Legislation – Health and Social Care Act 2012

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Introduction

PART 1
The health service in England

1 Secretary of State’s duty to promote comprehensive health service

2 The Secretary of State’s duty as to improvement in quality of services

3 The Secretary of State’s duty as to the NHS Constitution

4 The Secretary of State’s duty as to reducing inequalities

5 The Secretary of State’s duty as to promoting autonomy

6 The Secretary of State’s duty as to research

7 The Secretary of State’s duty as to education and training

8 Secretary of State’s duty as to reporting on and reviewing treatment of providers

9 The NHS Commissioning Board

10 Clinical commissioning groups

11 The Secretary of State’s duty as to protection of public health

12 Duties as to improvement of public health

13 Duties of clinical commissioning groups as to commissioning certain health services

14 Power of clinical commissioning groups as to commissioning certain health services

15 Power to require Board to commission certain health services

16 Secure psychiatric services

17 Other services etc. provided as part of the health service

18 Regulations as to the exercise by local authorities of certain public health functions

19 Regulations relating to EU obligations

20 Regulations as to the exercise of functions by the Board or clinical commissioning groups

21 Functions of Special Health Authorities

22 Exercise of public health functions of the Secretary of State

23 The NHS Commissioning Board: further provision

24 Financial arrangements for the Board

25 Clinical commissioning groups: establishment etc.

26 Clinical commissioning groups: general duties etc.

27 Financial arrangements for clinical commissioning groups

28 Requirement for primary medical services provider to belong to clinical commissioning group

29 Other health service functions of local authorities under the 2006 Act

30 Appointment of directors of public health

31 Exercise of public health functions of local authorities

32 Complaints about exercise of public health functions by local authorities

33 Abolition of Strategic Health Authorities

34 Abolition of Primary Care Trusts

35 Fluoridation of water supplies

36 Procedural requirements in connection with fluoridation of water supplies

37 Fluoridation of water supplies: transitional provision

38 Approval functions

39 Discharge of patients

40 After-care

41 Provision of pocket money for in-patients

42 Transfers to and from special hospitals

43 Independent mental health advocates

44 Patients’ correspondence

45 Notification of hospitals having arrangements for special cases

46 Role of the Board and clinical commissioning groups in respect of emergencies

47 Secretary of State’s emergency powers

48 New Special Health Authorities

49 Primary care services: directions as to exercise of functions

50 Charges in respect of certain public health functions

51 Pharmaceutical services expenditure

52 Secretary of State’s duty to keep health service functions under review

53 Secretary of State’s annual report

54 Certification of death

55 Amendments related to Part 1 and transitional provision

PART 2
Further provision about public health

56 Abolition of Health Protection Agency

57 Functions in relation to biological substances

58 Radiation protection functions

59 Repeal of AIDS (Control) Act 1987

60 Co-operation with bodies exercising functions in relation to public health

PART 3
Regulation of health and adult social care services

CHAPTER 1 Monitor

61 Monitor

62 General duties

63 Secretary of State’s guidance on duty under section 62(9)

64 General duties: supplementary

65 Power to give Monitor functions relating to adult social care services

66 Matters to have regard to in exercise of functions

67 Conflicts between functions

68 Duty to review regulatory burdens

69 Duty to carry out impact assessments

70 Information

71 Failure to perform functions

CHAPTER 2 Competition

72 Functions under the Competition Act 1998

73 Functions under Part 4 of the Enterprise Act 2002

74 Competition functions: supplementary

75 Requirements as to procurement, patient choice and competition

76 Requirements under section 75: investigations, declarations and directions

77 Requirements under section 75: undertakings

78 Guidance

79 Mergers involving NHS foundation trusts

80 Co-operation with the Office of Fair Trading

CHAPTER 3 Licensing

Licensing requirement

81 Requirement for health service providers to be licensed

82 Deemed breach of requirement to be licensed

83 Exemption regulations

84 Exemption regulations: supplementary

Licensing procedure

85 Application for licence

86 Licensing criteria

