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
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(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
5
sufficient for the transaction to be so considered.”
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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
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(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
23

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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—
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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.
(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)”.
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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—
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.”
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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
25
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)—
25
(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).