to make charges.
- (2) In section 272 of that Act (orders, regulations, rules and directions), in subsection (6) after paragraph (zc) insert—
(zd) regulations under section 186A(4),
.
Pharmaceutical services expenditure
51
- (1) After section 165 of the National Health Service Act 2006 insert—
(165A) (1) The Board must provide the Secretary of State with such information relating to the remuneration paid by the Board to persons providing pharmaceutical services or local pharmaceutical services as the Secretary of State may require. (2) The information must be provided in such form, and at such time or within such period, as the Secretary of State may require. (3) Schedule 12A makes further provision about pharmaceutical remuneration.
- (2) After Schedule 12 to that Act insert the Schedule set out in Schedule 3 to this Act.
Secretary of State’s duty to keep health service functions under review
52
In Part 13 of the National Health Service Act 2006, after section 247B (as inserted by section 60) insert—
(247C) (1) The Secretary of State must keep under review the effectiveness of the exercise by the bodies mentioned in subsection (2) of functions in relation to the health service in England. (2) The bodies mentioned in this subsection are— (a) the Board; (b) Monitor; (c) the Care Quality Commission and its Healthwatch England committee; (d) the National Institute for Health and Care Excellence; (e) the Health and Social Care Information Centre; (f) Special Health Authorities. (3) The Secretary of State may include in an annual report under section 247D the Secretary of State's views on the effectiveness of the exercise by the bodies mentioned in subsection (2) of functions in relation to the health service.
Secretary of State’s annual report
53
After section 247C of the National Health Service Act 2006 insert—
(247D) (1) The Secretary of State must publish an annual report on the performance of the health service in England. (2) The report must include the Secretary of State's assessment of the effectiveness of the discharge of the duties under sections 1A and 1C. (3) The Secretary of State must lay any report prepared under this section before Parliament.
Certification of death
54
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendments related to Part 1 and transitional provision
55
- (1) Schedule 4 (which makes further amendments of the National Health Service Act 2006 in consequence of the provision made by this Part) has effect.
- (2) Schedule 5 (which makes amendments of other enactments in consequence of the provision made by this Part) has effect.
- (3) Schedule 6 (which makes transitional provision in connection with this Part) has effect.
PART 2 — Further provision about public health
Abolition of Health Protection Agency
56
- (1) The Health Protection Agency is abolished.
- (2) The Health Protection Agency Act 2004 is repealed.
- (3) Subsection (2) does not apply to—
- (a) paragraph 3 of Schedule 3 to that Act (which amends Schedule 2 to the Immigration Act 1971), and
- (b) section 11(1) of that Act so far as it gives effect to that paragraph.
- (4) Schedule 7 (which makes amendments of other enactments in consequence of the provision made by this section) has effect.
Functions in relation to biological substances
57
- (1) The appropriate authority must—
- (a) devise standards for the purity and potency of biological substances,
- (b) prepare, approve, hold and distribute standard preparations of biological substances,
- (c) design appropriate procedures for testing biological substances,
- (d) provide or arrange for the provision of laboratory facilities for testing biological substances,
- (e) carry out tests on biological substances,
- (f) examine records kept in connection with the manufacture and quality control of biological substances,
- (g) report on the results of tests or examinations conducted in pursuance of paragraph (e) or (f), and
- (h) carry out or arrange for the carrying out of such research, or provide or arrange for the provision of such information or training, as it considers appropriate in connection with the functions mentioned in paragraphs (a) to (g).
- (2) The appropriate authority may do anything which it considers is appropriate for facilitating, or incidental or conducive to, the exercise of any of its functions under this section.
- (3) Subsections (4) and (5) apply to any person that exercises functions similar to those of the appropriate authority under this section (whether or not in relation to the United Kingdom).
- (4) The appropriate authority must co-operate with the person in the exercise of those functions.
- (5) The person must co-operate with the appropriate authority in the exercise of the authority's functions under this section.
- (6) The appropriate authority may make charges (whether or not on a commercial basis) in respect of anything done by it under this section.
- (7) Any function conferred on the appropriate authority by this section may be performed by either the Secretary of State or the Department of Health, Social Services and Public Safety in Northern Ireland acting alone or both of them acting jointly (and references in this section to the appropriate authority are to be construed accordingly).
- (8) In this section “biological substance” means a substance whose purity or potency cannot, in the opinion of the Secretary of State, be adequately tested by chemical means.
Radiation protection functions
58
- (1) The appropriate authority must take such steps as it considers appropriate for the purposes of protecting the public from radiation (whether ionising or not).
