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Health Bill


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

20

 

(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

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

5

Crown as they apply to other persons.

22      

Relevant authorities

(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

10

exercisable in relation to England by the Secretary of State.

(3)   

Subject to subsection (4), any functions to which this section applies are

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

15

consultation with the Assembly.

(5)   

A “cross-border body” is a body which—

(a)   

performs (and only performs) functions in respect of England and

Wales, and

(b)   

does not perform functions mainly in respect of England or mainly in

20

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

Northern Ireland by the Department of Health, Social Services and Public

25

Safety.

23      

Interpretation

(1)   

In this Chapter—

“accountable officer” is to be read in accordance with section 16(2);

“body” includes an unincorporated association;

30

“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—

(a)   

services provided to individuals for or in connection with the

35

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

section 28X(3)(a) of the National Health Service Act 1977 (c. 49)

40

(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

 
 

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

21

 

(c)   

in relation to Northern Ireland, has the meaning given by

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

5

section 128(1) of the 1977 Act,

(b)   

in relation to Scotland, has the meaning given by section 108(1)

of the National Health Service (Scotland) Act 1978 (c. 29), and

(c)   

in relation to Northern Ireland, has the meaning given by

Article 2(2) of the Health and Personal Social Services (Northern

10

Ireland) Order 1972;

“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

15

includes—

(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

20

(e)   

the disposal of such drugs.

Chapter 2

Medicines and pharmacies

24      

Requirements about supervision

(1)   

In section 10 of the Medicines Act 1968 (c. 67) (which provides for exemptions

25

for pharmacists in relation to certain dealings with medicinal products), after

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.

30

(7B)   

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, and in that case the thing is not to be so considered if no

such conditions are prescribed.

(7C)   

In any case, compliance with any applicable conditions is sufficient for

35

the thing to be so considered.”

(2)   

In section 52 of that Act (sale or supply of medicines not on general sale list)—

(a)   

the existing text is to be subsection (1),

(b)   

after that subsection insert—

“(2)   

The Health Ministers may make regulations prescribing

40

conditions which must be complied with if a transaction

mentioned in subsection (1)(c) is to be considered for the

purposes of this section as done under the supervision of a

pharmacist.

 
 

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

22

 

(3)   

Conditions prescribed under subsection (2) may relate to

supervision in the case where the pharmacist is not on the

premises, and in that case the transaction is not to be so

considered if no such conditions are prescribed.

(4)   

In any case, compliance with any applicable conditions is

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sufficient for the transaction to be so considered.”

25      

Control of pharmacy premises: individuals and partnerships

(1)   

For section 70 of the Medicines Act 1968 (c. 67) (pharmacy business carried on

by individual pharmacist or by partners) substitute—

“70     

Business carried on by individual pharmacist or by partners

10

(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

list, are sold by retail.

15

(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

they are on a general sale list or not), and

20

(b)   

the supply at those premises of such products in circumstances

corresponding to retail sale.

(3)   

This subsection is satisfied if a notice is conspicuously displayed at

those premises stating—

(a)   

the name of the responsible pharmacist for the time being,

25

(b)   

the number of his registration under the Pharmacy Act 1954 or

(in relation to Northern Ireland) the Pharmacy (Northern

Ireland) Order 1976, and

(c)   

the fact that he is for the time being in charge of the business at

those premises.

30

(4)   

The responsible pharmacist must be—

(a)   

the person carrying on the business, or

(b)   

if the business is carried on by a partnership, one of the partners

or, in Scotland, one of the partners who is a pharmacist, or

(c)   

another pharmacist.

35

(5)   

In relation to premises in Great Britain that have been registered

pharmacies for less than three years, the responsible pharmacist may

not be a person who is a pharmacist by virtue of section 4A of the

Pharmacy Act 1954 (qualification by European diploma) or any

corresponding provision applying to Northern Ireland.”

40

(2)   

In section 78 of the Medicines Act 1968 (restrictions on use of titles, descriptions

and emblems), in subsection (7), for the words from “under whose” to the end

substitute “who is in charge of the business at those premises (so far as

concerns the retail sale of medicinal products or the supply of such products in

circumstances corresponding to retail sale) is also a pharmacist”.