87 Grant or refusal of licence

88 Application and grant: NHS foundation trusts

89 Revocation of licence

90 Right to make representations

91 Notice of decisions

92 Appeals to the Tribunal

93 Register of licence holders

Licence conditions

94 Standard conditions

95 Special conditions

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

97 Conditions: supplementary

98 Conditions relating to the continuation of the provision of services etc.

99 Notification of commissioners where continuation of services at risk

100 Modification of standard conditions

101 Modification references to the Competition Commission

102 Modification of conditions by order under other enactments

103 Standard condition as to transparency of certain criteria

Enforcement

104 Power to require documents and information

105 Discretionary requirements

106 Enforcement undertakings

107 Further provision about enforcement powers

108 Guidance as to use of enforcement powers

109 Publication of enforcement action

110 Notification of enforcement action

Transitional provision

111 Imposition of licence conditions on NHS foundation trusts

112 Duration of transitional period

113 Orders under section 112: criteria for deciding applicable trusts

114 Repeal of sections 112 and 113

CHAPTER 4 Pricing

115 Price payable by commissioners for NHS services

116 The national tariff

117 The national tariff: further provision

118 Consultation on proposals for the national tariff

119 Consultation: further provision

120 Responses to consultation

121 Determination on reference under section 120

122 Changes following determination on reference under section 120

123 Power to veto changes proposed under section 122

124 Local modifications of prices: agreements

125 Local modifications of prices: applications

126 Applications under section 125: notification of commissioners

127 Correction of mistakes

CHAPTER 5 Health special administration

128 Health special administration orders

129 Objective of a health special administration

130 Health special administration regulations

131 Transfer schemes

132 Indemnities

133 Modification of this Chapter under Enterprise Act 2002

CHAPTER 6 Financial assistance in special administration cases

Establishment of mechanisms

134 Duty to establish mechanisms for providing financial assistance

135 Power to establish fund

Applications for financial assistance

136 Applications

137 Grants and loans

Charges on commissioners

138 Power to impose charges on commissioners

Levy on providers

139 Imposition of levy

140 Power of Secretary of State to set limit on levy and charges

141 Consultation

142 Responses to consultation

143 Amount payable

Supplementary

144 Investment principles and reviews

145 Borrowing

146 Shortfall or excess of available funds, etc.

CHAPTER 7 Miscellaneous and general

147 Secretary of State’s duty as respects variation in provision of health services

148 Service of documents

149 Electronic communications

150 Interpretation, transitional provision and consequential amendments

PART 4
NHS foundation trusts & NHS trusts

151 Governors

152 Directors

153 Members

154 Accounts: initial arrangements

155 Accounts: variations to initial arrangements

156 Annual report and forward plan

157 Meetings

158 Voting

159 Authorisation

160 Bodies which may apply for foundation trust status

161 Amendment of constitution

162 Panel for advising governors

163 Financial powers etc.

164 Goods and services

165 Private health care

166 Information

167 Significant transactions

168 Mergers

169 Acquisitions

170 Separations

171 Dissolution

172 Supplementary

173 Repeal of de-authorisation provisions

174 Trust special administrators

175 Objective of trust special administration

176 Procedure etc.

177 Action following final report

178 Sections 174 to 177: supplementary

179 Abolition of NHS trusts in England

180 Repeal of provisions on authorisation for NHS foundation trusts

PART 5
Public involvement and local government

CHAPTER 1 Public involvement

Healthwatch England

181 Healthwatch England

Local Healthwatch organisations

182 Activities relating to local care services

183 Local authority arrangements

184 Local arrangements: power to make further provision

185 Independent advocacy services

186 Requests, rights of entry and referrals

187 Annual reports

188 Transitional arrangements

189 Consequential provision

CHAPTER 2 Local government

Scrutiny functions of local authorities

190 Scrutiny functions of local authorities

191 Amendments consequential on section 190

Joint strategic needs assessments and strategies

192 Joint strategic needs assessments

193 Joint health and wellbeing strategies