- (2) The steps that may be taken under subsection (1) include—
- (a) the conduct of research or such other steps as the appropriate authority considers appropriate for advancing knowledge and understanding;
- (b) providing technical services (whether in laboratories or otherwise);
- (c) providing services for the prevention, diagnosis or treatment of illness arising from exposure to radiation;
- (d) providing training;
- (e) providing information and advice;
- (f) making available the services of any person or any facilities.
- (3) The appropriate authority may do anything which it considers appropriate for facilitating, or incidental or conducive to, the exercise of any of its functions under this section.
- (4) The appropriate authority may make charges (whether or not on a commercial basis) in respect of anything done by it under this section.
- (5) In the exercise of any function under this section which relates to a matter in respect of which a Health and Safety body has a function, the appropriate authority must—
- (a) consult the body, and
- (b) have regard to the body's policies.
- (6) Each of the following is a Health and Safety body—
- (a) the Health and Safety Executive;
- (b) the Health and Safety Executive for Northern Ireland.
- (c) the Office for Nuclear Regulation.
- (7) In subsection (2)(f), “facilities” has the same meaning as in the National Health Service Act 2006.
- (8) In this section, “the appropriate authority” means—
- (a) the Scottish Ministers to the extent that the functions are exercisable within devolved competence (within the meaning of the Scotland Act 1998);
- (b) the Department of Health, Social Services and Public Safety in Northern Ireland to the extent that the functions relate to a transferred matter (within the meaning of the Northern Ireland Act 1998);
- (c) the Secretary of State in any other case.
- (9) In this section, “the public” means—
- (a) where the appropriate authority is the Secretary of State, the public in Wales, Scotland and Northern Ireland,
- (b) where the appropriate authority is the Scottish Ministers, the public in Scotland, and
- (c) where the appropriate authority is the Department of Health, Social Services and Public Safety in Northern Ireland, the public in Northern Ireland.
- (10) This section does not apply in relation to England.
Repeal of AIDS (Control) Act 1987
59
- (1) The AIDS (Control) Act 1987 is repealed.
- (2) The AIDS (Control) (Northern Ireland) Order 1987 (S.I. 1987/1832 (N.I. 18)) is revoked.
Co-operation with bodies exercising functions in relation to public health
60
- (1) In Part 13 of the National Health Service Act 2006, before section 248 (and the cross-heading preceding it) insert—
(247B) (1) This section applies to any body or other person that exercises functions similar to those of the Secretary of State under section 2A (whether or not in relation to the United Kingdom). (2) The Secretary of State must co-operate with the body or other person in the exercise by it of those functions. (3) If the Secretary of State acts under subsection (2) at the request of the body or other person, the Secretary of State may impose charges in respect of any costs incurred by the Secretary of State in doing so. (4) The body or other person must co-operate with the Secretary of State in the exercise by the Secretary of State of functions under section 2A. (5) If the body or other person acts under subsection (4) at the request of the Secretary of State, it may impose charges in respect of any costs incurred by it in doing so.
- (2) In section 271 of that Act (territorial limit of exercise of functions), in subsection (3) after paragraph (d) insert—
(da) section 247B (co-operation in relation to public health functions),
.
PART 3 — Regulation of health and adult social care services
CHAPTER 1 — Monitor
Monitor
61
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General duties
62
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Secretary of State’s guidance on duty under section 62(9)
63
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General duties: supplementary
64
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power to give Monitor functions relating to adult social care services
65
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Matters to have regard to in exercise of functions
66
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conflicts between functions
67
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duty to review regulatory burdens
68
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duty to carry out impact assessments
69
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information
70
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Failure to perform functions
71
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER 2 — Competition
Functions under the Competition Act 1998
72
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Functions under Part 4 of the Enterprise Act 2002
73
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Competition functions: supplementary
74
- (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (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 section 87 of the Health and Social Care Act 2012.
,
- (b) in subsection (4) (meaning of “relevant statutory functions”), after paragraph (q) insert—
(r) in relation to any licence issued under section 87 of the Health and Social Care Act 2012, the duties of Monitor under sections 62 and 66 of that Act.
, and
- (c) in subsection (5) (meaning of “sectoral regulator”), after paragraph (i) insert—
(ia) Monitor;
.
Requirements as to procurement, patient choice and competition
75
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements under section 75: investigations, declarations and directions
76
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements under section 75: undertakings
77
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Guidance
78
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mergers involving NHS foundation trusts
79
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Co-operation with the Office of Fair Trading
80
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER 3 — Licensing
Licensing requirement
Requirement for health service providers to be licensed
81
- (1) Any person who provides a health care service for the purposes of the NHS must 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.