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

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26      

Control of pharmacy premises: bodies corporate

(1)   

For section 71 of the Medicines Act 1968 (c. 67) (pharmacy business carried on

by body corporate) substitute—

“71     

Business carried on by body corporate

(1)   

The conditions referred to in section 69(1)(b) of this Act are—

5

(a)   

that the retail pharmacy business, so far as concerns the

keeping, preparing and dispensing of medicinal products other

than medicinal products on a general sale list, is under the

management of a superintendent in respect of whom the

requirements specified in subsection (6) of this section are

10

fulfilled, and

(b)   

that subsections (2) and (3) of this section are both satisfied as

respects each of the premises where the business is carried on

and medicinal products, other than medicinal products on a

general sale list, are sold by retail.

15

(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 the premises mentioned in subsection (1)(b) of this section,

so far as concerns—

(a)   

the retail sale at those premises of medicinal products (whether

20

they are on a general sale list or not), and

(b)   

the supply at those premises of such products in circumstances

corresponding to retail sale.

(3)   

This subsection is satisfied if a notice is conspicuously displayed at

those premises stating—

25

(a)   

the name of the responsible pharmacist for the time being,

(b)   

the number of his registration under the Pharmacy Act 1954 or

(in relation to Northern Ireland) the Pharmacy (Northern

Ireland) Order 1976, and

(c)   

the fact that he is for the time being in charge of the business at

30

those premises.

(4)   

The responsible pharmacist must be—

(a)   

the superintendent mentioned in subsection (1)(a) of this

section, or

(b)   

a manager or assistant subject to the directions of the

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superintendent and who is a pharmacist.

(5)   

In relation to premises in Great Britain that have been registered

pharmacies for less than three years, the responsible pharmacist may

not be a person who is a pharmacist by virtue of section 4A of the

Pharmacy Act 1954 (qualification by European diploma) or any

40

corresponding provision applying to Northern Ireland.

(6)   

The requirements referred to in subsection (1)(a) of this section in

relation to a superintendent are that—

(a)   

he is a pharmacist,

(b)   

a statement in writing signed by him, and signed on behalf of

45

the body corporate, specifying his name and stating whether he

is a member of the board of that body or not, has been sent to

the registrar, and

 
 

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

24

 

(c)   

he does not act in a similar capacity for any other body

corporate.”

(2)   

In section 124 of the Medicines Act 1968 (c. 67) (offences by bodies corporate),

in subsection (2)(b), for “subsection (1)(a)” substitute “subsection (4)(b)”.

27      

Control of pharmacy premises: representative of pharmacist in case of death

5

or disability

In section 72 of the Medicines Act 1968 (representative of pharmacist in case of

death or disability), for subsection (2) substitute—

“(2)   

The conditions referred to in section 69(1)(c) of this Act are—

(a)   

that the name and address of the representative, and the name

10

of the pharmacist whose representative he is, have been notified

to the registrar, and

(b)   

that subsections (2A) and (2B) of this section are both satisfied

as respects each of the premises at which the business is carried

on and medicinal products, other than medicinal products on a

15

general sale list, are sold by retail.

(2A)   

This subsection is satisfied if a responsible pharmacist is in charge of

the business at the premises mentioned in subsection (2)(b) of this

section, so far as concerns—

(a)   

the retail sale at those premises of medicinal products (whether

20

they are on a general sale list or not), and

(b)   

the supply at those premises of such products in circumstances

corresponding to retail sale.

(2B)   

This subsection is satisfied if a notice is conspicuously displayed at

those premises stating—

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(a)   

the name of the responsible pharmacist for the time being,

(b)   

the number of his registration under the Pharmacy Act 1954 or

(in relation to Northern Ireland) the Pharmacy (Northern

Ireland) Order 1976, and

(c)   

the fact that he is for the time being in charge of the business at

30

those premises.”

28      

The responsible pharmacist

(1)   

After section 72 of the Medicines Act 1968 insert—

“72A    

The responsible pharmacist

(1)   

It is the duty of the responsible pharmacist mentioned in sections 70, 71

35

and 72 of this Act to secure the safe and effective running of the

pharmacy business at the premises in question so far as concerns—

(a)   

the retail sale at those premises of medicinal products (whether

they are on a general sale list or not), and

(b)   

the supply at those premises of such products in circumstances

40

corresponding to retail sale.