Health and Wellbeing Boards: establishment

194 Establishment of Health and Wellbeing Boards

Health and Wellbeing Boards: functions

195 Duty to encourage integrated working

196 Other functions of Health and Wellbeing Boards

Health and Wellbeing Boards: supplementary

197 Participation of NHS Commissioning Board

198 Discharge of functions of Health and Wellbeing Boards

199 Supply of information to Health and Wellbeing Boards

Care Trusts

200 Care Trusts

CHAPTER 3 The Health Service Commissioner for England

201 Disclosure of reports etc. by the Health Service Commissioner

PART 6
Primary care services

202 Medical services: minor amendments

203 Persons eligible to enter into general dental services contracts

204 Arrangements under section 107 of the National Health Service Act 2006

205 Payments in respect of costs of sight tests

206 Pharmaceutical needs assessments

207 Control of entry on pharmaceutical lists

208 Lists of performers of pharmaceutical services and assistants etc.

PART 7
Regulation of health and social care workers

209 Power to regulate social workers etc. in England

210 Training etc. of approved mental health professionals in England

211 Orders regulating social care workers in England: further provision

212 Abolition of the General Social Care Council

213 Regulation of social workers in England

214 The Health and Care Professions Council

215 Functions of the Council in relation to social work in England

216 Appeals in cases involving social workers in England

217 Approval of courses for approved mental health professionals

218 Exercise of function of approving courses, etc.

219 Arrangements with other health or social care regulators

220 References in enactments to registered health professionals, etc.

221 Functions of the Secretary of State in relation to social care workers

222 The Professional Standards Authority for Health and Social Care

223 Functions of the Authority

224 Funding of the Authority

225 Power to advise regulatory bodies, investigate complaints, etc.

226 Accountability and governance

227 Appointments to regulatory bodies

228 Establishment of voluntary registers

229 Accreditation of voluntary registers

230 Consequential provisions and savings, etc.

231 Abolition of the Office of the Health Professions Adjudicator

PART 8
The National Institute for Health and Care Excellence

232 The National Institute for Health and Care Excellence

233 General duties

234 Quality standards

235 Supply of quality standards to other persons

236 Advice or guidance to the Secretary of State or the Board

237 Advice, guidance, information and recommendations

238 NICE recommendations: appeals

239 Training

240 Advisory services

241 Commissioning guidance

242 NICE’s charter

243 Additional functions

244 Arrangements with other bodies

245 Failure by NICE to discharge any of its functions

246 Protection from personal liability

247 Interpretation of this Part

248 Dissolution of predecessor body

249 Consequential and transitional provision

PART 9
Health and adult social care services: information

CHAPTER 1 Information standards

250 Powers to publish information standards

251 Information standards: supplementary

CHAPTER 2 The Health and Social Care Information Centre

Establishment and general duties

252 The Health and Social Care Information Centre

253 General duties

Functions: information systems

254 Powers to direct Information Centre to establish information systems

255 Powers to request Information Centre to establish information systems

256 Requests for collection under section 255: confidential information

257 Requests under section 255: supplementary

258 Information systems: supplementary

259 Powers to require and request provision of information

260 Publication of information

261 Other dissemination of information

262 Other dissemination: directions and requests under sections 254 and 255

263 Code of practice on confidential information

264 Information Register

265 Advice or guidance

Functions: quality of health and social care information

266 Assessment of quality of information

267 Power to establish accreditation scheme

Functions: other

268 Database of quality indicators

269 Power to confer functions in relation to identification of GPs

270 Additional functions

271 Arrangements with other bodies

272 Failure by Information Centre to discharge any of its functions

273 Protection from personal liability

General and supplementary

274 Powers of Secretary of State or Board to give directions

275 Interpretation of this Chapter

276 Dissolution of predecessor body

277 Consequential provision

PART 10
Abolition of certain public bodies etc

278 The Alcohol Education and Research Council