Deemed breach of requirement to be licensed
82
- (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) is 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.
Exemption regulations
83
- (1) Regulations (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) either 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 exemption—
- (a) to comply with any direction given by NHS England about such matters as are specified in the exemption or are of a description so specified,
- (b) except to the extent that NHS England 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) to refer for determination by NHS England 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (b) NHS England, and
- (c) the Care Quality Commission and its Healthwatch England committee.
- (5) The 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) specify 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) if the exemption is granted to a prescribed person, must give notice of it to that person, and
- (b) must publish the exemption.
Exemption regulations: supplementary
84
- (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) 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 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) if 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) 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 in the case of the person.
- (4) Subsection (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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (ii) NHS England;
- (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 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 subsection (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) set 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.
Licensing procedure
Application for licence
85
- (1) A person seeking to hold a licence under this Chapter must make an application to NHS England.
- (2) The application must be made in such form, and contain or be accompanied by such information, as NHS England requires.
Licensing criteria
86
- (1) NHS England 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) NHS England may revise the criteria and, if it does so, must publish them as revised.
- (3) NHS England 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.
Grant or refusal of licence
87
- (1) This section applies where an application for a licence has been made under section 85.
- (2) If NHS England 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, NHS England 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 94) as are applicable to the licence, and
- (b) such other conditions included in the licence by virtue of section 95 (referred to in this Chapter as “the special conditions”), and
- (c) any conditions included in the licence by virtue of section 111 (imposition of licence conditions on NHS foundation trusts during transitional period).
Application and grant: NHS foundation trusts
88
- (1) This section applies where—
- (a) an NHS trust becomes an NHS foundation trust in pursuance of section 36 of the National Health Service Act 2006 (effect of authorisation of NHS foundation trust), or
- (b) an NHS foundation trust is established under sections 56 or 56B of that Act (mergers and separations).
- (2) The NHS foundation trust is to be treated by NHS England 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 section 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.
Revocation of licence
89
NHS England may at any time revoke a licence under this Chapter—
- (a) on the application of the licence holder, or
- (b) if NHS England is satisfied that the licence holder has failed to comply with a condition of the licence.
Right to make representations
90
- (1) NHS England must give notice—
- (a) to 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 89(b).
- (2) A notice under this section must—
- (a) set out NHS England’s reasons for its proposal;
- (b) specify the period within which representations with respect to the proposal may be made to NHS England.
- (3) The period so specified must be not less than 28 days beginning with the day after that on which the notice is received.
Notice of decisions
91
- (1) This section applies if NHS England decides to—
- (a) refuse an application for a licence under section 87, or
- (b) revoke a licence under section 89(b).
- (2) NHS England 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 section 92.
- (4) A decision of NHS England to revoke a licence under section 89(b) takes effect on such day as may be specified by NHS England, 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) where the licence holder notifies NHS England 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 NHS England receives the notification, or
- (c) the day after that period.
Appeals to the Tribunal
92
- (1) An appeal lies to the First-tier Tribunal against a decision of NHS England 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) wrong in law, or
- (c) unreasonable.
- (3) On an appeal under this section, the First-tier Tribunal may—
- (a) confirm NHS England’s decision,
- (b) direct that the decision is not to have effect, or
- (c) remit the decision to NHS England.
Register of licence holders
93
- (1) NHS England must maintain and publish a register of licence holders.
- (2) The register may contain such information as NHS England considers appropriate for the purpose of keeping members of the public informed about licence holders including, in particular, information about the revocation of any licence under this Chapter.
- (3) NHS England 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 NHS England for a copy of, or an extract from, the register is entitled to have one.
- (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 NHS England is payable for the copy or extract except—
- (a) in such circumstances as may be prescribed, or
- (b) in any case where NHS England considers it appropriate to provide the copy or extract free of charge.
Licence conditions
Standard conditions
94
- (1) NHS England 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) For 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) But 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 NHS England 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 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 for 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Special conditions
95
- (1) NHS England may—
- (a) ... include a special condition in a licence under this Chapter, and
- (b) ... modify a special condition of a licence.
- (2) Before including a special condition or making such modifications NHS England must give notice to—
- (a) the applicant or the licence holder (as the case may be),
- (b) the Secretary of State,
- (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (d) such integrated care boards as are likely to be affected by the proposed inclusion or modifications, and
- (e) the Care Quality Commission and its Healthwatch England committee.
