National Health Service Bill [HL]

House of Commons

Session 2005 - 06
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Other Bills before Parliament

National Health Service Bill [HL]

National Health Service Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Provision of pharmaceutical services
72

prescribed, in pursuance of functions in the health service, the Scottish
health service, the Northern Ireland health service or the armed forces
of the Crown, and
(e)
such other services as may be prescribed.
(4)
The descriptions of persons which may be prescribed for the purposes of
5
subsection (3)(d) are the following, or any sub-category of such a description—
(a)
persons who are registered in the register maintained under article 5 of
the Health Professions Order 2001,
(b)
persons who are registered pharmacists,
(c)
persons who are registered in the dental care professionals register
10
established under section 36B of the Dentists Act 1984 (c. 24),
(d)
persons who are optometrists,
(e)
persons who are registered osteopaths within the meaning of the
Osteopaths Act 1993 (c. 21),
(f)
persons who are registered chiropractors within the meaning of the
15
Chiropractors Act 1994 (c. 17),
(g)
persons who are registered nurses or registered midwives,
(h)
persons not mentioned above who are registered in any register
established, continued or maintained under an Order in Council under
section 60(1) of the Health Act 1999 (c. 8),
20
(i)
any other description of persons which appears to the Secretary of
State to be a description of persons whose profession is regulated by or
under a provision of, or made under, an Act of the Scottish Parliament
or Northern Ireland legislation and which the Secretary of State
considers it appropriate to specify.
25
(5)
A determination under subsection (3)(d) may—
(a)
make different provision for different cases,
(b)
provide for the circumstances or cases in which a drug, medicine or
appliance may be ordered,
(c)
provide that persons falling within a description specified in the
30
determination may exercise discretion in accordance with any
provision made by the determination in ordering drugs, medicines and
listed appliances.
(6)
The arrangements which may be made by a Primary Care Trust under
subsection (1) include arrangements for the provision of a service by means
35
such that the person receiving it does so otherwise than at the premises from
which it is provided.
(7)
Where a person with whom a Primary Care Trust makes arrangements under
subsection (1) wishes to provide services to persons outside the area of the
Primary Care Trust he may, subject to any provision made by regulations in
40
respect of arrangements under this section, provide such services under the
arrangements.
(8)
The services provided under this section are, together with additional
pharmaceutical services provided in accordance with a direction under section
127, referred to in this Act as “pharmaceutical services”.
45
(9)
In this section—
“armed forces of the Crown” does not include forces of a Commonwealth
country or forces raised in a colony,

National Health Service Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Provision of pharmaceutical services
73

“listed” means included in a list approved by the Secretary of State for the
purposes of this section,
“the Scottish health service” means the health service within the meaning
of the National Health Service (Scotland) Act 1978 (c. 29), and
“the Northern Ireland health service” means the health service within the
5
meaning of the Health and Personal Social Services (Northern Ireland)
Order 1972 (S.I. 1972/1265 (N.I.14)).
127
Arrangements for additional pharmaceutical services
(1)
The Secretary of State may—
(a)
give directions to a Primary Care Trust requiring it to arrange for the
10
provision to persons within or outside its area of additional
pharmaceutical services, or
(b)
by giving directions to a Primary Care Trust authorise it to arrange for
such provision if it wishes to do so.
(2)
Directions under this section may require or authorise a Primary Care Trust to
15
arrange for the provision of a service by means such that the person receiving
it does so otherwise than at the premises from which it is provided (whether
those premises are inside or outside the area of the Primary Care Trust).
(3)
The Secretary of State must publish any directions under this section in the
Drug Tariff or in such other manner as he considers appropriate.
20
(4)
In this section—
“additional pharmaceutical services”, in relation to directions, means the
services (of a kind that do not fall within section 126) which are
specified in the directions, and
“Drug Tariff” means the Drug Tariff published under regulation 18 of the
25
National Health Service (Pharmaceutical Services) Regulations 1992
(S.I. 1992/662) or under any corresponding provision replacing, or
otherwise derived from, that regulation.
128
Terms and conditions, etc
(1)
Directions under section 127 may require the Primary Care Trust to which they
30
apply, when making arrangements—
(a)
to include, in the terms on which the arrangements are made, such
terms as may be specified in the directions,
(b)
to impose, on any person providing a service in accordance with the
arrangements, such conditions as may be so specified.
35
(2)
The arrangements must secure that any service to which they apply is
provided only by a person—
(a)
whose name is included in a pharmaceutical list, or
(b)
who has entered into a pharmaceutical care services contract under
section 17Q of the National Health Service (Scotland) Act 1978.
40
(3)
Different arrangements may be made with respect to—
(a)
the provision of the same service by the same person but in different
circumstances, or
(b)
the provision of the same service by different persons.

