Health Bill

House of Commons

Session 2005 - 06
Internet Publications
Other Bills before Parliament

Health Bill

Health Bill
Part 2 — Prevention and Control of Health Care Associated Infections
13

(9)
In such a case subsection (1)—
(a)
does not apply in relation to that review so as to enable the
CHAI to serve a further improvement notice on that body in
respect of that failure; but
(b)
does apply in relation to that review so as to enable the CHAI (if
5
the conditions in subsections (1) and (2) are satisfied) to serve an
improvement notice on that body in respect of a different failure
to observe the code.
53B
Code of practice: action by CHAI following service of improvement
notice
10
(1)
This section applies where the CHAI has served an improvement notice
on a body under section 53A.
(2)
If, before the end of the specified period—
(a)
the body requests the CHAI to extend that period, and
(b)
the CHAI considers that there are exceptional circumstances
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which justify its extending that period by a further period of
time,

the CHAI may, by a notice served on the body, extend the specified
period by that further period.
(3)
In this section “the specified period” means—
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(a)
the period specified under section 53A(3)(c), or
(b)
if that period has been extended under subsection (2) above,
that period as so extended.
(4)
Where the specified period has ended or the body notifies the CHAI
before the end of that period that it has complied with the improvement
25
notice, the CHAI must—
(a)
conduct a review under section 52(3)(b) with a view to assessing
the body’s compliance with the notice, and
(b)
then comply with subsection (5) or (6);

and the making of any report in accordance with subsection (5) or (6) is
30
to be taken as satisfying the requirement to publish a report under
section 52(7) in respect of the review.
(5)
If the CHAI—
(a)
remains of the view that the relevant provisions of the code are
not being observed in any material respect in relation to the
35
provision of health care by or for the body, and
(b)
having regard to all the circumstances, is of the view that it is
required to make a report under section 53(2) (and, if relevant,
section 53(6)),

the CHAI must accordingly make a report under that provision (or, as
40
the case may be, under each of those provisions).
(6)
If the CHAI does not make any such report or reports, it must instead
make a report—
(a)
to the Secretary of State, and
(b)
(if the body is an NHS foundation trust) to the regulator,
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setting out the matters mentioned in subsection (7) or (8).

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
14

(7)
If the CHAI is of the view that the relevant provisions of the code are
being observed in relation to the provision of health care by or for the
body, the matters are—
(a)
that the CHAI is of that view, and
(b)
its reasons for that view.
5
(8)
If the CHAI is of the view that the relevant provisions of the code are
not being so observed in any respect (material or otherwise), the
matters are—
(a)
that the CHAI is of that view,
(b)
its reasons for that view,
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(c)
if its view is that those provisions are not being observed in any
material respect, its reasons for not forming the view mentioned
in subsection (5)(b), and
(d)
(whether or not paragraph (c) applies) any action which it
proposes to take in relation to the body in connection with the
15
failure to observe the code.
(9)
The CHAI must send a copy of any report made by it in accordance
with subsection (5) or (6) in relation to a Primary Care Trust or an NHS
trust to the relevant Strategic Health Authority.
(10)
In this section “the relevant provisions of the code” means the
20
provisions of the code in relation to which the CHAI formed the view
mentioned in section 53A(1)(a).”
Part 3
Drugs, Medicines and Pharmacies
Chapter 1
25
Supervision of management and use of controlled drugs
16
Accountable officers and their responsibilities as to controlled drugs
(1)
The relevant authority may by regulations make provision for or in connection
with requiring designated bodies to nominate or appoint persons who are to
have prescribed responsibilities in relation to the safe, appropriate and
30
effective management and use of controlled drugs in connection with—
(a)
activities carried on by or on behalf of the designated bodies, and
(b)
activities carried on by or on behalf of bodies or persons providing
services under arrangements made with the designated bodies.
(2)
The person who is to be so nominated or appointed by a designated body is to
35
be known as its accountable officer.

This is subject to any regulations made by virtue of subsection (5)(e).
(3)
In this Chapter “designated body” means—
(a)
a body falling within any description of bodies prescribed as
designated bodies for the purposes of this section, or
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(b)
a body prescribed as a responsible body for those purposes.
(4)
The bodies that may be prescribed as designated bodies for the purposes of this
section are bodies appearing to the relevant authority—