- (3) NHS England must also publish the notice under subsection (2).
- (4) The notice under subsection (2) must—
- (a) state that NHS England proposes to include the special condition or make the modifications and set out its or their proposed effect,
- (b) set out NHS England’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 NHS England.
- (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) In this section, a reference to modifying a condition includes a reference to amending, omitting or adding a condition.
Limits on Monitor’s functions to set or modify licence conditions
96
- (1) This section applies to the following functions of NHS England —
- (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 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, or to licences of a particular description (see section 100).
- (2) NHS England 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 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 provided for the purposes of the NHS;
- (d) for the purpose of ensuring the continued provision of health care services for the purposes of the NHS;
- (da) for the purpose of ensuring that decisions relating to the provision of health care services for the purposes of the NHS are made with regard to all their likely effects in relation to the matters referred to in subsection (2A);
- (e) for the purpose of enabling health care services provided for the purposes of the NHS to be provided in an integrated way where NHS England considers that this would achieve one or more of the objectives referred 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 NHS England considers that this would achieve one or more of the objectives referred to in subsection (3);
- (g) for the purpose of enabling, promoting or securing co-operation between providers of health care services for the purposes of the NHS, or between such providers and—
- (i) NHS bodies, within the meaning of section 72 of the National Health Service Act 2006, or
- (ii) local authorities in England (and for this purpose “local authority” has the meaning given by section 275(1) of the National Health Service Act 2006);
- (h) for purposes connected with the governance of persons providing health care services for the purposes of the NHS;
- (i) for purposes connected with NHS England’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;
- (j) for purposes connected with the operation of the licensing regime established by this Chapter;
- (k) for such other purposes as may be prescribed.
- (2A) The matters referred to in subsection (2)(da) are—
- (a) the health and well-being of the people of England;
- (b) the quality of services provided to individuals—
- (i) by relevant bodies, or
- (ii) in pursuance of arrangements made by relevant bodies,
for or in connection with the prevention, diagnosis or treatment of illness, as part of the health service in England;
- (c) efficiency and sustainability in relation to the use of resources by relevant bodies for the purposes of the health service in England.
- (2B) For the purposes of subsection (2)(da) (as read with subsection (2A))—
- (a) a reference to the effects of decisions in relation to the health and well-being of the people of England includes a reference to the effects of the decisions in relation to inequalities between the people of England with respect to their health and well-being;
- (b) a reference to effects of decisions in relation to the quality of services provided to individuals includes a reference to the effects of the decisions in relation to inequalities between individuals with respect to the benefits that they can obtain from those services.
- (2C) In subsection (2A) “relevant bodies” means—
- (a) NHS England,
- (b) integrated care boards,
- (c) NHS trusts established under section 25, and
- (d) NHS foundation trusts.
- (3) The objectives referred to in subsection (2)(e), and (f) are—
- (a) improving the quality of health care services provided for the purposes of the NHS (including the outcomes that are achieved from their provision) or the efficiency of their provision,
- (b) reducing inequalities between persons with respect to their ability to access those services, and
- (c) reducing inequalities between persons with respect to the outcomes achieved for them by the provision of those services.
- (4) NHS England must not exercise a function to which this section applies in a way which 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) some other aspect of its or their status.
- (5) In subsection (2)(f), “health-related services” and “social care services” each have the meaning given in section 62(11).
Conditions: supplementary
97
- (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 NHS England such fees of such amounts as NHS England may determine in respect of the exercise by NHS England of its functions under this Chapter,
- (b) requiring the licence holder to comply with any requirement imposed on it by NHS England under Chapter 6 (financial assistance in special administration cases),
- (c) requiring 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 people who use such services,
- (d) requiring the licence holder to give notice to the CMA 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) requiring the licence holder to provide NHS England with such information as NHS England 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 NHS England may direct,
- (g) requiring the licence holder to charge for the provision of health care services for the purposes of the NHS in accordance with the NHS payment scheme (see section 114A),
- (h) requiring the licence holder to comply with other rules published by NHS England about the charging for the provision of health care services for the 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 ensure the continued provision of one or more of the health care services that the licence holder provides for the purposes of the NHS,
- (ii) to give NHS England notice (of such period as may be determined by or under the licence) of the licence holder's intention to cease providing a health care service for the purposes of the NHS, and
- (iii) if NHS England so directs, to continue providing that service for a period determined by NHS England,
- (j) about the use or disposal by the licence holder of assets used in the provision of health care services for the purposes of the NHS in order to ensure the continued provision of one or more of the health care services that the licence holder provides for those purposes, and
- (k) about the making by the licence holder of investment in relation to the provision of health care services for the purposes of the NHS in order to ensure the continued provision of one or more of the health care services that the licence holder provides for those purposes.
