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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

15

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,

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(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).

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(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

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(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;

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(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;

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(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

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(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.

45

 
 

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 2 — Medicines and pharmacies

21

 

Chapter 2

Medicines and pharmacies

24      

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

 
 

 
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Revised 27 October 2005