National Health Service Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Provision of pharmaceutical services
74

(4)
A Primary Care Trust must provide details of proposed arrangements
(including the remuneration to be offered for the provision of services) to any
person who asks for them.
(5)
After making any arrangements, a Primary Care Trust must publish, in such
manner as the Secretary of State may direct, such details of the arrangements
5
as he may direct.
(6)
“Pharmaceutical list” includes, subject to any provision of the directions in
question, a list published in accordance with regulations made under—
(a)
section 83(2)(a) of the National Health Service (Wales) Act 2006 (c. 00),
or
10
(b)
Article 63(2A)(a) of the Health and Personal Social Services (Northern
Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)).
129
Regulations as to pharmaceutical services
(1)
Regulations must provide for securing that arrangements made by a Primary
Care Trust under section 126 will—
15
(a)
enable persons for whom drugs, medicines or appliances mentioned in
that section are ordered as there mentioned to receive them from
persons with whom such arrangements have been made, and
(b)
ensure the provision of services prescribed under subsection (3)(e) of
that section by persons with whom such arrangements have been
20
made.
(2)
The regulations must include provision—
(a)
for the preparation and publication by a Primary Care Trust of one or
more lists of persons, other than medical practitioners and dental
practitioners, who undertake to provide pharmaceutical services from
25
premises in the area of the Primary Care Trust,
(b)
that an application to a Primary Care Trust for inclusion in a
pharmaceutical list must be made in the prescribed manner and must
state—
(i)
the services which the applicant will undertake to provide and,
30
if they consist of or include the supply of appliances, which
appliances he will undertake to supply, and
(ii)
the premises from which he will undertake to provide those
services,
(c)
that, except in prescribed cases (which may, in particular, include
35
cases of applications for the provision only of services falling within
subsection (7))—
(i)
an application for inclusion in a pharmaceutical list by a person
not already included, and
(ii)
an application by a person already included in a pharmaceutical
40
list for inclusion also in respect of services or premises other
than those already listed in relation to him,

may be granted only if the Primary Care Trust is satisfied, in
accordance with the regulations, that it is necessary or expedient to
grant the application in order to secure in the neighbourhood in which
45
the premises are located the adequate provision by persons included in
the list of the services, or some of the services, specified in the
application, and

National Health Service Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Provision of pharmaceutical services
75

(d)
for the removal of an entry in respect of premises from a
pharmaceutical list if it has been determined in the prescribed manner
that the person to whom the entry relates—
(i)
has never provided from those premises, or
(ii)
has ceased to provide from them,
5