- (2) In subsection (1) “specified” means specified in a condition.
- (3) NHS England 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) may 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) The 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) A 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.
Conditions relating to the continuation of the provision of services etc.
98
- (1) The things which a licence holder may be required to do by a condition under section 97(1)(i)(i) include, in particular—
- (a) providing information to the commissioners of services to which the condition applies and to such other persons as NHS England may direct,
- (b) allowing NHS England to enter premises owned or controlled by the licence holder and to inspect the premises and anything on them, and
- (c) co-operating with such persons as NHS England may appoint to assist in the management of the licence holder's affairs, business and property.
- (2) A commissioner of services to which a condition under section 97(1)(i), (j) or (k) applies must co-operate with persons appointed under subsection (1)(c) in their provision of the assistance that they have been appointed to provide.
- (3) Where a licence includes a condition under section 97(1)(i), (j) or (k), NHS England must carry out an ongoing assessment of the risks to the continued provision of services to which the condition applies.
- (4) NHS England must publish guidance—
- (a) for commissioners of a service to which a condition under section 97(1)(i), (j) or (k) applies about the exercise of their functions in connection with the licence holders who provide the service, and
- (b) for such licence holders about the conduct of their affairs, business and property at a time at which such a condition applies.
- (5) A commissioner of services to which a condition under section 97(1)(i), (j), or (k) applies must have regard to guidance under subsection (4)(a).
- (5A) In subsections (4)(a) and (5) “commissioner” does not include NHS England.
- (6) NHS England may revise guidance under subsection (4) and, if it does so, must publish the guidance as revised.
- (7) Before publishing guidance under subsection (4) or (6), NHS England must obtain the approval of—
- (a) the Secretary of State, ...
- (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notification of commissioners where continuation of services at risk
99
- (1) This section applies where NHS England—
- (a) takes action in the case of a licence holder in reliance on a condition in the licence under section 97(1)(i), (j) or (k), and
- (b) does so because it is satisfied that the continued provision for the purposes of the NHS of health care services to which that condition applies is being put at significant risk by the configuration of certain health care services provided for those purposes.
- (2) In subsection (1), a reference to the provision of services is a reference to their provision by the licence holder or any other provider.
- (3) NHS England must as soon as reasonably practicable notify such integrated care boards as NHS England considers appropriate—
- (a) of the action it has taken, and
- (b) of its reasons for being satisfied as mentioned in subsection (1)(b).
- (4) NHS England must publish for each financial year a list of the notifications under this section that it has given during that year; and the list must include for each notification a summary of NHS England’s reasons for being satisfied as mentioned in subsection (1)(b).
- (5) ... Integrated care boards, having received a notification under this section, must have regard to it in arranging for the provision of health care services for the purposes of the NHS.
Modification of standard conditions
100
- (1) NHS England may, subject to the requirements of this section, modify the standard conditions applicable to all licences under this Chapter or to licences of a particular description.
- (1A) Before making modifications under subsection (1) that NHS England consider to be a major change, NHS England must—
- (a) carry out an assessment of the likely impact of the modifications, or
- (b) publish a statement setting out its reasons for concluding that such assessment is not needed.
- (2) Before making any modifications under subsection (1) NHS England must give notice to—
- (a) each relevant licence holder,
- (b) the Secretary of State,
- (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (d) every integrated care board, and
- (e) the Care Quality Commission and its Healthwatch England committee.
- (3) NHS England must also publish the notice under subsection (2).
- (4) The notice under subsection (2) must—
- (a) state that NHS England proposes to make the modifications,
- (b) set out the proposed effect of the modifications,
- (ba) set out any impact assessment carried out by NHS England under subsection (1A)(a),
- (c) set out NHS England’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 NHS England.
- (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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (10) Where NHS England modifies the standard conditions applicable to all licences or (as the case may be) to licences of a particular description under this section, NHS England—
- (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 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) must publish the modifications.
- (11) In this section..., “relevant licence holder”—
- (a) in relation to proposed modifications of the standard conditions applicable 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 amending, omitting or adding a condition.
Modification references to the Competition Commission
101
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Modification of conditions by order under other enactments
102
- (1) This section applies where the CMA or Secretary of State (the “relevant authority”) makes a relevant order.