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
15

(a)
to be directly or indirectly concerned with the provision of health care
(whether or not for the purposes of the health service), or
(b)
to be otherwise carrying on activities that involve, or may involve, the
supply or administration of controlled drugs.
(5)
Regulations under this section may make provision—
5
(a)
for conditions that must be satisfied in relation to a person if he is to be
nominated or appointed by a designated body as the body’s
accountable officer;
(b)
for a single person to be nominated or appointed as the accountable
officer for each of two or more designated bodies where those bodies
10
are satisfied as to the prescribed matters;
(c)
requiring a designated body that has an accountable officer to provide
the officer with funds and other resources necessary for enabling the
officer to discharge his responsibilities as accountable officer for the
body;
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(d)
for ensuring that an accountable officer, in discharging his
responsibilities, has regard to best practice in relation to the use of
controlled drugs;
(e)
for the persons required to be nominated or appointed as mentioned in
subsection (1) to be known by such name as is prescribed;
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(f)
for making such amendments of any enactment as appear to the
relevant authority to be required in connection with any provision
made in pursuance of paragraph (e);
(g)
for creating offences punishable on summary conviction by a fine not
exceeding level 5 on the standard scale or for creating other procedures
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for enforcing any provisions of the regulations.
(6)
The responsibilities that may be imposed on a designated body’s accountable
officer by regulations under this section include responsibilities as to the
establishment and operation of arrangements for—
(a)
securing the safe management and use of controlled drugs;
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(b)
monitoring and auditing the management and use of such drugs;
(c)
ensuring that relevant individuals receive appropriate training and
that their training needs are regularly reviewed;
(d)
monitoring and assessing the performance of such individuals in
connection with the management or use of such drugs;
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(e)
making periodic inspections of premises used in connection with the
management or use of such drugs;
(f)
recording, assessing and investigating concerns expressed about
incidents that may have involved improper management or use of such
drugs;
40
(g)
ensuring that appropriate action is taken for the purpose of protecting
patients or members of the public in cases where such concerns appear
to be well-founded;
(h)
where required by regulations under section 17, the sharing of
information.
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(7)
The arrangements mentioned in subsection (6) may be arrangements
established (according to the circumstances)—
(a)
by the accountable officer,
(b)
by the designated body (or any of the designated bodies) for which he
is the accountable officer, or
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Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
16

(c)
by a body or person acting on behalf of, or providing services under
arrangements made with, the designated body (or any of the
designated bodies).
(8)
In subsection (6)—
(a)
references to the management or use of controlled drugs are to the
5
management or use of drugs in connection with activities carried on by
a body or person within subsection (7)(b) or (c), and
(b)
“relevant individual” means a person who, whether as—
(i)
a health care professional, or
(ii)
an employee who is not a health care professional, or
10
(iii)
otherwise,

is engaged in any activity carried on by a body or person within
subsection (7)(b) or (c) that involves, or may involve, the management
or use of controlled drugs.
(9)
A designated body may confer on its accountable officer such powers as it
15
thinks appropriate to enable him to discharge any of the responsibilities
imposed on him as accountable officer for the body by regulations under this
section.
(10)
Nothing in subsections (5) to (7) is to be read as prejudicing the generality of
subsection (1).
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(11)
In this section “prescribed” means prescribed by regulations under this section.
17
Co-operation between health bodies and other organisations
(1)
The relevant authority may by regulations make provision for or in connection
with requiring responsible bodies to co-operate with each other in connection
with—
25
(a)
the identification of cases in which action may need to be taken in
respect of matters arising in relation to the management or use of
controlled drugs by relevant individuals;
(b)
the consideration of issues relating to the taking of action in respect of
such matters;
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(c)
the taking of action in respect of such matters.
(2)
In this Chapter “responsible body” means—
(a)
a body falling within any description of bodies prescribed as
responsible bodies for the purposes of this section, or
(b)
a body prescribed as a responsible body for those purposes.
35
(3)
The bodies that may be prescribed as responsible bodies for the purposes of
this section are—
(a)
bodies which fall within subsection (4); and
(b)
police forces.
(4)
Bodies fall within this subsection if they appear to the relevant authority—
40
(a)
to be directly or indirectly concerned with the provision of health care
(whether or not for the purposes of the health service),
(b)
to be otherwise carrying on activities that involve, or may involve, the
supply or administration of controlled drugs,
(c)
to have powers of inspection in relation to the management or use of
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controlled drugs,

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
17

(d)
to be public or local authorities with responsibilities in relation to social
care, or
(e)
to be public or local authorities (not within paragraphs (a) to (d)) whose
responsibilities include responsibilities with respect to matters such as
are mentioned in subsection (1).
5
(5)
Regulations under this section may make provision—
(a)
for requiring a responsible body to disclose information to any other
such body or bodies in prescribed circumstances, or in circumstances
where it appears to the responsible body that the prescribed conditions
are satisfied, whether or not the disclosure of information has been
10
requested;
(b)
in relation to a responsible body which has an accountable officer, for
requiring disclosures to be made by or to that officer instead of by or to
the body;
(c)
in relation to a responsible body which is a police force, for imposing
15
duties on the chief officer;
(d)
for requiring a responsible body, in prescribed circumstances, to
consult the prescribed accountable officer in connection with any
requirement imposed on the body under the regulations;
(e)
for imposing duties on accountable officers in relation to the taking of
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action for the purpose of protecting the safety of patients or the general
public.
(6)
The duties that may be imposed on an accountable officer in pursuance of
subsection (5)(e) include a duty to make recommendations to a responsible
body as to any action which the officer considers that the body should take for
25
the purpose mentioned in that provision.
(7)
The action that may be so recommended includes action in relation to the
institution of disciplinary proceedings.
(8)
Nothing in subsections (5) to (7) is to be read as prejudicing the generality of
subsection (1).
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(9)
In this section—
(a)
“chief officer” means—
(i)
in relation to a police force in England and Wales, the chief
officer of police;
(ii)
in relation to a police force in Scotland, the chief constable;
35
(iii)
in relation to the Police Service of Northern Ireland or the Police
Service of Northern Ireland Reserve, the Chief Constable of the
Police Service of Northern Ireland;
(b)
“police force” means—
(i)
a police force in England, Wales or Scotland, or
40
(ii)
the Police Service of Northern Ireland or the Police Service of
Northern Ireland Reserve;
(c)
“prescribed” means prescribed by regulations under this section;
(d)
“relevant individual” means a person who, whether as—
(i)
a health care professional, or
45
(ii)
an employee who is not a health care professional, or
(iii)
otherwise,