(2)   

A person may not be the responsible pharmacist in respect of more than

one set of premises at the same time, except in circumstances specified

by the Health Ministers in regulations, and then only if such conditions

as may be so specified are complied with.

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

25

 

(3)   

The responsible pharmacist must establish (if they are not already

established), maintain and keep under review procedures designed to

secure the safe and effective running of the business as mentioned in

subsection (1) of this section.

(4)   

The responsible pharmacist must make a record (which must be

5

available at the premises) of—

(a)   

who the responsible pharmacist is in relation to the premises on

any day and at any time, and

(b)   

such other matters as the Health Ministers specify in

regulations.

10

(5)   

It is the duty of the person carrying on the business to secure that—

(a)   

the record is properly maintained, and

(b)   

it is preserved for at least as long as is specified in regulations

made by the Health Ministers.

(6)   

The Health Ministers may make further provision in regulations in

15

relation to the responsible pharmacist.

(7)   

The regulations may, in particular, make further provision about the

matters mentioned in subsections (1) to (4) of this section, and make

provision about—

(a)   

the qualifications and experience which a person must have if

20

he is to be a responsible pharmacist,

(b)   

the responsible pharmacist’s absence from the premises,

(c)   

the supervision by the responsible pharmacist, when he is not

present on the premises, of relevant activities there,

(d)   

circumstances in which the responsible pharmacist may

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supervise relevant activities at a pharmacy of which he is not

the responsible pharmacist,

(e)   

the form in which the procedures referred to in subsection (3) of

this section are to be recorded and matters which must be

covered by them,

30

(f)   

the form in which the record referred to in subsection (4) of this

section is to be kept and particulars which must be included in

it.

(8)   

A person who does not have the qualifications and experience required

by regulations made by virtue of subsection (7)(a) is not to be

35

considered as a responsible pharmacist for the purposes of sections 70

to 72 of this Act.

(9)   

Subsection (10) applies if a person—

(a)   

fails to comply with the requirements of subsection (2) or

regulations made under it,

40

(b)   

fails to comply with any requirements as to absence from the

premises contained in regulations made by virtue of subsection

(7)(b).

(10)   

If this subsection applies, the person in question is not to be considered

while the failure continues as being in charge of the business at the

45

premises in question (or in a subsection (9)(a) case at any of them) for

the purposes of sections 70 to 72 of this Act.

 
 

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

26

 

(11)   

In subsection (7)(c) and (d), “relevant activities” means things

mentioned in section 10 and transactions mentioned in section 52(1)(c)

of this Act.”

(2)   

In section 77 of the Medicines Act 1968 (c. 67) (annual return of premises to

registrar), omit paragraph (b) and the “and” immediately preceding it.

5

(3)   

In section 84 of the Medicines Act 1968 (offences), before subsection (1) insert—

“(A1)   

A person who fails to comply with either of the following shall be guilty

of an offence and liable on summary conviction to a fine not exceeding

level 3 on the standard scale—

(a)   

subsection (4) of section 72A of this Act (which requires the

10

making of entries in a record relating to the responsible

pharmacist),

(b)   

subsection (5) of that section (which requires the keeping and

preservation of the record).”

(4)   

In section 108 of the Medicines Act 1968 (enforcement in England and Wales),

15

in subsection (2)—

(a)   

after paragraph (a) insert—

“(aa)   

the provisions of subsections (4) and (5) of section 72A

of this Act;”,

(b)   

after “paragraphs (a)” insert “, (aa)”.

20

(5)   

In section 110 of the Medicines Act 1968 (enforcement in Northern Ireland), in

subsection (2), after “paragraphs (a)”, in both places, insert “, (aa)”.

29      

Order-making powers

In section 129 of the Medicines Act 1968 (orders and regulations), in subsection

(5)—

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(a)   

after “power to make” insert “an order or”,

(b)   

after “making the” insert “order or”.

30      

Orders under s.60 of the Health Act 1999

In Schedule 3 to the Health Act 1999 (c. 8) (which makes further provision

about orders under section 60 of that Act regulating health care professions),

30

omit paragraph 2(2) (which imposes a limitation on amendment of the

Medicines Act 1968).

 
 

 
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