|
| |
|
(2) | The Health Protection Agency Act 2004 is repealed.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. |
| 5 |
47 | 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 |
| |
| 10 |
(c) | design appropriate procedures for testing biological substances, |
| |
(d) | provide or arrange for the provision of laboratory facilities for testing |
| |
| |
(e) | carry out tests on biological substances, |
| |
(f) | examine records kept in connection with the manufacture and quality |
| 15 |
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 |
| 20 |
appropriate in connection with the functions mentioned in paragraphs |
| |
| |
(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 |
| |
| 25 |
(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 |
| |
| |
(4) | The appropriate authority must co-operate with the person in the exercise of |
| |
| 30 |
(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. |
| |
| 35 |
“appropriate authority” means the Secretary of State and the Department |
| |
of Health, Social Services and Public Safety in Northern Ireland acting |
| |
| |
“biological substance” means a substance whose purity or potency |
| |
cannot, in the opinion of the Secretary of State, be adequately tested by |
| 40 |
| |
48 | Radiation 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 |
| |
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 |
| 5 |
arising from exposure to radiation; |
| |
| |
(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 |
| 10 |
facilitating, or incidental or conducive to, the exercise of any of its functions |
| |
| |
(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 |
| 15 |
respect of which a Health and Safety body has a function, the appropriate |
| |
| |
(a) | consult the body, and |
| |
(b) | have regard to the body’s policies. |
| |
(6) | Each of the following is a Health and Safety body— |
| 20 |
(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 |
| |
| |
(8) | In this section, “the appropriate authority” means— |
| 25 |
(a) | the Scottish Ministers to the extent that the functions are exercisable |
| |
within devolved competence (within the meaning of the Scotland Act |
| |
| |
(b) | the Department of Health, Social Services and Public Safety in |
| |
Northern Ireland to the extent that the functions relate to a transferred |
| 30 |
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, |
| 35 |
(b) | where the appropriate authority is the Scottish Ministers, the public in |
| |
| |
(c) | where the appropriate authority is the Department of Health, Social |
| |
Services and Public Safety in Northern Ireland, the public in Northern |
| |
| 40 |
(10) | This section does not apply in relation to England. |
| |
49 | Repeal 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)) is |
| |
| |
50 | Co-operation with bodies exercising functions in relation to public health |
| |
In Part 13 of the National Health Service Act 2006, before section 248 (and the |
| |
cross-heading preceding it) insert— |
| 5 |
“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 |
| |
similar to those of the Secretary of State under section 2A (whether or |
| |
not in relation to the United Kingdom). |
| 10 |
(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. |
| 15 |
(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.” |
| 20 |
| |
Economic regulation of health and adult social care services |
| |
| |
| |
| 25 |
(1) | The body corporate known as the Independent Regulator of NHS Foundation |
| |
| |
(a) | is to continue to exist, and |
| |
(b) | is to be known as Monitor. |
| |
(2) | Schedule 7 (which makes further provision about Monitor) has effect. |
| 30 |
| |
(1) | The main duty of Monitor in exercising its functions is to protect and promote |
| |
the interests of people who use health care services— |
| |
(a) | by promoting competition where appropriate, and |
| |
(b) | through regulation where necessary. |
| 35 |
(2) | In carrying out its main duty, Monitor must have regard in particular to the |
| |
likely future demand for health care services. |
| |
|
| |
|
| |
|
(3) | Monitor must, in exercising its functions, promote the economic, efficient and |
| |
effective provision of health care services for the purposes of the NHS. |
| |
(4) | 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). |
| 5 |
(5) | But nothing in this section 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. |
| |
(6) | A reference in this Part to health care services is a reference to the services to |
| |
which Monitor’s functions relate. |
| 10 |
(7) | “Health care” means all forms of health care provided for individuals, whether |
| |
relating to physical or mental health. |
| |
(8) | “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 |
| 15 |
that Act) of the Secretary of State or local authorities. |
| |
(9) | A reference in this Part to the provision of health care services for the purposes |
| |
of the NHS is a reference to their provision for those purposes in accordance |
| |
| |
53 | Power to give Monitor functions relating to adult social care services |
| 20 |
(1) | Regulations may provide for specified functions of Monitor also to be |
| |
exercisable in relation to adult social care services. |
| |
(2) | The regulations may amend this Part. |
| |
| |
(a) | includes all forms of personal care and other practical assistance |
| 25 |
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 |
| 30 |
and Skills is the registration authority under section 5 of the Care |
| |
| |
54 | Matters to have regard to in exercise of functions |
| |
In exercising its functions, Monitor must have regard to— |
| |
