Health Bill

House of Commons

Session 2005 - 06
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Other Bills before Parliament

Health Bill

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

(g)
for creating offences punishable on summary conviction by a fine not
exceeding level 5 on the standard scale or for creating other procedures
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
5
establishment and operation of arrangements for—
(a)
securing the safe management and use of controlled drugs;
(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;
10
(d)
monitoring and assessing the performance of such individuals in
connection with the management or use of such drugs;
(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
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incidents that may have involved improper management or use of such
drugs;
(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;
20
(h)
where required by regulations under section 17, the sharing of
information.
(7)
The arrangements mentioned in subsection (6) may be arrangements
established (according to the circumstances)—
(a)
by the accountable officer,
25
(b)
by the designated body (or any of the designated bodies) for which he
is the accountable officer, or
(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).
30
(8)
In subsection (6)—
(a)
references to the management or use of controlled drugs are to the
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—
35
(i)
a health care professional, or
(ii)
an employee who is not a health care professional, or
(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
40
or use of controlled drugs.
(9)
A designated body may confer on its accountable officer such powers as it
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.
45
(10)
Nothing in subsections (5) to (7) is to be read as prejudicing the generality of
subsection (1).
(11)
In this section “prescribed” means prescribed by regulations under this section.

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
16

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—
(a)
the identification of cases in which action may need to be taken in
5
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;
(c)
the taking of action in respect of such matters.
10
(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.
(3)
The bodies that may be prescribed as responsible bodies for the purposes of
15
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—
(a)
to be directly or indirectly concerned with the provision of health care
20
(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
controlled drugs,
25
(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).
30
(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
35
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
40
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
45
action for the purpose of protecting the safety of patients or the general
public.

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

(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
the purpose mentioned in that provision.
(7)
The action that may be so recommended includes action in relation to the
5
institution of disciplinary proceedings.
(8)
Nothing in subsections (5) to (7) is to be read as prejudicing the generality of
subsection (1).
(9)
In this section—
(a)
“chief officer” means—
10
(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;
(iii)
in relation to the Police Service of Northern Ireland or the Police
Service of Northern Ireland Reserve, the Chief Constable of the
15
Police Service of Northern Ireland;
(b)
“police force” means—
(i)
a police force in England, Wales or Scotland, or
(ii)
the Police Service of Northern Ireland or the Police Service of
Northern Ireland Reserve;
20
(c)
“prescribed” means prescribed by regulations under this section;
(d)
“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
(iii)
otherwise,
25

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
arrangements made with, a designated body that involves, or may
involve, the management or use of controlled drugs.
18
Controlled drugs: power to enter and inspect
30
(1)
A constable or an authorised person may, for the purpose of securing the safe,
appropriate and effective management and use of controlled drugs—
(a)
enter any relevant premises;
(b)
inspect any precautions taken on the premises for the safe custody of
controlled drugs;
35
(c)
inspect any stocks of controlled drugs kept on the premises;
(d)
require any relevant records kept on the premises to be produced for
his inspection.
(2)
The powers conferred by subsection (1) may be exercised only—
(a)
at a reasonable hour, and
40
(b)
on production (if required) of the written authority of the person
exercising them.
(3)
The power conferred by subsection (1)(d) includes power—
(a)
to take copies of or extracts from relevant records, and

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

(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.
(4)
In this section “authorised person” means (subject to subsection (5))—
(a)
a person authorised by the relevant authority,
5
(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
designated body authorised by it.

Authorisations given under this subsection may be general or specific.
10
(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
members of its staff under subsection (4)(c).
(6)
The relevant authority may by regulations prescribe descriptions of premises
15
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.
(7)
The premises that may be so prescribed are premises (or parts thereof)
appearing to the relevant authority to be used in connection with—
20
(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.
(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
25
Drugs Act 1971 (c. 38).
(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
30
subsequent directions under that subsection.
19
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),
35
(b)
conceals from a person acting under section 18(1) anything which that
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—
40
(a)
on conviction on indictment, to imprisonment for a term not exceeding
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.

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

(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
months.
20
Guidance
(1)
The relevant authority may issue guidance to designated bodies in connection
5
with—
(a)
determining whether conditions specified in regulations under section
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
10
responsibilities imposed on him by regulations under section 16;
(c)
the exercise by designated bodies of their powers under section 16(9);
(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
15
with their discharge of any duties imposed on them by regulations under
section 17.
(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
20
under this section in exercising any functions to which the guidance relates.
21
Crown application
(1)
This Chapter binds the Crown.
(2)
No contravention by the Crown of any provision of this Chapter shall make the
Crown criminally liable; but the High Court (or, in Scotland, the Court of
25
Session) may declare unlawful any act or omission of the Crown which
constitutes such a contravention.
(3)
The provisions of this Chapter apply to persons in the public service of the
Crown as they apply to other persons.
22
Relevant authorities
30
(1)
This section applies to functions conferred on the relevant authority by this
Chapter.
(2)
Subject to subsection (4), any functions to which this section applies are
exercisable in relation to England by the Secretary of State.
(3)
Subject to subsection (4), any functions to which this section applies are
35
exercisable in relation to Wales by the National Assembly for Wales.
(4)
Any power of the relevant authority to make regulations under this Chapter is
exercisable in relation to cross-border bodies by the Secretary of State after
consultation with the Assembly.
(5)
A “cross-border body” is a body which—
40
(a)
performs (and only performs) functions in respect of England and
Wales, and