279 The Appointments Commission

280 The National Information Governance Board for Health and Social Care

281 The National Patient Safety Agency

282 The NHS Institute for Innovation and Improvement

283 Standing advisory committees

PART 11
Miscellaneous

284 Special notices of births and deaths

285 Provision of information by Registrar General

286 Provision of information by Registrar General: Wales

287 Provision of statistical information by Statistics Board

288 Monitor: duty to co-operate with Care Quality Commission

289 Care Quality Commission: duty to co-operate with Monitor

290 Other duties to co-operate

291 Breaches of duties to co-operate

292 Requirement for Secretary of State to approve remuneration policy etc.

293 Conduct of reviews etc.

294 Failure to discharge functions

295 Arrangements between the Board and Northern Ireland Ministers

296 Arrangements between the Board and Scottish Ministers etc.

297 Relationships between the health services

298 Advice or assistance to public authorities in the Isle of Man or Channel Islands

299 Certificate of consent of community patients to treatment

300 Transfer schemes

301 Transfer schemes: supplemental

302 Subsequent property transfer schemes

PART 12
Final provisions

303 Power to make consequential provision

304 Regulations, orders and directions

305 Financial provision

306 Commencement

307 Commencement: consultation with Scottish Ministers

308 Extent

309 Short title

SCHEDULES

SCHEDULE 1 The National Health Service Commissioning Board

SCHEDULE 2 Clinical commissioning groups

SCHEDULE 3 Pharmaceutical remuneration

SCHEDULE 4 Amendments of the National Health Service Act 2006

SCHEDULE 5 Part 1: amendments of other enactments

SCHEDULE 6 Part 1: transitional provision

SCHEDULE 7 Abolition of the Health Protection Agency: consequential amendments

SCHEDULE 8 Monitor

SCHEDULE 9 Requirements under section 77: undertakings

SCHEDULE 10 References by Monitor to the Competition Commission

SCHEDULE 11 Further provision about Monitor’s enforcement powers

SCHEDULE 12 Procedure on references under section 120

SCHEDULE 13 Part 3: minor and consequential amendments

SCHEDULE 14 Abolition of NHS trusts in England: consequential amendments

SCHEDULE 15 Part 7: consequential amendments and savings

SCHEDULE 16 The National Institute for Health and Care Excellence

SCHEDULE 17 Part 8: consequential amendments

SCHEDULE 18 The Health and Social Care Information Centre

SCHEDULE 19 Part 9: consequential amendments

SCHEDULE 20 Part 10: consequential amendments and savings

SCHEDULE 21 Amendments relating to relationships between the health services

SCHEDULE 22 Property transfer schemes

SCHEDULE 23 Staff transfer schemes

PART 3Regulation of health and adult social care services

CHAPTER 1Monitor

61Monitor

(1)

The body corporate known as the Independent Regulator of NHS Foundation Trusts—

(a)

is to continue to exist, and

(b)

is to be known as Monitor.

(2)

Schedule 8 (which makes further provision about Monitor) has effect.

62General duties

(1)

The main duty of Monitor in exercising its functions is to protect and promote the interests of people who use health care services by promoting provision of health care services which—

(a)

is economic, efficient and effective, and

(b)

maintains or improves the quality of the services.

(2)

In carrying out its main duty, Monitor must have regard to the likely future demand for health care services.

(3)

Monitor must exercise its functions with a view to preventing 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.

(4)

Monitor must exercise its functions with a view to enabling health care services provided for the purposes of the NHS to be provided in an integrated way where it considers that this would—

(a)

improve the quality of those services (including the outcomes that are achieved from their provision) or the efficiency of their provision,

(b)

reduce inequalities between persons with respect to their ability to access those services, or

(c)

reduce inequalities between persons with respect to the outcomes achieved for them by the provision of those services.

(5)

Monitor must exercise its functions with a view to 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 it considers that this would—

(a)

improve the quality of those health care services (including the outcomes that are achieved from their provision) or the efficiency of their provision,

(b)

reduce inequalities between persons with respect to their ability to access those health care services, or

(c)

reduce inequalities between persons with respect to the outcomes achieved for them by the provision of those health care services.