the services, or any of the services, which he is listed as undertaking to
provide from them.
(3)
The regulations may prescribe the extent to which the provision of LP services
(within the meaning given by paragraph 1 of Schedule 12) must be taken into
account in determining whether to grant an application for inclusion in a
10
pharmaceutical list.
(4)
The regulations may include the provision mentioned in subsection (5) for the
case where—
(a)
two or more applications referred to in subsection (2)(c)(i) or (ii) relate
to the same neighbourhood,
15
(b)
they are considered together by the Primary Care Trust, and
(c)
the Primary Care Trust would be satisfied as mentioned in subsection
(2)(c) in relation to each application taken on its own, but is not so
satisfied in relation to all of them taken together.
(5)
The provision mentioned in this subsection is provision for the Primary Care
20
Trust, in determining which application (or applications) to grant, to take into
account any proposals specified in the applications in relation to the sale or
supply at the premises in question, otherwise than by way of pharmaceutical
services or in accordance with a private prescription, of—
(a)
drugs and medicines, and
25
(b)
other products for, or advice in relation to, the prevention, diagnosis,
monitoring or treatment of illness or handicap, or the promotion or
protection of health.
(6)
The regulations may include provision—
(a)
that an application to a Primary Care Trust may be granted in respect
30
of some only of the services specified in it,
(b)
that an application to a Primary Care Trust relating to services of a
prescribed description may be granted only if it appears to the Primary
Care Trust that the applicant has satisfied such conditions with regard
to the provision of those services as may be prescribed,
35
(c)
that an application to a Primary Care Trust by a person who qualified
to have his name registered under the Pharmacy Act 1954 (c. 61) by
virtue of section 4A of that Act (qualification by European diploma)
may not be granted unless the applicant satisfies the Primary Care
Trust that he has the knowledge of English which, in the interest of
40
himself and persons making use of the services to which the application
relates, is necessary for the provision of pharmaceutical services in the
area of the Primary Care Trust,
(d)
that the inclusion of a person in a pharmaceutical list in pursuance of
such an application may be for a fixed period,
45
(e)
that, where the premises from which an application states that the
applicant will undertake to provide services are in an area of a
prescribed description, the applicant may not be included in the
pharmaceutical list unless his inclusion is approved by reference to

National Health Service Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Provision of pharmaceutical services
76

prescribed criteria by the Primary Care Trust in whose area those
premises are situated,
(f)
that that Primary Care Trust may give its approval subject to
conditions,
(g)
as to other grounds on which a Primary Care Trust may, or must, refuse
5
to grant an application (including grounds corresponding to the
conditions referred to in section 151(2), (3) or (4) as read with section
153),
(h)
as to information which must be supplied to a Primary Care Trust by a
person included, or seeking inclusion, in a pharmaceutical list (or by
10
arrangement with him),
(i)
for the supply to a Primary Care Trust by an individual—
(i)
who is included, or seeking inclusion, in a pharmaceutical list,
or
(ii)
who is a member of the body of persons controlling a body
15
corporate included, or seeking inclusion, in a pharmaceutical
list,

of a criminal conviction certificate under section 112 of the Police Act
1997 (c. 50), a criminal record certificate under section 113 of that Act or
an enhanced criminal record certificate under section 115 of that Act,
20
(j)
for grounds on which a Primary Care Trust may defer a decision
whether or not to grant an application,
(k)
for the disclosure by a Primary Care Trust, to prescribed persons or
persons of prescribed descriptions, of information of a prescribed
description about applicants for inclusion in a pharmaceutical list, and
25
refusals by the Primary Care Trust to grant such applications,
(l)
as to criteria to be applied in making decisions under the regulations
(other than decisions required by virtue of paragraph (e)),
(m)
as to the making of declarations about—
(i)
financial interests,
30
(ii)
gifts above a prescribed value, and
(iii)
other benefits received.
(7)
A service falls within this subsection if the means of providing it is such that
the person receiving it does so otherwise than at the premises from which it is
provided.
35
(8)
The regulations may, in respect of services falling within subsection (7),
include provision—
(a)
requiring persons to be approved for the purposes of providing such
services, or
(b)
requiring the Primary Care Trust to make the grant of an application
40
subject to prescribed conditions.
(9)
The approval mentioned in subsection (8)(a) is approval by the Secretary of
State or such other person as may be specified in the regulations, in accordance
with criteria to be specified in or determined under the regulations (whether
by the Secretary of State or by another person so specified).
45
(10)
Before making regulations by virtue of subsection (6)(m), the Secretary of State
must consult such organisations as he considers appropriate appearing to him
to represent persons providing pharmaceutical services.

National Health Service Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Provision of pharmaceutical services
77