(a) | the need to maintain the safety of people who use health care services, |
| 35 |
(b) | the desirability of securing continuous improvement in the quality of |
| |
health care services for the purposes of the NHS, |
| |
(c) | the desirability of securing continuous improvement in the efficiency |
| |
with which health care services are provided for the purposes of the |
| |
| 40 |
(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 |
| |
purposes operates fairly, |
| |
|
| |
|
| |
|
(e) | the need for commissioners of health care services for the purposes of |
| |
the NHS to ensure that people who require health care services for |
| |
those purposes are provided with access to them, |
| |
(f) | the need for commissioners of health care services for the purposes of |
| |
the NHS make the best use of resources when doing so, |
| 5 |
(g) | the desirability of promoting investment by providers of health care |
| |
services for the purposes of the NHS in the provision of health care |
| |
services for those purposes, |
| |
(h) | the need to promote research into matters relevant to the NHS by |
| |
persons who provide health care services for the purposes of the NHS, |
| 10 |
(i) | the need for high standards in the education and training of health care |
| |
professionals who provide health care services for the purposes of the |
| |
| |
(j) | the manner in which the Secretary of State performs the duty under |
| |
section 1A(1) of the National Health Service Act 2006 (improvement in |
| 15 |
quality of services), and |
| |
(k) | the manner in which the National Health Service Commissioning |
| |
Board performs the duties under section 1D(3) of that Act |
| |
(commissioning of services), |
| |
(l) | the manner in which the National Health Service Commissioning |
| 20 |
Board performs the duty under section 13D(1) of that Act |
| |
(improvement in quality of services). |
| |
55 | Conflicts between functions |
| |
(1) | In a case where Monitor considers that any of its general duties conflict with |
| |
each other, it must secure that the conflict is resolved in the manner it considers |
| 25 |
| |
(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) |
| 30 |
or under sections 101 and 102 of this Act (designation of NHS |
| |
foundation trusts in transitional period), and |
| |
(b) | its exercise of any of its other functions. |
| |
(3) | Monitor must ignore the functions it has under sections 101 and 102 when |
| |
| 35 |
(a) | its functions under Chapter 2 (competition), |
| |
(b) | such of its functions under Chapter 4 (licensing) as relate to securing |
| |
the continued provision of designated services, or |
| |
(c) | its functions under Chapter 5 (pricing). |
| |
(4) | If Monitor secures the resolution of a conflict between its general duties in a |
| 40 |
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. |
| 45 |
(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; |
| 5 |
(e) | a major change in the standard conditions of licences under Chapter 4 |
| |
| |
(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 |
| 10 |
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 |
| 15 |
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 |
| |
| |
56 | Duty to review regulatory burdens |
| 20 |
(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 |
| 25 |
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— |
| 30 |
(a) | what it proposes to do pursuant to subsection (1) in the period to which |
| |
| |
(b) | what it has done pursuant to that subsection since publishing the |
| |
| |
(c) | where a burden relating to the exercise of the function which has |
| 35 |
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. |
| |
| |
(a) | must be published as soon as practicable after the commencement of |
| 40 |
| |
(b) | must relate to the period of 12 months beginning with the date of |
| |
| |
(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 |
| |
| |
(7) | Monitor must, in exercising its functions, have regard to the statement that is |
| 5 |
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. |
| |
57 | Duty to carry out impact assessments |
| |
(1) | This section applies where Monitor is proposing to do something that it |
| 10 |
| |
(a) | be likely to have a significant impact on persons who provide health |
| |
care services for the purposes of the NHS; |
| |
(b) | be likely to have a significant impact on people who use health care |
| |
services provided for the purposes of the NHS; |
| 15 |
(c) | be likely to have a significant impact on the general public in England |
| |
(or in a particular part of England); |
| |
(d) | be likely to involve a major change in the activities Monitor carries on; |
| |
(e) | be likely to involve a major change in the standard conditions of |
| |
licences under Chapter 4 (see section 87). |
| 20 |
(2) | But this section does not apply to— |
| |
(a) | the exercise of functions that Monitor has by virtue of section 60 or 61, |
| |
(b) | the carrying out by Monitor of an analysis of how markets involving |
| |
the provision of health care services are operating, or |
| |
(c) | the exercise of functions under Chapter 2. |
| 25 |
(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 |
| |
| 30 |
(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 55)— |
| |
(a) | would be secured by implementation of the proposal, but |
| 35 |
(b) | would not be secured by the exercise of functions that Monitor has by |
| |
virtue of section 60 or 61. |
| |
(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 |
| 40 |
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 notice is published under subsection (4). |
| 45 |
|
| |
|