(6)

Monitor must, in carrying out its duties under subsections (4) and (5), have regard to the way in which—

(a)

the National Health Service Commissioning Board carries out its duties under section 13N of the National Health Service Act 2006, and

(b)

clinical commissioning groups carry out their duties under section 14Z1 of that Act.

(7)

Monitor must secure that people who use health care services, and other members of the public, are involved to an appropriate degree in decisions that Monitor makes about the exercise of its functions (other than decisions it makes about the exercise of its functions in a particular case).

(8)

Monitor must obtain advice appropriate for enabling it effectively to discharge its functions from persons who (taken together) have a broad range of professional expertise in—

(a)

the prevention, diagnosis or treatment of illness (within the meaning of the National Health Service Act 2006), and

(b)

the protection or improvement of public health.

(9)

Monitor must exercise its functions in a manner consistent with the performance by the Secretary of State of the duty under section 1(1) of the National Health Service Act 2006 (promotion of comprehensive health service).

(10)

Monitor must not exercise its functions for the purpose of causing a variation in the proportion of health care services provided for the purposes of the NHS that is provided by persons of a particular description if that description is by reference to—

(a)

whether the persons in question are in the public or (as the case may be) private sector, or

(b)

some other aspect of their status.

(11)

In this section—

“health-related services” means services that may have an effect on people’s health but are not health care services or social care services;

“social care services” means services that are provided in pursuance of the social services functions of local authorities (within the meaning of the Local Authority Social Services Act 1970).

63Secretary of State’s guidance on duty under section 62(9)

(1)

The Secretary of State may, for the purpose of assisting Monitor to comply with its duty under section 62(9), publish guidance on—

(a)

the objectives specified in the mandate published under section 13A of the National Health Service Act 2006 which the Secretary of State considers to be relevant to Monitor’s exercise of its functions, and

(b)

the Secretary of State’s reasons for considering those objectives to be relevant to Monitor’s exercise of its functions.

(2)

In exercising its functions, Monitor must have regard to guidance under subsection (1).

(3)

Where the Secretary of State publishes guidance under subsection (1), the Secretary of State must lay a copy of the published guidance before Parliament.

(4)

The Secretary of State—

(a)

may revise guidance under subsection (1), and

(b)

if the Secretary of State does so, must publish the guidance as revised and lay it before Parliament.

64General duties: supplementary

(1)

This section applies for the purposes of this Part.

(2)

“Anti-competitive behaviour” means behaviour which would (or would be likely to) prevent, restrict or distort competition and a reference to preventing anti-competitive behaviour includes a reference to eliminating or reducing the effects (or potential effects) of the behaviour.

(3)

“Health care” means all forms of health care provided for individuals, whether relating to physical or mental health, with a reference in this Part to health care services being read accordingly; and for the purposes of this Part it does not matter if a health care service is also an adult social care service (as to which, see section 65).

(4)

“The NHS” means the comprehensive health service continued under section 1(1) of the National Health Service Act 2006, except the part of it that is provided in pursuance of the public health functions (within the meaning of that Act) of the Secretary of State or local authorities.

(5)

A reference to the provision of health care services for the purposes of the NHS is a reference to their provision for those purposes in accordance with that Act.

(6)

Nothing in section 62 requires Monitor to do anything in relation to the supply to persons who provide health care services of goods that are to be provided as part of those services.

65Power to give Monitor functions relating to adult social care services

(1)

Regulations may provide for specified functions of Monitor also to be exercisable in relation to adult social care services.

(2)

Any regulations under this section must apply in relation to England only.

(3)

The regulations may amend this Part.

(4)

“Adult social care”—

(a)

includes all forms of personal care and other practical assistance provided for individuals who, by reason of age, illness, disability, pregnancy, childbirth, dependence on alcohol or drugs, or any other similar circumstances, are in need of such care or other assistance, but

(b)

does not include anything provided by an establishment or agency for which Her Majesty’s Chief Inspector of Education, Children’s Services and Skills is the registration authority under section 5 of the Care Standards Act 2000.