(11)
In this Act a “pharmaceutical list” means a list published in accordance with
regulations made under subsection (2)(a).
130
Regulations under section 129: appeals, etc
(1)
Regulations under section 129 must include provision conferring on such
persons as may be prescribed rights of appeal from decisions made by virtue
5
of that section.
(2)
If regulations made by virtue of section 129(6)(g) provide that a Primary Care
Trust may refuse to grant an application, they must also provide for an appeal
(by way of redetermination) to the FHSAA against the decision of the Primary
Care Trust.
10
(3)
Regulations under section 129 must be so framed as to preclude—
(a)
a person included in a pharmaceutical list, and
(b)
an employee of such a person,

from taking part in the decision whether an application such as is mentioned
in section 129(2)(c) should be granted or an appeal against such a decision
15
brought by virtue of subsection (1) of this section should be allowed.
131
Power to charge
(1)
The Secretary of State may give directions to a Primary Care Trust requiring it
to charge a fee in cases or descriptions of case specified in the directions to
persons who make an application referred to in section 129(2)(c)(i) or (ii).
20
(2)
The Secretary of State may in the directions—
(a)
specify the fee himself, or
(b)
require the Primary Care Trust to determine the amount of the fee in
accordance with any requirements set out in the directions.
(3)
Before determining the amount of the fee-
25
(a)
in a subsection (2)(a) case, the Secretary of State must consult such
organisations as he considers appropriate that appear to him to
represent persons providing pharmaceutical services and such
organisations as he considers appropriate that appear to him to
represent Primary Care Trusts,
30
(b)
in a subsection (2)(b) case, the Primary Care Trust must undertake any
consultation required by the directions.
(4)
The Secretary of State must publish in such manner as he considers appropriate
any directions he gives under this section.
(5)
In a subsection (2)(b) case, the Primary Care Trust must publish in such manner
35
as it considers appropriate the fee which it determines.
132
Persons authorised to provide pharmaceutical services
(1)
Except as may be provided for by or under regulations, no arrangements may
be made by a Primary Care Trust with a medical practitioner or dental
practitioner under which he is required or agrees to provide pharmaceutical
40
services to any person to whom he is rendering primary medical services or
primary dental services.

National Health Service Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Provision of pharmaceutical services
78

(2)
Except as may be provided for by or under regulations, no arrangements for
the dispensing of medicines may be made under this Chapter with persons
other than persons who—
(a)
are registered pharmacists or persons lawfully conducting a retail
pharmacy business in accordance with section 69 of the Medicines Act
5
1968 (c. 67), and
(b)
undertake that all medicines supplied by them under the arrangements
will be dispensed either by or under the supervision of a registered
pharmacist.
(3)
Regulations must provide for the preparation and publication by each Primary
10
Care Trust of one or more lists of medical practitioners who undertake to
provide drugs, medicines or listed appliances (within the meaning given by
section 126) under arrangements with the Primary Care Trust.
(4)
The regulations may, in particular, include provision—
(a)
as to grounds on which a Primary Care Trust may, or must, refuse to
15
grant an application for inclusion in a list of medical practitioners
referred to in subsection (3) (including grounds corresponding to the
conditions referred to in section 151(2), (3) or (4) as read with section
153(2)),
(b)
as to information which must be supplied to a Primary Care Trust by a
20
medical practitioner included, or seeking inclusion, in such a list (or by
arrangement with him),
(c)
for the supply to a Primary Care Trust by a medical practitioner who is
included, or seeking inclusion, in such a list of a criminal conviction
certificate under section 112 of the Police Act 1997 (c. 50), a criminal
25
record certificate under section 113 of that Act or an enhanced criminal
record certificate under section 115 of that Act,
(d)
for grounds on which a Primary Care Trust may defer a decision
whether or not to grant an application for inclusion in such a list,
(e)
for the disclosure by a Primary Care Trust to prescribed persons or
30
persons of prescribed descriptions, of information of a prescribed
description about applicants for inclusion in such a list, and refusals by
the Primary Care Trust to grant such applications,
(f)
as to criteria to be applied in making decisions under the regulations.
(5)
If regulations made by virtue of subsection (4)(a) provide that a Primary Care
35
Trust may refuse to grant an application for inclusion in such a list, they must
also provide for an appeal (by way of redetermination) to the FHSAA against
the decision of the Primary Care Trust.
(6)
The regulations must include provision for the removal of an entry from a list
in prescribed circumstances.
40
(7)
No arrangements for the provision of—
(a)
pharmaceutical services falling within section 126(3)(e), or
(b)
additional pharmaceutical services provided in accordance with a
direction under section 127,

may be made with persons other than those who are registered pharmacists or
45
are of a prescribed description.
(8)
Where—
(a)
arrangements for the provision of pharmaceutical services have been
made with a registered pharmacist, and