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
20

(b)
does not perform functions mainly in respect of England or mainly in
respect of Wales.
(6)
Any functions to which this section applies are exercisable in relation to
Scotland by the Secretary of State after consultation with the Scottish Ministers.
(7)
Any functions to which this section applies are exercisable in relation to
5
Northern Ireland by the Department of Health, Social Services and Public
Safety.
23
Interpretation
(1)
In this Chapter—
“accountable officer” is to be read in accordance with section 16(2);
10
“body” includes an unincorporated association;
“controlled drug” has the meaning given by section 2 of the Misuse of
Drugs Act 1971 (c. 38);
“designated body” has the meaning given by section 16(3);
“health care” means—
15
(a)
services provided to individuals for or in connection with the
prevention, diagnosis or treatment of illness, and
(b)
the promotion and protection of public health;
“health care professional”—
(a)
in relation to England and Wales, has the meaning given by
20
section 28X(3)(a) of the National Health Service Act 1977 (c. 49)
(referred to in this Act as “the 1977 Act”),
(b)
in relation to Scotland, has the meaning given by section 17D(2)
of the National Health Service (Scotland) Act 1978 (c. 29), and
(c)
in relation to Northern Ireland, has the meaning given by
25
Article 15C of the Health and Personal Social Services
(Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I. 14));
“illness”—
(a)
in relation to England and Wales, has the meaning given by
section 128(1) of the 1977 Act,
30
(b)
in relation to Scotland, has the meaning given by section 108(1)
of the National Health Service (Scotland) Act 1978, and
(c)
in relation to Northern Ireland, has the meaning given by
Article 2(2) of the Health and Personal Social Services (Northern
Ireland) Order 1972;
35
“relevant authority” is to be read in accordance with section 22;
“relevant records” has the meaning given by section 18(8);
“responsible body” has the meaning given by section 17(2).
(2)
In this Chapter any reference to the management or use of controlled drugs
includes—
40
(a)
the storage, carriage and safe custody of such drugs,
(b)
the prescribing and supply of such drugs,
(c)
the administration of such drugs,
(d)
the recovery of such drugs when no longer needed, and
(e)
the disposal of such drugs.
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Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 2 — Medicines and pharmacies
21

Chapter 2
Medicines and pharmacies
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Requirements about supervision
(1)
In section 10 of the Medicines Act 1968 (c. 67) (which provides for exemptions
for pharmacists in relation to certain dealings with medicinal products), after
5
subsection (7) insert—
“(7A)
The Health Ministers may make regulations prescribing conditions
which must be complied with if a thing is to be considered for the
purposes of this section as done under the supervision of a pharmacist.
(7B)
Compliance with the applicable conditions is sufficient for the thing to
10
be so considered.
(7C)
Conditions prescribed under subsection (7A) may relate to supervision
in the case where the pharmacist is not at the place where the thing is
being done.”
(2)
In section 52 of that Act (sale or supply of medicines not on general sale list)—
15
(a)
the existing text is to be subsection (1),
(b)
after that subsection insert—
“(2)
The Health Ministers may make regulations prescribing
conditions which must be complied with if a transaction
mentioned in subsection (1)(c) is to be considered for the
20
purposes of this section as done under the supervision of a
pharmacist.
(3)
Compliance with the applicable conditions is sufficient for the
transaction to be so considered.
(4)
Conditions prescribed under subsection (2) may relate to
25
supervision in the case where the pharmacist is not on the
premises.”
25
Control of pharmacy premises: individuals and partnerships
(1)
For section 70 of the Medicines Act 1968 (pharmacy business carried on by
individual pharmacist or by partners) substitute—
30
“70
Business carried on by individual pharmacist or by partners
(1)
The conditions referred to in section 69(1)(a) of this Act are that
subsections (2) and (3) of this section are both satisfied as respects each
of the premises where the retail pharmacy business is carried on and
medicinal products, other than medicinal products on a general sale
35
list, are sold by retail.
(2)
This subsection is satisfied if a responsible pharmacist who satisfies the
requirements of subsections (4) and (5) of this section is in charge of the
business at those premises, so far as concerns—
(a)
the retail sale at those premises of medicinal products (whether
40
they are on a general sale list or not), and