- (2) A relevant order may modify—
- (a) the conditions of a particular licence, or
- (b) the 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) In 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 of 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) an order under section 160 or 161 of that Act where the feature, or combination of features, of the market or markets in the United Kingdom for goods or services which prevents, restricts or distorts competition relates to—
- (i) the commissioning by NHS England or an integrated care board of health care 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) Where 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 NHS England, make such incidental or consequential modifications as the relevant authority considers necessary 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) must 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) In this section, a reference to modifying a condition includes a reference to amending, omitting or adding a condition.
Standard condition as to transparency of certain criteria
103
- (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) apply 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 and selection criteria”, in relation to a licence holder, means criteria for determining—
- (a) whether 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.
- (3) The following powers must not be exercised so as to omit the condition mentioned in subsection (1) from any licence under this Chapter—
- (a) the power conferred on NHS England by section 100 to modify the standard conditions applicable to all licences, or to licences of a particular description,
- (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and
- (c) the powers conferred by section 102 on the CMA and Secretary of State to modify those conditions or the conditions of a particular licence.
Enforcement
Power to require documents and information
104
- (1) NHS England 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) a 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 83 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 purposes of the NHS in breach of that requirement,
- (e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and
- (f) an integrated care board.
- (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 information, documents or records in legible form.
- (4) In this section “regulatory functions”, in relation to NHS England, has the meaning given by section 13SB(2) of the National Health Service Act 2006.
Discretionary requirements
105
- (1) NHS England may impose one or more discretionary requirements on a person if NHS England is satisfied 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 (see section 81),
- (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 licence, or
- (c) is in breach of a requirement imposed by NHS England under section 104.
- (2) In this Chapter, “discretionary requirement” means—
- (a) a requirement to pay a monetary penalty to NHS England of such amount as NHS England may determine (referred to in this Chapter as a “variable monetary penalty”),
- (b) a requirement to take such steps within such period as NHS England 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 NHS England may specify, 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) NHS England must not impose discretionary requirements on a person on more than 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 it 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.
Enforcement undertakings
106
- (1) NHS England may accept an enforcement undertaking from a person if NHS England has reasonable 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 service for the purposes of the NHS in breach of a condition of the licence, or
- (c) is in breach of a requirement imposed by NHS England under section 104.
- (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 specified 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 not 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) action of such a description as may be prescribed.
- (4) Where NHS England 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) NHS England may not impose on that person any discretionary requirement which it would otherwise have power to impose by virtue of section 105 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), NHS England may not revoke that person's licence under section 89(b).
- (5) Where a person from whom NHS England has accepted an enforcement undertaking has failed to comply fully with the undertaking but has complied with part of it, NHS England must take the partial compliance into account in deciding whether—
- (a) to impose a discretionary requirement on the person in respect of the breach 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 89(b).
Further provision about enforcement powers
107
Schedule 11 (Part 1 of which makes further provision about discretionary requirements and Part 2 of which makes further provision about enforcement undertakings) has effect.
Guidance as to use of enforcement powers
108
- (1) NHS England must publish guidance about how it intends to exercise its functions under sections 105 and 106 and Schedule 11.
- (2) NHS England may revise the guidance and, if it does so, must publish the guidance as revised.
- (3) NHS England must consult such persons as it considers appropriate before publishing or revising the guidance.
- (4) Guidance relating to NHS England’s functions under section 105 must include information about—
- (a) the circumstances in which NHS England is likely to impose a discretionary requirement,
- (b) the circumstances in which NHS England may not impose a discretionary requirement,
- (c) the matters likely to be taken into account by NHS England in determining the amount of any variable monetary penalty to be imposed (including, where relevant, any discounts for voluntary reporting of breaches in respect of which a penalty may be imposed), and
- (d) rights to make representations and rights of appeal.
- (5) NHS England must have regard to the guidance or (as the case may be) revised guidance in exercising its functions under sections 105 and 106 and Schedule 11.
Publication of enforcement action
109
- (1) NHS England must include information about the following in its annual report—
- (a) the cases in which a discretionary requirement has been imposed during the financial year to which the report relates, and
- (b) the cases in which an enforcement undertaking has been accepted during that financial year.
- (2) But NHS England must not include information which it is satisfied is—
- (a) commercial information the disclosure of which would, or might, significantly harm the legitimate business interests of the person to whom it relates;
- (b) information relating to the private affairs of an individual the disclosure of which would, or might, significantly harm that person's interests.
- (3) The reference in subsection (1)(a) to cases in which a discretionary requirement has been imposed does not include a reference to a case where a discretionary requirement has been imposed but overturned on appeal.