66Matters to have regard to in exercise of functions

(1)

In exercising its functions, Monitor must have regard, in particular, to the need to maintain the safety of people who use health care services.

(2)

Monitor must, in exercising its functions, also have regard to the following matters in so far as they are consistent with the matter referred to in subsection (1)—

(a)

the desirability of securing continuous improvement in the quality of health care services provided for the purposes of the NHS and in the efficiency of their provision,

(b)

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

(c)

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

(d)

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

(e)

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

(f)

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

(g)

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

(h)

where the Secretary of State publishes a document for the purposes of section 13E of the National Health Service Act 2006 (improvement of quality of services), any guidance published by the Secretary of State on the parts of that document which the Secretary of State considers to be particularly relevant to Monitor’s exercise of its functions.

(3)

Where the Secretary of State publishes guidance referred to in subsection (2)(h), the Secretary of State must lay a copy of the published guidance before Parliament.

(4)

The Secretary of State—

(a)

may revise the guidance, and

(b)

if the Secretary of State does so, must publish the guidance as revised and lay it before Parliament.

67Conflicts between functions

(1)

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

(2)

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

(a)

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

(b)

its exercise of any of its other functions.

(3)

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

(a)

its functions under Chapter 2 (competition);

(b)

its functions under Chapter 4 (pricing).

(4)

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

(a)

the nature of the conflict,

(b)

the manner in which it decided to resolve it, and

(c)

its reasons for deciding to resolve it in that manner.

(5)

A case comes within this subsection if it involves—

(a)

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

(b)

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

(c)

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

(d)

a major change in the activities Monitor carries on;

(e)

a major change in the standard conditions of licences under Chapter 3 (see section 94).

(6)

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

(7)

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

(8)

Every annual report of Monitor must include—

(a)

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

(b)

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

(9)

Monitor’s general duties for the purposes of this section are its duties under sections 62 and 66.

68Duty to review regulatory burdens

(1)

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

(a)

impose burdens which it considers to be unnecessary, or

(b)

maintain burdens which it considers to have become unnecessary.

(2)

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

(3)

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

(4)

Monitor must from time to time publish a statement setting out—

(a)

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

(b)

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

(c)

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

(5)

The first statement—

(a)

must be published as soon as practicable after the commencement of this section, and

(b)

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

(6)

A subsequent statement—

(a)

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

(b)

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

(7)

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

(8)

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

69Duty to carry out impact assessments

(1)

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

(a)

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

(b)

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

(c)

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

(d)

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

(e)

to involve a major change in the standard conditions of licences under Chapter 3 (see section 94).

(2)

But this section does not apply to—

(a)

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

(b)

the exercise of functions under or by virtue of Chapter 2.

(3)

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

(4)

Before implementing the proposal, Monitor must either—

(a)

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

(b)

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

(5)

The assessment must set out Monitor’s explanation of how the discharge of its general duties (within the meaning of section 67)—

(a)

would be secured by implementation of the proposal, but

(b)

would not be secured by the exercise of functions that Monitor has by virtue of section 72 or 73.

(6)

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

(7)

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

(8)

Monitor may not implement the proposal unless the consultation period has ended.

(9)

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

(a)

are in addition to the other requirement, but

(b)

may be met contemporaneously with it.

(10)

Every annual report of Monitor must set out—

(a)

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

(b)

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

70Information

(1)

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

(2)

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

(3)

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

71Failure to perform functions

(1)

This section applies if the Secretary of State considers that Monitor is failing, or has failed, to perform any function of Monitor’s, other than a function it has by virtue of section 72 or 73, and that the failure is significant.

(2)

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

(3)

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

(4)

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

(a)

perform the functions to which the direction relates, or

(b)

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

(5)

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

(6)

For the purposes of this section—

(a)

a failure to perform a function includes a failure to perform it properly, and

(b)

a failure to perform a function properly includes a failure to perform it consistently with what the Secretary of State considers to be the interests of the health service in England or (as the case may be) with what otherwise appears to the Secretary of State to be the purpose for which it is conferred; and “the health service” has the same meaning as in the National Health Service Act 2006.