is engaged in any activity carried on by a designated body, or by a body
or person acting on behalf of, or providing services under

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
18

arrangements made with, a designated body that involves, or may
involve, the management or use of controlled drugs.
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Controlled drugs: power to enter and inspect
(1)
A constable or an authorised person may, for the purpose of securing the safe,
appropriate and effective management and use of controlled drugs—
5
(a)
enter any relevant premises;
(b)
inspect any precautions taken on the premises for the safe custody of
controlled drugs;
(c)
inspect any stocks of controlled drugs kept on the premises;
(d)
require any relevant records kept on the premises to be produced for
10
his inspection.
(2)
The powers conferred by subsection (1) may be exercised only—
(a)
at a reasonable hour, and
(b)
on production (if required) of the written authority of the person
exercising them.
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(3)
The power conferred by subsection (1)(d) includes power—
(a)
to take copies of or extracts from relevant records, and
(b)
to take possession of any relevant records kept on the premises and
retain them for so long as the person exercising the power considers
necessary.
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(4)
In this section “authorised person” means (subject to subsection (5))—
(a)
a person authorised by the relevant authority,
(b)
an accountable officer, and
(c)
where a designated body is required by regulations under section 16 to
nominate or appoint an accountable officer, a member of the staff of the
25
designated body authorised by it.

Authorisations given under this subsection may be general or specific.
(5)
The accountable officer of a designated body of a description specified in
directions given by the relevant authority is not an authorised person for the
purposes of this section; and such a designated body may not authorise
30
members of its staff under subsection (4)(c).
(6)
The relevant authority may by regulations prescribe descriptions of premises
which are to be “relevant premises” for the purposes of subsection (1) in
relation to constables and authorised persons of descriptions prescribed in the
regulations.
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(7)
The premises that may be so prescribed are premises (or parts thereof)
appearing to the relevant authority to be used in connection with—
(a)
the provision of health care (whether or not for the purposes of the
health service), or
(b)
the supply or administration of controlled drugs.
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(8)
In this Chapter “relevant records” means records kept with respect to
controlled drugs in pursuance of regulations under section 10 of the Misuse of
Drugs Act 1971 (c. 38).

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
19

(9)
Directions under subsection (5) are to be given by regulations or in writing; but
any such directions which relate to more than one designated body are to be
given by regulations.
(10)
Directions under subsection (5) given in writing may be varied or revoked by
subsequent directions under that subsection.
5
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Offences in connection with power to enter and inspect
(1)
A person commits an offence if he—
(a)
intentionally obstructs a person in the exercise of his powers under
section 18(1),
(b)
conceals from a person acting under section 18(1) anything which that
10
person is entitled to inspect, or
(c)
without reasonable excuse fails to produce any relevant records which
a person acting under section 18(1) requires to be produced.
(2)
A person guilty of an offence under subsection (1) is liable—
(a)
on conviction on indictment, to imprisonment for a term not exceeding
15
two years or to a fine, or to both;
(b)
on summary conviction, to imprisonment for a term not exceeding 12
months or to a fine not exceeding the statutory maximum, or to both.
(3)
In the application of this section to Scotland and Northern Ireland, the
reference to 12 months in subsection (2)(b) is to be read as a reference to 6
20
months.
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Guidance
(1)
The relevant authority may issue guidance to designated bodies in connection
with—
(a)
determining whether conditions specified in regulations under section
25
16 have been satisfied in relation to the nomination or appointment of
a person as a designated body’s accountable officer;
(b)
the discharge by a designated body’s accountable officer of any
responsibilities imposed on him by regulations under section 16;
(c)
the exercise by designated bodies of their powers under section 16(9);
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(d)
the exercise by designated bodies of their powers under section
18(4)(c).
(2)
The relevant authority may issue guidance to responsible bodies in connection
with their discharge of any duties imposed on them by regulations under
section 17.
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(3)
Guidance under this section may make different provision for different cases
or circumstances.
(4)
Designated bodies and responsible bodies must have regard to any guidance
under this section in exercising any functions to which the guidance relates.
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Crown application
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(1)
This Chapter binds the Crown.