Notification of enforcement action
110
- (1) As soon as reasonably practicable after imposing a discretionary requirement or accepting an enforcement undertaking NHS England must notify the following of that fact—
- (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (b) such integrated care boards as are likely to be affected by the imposition of the requirement or the acceptance of the undertaking, and
- (c) any person exercising regulatory functions in relation to the person on whom the discretionary requirement was imposed or from whom the enforcement undertaking was accepted.
- (2) In subsection (1) “regulatory functions” has the same meaning as in the Legislative and Regulatory Reform Act 2006 (see section 32 of that Act).
Transitional provision
Imposition of licence conditions on NHS foundation trusts
111
- (1) Where NHS England is satisfied that the governance of an NHS foundation trust is such that the trust will fail to comply with the conditions of its licence, NHS England may include in the licence such conditions relating to governance as it considers appropriate for the purpose of reducing that risk.
- (2) The circumstances in which NHS England may be satisfied as mentioned in subsection (1) include circumstances where it is satisfied that the council of governors, the board of directors or the council of governors and board of directors taken together are failing—
- (a) to secure compliance with conditions in the trust’s licence, or
- (b) to take steps to reduce the risk of a breach of a condition in the trust’s licence.
- (2A) Where a warning notice under section 29A of the Health and Social Care Act 2008 is given to an NHS foundation trust, NHS England may include in the trust's licence such conditions as it considers appropriate in connection with the matters to which the notice relates.
- (3) A condition included under subsection (1) or (2A) has effect until this section ceases, by virtue of section 112, to have effect in relation to the trust.
- (4) NHS England may modify a condition included under subsection (1) or (2A).
- (5) Where NHS England is satisfied that the trust has breached or is breaching a condition included under subsection (1) or (2A), NHS England may by notice require the trust to—
- (a) remove one or more of the directors or members of the council of governors and appoint interim directors or members of the council;
- (b) suspend one or more of the directors or members of the council from office as a director or member for a specified period;
- (c) disqualify one or more of the directors or members of the council from holding office as a director or member for a specified period.
- (6) Where NHS England is satisfied that a person has failed or is failing to comply with a notice under subsection (5), NHS England may do one or more of the things which it may require the trust to do under that subsection.
- (7) Subsection (5) does not prevent NHS England from exercising in relation to a condition included in a licence under subsection (1) or (2A) the powers conferred by sections 105 and 106 (breach of licence condition etc: enforcement powers which apply during and after period in which this section and sections 112 to 114 have effect).
- (8) Where NHS England includes a condition under subsection (1) or (2A), it may also make such incidental or consequential modifications as it considers necessary or expedient of any other condition of the licence concerned which is affected.
- (9) Where NHS England includes a condition under subsection (1) or (2A) by modifying a standard condition of the licence concerned, the modification does not prevent any other part of the condition from continuing to be regarded as a standard condition for the purposes of this Chapter.
- (10) In this section, a reference to failing to discharge functions includes a reference to failing to discharge those functions properly.
- (11) Omit section 52 of the National Health Service Act 2006 (failing NHS foundation trusts); and in consequence of that, omit—
- (a) section 39(2)(f) of that Act (copy of notice under section 52 of that Act to be on register), and
- (b) paragraph 22(1)(f) of Schedule 7 to that Act (copy of that notice to be available for public inspection).
Duration of transitional period
112
- (1) Section 111 ceases to have effect in relation to an NHS foundation trust on such day as the Secretary of State may by order specify.
- (2) Different days may be appointed in relation to different NHS foundation trusts.
- (3) A day specified under subsection (1) must not—
- (a) in the case of an NHS foundation trust authorised on or before 1 April 2014, be before 1 April 2016;
- (b) in the case of an NHS foundation trust authorised after 1 April 2014, be before the end of the period of two years beginning with the day on which the trust was authorised.
- (4) In this section, a reference to being authorised is a reference to being given an authorisation under section 35 of the National Health Service Act 2006.
- (5) Section 111 is repealed as soon as there are—
- (a) no NHS foundation trusts in relation to which it has effect, and
- (b) no NHS trusts in existence ....
Orders under section 112: criteria for deciding applicable trusts
113
- (1) Where the Secretary of State proposes to make an order under section 112, the Secretary of State must notify NHS England.
- (2) NHS England, having received a notification under subsection (1), must set the criteria that are to be applied for the purpose of determining to which NHS foundation trusts the order should apply.
- (3) Before setting criteria under subsection (2), NHS England must—
- (a) consult the Care Quality Commission and such other persons as NHS England considers appropriate, and
- (b) obtain the approval of the Secretary of State.
