Health and Social Care Bill (HC Bill 221)

(2) After Schedule 12 to that Act insert the Schedule set out in Schedule 3 to this
Act.

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

In Part 13 of the National Health Service Act 2006, before section 248 (and the
5cross-heading preceding it) insert—

“Duty to keep under review

247B Secretary of State’s duty to keep health service functions under review

(1) The Secretary of State must keep under review the effectiveness of the
10exercise 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) 15the Care Quality Commission;

(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
20247C 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.”

49 Secretary of State’s annual report

In Part 13 of the National Health Service Act 2006 before section 248 (and the
25cross-heading preceding it) insert—

“Annual report

247C Secretary of State’s annual report

(1) The Secretary of State must publish an annual report on the
performance of the health service in England.

(2) 30The Secretary of State must lay any report prepared under this section
before Parliament.”

50 Certification of death

(1) Chapter 2 of Part 1 of the Coroners and Justice Act 2009 (notification,
certification and registration of deaths) is amended as follows.

(2) 35In section 19 (medical examiners)—

(a) in subsection (1) for “Primary Care Trusts” substitute “Local
authorities”,

(b) in subsection (2) for “Trust” (in each place where it occurs) substitute
“local authority”, and

(c) in subsection (5) for “a Primary Care Trust” substitute “a local
authority”.

(3) 5In section 20 (medical certificate of cause of death), in subsection (5) for
“Primary Care Trust” substitute “local authority”.

51 Amendments related to Part 1 and transitional provision

(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) 10Schedule 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 15Further provision about public health

52 Abolition of Health Protection Agency

(1) The Health Protection Agency is abolished.

(2) The Health Protection Agency Act 2004 is repealed.

(3) Subsection (2) does not apply to—

(a) 20paragraph 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.

53 25 Functions in relation to biological substances

(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) 30design 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
35control 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
40appropriate 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
5those 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
10the 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) In this section—

• “appropriate authority” means the Secretary of State and the Department
  15of Health, Social Services and Public Safety in Northern Ireland acting
  jointly;

• “biological substance” means a substance whose purity or potency
  cannot, in the opinion of the Secretary of State, be adequately tested by
  chemical means.

54 20Radiation protection functions

(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
25considers 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) 30providing 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) 35The 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) 40consult 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.

(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
5within 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) 10the 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
15Scotland, 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.

55 20Repeal of AIDS (Control) Act 1987

(1) The AIDS (Control) Act 1987 is repealed.

(2) The AIDS (Control) (Northern Ireland) Order 1987 (S.I. 1987/1832 (N.I. 18)S.I. 1987/1832 (N.I. 18)) is
revoked.

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

(1) 25In Part 13 of the National Health Service Act 2006, before section 248 (and the
cross-heading preceding it) insert—

“Co-operation in relation to public health functions

247A Co-operation in relation to public health functions

(1) This section applies to any body or other person that exercises functions
30similar 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
35body 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
40the 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 247A (co-operation in relation to public health
functions),”.

5Part 3 Regulation of health and adult social care services

CHAPTER 1 Monitor

57 Monitor

(1) The body corporate known as the Independent Regulator of NHS Foundation
10Trusts—

(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.

58 General duties

(1) 15The 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) 20In 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) 25Monitor 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) 30reduce 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
35health 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
40their 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) 5Monitor 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 13M of the National Health Service Act 2006, and

(b) commissioning consortia carry out their duties under section 14Y of
10that 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) 15Monitor 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) 20the 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
25in 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) 30some 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
  35social services functions of local authorities (within the meaning of the
  Local Authority Social Services Act 1970).

59 General duties: supplementary

(1) This section applies for the purposes of this Part.

(2) “Anti-competitive behaviour” means behaviour which would (or would be
40likely 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
45services 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 60).

(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
5provided 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 58 requires Monitor to do anything in relation to the supply
10to persons who provide health care services of goods that are to be provided as
part of those services.

60 Power 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) 15The regulations may amend this Part.

(3) “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
20similar 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.

61 25Matters to have regard to in exercise of functions

In exercising its functions, Monitor must have regard to—

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

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

(c) 30the desirability of securing continuous improvement in the efficiency
with which health care services are provided for the purposes of the
NHS,

(d) the need for commissioners of health care services for the purposes of
the NHS to ensure that the provision of access to the services for those
35purposes operates fairly,

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

(f) the need for commissioners of health care services for the purposes of
40the NHS to make the best use of resources when doing so,

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

(h) the desirability of promoting investment by persons who provide
45health care services for the purposes of the NHS in the provision of
health care services for those purposes,

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

(j) the need for high standards in the education and training of health care
professionals who provide health care services for the purposes of the
5NHS,

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

(l) the manner in which the National Health Service Commissioning
10Board performs the duties under section 1E(3) of that Act
(commissioning of services), and

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

62 15Conflicts 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
20regarded 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 116 and 117 of this Act (designation of NHS
foundation trusts in transitional period) or under paragraph 17 of
25Schedule 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 116 and 117 when
exercising—

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

(b) 30such of its functions under Chapter 4 (licensing) as relate to securing
the continued provision of designated services;

(c) its functions under Chapter 5 (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
35unusual 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) 40a 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
45England (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 4
(see section 101).

(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) 5The 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) 10a 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 58 and 61.

63 15Duty 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) 20In 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) 25Monitor 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) 30where 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) 35must 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) 40must 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.

64 5Duty 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) 10to 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) 15to involve a major change in the standard conditions of licences under
Chapter 4 (see section 101).

(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) 20the 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
25implementation, 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 62)—

(a) 30would 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 67 or 68.

(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
35relate, 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
40with 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.