- (4) If the Secretary of State approves the proposed criteria, NHS England must—
- (a) publish the criteria,
- (b) determine, by applying the criteria, to which trusts the order should apply,
- (c) notify the Secretary of State of its determination, and
- (d) publish a list of the trusts concerned.
- (5) If the Secretary of State does not approve the proposed criteria, NHS England must propose revised criteria; and subsections (3)(b) and (4) apply in relation to the proposed revised criteria as they apply in relation to the criteria previously proposed.
- (6) The Secretary of State, having received a notification under subsection (4)(c), must review NHS England’s determination under subsection (4)(b).
Repeal of sections 112 and 113
114
- (1) Sections 112 and 113 are repealed immediately after section 111 is repealed; and in consequence of that—
- (a) in section 67(2)(a), omit “or under sections 111 and 113 of this Act (imposition of licence conditions on NHS foundation trusts during transitional period)”,
- (b) omit section 67(3),
- (c) in section 87(4), after paragraph (a) insert “and”, and
- (d) in section 87(4), omit paragraph (c) and the preceding “and”.
- (2) This section is repealed immediately after sections 112 and 113 are repealed.
CHAPTER 4 — The NHS payment scheme
Price payable by commissioners for NHS services
115
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The national tariff
116
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The national tariff: further provision
117
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Consultation on proposals for the national tariff
118
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Consultation: further provision
119
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Responses to consultation
120
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Determination on reference under section 120
121
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Changes following determination on reference under section 120
122
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Power to veto changes proposed under section 122
123
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Local modifications of prices: agreements
124
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Local modifications of prices: applications
125
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Applications under section 125: notification of commissioners
126
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Correction of mistakes
127
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CHAPTER 5 — Health special administration
Health special administration orders
128
- (1) In this Chapter “health special administration order” means an order which—
- (a) is made by the court in relation to a relevant provider, and
- (b) directs that the affairs, business and property of the provider are to be managed by one or more persons appointed by the court.
- (2) An application to the court for a health special administration order may be made only by NHS England.
- (3) A person appointed as mentioned in subsection (1)(b) is referred to in this Chapter as a “health special administrator”.
- (4) A health special administrator of a company—
- (a) is an officer of the court, and
- (b) in exercising functions in relation to the company, is the company's agent.
- (5) A person is not to be the health special administrator of a company unless the person is qualified to act as an insolvency practitioner in relation to the company.
- (6) A health special administrator of a relevant provider must manage its affairs, business and property, and exercise the health special administrator's functions, so as to—
- (a) achieve the objective set out in section 129 as quickly and as efficiently as is reasonably practicable,
- (b) in seeking to achieve that objective, ensure that any regulated activity carried on in providing the services provided by the provider is carried on in accordance with any requirements or conditions imposed in respect of that activity by virtue of Chapter 2 of Part 1 of the Health and Social Care Act 2008,
- (c) so far as is consistent with the objective set out in section 129, protect the interests of the creditors of the provider as a whole, and
- (d) so far as is consistent with that objective and subject to those interests, protect the interests of the members of the provider as a whole.
- (7) In relation to a health special administration order applying to a non-GB company, references in this Chapter to the affairs, business and property of the company are references only to its affairs and business so far as carried on in Great Britain and to its property in Great Britain.
- (8) In this section—
- (a) a reference to a person qualified to act as an insolvency practitioner in relation to a company is to be construed in accordance with Part 13 of the Insolvency Act 1986 (insolvency practitioners and their qualifications);
- (b) “regulated activity” has the same meaning as in Part 1 of the Health and Social Care Act 2008 (see section 8 of that Act).
- (9) In this Chapter—
- “business” and “property” each have the same meaning as in the Insolvency Act 1986 (see section 436 of that Act);
- “company” includes a company not registered under the Companies Act 2006;
- “court”, in relation to a company, means the court—having jurisdiction to wind up the company, orthat would have such jurisdiction apart from section 221(2) or 441(2) of the Insolvency Act 1986 (exclusion of winding up jurisdiction in case of companies incorporated in, or having principal place of business in, Northern Ireland);
- “member” is to be read in accordance with section 250 of the Insolvency Act 1986;
- “non-GB company” means a company incorporated outside Great Britain;
- “relevant provider” means a company which is providing services to which a condition included in the company's licence under section 97(1)(i), (j) or (k) applies;
- “wholly-owned subsidiary” has the meaning given by section 1159 of the Companies Act 2006.
Objective of a health special administration
129
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